(90 days)
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.
The Meniscal Repair Device is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
The provided document is a 510(k) summary for a Meniscal Repair Device (Bone Screw) and details its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/machine learning performance.
The study referenced is a non-clinical comparative pull-out strength test, which is a biomechanical test for a physical device, not an evaluation of an AI or algorithmic device.
Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/machine learning acceptance criteria and studies from this document. The document describes a traditional medical device (a bone screw) and its safety and effectiveness in comparison to existing devices.
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Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three chevrons inside. The word "Linvatec" is in a bold, sans-serif font.
K9 7453Y
11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264
Carol A. Weideman, Ph.D.
Director Regulatory Affairs
December 2, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical In accordanoe 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Meniscal Repair Device.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Company Contact B.
Carol A. Weideman, Ph.D. Director, Regulatory Affairs
Device Name c.
Meniscal Repair Device Trade Name : Bone Screw Common Name: Smooth or threaded metallic bone Classification Name: fixation fastener
- Predicate/Legally Marketed Devices D. Bionix BIOFIX SR-PLLA Meniscus Arrow. Linvatec BioScrew® Absorbable Interference Screw
Device Description E.
The Meniscal Repair Device is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
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Summary of Safety and Effectiveness Meniscal Repair Device 510 (k) # Kazyss88 Page 2 of 3
Intended Use r.
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy.
Substantial Equivalence G.
The Meniscal Repair Device is substantially equivalent in design, function and intended use to Bionix BIOFIX The material is the same as SR-PLLA Meniscus Arrow. the Linvatec BioScrew® Absorbable Interference Screw
A comparative pull-out strength test was conducted to prove safety and effectiveness. The control device was the BIOFIX Arrow.
The similarities/dissimilarities to the predicate are shown in the attached table.
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Summary of Safety and Effectiveness Meniscal Repair Device
510(k) # K974538_____________________________________________________________________________________________________________________________________ Page 3 of 3
CHART OF SIMILARITIES AND DISSIMILARITIES
| CompanyName | Device Name | Intended Use | Material | Single-UseReusable | Method ofSterilization | Design |
|---|---|---|---|---|---|---|
| New ProductLinvatec | MeniscalRepair Device | Fixation of longitudinalvertical meniscus lesions(bucket handle) locatedin the vascularized areaof the meniscus. | Poly (L-lactic Acid) | SterileSingle-use | ETO24 month shelflife | CannulatedBarbed tackwith headSizes:1.3mmdiameter x10mm-16mmlength |
| PredicateLinvatecCorporation | BioScrewAbsorbableInterferenceScrew510(k) # K960940 | Provide interferencefixation in ACL and PCLreconstruction | Poly (L-lactic Acid) | SterileSingle-use | ETO24 month shelflife | CannulatedSizes:7mm-9mmdiameter x20mm-30mmlength |
| PredicateBionix, Inc. | Biofix® SR-PLLA MeniscusArrow510(k) # K955768 | Fixation of longitudinalvertical meniscus lesions(bucket-handle) locatedin the vascularized areaof the meniscus. | Self-reinforcedPoly (L-lactic Acid) | SterileSingle-use | Gamma36 month shelflife | Non-cannulatedBarbed tackwith headSizes:1.1mmdiameter x10mm-16mmlength |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with the bird's head facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carol A. Weideman, Ph.D. Director, Requlatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
MAR - 3 1998
Re: K974538 Trade Name: Meniscal Repair Device Regulatory Class: II Product Codes: HWC and MAI Dated: December 2, 1997 Received: December 3, 1997
Dear Dr. Weideman:
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 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 requlatory In addition, FDA may publish further announcements action. 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 - Carol A. Weideman, Ph.D.
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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Image /page/5/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three chevrons inside. The word "Linvatec" is in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464
Date: December 2, 1997 Page 1 of ਜੋ
510(k) Number (if known): K974538
Meniscal Repair Device Device Name:
Indications for Use:
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the device is accomplished through arthroscopy or arthrotomy.
(PLEASE DO NOT WRITE BEION THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over-the-Counter Use_
(Per 21 CFR 801.109)
signature
n Sign-Off) (Divisio Division of General Restorative I 510(k) Number
(Optional Format 1-2-96)
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Image /page/5/Picture/18 description: The image shows the logo for A Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a hexagon with smaller triangles inside. The company name is written in a serif font.
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