(87 days)
No
The 510(k) summary describes a mechanical suture anchor and inserter system with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as stabilizing damaged soft tissue in conjunction with appropriate postoperative immobilization throughout the healing period, which aligns with the definition of a therapeutic device.
No
The device is described as a "suture anchor system" used to reattach soft tissue to bone for stabilization and healing, which is a surgical repair function, not a diagnostic one.
No
The device description clearly states it is a "bioabsorbable screw-in suture anchor" and a "disposable inserter device," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used to reattach soft tissue to bone during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a bioabsorbable suture anchor and inserter, which are physical implants and surgical tools. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or disease monitoring.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
Product codes
MAI
Device Description
The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene 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
bone, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 2 2 2 2009
510(k) SUMMARY ConMed Linvatec Bio Mini-Revo
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 K090835
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Joy Lovett Regulatory Affairs Specialist (727) 399-5137 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
|---|---|
| Common Name: | Bioabsorbable suture anchor |
| Classification Name: | Biodegradable soft tissue fixation fastener |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 888.3030 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K072291 |
| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
| Device Name: | Bio-FASTak Suture Anchor |
| Company Name: | Arthrex, Inc. |
| 510(k) #: | K061863 |
1
E. Device Description
The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene 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.
1690935 (pg 212)
F. Intended Use/ Indications
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
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, K072291 and K061863,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle with three overlapping wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 22 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Blvd. Largo, Florida 33773
K090835 Re:
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 Dated: March 23, 2009 Received: March 27, 2009
Dear Ms. Lovett:
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 for associated in 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 I ou may and 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to basen assement 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 I loase be active and a determination that your device complies with other requirements of the Act that +DT has Intatutes and regulations administered by other Federal agencies. You must or any it carates and regaraments, 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 forth in and qualis) by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Joy Lovett
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 toll-free 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 Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices. Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K090835(pg 1/1)
Indications for Use
K090835 510(k) Number (if known): ConMed Linvatec Bio Mini-Revo Suture Anchor Device Name:
Indications for Use:
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mikkelsen
(Division Sign-Off) (Division Sign-on), Orthopedic, and Restorative Devices
510(k) Number K090835