(90 days)
The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its diagnosis of a severed conacial by non-invasive maneuvers.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "TenoScope". It does not contain information about acceptance criteria, device performance, test studies, sample sizes, or expert qualifications. It is purely regulatory correspondence confirming that the device is substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and the well-being of the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
9200 Corporate Boulevard Rockville MD 20850
Food and Drug Administration
MAY 2 1 1997
Mr. James Hobbs President Luxtec Corporation 326 Clark Street Worcester, Massachusetts 01606-1214
Re: K970642 Trade Name: TenoScope Regulatory Class: II Product Code: HRX Dated: February 17, 1997 Received: February 20, 1997
Dear Mr. Hobbs:
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 provisions of 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 (Special Controls) or 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Feod 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - James Hobbs
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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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT FOR INDICATIONS FOR USE
510(K) Number: K97056 / 270642
Device Name: TenoScope
Indications for Use:
The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its diagnosis of a severed conacial by non-invasive maneuvers.
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(Division)Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.