(89 days)
Not Found
No
The 510(k) summary describes a mechanical bone anchor and suture, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the repair, repositioning, or reattachment of soft tissues, ligaments, and tendons, which are therapeutic actions to restore normal function.
No
The device description and intended use indicate that the Mitek Mini Anchor is a surgical implant used for the repair and reattachment of soft tissues, ligaments, and tendons, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, disposable bone anchor made of titanium alloy and nickel-titanium, supplied with a polyester suture. This indicates a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to the surgical repair, repositioning, or reattachment of soft tissues, ligaments, and tendons to bone in various anatomical locations. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The device is a bone anchor with a suture, designed to be implanted into bone. This is a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnosis, or condition.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used to physically repair structures within the body.
N/A
Intended Use / Indications for Use
Mitek Mini Anchors have been found substantially equivalent in previous Premarket Notifications for the following indications:
| Shoulder: Bankart Repair | |
|---|---|
| Ankle: | Midfoot Reconstructions |
| Foot: | Hallux Valgus Reconstruction |
| Wrist: | Scapholunate Ligament Reconstruction |
| Hand: | Ulnar or Lateral Collateral Ligament Reconstruction |
| Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence |
This current 510(k) allows modification of the Mini Anchor labeling in order to add the following indication:
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Product codes (comma separated list FDA assigned to the subject device)
JDR (21 CFR 888.3030), DZL
Device Description
The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded with a polyester suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Wrist, Hand, Pubis, mandible
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 mandibular condyle), Strength comparison (Mini Anchor vs. bone tunnels in fresh frozen human mandible)
Long-term stability: Evaluation of osteointegration and positional stability in Mini Anchors used for new indication
Clinical data: Long-term patient follow-up evaluation of Mini Anchors used for new indication
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.
K921873 - Mitek Mini Anchor, K930892 - Mitek Mini Anchor, K936311 - Mitek Mini 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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
510(k) Summary
| Trade Name: | Mitek Mini Anchor |
|---|---|
| Sponsor: | Mitek Products |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Registration #1221934 | |
| Contact: | Paula E. Bulger |
| Manager, Regulatory Affairs | |
| 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: | K921873 - Mitek Mini Anchor |
| K930892 - Mitek Mini Anchor | |
| K936311 - Mitek Mini Anchor |
Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded with a polyester suture.
Indications for Use:
Mitek Mini Anchors have been found substantially equivalent in previous Premarket Notifications for the following indications:
| Shoulder: Bankart Repair | |
|---|---|
| Ankle: | Midfoot Reconstructions |
| Foot: | Hallux Valgus Reconstruction |
| Wrist: | Scapholunate Ligament Reconstruction |
| Hand: | Ulnar or Lateral Collateral Ligament Reconstruction |
| Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence |
This current 510(k) allows modification of the Mini Anchor labeling in order to add the following indication:
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of the Mini Anchor for the expanded indication:
1
| Performance testing: | Pull-out force (preserved human cadaver mandibular condyle)
Strength comparison (Mini Anchor vs. bone tunnels in fresh frozen human mandible) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Long-term stability: | Evaluation of osteointegration and positional stability in Mini Anchors used for new indication |
| Clinical data: | Long-term patient follow-up evaluation of Mini Anchors used for new indication |
Conclusion:
Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Mini Anchor with expanded indication has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three wavy lines forming the profile of a person's head and shoulders. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 2 1999
Ms. Paula E. Bulger Regulatory Affairs Manager Mitek Products Ethicon, Inc. 60 Glacier Drive Westwood, MA 02090
Re: K992623
Mitek Mini Anchor Trade Name: Requlatory Class: II Product Code: DZL Dated: August 4, 1999 Received: August 5, 1999
Dear Ms. Bulger:
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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Bulger
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 regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _
899623 510(k) Number (if known): __
Device Name: __Mitek Mini Anchor
Indications for Use:
| Shoulder: | Bankart Repair |
|---|---|
| Ankle: | Midfoot Reconstructions |
| Foot: | Hallux Valgus Reconstruction |
| Wrist: | Scapholunate Ligament Reconstruction |
| Hand: | Ulnar or Lateral Collateral Ligament Reconstruction |
| Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress |
| urinary incontinence |
The Mitek Mini Anchor is also indicated for the repair, repositioning or reattachment of soft tissues, ligaments and tendons to the mandible for surgical stabilization of the TMJ articular disc.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
Susan Runny
(Division Sign-Off) Division of Dental, Infection Co and General Hospital Devi 510(k) Number .
000007
.