(65 days)
The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
Reusable Biopsy Forceps
I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for the "TeleMed Systems Reusable Biopsy Forceps." The document is an FDA 510(k) clearance letter dated January 21, 1998, which states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include any performance data or study design specifics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 21 1998
Samual D. Wade RAC Vice President - Operations TeleMed Systems, Inc. 19 Brigham Street, Unit 1 Marlborough, MA 01752
Re: K974312
TeleMed Systems Reusable Biopsy Forceps Dated: November 11, 1997 Received: November 17, 1997 Regulatory Class: II 21 CFR 876.1075/Procode: 78 KNW
Dear Mr. Wade:
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 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 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 vou might have under sections 531 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 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.
h.J.liau Yi
Lillian Yin, Ph.D.
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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K 97431V
Indication for Use:
The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
Robert R Salling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices 974712 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.