(28 days)
Not Found
No
The description details a mechanical suture anchor system and its components, with no mention of software, algorithms, or any technology that would suggest AI or ML capabilities.
Yes
The device is described as stabilizing damaged soft tissue and reattaching it to bone, which are therapeutic actions.
No
Explanation: The device is a suture anchor system used to reattach soft tissue to bone in orthopedic surgical procedures. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly details physical components made of PEEK, ultra-high molecular weight polyethylene, stainless steel, and polycarbonate, which are hardware.
Based on the provided text, the NANO™ Suture Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The NANO™ Suture Anchor is a surgical implant used to physically reattach soft tissue to bone within the body. Its function is mechanical and structural, not diagnostic.
The description clearly outlines its use in orthopedic surgical procedures to stabilize damaged soft tissue, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The NANO™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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
MBI
Device Description
The ConMed Linvatec NANO™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of medical-grade PEEK and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is non-absorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor.
The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. 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 surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation testing of the NANO™ Suture Anchor includes fixation strength, cyclic loading, insertion, driver strength, biocompatibility, sterilization, shelf-life, packaging/transportation and comparator testing qualifications.
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
§ 888.3040 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
K112965(pg 1/2)
NOV - 2 2011
5. 510(k) Summarv
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 510(k) Number
Date Prepared: October 3, 2011
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Regulatory Contact: Ashlea Ricci, RAC Regulatory Affairs Specialist (727) 399-5564 Telephone (727) 399-5264 Fax
C. Device Name
| Trade Name: | NANO™ Suture Anchor |
|---|---|
| Common Name: | Non-absorbable Suture Anchor System |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft tissue |
| Proposed Class/Device: | Class II |
| Product Code: | MBI |
| Regulation: | 21 CFR Part 888.3040 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec Soft Tissue to Bone System |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K091549 |
| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K090835 |
E. Device Description
The ConMed Linvatec NANO™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of medical-grade PEEK and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is non-absorbable and is available in two
- 18 - 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1
: :
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sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor.
The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for sinqle use and is removed at the end of the repair leaving behind the suture anchor construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or ioint 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 surgical instruments, including drill bits, quides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.
F. Testing
The verification and validation testing of the NANO™ Suture Anchor includes fixation strength, cyclic loading, insertion, driver strength, biocompatibility, sterilization, shelf-life, packaging/transportation and comparator testing qualifications.
G. Intended Use / Indications
The NANO™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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.
H. Substantial Equivalence
The NANO™ Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Soft Tissue to Bone System (K091549) and the ConMed Linvatec Bio-Mini-Revo Suture Anchor (K090835).
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines representing its wings and body. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConMed Linvatec, Inc. % Ashlea Ricci, RAC Regulatory Affairs Specialist 11311 Concept Boulevard Largo, FL 33773
NOV - 2 2011
Re: K112965
Trade/Device Name: NANO™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener ._Regulatory Class: Class II Product Code: MBI Dated: October 4, 2011 Received: October 5, 2011
Dear Ms. Ricci:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page - 2 -- Ms. Ashlea Ricci
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6. Indications for Use
510(k) Number (if known):
K112965 (pg 1/1)
Device Name: NANO™ Suture Anchor
Indications for Use:
The NANO™ Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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 Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (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)
(Division Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K112965