(46 days)
The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.
TUNIS™ - Transurethral Injection System Probe/Device
This document is a 510(k) clearance letter from the FDA for a medical device called the "Tunis™ Transurethral Injection/Aspiration System Probe Device." It signifies that the device has been found substantially equivalent to a predicate device and can be marketed.
Crucially, this document does not contain information about acceptance criteria, device performance details, or any study results proving the device meets acceptance criteria.
The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, ensuring similar safety and effectiveness. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a pre-market approval (PMA) would for novel, high-risk devices.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the original 510(k) submission document (K983765) itself, which might contain summaries of performance testing, albeit less rigorous than what's typically expected for a PMA.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Ashvin Desai Ximed Medical Systems/ Prosurg, Inc. Prosurg, Inc. 2193 Trade Zone Blvd. San Jose, CA 95131
Re: K983765 Tunis™ Transurethral Injection/ Aspiration System Probe Device Dated: October 22, 1998 Received: October 26, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FBK
Dear Mr. Desai:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmallsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SIO (k) NUMBER (IF KNOWN) : # K983765 DEVICE NAME : TUNIS™ - Transurethral Injection System Probe/Device INDICATIONS FOR USE:
The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
David h. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.