(88 days)
Not Found
No
The 510(k) summary describes a mechanical bone anchor system and its accessories. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a bone anchor system designed to secure soft tissue to bone in various repairs and reconstructions of the extremities, which directly addresses a medical condition or injury.
No
Explanation: The device is an implantable bone anchor system used for securing soft tissue to bone during surgical repairs, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "Titanium Bone Anchor System" and includes physical components like the anchor, drill bit, delivery/extraction handle, and drill guide.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device for securing soft tissue to bone in the extremities. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a bone anchor, drill bit, handle, and drill guide – all components of a surgical system used in vivo (within the body) during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific analytes, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 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 epicylitis repair
4 Biceps tendon reattachment
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC, GAS
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. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, foot, elbow, wrist and hand repairs and reconstructions
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)
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 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device of similar diameter and corkscrew geometry (OBL 2.0 mm Mini Tac). The failure mode observed for the Axya anchor and the predicate anchor was the same (i.e. anchor pull-out).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 0 4 2002
K022207
page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
General Company Information
Axya Medical, Inc. Name:
- 100 Cummings Center Address: Suite 444C Beverly, MA 01915
- (978) 232 9997 Telephone: (978) 232 - 9998 Fax:
General Device Information
| Product Name: | Model 3000 AxyaLoop™ Titanium Bone Anchor |
|---|---|
| Classification: | "Non-degradable soft tissue fixation fastener", Product code: MB |
| Class II |
Predicate Devices
Axya Medical, Inc. Model 1000 AxyaLoop™ Suture Anchor [501(k) Number K003971]
Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor [510(k) Number K000797]
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. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
1
Indications
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 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 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 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device of similar diameter and corkscrew geometry (OBL 2.0 mm Mini Tac). The failure mode observed for the Axya anchor and the predicate anchor was the same (i.e. anchor pull-out).
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 manufacturer.
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 guidelines.
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 consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
OCT 04 2002
Mr. Howard L. Schrayer Axya Medical, Inc. 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
Re: K022207
Trade/Device Name: Model 3000 AxyaLoop™ Titanium Bone Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: MBI, HWC, GAS Dated: July 3, 2002 Received: July 8, 2002
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 (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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Q. Mark A. Milliman
Celia M. Witten, Ph.D., M.D. 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 1
KorzioT 510(k) Number (if known):
Device Name: Axya, Model 3000 AxyaLoop™ Titanium Bone Anchor
Indications For Use:
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 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
(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 __K022207
Prescription Use __ OR Over-The-Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)