(64 days)
Not Found
No
The summary describes a mechanical implant for suture fixation and does not mention any computational or data-driven components indicative of AI/ML.
No
Explanation: This device is used for the fixation of sutures to bone for repair/reconstruction of ligaments and tendons, which is a structural or mechanical function, not a therapeutic one that directly treats a disease or condition.
No
The device is described as an implant used for the fixation of sutures to bone for repair/reconstruction of ligaments and tendons, which functions as a treatment device rather than a diagnostic one.
No
The device description explicitly states it is a "sterile implant used to anchor or lock suture within pre-drilled bone sites," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant used for fixing sutures to bone for the repair and reconstruction of ligaments and tendons in the hand and wrist. This is a direct surgical intervention on the body.
- Device Description: The description confirms it's a sterile implant used to anchor suture within bone sites to secure soft tissue. This is a mechanical device for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:
- Repair/reconstruction of collateral ligaments, Flexor and Extensor Hand: tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits.
- Repair/reconstruction of ligaments and tendons on the dorsal and Wrist: volar aspects of the carpal bones.
Product codes (comma separated list FDA assigned to the subject device)
JDR, MBI, GAT
Device Description
The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits (Hand); carpal bones (Wrist).
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)
Performance testing: Pull-out force (preserved human cadaver hand and wrist) Strength comparison (TALON vs. Mitek Micro Anchor)
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.
K931782 - Mitek LS Anchor, K962511, K982420 - Mitek Micro Anchor
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
DEC - 2 1999
Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notifi September 28, 1999
510(k) Summary
| Trade Name: | TALON™ Anchor Snap-Pak |
|---|---|
| Sponsor: | Mitek Products |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Registration #1221934 | |
| Contact: | Paula E. Bulger |
| Regulatory Affairs Project Manager | |
| Mitek Products | |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Phone: (781) 251-2700 | |
| Fax: (781) 461-9166 | |
| Device Generic Name: | Staple, Fixation, Bone |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Product Code: | JDR (21 CFR 888.3030) |
| Predicate Devices: | K931782 - Mitek LS Anchor |
| K962511, K982420 - Mitek Micro Anchor |
Product Description: The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
Indications for Use:
The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:
- Repair/recosntruction of collateral ligaments, Flexor and Extension tendons at the PIP (Proximalo Hand: Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal interphalangeal) joints for all digits.
- Repair/reconstruction of ligaments and tendons on the dorsal and volar aspects of the carpal bones. Wrist:
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of TALONTM Anchor Snap-Pak:
Performance testing: Pull-out force (preserved human cadaver hand and wrist) Strength comparison (TALON vs. Mitek Micro Anchor)
Conclusion:
Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the TALON™ Anchor Snap-Pak has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Ms. Cynthia A. Sinclair Requlatory Consultant Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts
Re: K993261 TALON™ Anchor Snap-Pak Regulatory Class: II Product Codes: MBI and GAT Dated: September 28, 1999 September 29, 1999 Received:
Dear Ms. Sinclair:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
2
Page 2 - Ms. Cynthia A. Sinclair
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) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil RP Ogden
James E. Dillard III for
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notification September 28, 1999
Page __ 1___ of ___ 1___
510(k) Number (if known): ا
Device Name: __TALON™ Anchor Snap-Pak
Indications for Use:
The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:
- Repair/reconstruction of collateral ligaments, Flexor and Extensor Hand: tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits.
- Repair/reconstruction of ligaments and tendons on the dorsal and Wrist: volar aspects of the carpal bones.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | NRO |
|---|---|
| Division of General Restorative | |
| 510(k) Number | K993261 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |