DaVinci Laproscopical Surgical Arm

13 Aug 09 DaVinci Laparoscopic Surgical Arm JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION I. Agency and Contracting Activity AFDW/A7KM proposes to enter into a contract on a basis other than full and open competition on behalf of Wilford Hall Medical Center, Lackland Air Force Base, TX. II. Description of Action This J&A seeks approval to contract for a sole source acquisition to obtain two Da Vinci robotic laparoscopic surgical systems manufactured by Intuitive Surgical, 1266 Kifer Road, Sunnydale, CA 94086. Intuitive surgical is the manufacturer and sole distributor for this system. III. Description of Supplies/Services One Robotic laparoscopic surgical systems, IS2000 Da Vinci S Surgical System with HD to include the surgeon console, the HD vision system, the four arm patient side system, and the accessories starter kit to include the following: (1) Cannula Mount, Camera, (3) Cannula, Instrument, (3) Drape, Instrument Arm, (1) Drape, Camera Arm, (1) Drape, Camera, (1) Drape, Monitor, (1) Latching Obturator, Sharp, (1) Latching Obturator, Blunt, (1) Box Cannula Seals, (1) Allen Wrench, 1/16", Emergency Stop, (1) Blade Protector; HD Camera Starter Kit to include the following: (1) HD Camera, (1) Scope, 0 Degree, (1) Scope, 30 Degree, (1) Universal Scope Alignment Target, (1) Bifurcated Light Guide Cable, (1) Sterile Adapter, Camera, (1) Sterile Adapter, Camera Arm; Training Instruments Starter Kit to include: (1) Training Potts Scissors, (2) Training Black Diamond Micro Forceps, (2) Training Large Needle Driver, (1) Training DeBakey Forceps; Two Complete Training kits include the following: (2) Small clip applier, (8) large needle driver, (2) DeBakey Foreceps, (2) Cadiere Forceps, (4) ProGrasp Forceps, (4) Maryland Bipolar Forceps, (6) Hot Shears, (4) Permanent Cautery Hook, (2) Permanent Cautery Spatula Instrument, (4) Fenestrated Bipolar Forceps, (2) Tenaculum Forceps, (4) Suture Cut Needle Driver, (2) Hem-o-lok Clip Applier, Large, (2) Dual Blade Retractor, (2) Grasping Retractor (Graptor), (2) 8mm Bladeless Obturator, (2) 8mm Bladless Obturator, Long, (4) Cannula Seal, (4) Tip Cover Accessory, (6) Cannula, Instrument, (2) Latching Obturator, Blunt, (2) Latching Obturator, Blunt, Long, (2) Drape, Instrument Arm, (2) Drape, Camera Arm, (2) Drape, Vision-Cart Monitor 19", (2) Drape, Camera, (2) Universal Endoscope, 12mm Alignment Target, (2) Sterile Adapter, Camera Arm, (2) Cannula Mount, Camera (ethicon), (4) Wrench, Emergency Grip Release, (2) Bifurcated Light Guide Cable, (2) Illuminator Lamp Module, Single, (2) 3D - 8.5mm Endoscope Starter Kit, (2) 8.5mm Camera Cannula Seals. . The acquisition of the system should include initial installation with a complete on-site maintenance inspection and all necessary systems testing. Estimated cost of this requirement is $XXXXXXXXXX based upon past procurements and Item Manager personal knowledge. IV. Authority The statutory authority permitting other than full and open competition is 10 USC 2304(c) (1) implemented by the Federal Acquisition Regulation (FAR) Subpart 13.501(a), "Sole Source Acquisitions." FAR 6.302-1-- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. V. Applicability of Authority The robotic laparoscopic surgical system manufactured by Intuitive Surgical is the only Food and Drug Administration (FDA) approved master-slave robotic surgical system currently available in the commercial market. The background information on the FDA's role in regulating medical equipment is provided below. The system is the only available technology that can provide the surgeon with the intuitive control, range of motion, fine tissue manipulation capability, and 3-D visualization characteristic of open surgery, while simultaneously allowing the surgeon to work through small ports of minimally invasive surgery. FDA Approval Background for Medical Equipment Source: http://www.fda.gov/default.htm The FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: - Establishment registration, - Medical Device Listing, - Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), - Investigational Device Exemption (IDE) for clinical studies - Quality System (QS) regulation, - Labeling requirements, and - Medical Device Reporting (MDR) Establishment Registration - 21 CFR Part 807 Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Medical Device Listing - 21 CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers that commercially distribute the device, contract sterilizers that commercially distribute the device, repackagers and relabelers, specification developers, reprocessors single-use devices, remanufacturer, manufacturers of accessories and components sold directly to the end user, U.S. manufacturers of "export only" devices. Premarket Notification 510(k) - 21 CFR Part 807 Subpart E If your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent. Premarket Approval (PMA) - 21 CFR Part 814 Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. Investigational Device Exemption (IDE) - 21 CFR Part 812 An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin. Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820 The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements. The quality system regulation includes design controls (21 CFR 820.30) which must complied with during the design and development of the device. Information on design controls can be found in the following guidance documents: Labeling - 21 CFR Part 801 Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device. Medical Device Reporting - 21 CFR Part 803 Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported. The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. VI. Efforts to Obtain Competition Since the Da Vinci system is the only FDA approved robotic laparoscopic system available, efforts to include additional sources has been limited. The staff physicians/surgeons are constantly surveying the professional literature and attending professional development seminars to stay abreast of any developments in this specialized field. VII. Fair and Reasonable Costs Since the Da Vinci robot system is the only FDA approved laparoscopic robotic system, the government does not have a comparable product available in the commercial market place to compare it to. The three listed kits (i.e. accessories kit, HD Camera Kit, Training Instruments Starter Kit) associated with this system are included in the overall system price and have not been priced separately. In order to obtain a potential baseline for the appropriate cost for the system, we contacted the following civilian medical institutions that advertised the availability of Da Vinci assisted surgery at their facilities: United Hospital 333 North Smith Avenue St. Paul, MN 55102 651-241-8000 Durham Regional Hospital 3643 North Roxboro Road Durham, N.C. 27704 919-470-4000 Mount Sinai Medical Center 5 East 98th Street New York, NY 10029 (212) 241-6070 VIII. Market Research At this time the identified manufacturer is the sole source for this laparoscopic robotic system requirement. "The Food and Drug Administration first cleared the da Vinci Surgical System in 2000 for general laparoscopic surgeries such as gall bladder removal and for treatment of severe heartburn. Since then, use of the system has increased and expanded into several other surgical areas. These include removal of the prostate (radical prostatectomy); non-cardiac chest procedures involving the lungs, esophagus, and a blood vessel inside the chest cavity (internal thoracic artery); and certain procedures involving surgical incisions into the heart, such as mitral valve repair. In April 2005, the FDA cleared the da Vinci system for gynecological laparoscopic procedures. Surgeons are now able to remove the uterus (hysterectomy) and to remove uterine fibroids (myomectomy) using the device. The system has also been cleared for use in all urologic procedures. And, in 2004, the FDA broadened the application of the da Vinci system for assisting in coronary artery bypass surgery. The da Vinci Surgical System is the only operative surgical device of its kind on the market in the United States. In 2003, Intuitive Surgical bought Computer Motion of Goleta, Calif. Computer Motion was the manufacturer of the Zeus Robotic Surgical System, which is no longer actively being marketed." (Source: http://www.fda.gov/fdac/features/2005/405_computer.html). IX. Other Facts Robotic laparoscopic prostatectomy is rapidly becoming the standard surgical treatment for prostate cancer. Wilford Hall Medical Center currently performs 80 prostatectomies as open cases (i.e. non-laproscopic), and about 25 standard laparoscopic cases per year. The procedures cost the government approximately $XXX (Medicare) to $XXX (Non-Medicare) if the patient has to be seen by a network provider downtown. As Wilford Hall Medical Center and Brooke Army Medical Center combine in the future, we can only expect the surgical case load to increase. In addition, Walter Reed Army Medical Center already has the Da Vinci robot system and the procurement of this system for Wilford Hall would result in a myriad of collaborative training and research opportunities in developing telepresence surgery that may eventually be incorporated onto the battlefield. The Graduate Medical Education requirements will soon include robotic laparoscopic surgery as the standard of care for residency training programs nationwide. X. Interested Sources At this time, this J & A is being processed in advance of the combined synopsis/solicitation posting on FBO. If responses to the combined synopsis/solicitation indicate additional sources are available, the file will be documented accordingly and the requirement competed among all eligible sources. The manufacturer for this system only sells direct and does not have a distributor network so we cannot generate a list of sources other than the manufacturer. XI. Steps to Foster Competition None. Until another laparoscopic robotic system is approved by the FDA, the Da Vinci system is the only known system capable of meeting the government's needs for this type of capability. XII. Contracting Officer's Certification The Contracting Officer's signature on the Justification Review Document evidences that he/she has determined this document to be both accurate and complete to the best of her knowledge and belief (FAR 6.303-2(a)(12)). XIII. Technical/Requirements Personnel's Certification As evidenced by their signatures on the Justification Review Document, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility is both accurate and complete.