(25 days)
The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.
The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a bone punch and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Self-Tapping Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material. The Model 6500 Self-Tapping Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Axya Model 6500) | Predicate Device Performance (Axya Model 2000 & Arthrex Corkscrew) |
|---|---|---|
| Anchor Pull-Out Strength | Compared favorably | - Included in in-vitro study for comparison |
| Failure Mode | Predominately the same | - Predominately the same |
| Sterilization Process | Equivalent to original suture manufacturer's | - Implied to be acceptable for predicate devices |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the sample size (number of anchors tested) for the in-vitro study evaluating anchor pull-out strength.
- Data Provenance: The study was conducted in-vitro. This suggests a laboratory setting rather than using human or animal biological samples for the primary evaluation of pull-out strength. The country of origin is not specified but is presumably the US, given the submission to the FDA.
3. Number of Experts and Their Qualifications for Establishing Ground Truth (Test Set)
This information is not provided in the document. The study described is an in-vitro mechanical test. Ground truth in this context would likely be based on physical measurements and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As the study is an in-vitro mechanical test, there would be no need for expert adjudication in the traditional sense, which typically applies to subjective interpretations of medical images or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is an in-vitro mechanical test of device performance, not a study involving human readers or clinical cases.
6. Standalone (Algorithm Only) Performance Study
No, a standalone study was not done. This device is a mechanical bone anchor, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance (specifically pull-out strength) was based on physical measurements and engineering principles as specified in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)." This is a form of objective, quantitative data derived from a controlled laboratory setting.
8. Sample Size for the Training Set
This information is not applicable/provided. This device is a mechanical product, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The "training" in manufacturing would relate to process validation and quality control, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
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OCT 7 - 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Axya Medical, Inc. |
|---|---|
| Contact: | Howard SchrayerRegulatory Affairs Consultant |
| Address: | 100 Cummings CenterSuite 444CBeverly, MA 01915 |
| Telephone: | (978) 232 - 9997 |
| Fax: | (978) 232 - 9998 |
- Date Prepared September 27, 2005
General Device Information
| Product Name: | Model 6500 AxyaLoop™ Self-Tapping Bone Anchor |
|---|---|
| Classification: | "Non-degradable soft tissue fixation fastener"Product code: MBI and HWC - Class II |
Predicate Devices
Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor [510(k) Number K011912]
Arthrex Inc. Corkscrew™ Suture Anchor Model AR-1925S [501(k) Number K003816]
Description
The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a bone punch and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Self-Tapping Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.
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The Model 6500 Self-Tapping Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
Intended Use (Indications)
The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.
Substantial Equivalence
This submission supports the position that the Axya Model 6500 Self-Tapping Bone Anchor is substantially equivalent to a number of previously cleared devices, including the Axia Model 2000 AxyaLoop Self-Tapping Bone Anchor [510(k) Number K011912] and the Arthrex Inc. Corkscrew Model AR-1324B Suture Anchor [510(k) Number K003816].
The 510(k) Notice contains summaries of an in_vitro study that was conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996).
The data presented demonstrate that the anchor pull-out force of the Axya Model 6500 AxyaLoop Self-Tapping Bone Anchor compared favorably with that of the predicate device of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor.
The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized using a process equivalent to the process used by the original suture manufacturer.
Conclusion
Axya Medical, Inc. believes that the information provided establishes that similar legally marketed have been used for the same clinical applications as the Axya Model 6500 Self-Tapping Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and devices produced by Axya have been tested in accordance with applicable FDA guidelines.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three branches instead of the usual two.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard L. Schrayer Regulatory Affairs Consultant Axya Medical, Inc. 100 Cummings Center Suite 444C Beverly, Massachusetts 01915
Re: K052491
Trade/Device Name: Model 6500 AxyaLoop™ Self-Tapping Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: MBI, HWC Dated: September 9, 2005 Received: September 13, 2005
Dear Mr. Schrayer:
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 (OS) 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. Howard L. Schrayer
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Axya, Model 6500 AxyaLoop™ Self-Tapping Bone Anchor
Indications For Use:
The Axya Model 6500 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm anchors may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052491
§ 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.