(204 days)
Not Found
No
The summary describes a mechanical bone anchor system and its accessories, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes.
The device is indicated for securing soft tissue to bone in repairs and reconstructions, which are therapeutic medical procedures.
No
The device is a bone anchor system designed for surgical repair and reconstruction of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Titanium Bone Anchor System" which includes physical components like a bone anchor, drill bit, delivery/extraction handle, and drill guide. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for securing soft tissue to bone in surgical repairs of the extremities. This is a surgical implant and not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a bone anchor system, which is a physical implant used in surgery.
- No mention of in vitro testing: There is no indication that this device is used to test samples like blood, urine, or tissue outside of the body.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical tool and implant used directly in the body during a procedure.
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 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
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR, HWC, MAI
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.
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
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)
Not Found
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.
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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 Schrayer |
| Regulatory 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
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.
1
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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.
2
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.
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), 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
4
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:
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
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