(333 days)
Not Found
No
The summary describes a mechanical suture anchor and its material composition. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an implantable suture anchor intended to reattach soft tissue to bone, which is a therapeutic intervention.
No
The device is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a bioabsorbable screw-in suture anchor made of a PLA Copolymer, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "bioabsorbable screw-in suture anchor" used to physically secure tissue. This is a surgical implant.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly a surgical implant used in vivo (within the living body), not a device used to test samples in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair.
Product codes
MAI, JDR, HWC
Device Description
The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylone suture. The Bio Mini-Revo® suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the numbers 1 and 2 written in black ink on a white background. The number 1 is written with a hashtag symbol before it, and the number 2 is written to the right of a vertical line. The handwriting appears to be casual and slightly messy.
510(k) Summary ConMed Linvatec Bio Mini-Revo Suture Anchor June 30, 2008
JUL 1 4 2008
510(k) SUMMARY ConMed Linvatec Bio Mini-Revo Suture Anchor
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number K072291.
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Jon Ward Regulatory Consultant Telephone: 813-645-2855 FAX: 813-645-2856
C. Device Name
| Trade Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
|---|---|
| Common Name: | Bioabsorbable suture anchor |
| Classification Names: | Biodegradable soft tissue fixation fastener |
| Proposed Class: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |
D. Predicate/Legally Marketed Devices
The predicate/legally marketed devices for the Bio Mini-Revo are:
| Device name: | Bio Mini-Revo |
|---|---|
| Company name: | ConMed Linvatec |
| 510(k) #: | K053561 |
1
510(k) Summary ConMed Linvatec Bio Mini-Revo Suture Anchor June 30, 2008
Device name: Bio-FASTak Suture Anchor Company name: Arthrex 510(k) #: K061863
E. Device Description
The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylone suture. The Bio Mini-Revo® suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.
-
F. Intended Use
The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair. -
G. Substantial Equivalence
The ConMed Linvatec Bio Mini-Revo Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices, K053561 and K061863.
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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 features a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec % Mr. Jon Ward 11311 Concept Boulevard Largo, FL 33773-4908
JUL 1 4 2008
Re: K072291 Trade/Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, JDR, HWC Dated: June 30, 2008 Received: July 2, 2008
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jon Ward
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at tollfree number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072291
Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor________________________________________________________________________________________________________________
Indications for Use:
The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair.
Prescription Use 2 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Chaubau Bneelmo for may
Division of General, Restorative, and Neurological Devices
510(k) Number K072