(67 days)
THE MEDICAL ENGINEERING LABORATORIES, INC, TRI TALON RETRIEVAL FORCEPS (TRIPOD) IS INTENDED TO FOR USE IN THE FOLLOWING APPLICATIONS:
GASTROSCOPE, SIGMOIDOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOOD IMPACTION OR FOREIGN OBJECTS FROM THE ESOPHAGUS OR STOMACH.
COLONOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENTS CHANNEL FOR REMOVAL OF FOREIGN OBJECTS OR POLYPS FROM THE COLON.
BRONCHOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOREIGN OBJECTS FROM THE LUNG.
URETEROSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR THE REMOVAL OF STONES AND FOREIGN OBJECTS FROM THE URETER AND BLADDER.
Not Found
The provided text is related to a 510(k) clearance letter for a medical device called "TRI TALON RETRIEVAL FORCEPS". This document indicates FDA clearance for marketing based on substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study design, sample size, ground truth establishment, or expert involvement typically found in a clinical performance study report.
Therefore, I cannot fulfill your request for the detailed information as the provided text does not contain it. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on new clinical performance data with specific acceptance criteria in the way you've described for AI/diagnostic devices.
To provide the requested information, I would need a clinical study report or a different type of regulatory submission that details the performance evaluation of the device against specific criteria.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a wave-like shape at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Mr. William J. Young, Jr. President Medical Engineering Laboratory The Charles Building 108 West Warren Street Shelby. North Carolina 28150
Re: K973071
TRI TALON RETRIEVAL FORCEPS Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: II 21 CFR 8876.1500/Product code: 78 KOG
Dear Mr. Young, Jr .:
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 use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 801 and additionally 809.10 for in yitro 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/dsmamain.html".
Sincerely yours.
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
THE MEDICAL ENGINEERING LABORATORIES, INC, TRI TALON RETRIEVAL FORCEPS (TRIPOD) IS INTENDED TO FOR USE IN THE FOLLOWING APPLICATIONS:
GASTROSCOPE, SIGMOIDOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOOD IMPACTION OR FOREIGN OBJECTS FROM THE ESOPHAGUS OR STOMACH.
COLONOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENTS CHANNEL FOR REMOVAL OF FOREIGN OBJECTS OR POLYPS FROM THE COLON.
BRONCHOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOREIGN OBJECTS FROM THE LUNG.
URETEROSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR THE REMOVAL OF STONES AND FOREIGN OBJECTS FROM THE URETER AND BLADDER.
WM.A.Y.
WILLIAM YOUNG
WIKLANT. FOONG PRESIDENT
8-15-97
DATE
Robert D. Rething/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number (973021)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _
§ 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.