TRI TALON RETRIEVAL FORCEPS

K973071 · Medical Engineering Laboratory, Inc. · OCZ · Oct 24, 1997 · Gastroenterology, Urology

Device Facts

Record IDK973071
Device NameTRI TALON RETRIEVAL FORCEPS
ApplicantMedical Engineering Laboratory, Inc.
Product CodeOCZ · Gastroenterology, Urology
Decision DateOct 24, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended Use

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.

Device Story

Tri Talon Retrieval Forceps (Tripod) is a mechanical retrieval instrument designed for use through accessory channels of endoscopes (gastroscope, sigmoidoscope, colonoscope, bronchoscope, ureteroscope). Device consists of a multi-pronged grasping mechanism operated by a physician to capture and remove foreign bodies, food, polyps, or stones. Operation is purely mechanical; physician manipulates handle to extend/retract and open/close grasping prongs at distal end. Used in clinical settings during endoscopic procedures to clear obstructions or retrieve tissue/objects, potentially reducing need for more invasive surgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical retrieval forceps; multi-pronged grasping design; manual actuation via handle; compatible with standard endoscopic accessory channels; non-powered; sterile, single-use or reusable (implied by nature of device).

Indications for Use

Indicated for removal of foreign objects, food impaction, polyps, or stones from the esophagus, stomach, colon, lung, ureter, or bladder via endoscopic accessory channels.

Regulatory Classification

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.

Special Controls

*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.

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ K973071 ## 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 _
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