The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture or size 3/0 TephaFLEX™ absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle
1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist and Hand
1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

Device Description

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. The Axya Model 3000 Titanium Bone Anchor is prethreaded with either non-absorbable suture or size 3/0 TephaFLEX™ suture material.

AI/ML Overview

This document is a 510(k) summary for the Axya Medical, Inc. Model 3000 AxyaLoop™ Titanium Bone Anchor. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) process for this type of device (a bone anchor) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring performance against specific, pre-defined quantitative acceptance criteria through a clinical study in the way a diagnostic device might.

Therefore, many of the requested items (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this type of submission.

Here's a breakdown of what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance: The device performs comparably to predicate devices in mechanical tests (e.g., pull-out strength, fatigue).	"The materials from which the Axya device is fabricated have an established history of use in medical applications, and the devices produced by Axya have been tested in accordance with applicable FDA guidelines." (This implies mechanical testing was done to ensure equivalence, but specific criteria and results are not detailed here.)
Material Biocompatibility: Materials are safe for long-term implantation.	"The materials from which the Axya device is fabricated have an established history of use in medical applications..." (Titanium and specified sutures are well-established biocompatible materials.)
Sterility: Components are sterile.	"The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturers."
Indications for Use: The device can be safely and effectively used for listed indications.	Demonstrated through substantial equivalence to predicate devices used for similar indications.

2. Sample sized used for the test set and the data provenance:

Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of diagnostic or AI performance. The "testing" referred to is primarily bench testing for mechanical properties and material equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. No clinical "test set" requiring expert ground truthing is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a hardware medical device (bone anchor), not an AI diagnostic or assistive device. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a hardware medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. For a bone anchor, the "ground truth" for its performance is typically established through biomechanical testing (e.g., tensile strength, pull-out force) and material science, demonstrating equivalence to established devices and safety of materials. Clinical outcomes for equivalence are usually based on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable / Not provided. No "training set" in the AI sense is relevant for this device.

9. How the ground truth for the training set was established:

Not applicable / Not provided.

Summary of the study/evidence provided in the 510(k) submission:

The submission relies on claims of substantial equivalence to predicate devices (Axya Medical, Inc. Model 3000 AxyaLoop™ Suture Anchor [K022207] and Depuy Mitek QUICKANCHOR Plus Bone Anchor [K041115]).

The evidence provided for this substantial equivalence primarily consists of:

Material Equivalence: The device is made from materials (Titanium, non-absorbable sutures, TephaFLEX™ absorbable suture) with an "established history of use in medical applications."
Design and Functionality Equivalence: The corkscrew-style thread and 2.0 mm diameter are presented as suitable for the specified anatomical areas, implying similar biomechanical function to predicates.
Sterilization Process Equivalence: The sterilization process is stated to be "equivalent to the process used by the original suture manufacturers."
Testing in accordance with FDA guidelines: While specific results are not provided here, the document states that "the devices produced by Axya have been tested in accordance with applicable FDA guidelines." This typically refers to bench testing for mechanical properties (e.g., pull-out strength) to demonstrate that the device performs equivalently to the predicate devices.
Indications for Use Equivalence: The specified indications for use (foot, ankle, elbow, wrist, hand repairs) are similar to those for which predicate bone anchors are marketed.

In essence, the "study" proving the device meets criteria is a combination of material characterization, bench testing (mechanical performance), and a comparison of design and indications to already-approved predicate devices to establish substantial equivalence, rather than a clinical trial with acceptance criteria for patient outcomes or diagnostic performance.

Summary

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K07.77) page 1/42

0C7 1 2007

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 Center Suite 444C Beverly, MA 01915

Telephone: (978) 232 - 9997 Fax: (978) 232 - 9998

Date Prepared March 20, 2007

General Device Information

Product Name:	Model 3000 AxyaLoop™ Titanium Bone Anchor
---------------	-------------------------------------------

Classification: "Non-degradable soft tissue fixation fastener" Product code: MBI - Class II

Predicate Devices

Axya Medical, Inc. Model 3000 AxyaLoop™ Suture Anchor [501(k) Number K022207]

Depuy Mitek QUICKANCHOR Plus Bone Anchor [510(k) Number K041115]

Description

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Indications

The Axya Model 3000 AxvaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle

1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow wrist and Hand

1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

Substantial Equivalence

This submission supports the position that the Axya Model 3000 Titanium Bone Anchor is substantially equivalent to a number of previously cleared devices, including those referenced above.

The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturers.

Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar, legally marketed bone anchors have been used for the same clinical applications as the Axya Model 3000 Titanium Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and the devices produced by Axya have been tested in accordance with applicable FDA quidelines.

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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 consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Axya Medical, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, MA 01915

OCT 1 1 2007

Re: K070773 Trade/Device Name: Model 3000 AxyaLoop™ Titanium Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR, HWC, MAI Dated: September 14, 2007 Received: September 17, 2007

Dear Mr. Schraver:

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. Ilsting 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. 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" (21 CFR 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 N. Melke

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of

INDICATIONS FOR USE

510(k) Number (if known): 长い707 73

Device Name: Axya, Model 300 AxyaLoop™ Titanium Bone Anchor

Indications For Use:

Foot and Ankle

1 Hallux Valgus repairs

2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist and Hand

1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

ﻟﻠﺘﻌﻠﻴ Prescription Use_ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubara Bushnd

and Neurological Devices

510(k) Number K070773 4

Regulation Number and Section

§ 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.