(27 days)
The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.
The device description of the Meniscus Arrow™ is as follows.
- Composed of poly-L/D-polylactide copolymer
- Length 10, 13 and 16mm
- Diameter 1.1mm
The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).
The provided text is a 510(k) summary for the Bionx Implants Inc. Meniscus Arrow™ and an FDA clearance letter. It clearly states the device's intended use and describes its similarities to a predicate device, the Biofix® Biodegradable Meniscus Arrow System (K955768).
However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or specific details about training or test sets. Instead, the clearance for Meniscus Arrow™ is based on its substantial equivalence to the predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from the provided text. The document focuses on demonstrating that the new Meniscus Arrow™ is fundamentally the same as its already-cleared predecessor.
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510(k) Summary Bionx Implants Inc. Meniscus Arrow™
K99 3453
Submitter´s Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
Contacts:
Gerard S. Carlozzi President and Chief Operating Officer (215) 643-5000 Phone: (215) 653-0984 Facsimile:
Bionx Implants Ltd. Tuija Annala Regulatory Affairs Assistant P.O.Box 3 FIN-33721 Tampere Finland 358-3-316 5679 Phone: Facsimile: 358-3-316 5688
September 17th, 1999 Date prepared:
Name of the device:
| A. | Trade or Proprietary Name: | Meniscus Arrow TM |
|---|---|---|
| B. | Common Name: | Bioabsorbable Meniscus Arrow System |
| C. | Classification Name: | Biodegradable soft tissue fixation fastener |
| D. | Device Product Code: | MAI |
Predicate Device:
Bionx Implants Inc. Biofix® Biodegradable Meniscus Arrow System (K955768)
Intended Use:
The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.
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The principles of operation remain, but the Meniscus Arrow™ Inserter, so called Crossbow®, simplifies the procedure. The previous piston was used mounted on a reciprocating instrument run by air pressure, electricity or the implant was manually hammered into the meniscus. Among these possibilities we now offer the opportunity to use our modified Meniscus Arrow™ Inserter, Crossbow®, which is a manual, spring-powered instrument and there is no need to connect it to air pressure or electricity.
Device Description:
The device description of the Meniscus Arrow™ is as follows.
- Composed of poly-L/D-polylactide copolymer ।
- Length 10, 13 and 16mm -
- -Diameter 1.1mm
The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).
Substantial Equivalence:
The Meniscus Arrow™ has the following similarities to the cleared Biofix® Biodegradable Meniscus Arrow System (K955768):
- has the same indicated use -
- use the same operating principle -
- incorporate the same basic design -
- is manufactured by same machinery
- is packaged and sterilized using the same materials and processes -
- has the same shelf life
- are packaged and sterilized using the same materials and processes -
- has the same trade name
In summary, the Meniscus ArrowTM described is substantially equivalent to the predicate device. This change of raw material does not raise any problems concerning safety or efficacy of the device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
Mrs. Tuija Annala Regulatory Affairs Assistant Bionx Implants Limited P.O. Box 3 FIN-33721 Tampere Finland
Re: K993453 Biofix® Biodegradable Meniscus Arrow™ System Trade Name: Requlatory Class: II Product Code: MAI September 17, 1999 Dated: Received: October 13, 1999
Dear Mrs. Annala:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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. ਸੇ 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 requlation 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 - Mrs. Tuija Annala
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.
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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INDICATIONS FOR USE
K993453 510(K) Number (if known): _
Device Name:
Meniscus Arrow™
Indications for Use:
The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use_ (Per 21 CFR 801.109)
OR Over-The-Counter Use_
Aseel
510(k) N
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.