(50 days)
The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Scholly Flexilix II Arthroscopic and Accessories". It does not contain information about the acceptance criteria, specific studies, or performance data for the device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a bird with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The text is in all caps.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Mr. Joseph Ress Consultant Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachussetts 02468
Received: July 26, 1999
Re: K992040 Trade Name: Scholly Flexilix II Arthroscopic and Accessories Regulatory Class: II Product Code: HRX Dated: July 21, 1999
Dear Mr. Ress:
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 control provisions of the Act. The general control 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 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 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 - Mr. Joseph Ress
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) 594-4659. 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
Page 1 of 1
510 (K) Number: K992040
Device Name: Schoelly Flexilux II Arthroscope
Indications for Use:
The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrance of CDRH, Office of Device Evaluation (ODE)
OR
Perscription Use YES
Over-The-Counter Use NO
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(Division Sigh Off) Division of General Restorative D 510(k) Number
§ 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.