(73 days)
Not Found
No
The document describes a mechanical bone anchor and associated surgical tools, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is indicated for securing suture to bone in the repair of shoulder injuries, which falls under the definition of a therapeutic intervention.
No
The device is a bone anchor used for securing sutures to bone during surgical repair procedures, not for diagnosing conditions.
No
The device description clearly states it is a bone anchor, which is a physical implantable device made of material and designed with a specific geometry. It also mentions associated physical tools (bone punch, delivery/extraction tool). This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is a surgical implant used to physically secure suture to bone during shoulder repair procedures. It is used in vivo (within the living body), not in vitro (in a lab setting).
- Intended Use: The intended use clearly states it's for "securing synthetic monofilament non-absorbable suture to bone" in the repair of shoulder injuries. This is a surgical function, not a diagnostic one.
The information provided describes a surgical device used for mechanical fixation within the body, which is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor 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.
Product codes
MBI, HWC
Device Description
The device described in this submission is designed with a corkscrew style thread and will be made available initially in two sizes (diameters) specifically for use in shoulder repairs. (i.e. rotator cuff repairs). The Axya Self-Tapping Bone Anchor will be made available as a system together with a bone punch and a delivery/extraction tool. 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 2000 AxyaLoop Self-Tapping Bone Anchor is prethreaded with size 2 USP polypropylene monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers.
The Model 2000 Self-Tapping Bone Anchor is designed to be used 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
Shoulder
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
The 510(k) Notice contains summaries of in vitro studies which were 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 2000 AxyaLoop Self-Tapping Bone Anchor was equivalent to that of the predicate device of similar corkscrew geometry (Mitek Fastin RC). The failure mode observed for the both anchors was predominately anchor pull-out.
Key Metrics
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
SUMMARY OF SAFETY AND EFFECTIVENESS
General Company Information
Name: Axya Medical, Inc.
Address: 100 Cummings Center Suite 444C Beverly, MA 01915
| Telephone: | (978) 232 - 9997 |
|---|---|
| Fax: | (978) 232 - 9998 |
General Device Information
| Product Name: | Model 2000 AxyaLoop™ Self-Tapping Bone Anchor |
|---|---|
| Classification: | "Non-degradable soft tissue fixation fastener", Product code: MBI |
| Class II |
Predicate Device
Mitek. Fastin ® RC Suture Anchor [501(k) Number K983818]
Description
The device described in this submission is designed with a corkscrew style thread and will be made available initially in two sizes (diameters) specifically for use in shoulder repairs. (i.e. rotator cuff repairs). The Axya Self-Tapping Bone Anchor will be made available as a system together with a bone punch and a delivery/extraction tool. 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 2000 AxyaLoop Self-Tapping Bone Anchor is prethreaded with size 2 USP polypropylene monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers.
The Model 2000 Self-Tapping Bone Anchor is designed to be used in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.
1
Indications
The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor 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 2000 AxyaLoop Self-Tapping Bone Anchor is substantially equivalent to previously cleared devices, including the Mitek Fastin ® Suture Anchor [501(k) Number K983818].
The 510(k) Notice contains summaries of in vitro studies which were 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 2000 AxyaLoop Self-Tapping Bone Anchor was equivalent to that of the predicate device of similar corkscrew geometry (Mitek Fastin RC). The failure mode observed for the both anchors was predominately 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 anchor devices have been used for the same clinical applications as the Axya Model 2000 AxyaLoop 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2001
Mr. Howard L. Schrayer Axya Medical, Incorporated 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
Re : K011912 Model 2000 AxyaLoop™ Self-Tappinq Trade/Device Name: Bone Anchor Regulation Number: 888.3030 and 888.3040 Requlatory Class: II Product Code: MBI and HWC Dated: June 18, 2001 Received: June 19, 2001
Dear Mr. Schrayer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
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Page 2 - Mr. Schrayer
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. 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 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,
Mula M Mulkerso
lia 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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Kol 1912 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Axya, Model 2000 AxyaLoop™ Self-Tapping Bone Anchor
Indications For Use:
The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing The raya monofilament non-absorbable suture to bone. This device is intended for use in bynthout monomainonies. The 5mm anchor may typically be used to repair rotator cuff ropair of onourael financhor may typically be used to repair recurrent dislocation of the injuries: "The o min anchor inaly typedia wetaphyseal cortex such as in the case of a Bankart lesion repair procedure.
(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 | K011912 |
|---|---|
| --------------- | --------- |
Use __________ OR Over-The-Counter Use __________Prescription U: (Per 21 CFR 801.109)
(Optional Format 1-2-96)