(75 days)
Not Found
Not Found
No
The summary describes a physical implantable device for meniscal repair and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for fixation of meniscus lesions, indicating it is intended to treat a medical condition.
No
The device is described as a "fixation device" for meniscal lesions, indicating its purpose is for treatment or repair, not for diagnosing a condition.
No
The device description clearly states it is a physical, implantable fixation device made of absorbable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "fixation device" used for "implantation" during "arthroscopy or arthrotomy." This means it is a surgical implant used within the body to repair a meniscus lesion.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition based on bodily fluids or tissues.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / 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 fixation device is accomplished through arthroscopy or arthrotomy.
Product codes
MBI, HWC
Device Description
The Meniscal Repair Device is a cannulated, sterile, single-use fixation device 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 device is colored with D&C violet #2 at less than 0.01 wt.8.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Linvatec Meniscal Repair Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUL 27 1998
Image /page/0/Picture/1 description: The image shows the text "K981692" in a handwritten style at the top. Below this text is the logo for Linvatec, which includes a geometric design to the left of the company name. The logo is in black and white, and the text is clear and legible.
11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264
Carol A. Weideman, Ph.D.
Director Regulatory Affairs
May 12, 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 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
B. Company Contact
Carol A. Weideman, Ph.D. Director, Regulatory Affairs
C. Device Name
Trade Name : Meniscal Repair Device Common Name: Bone Screw Smooth or threaded metallic bone Classification Name: fixation fastener
- D. Predicate/Legally Marketed Devices Linvatec Meniscal Repair Device
E. Device Description
The Meniscal Repair Device is a cannulated, sterile, single-use fixation device 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 device is colored with D&C violet #2 at less than 0.01 wt.8.
Image /page/0/Picture/18 description: The image shows the logo for Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the text "A Bristol-Myers Squibb Company" on the right. The geometric design is a complex pattern of lines and shapes, while the text is in a clear, sans-serif font. The logo is simple and professional, and it is likely used to represent the company in a variety of contexts.
1
Summary of Safety and Effectiveness Meniscal R 510 (k) # May 12, 1998
Page 2 of 3
F. Intended 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 fixation device is accomplished through arthroscopy or arthrotomy.
Substantial Equivalence G.
The colored Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec Meniscal Repair Device. The material is the same as the Linvatec Meniscal Repair Device.
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be part of a document or sign.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
JUL 27 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carol A. Weideman, Ph.D. · Director of Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773
Re: K981692 Meniscal Repair Device Regulatory Class: II Product Codes: MBI and HWC Dated: May 12, 1998 Received: May 13, 1998
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 The general controls provisions of the Act 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
3
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 requlation (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/4/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 made up of three angled lines that form a triangle. The word "Linvatec" is written in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464
May 12, 1998 Date:
1 of ਹ Page
510(k) Number (if known): K981692
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 BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use
(Per 21 CFR 801.109)
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to coeele
OR
510(k) Numb
(Optional Format 1-2-96)