(89 days)
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.
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.
The provided text is a 510(k) summary for the Mitek Mini Anchor and does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the requested format. It primarily focuses on demonstrating substantial equivalence for an expanded indication.
Here's an analysis of why the requested information cannot be fully provided based on the extract:
- Acceptance Criteria and Reported Device Performance Table: The document lists "Performance testing" (Pull-out force, Strength comparison), "Long-term stability" (Evaluation of osteointegration and positional stability), and "Clinical data" (Long-term patient follow-up). However, it does not provide specific numerical acceptance criteria (e.g., minimum pull-out force in Newtons) for these tests nor does it report the actual test results or performance metrics of the device against any such criteria.
- Sample size and data provenance for the test set: Not mentioned.
- Number of experts and qualifications for ground truth: Not applicable as the studies described are in vitro (cadaveric) and in vivo (clinical follow-up) performance tests, not AI model evaluation requiring expert consensus for ground truth.
- Adjudication method for the test set: Not applicable for the type of studies described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is a medical device, not an AI/imaging algorithm.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used:
- For "Pull-out force" and "Strength comparison," the ground truth would be the direct measurement of force from the cadaveric specimens.
- For "Long-term stability," it would involve observations/measurements of osteointegration and positional stability.
- For "Clinical data," it would be patient outcomes as observed during follow-up.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary is a regulatory document affirming substantial equivalence based on a comparison to predicate devices and general safety/performance data, but it does not detail the specific acceptance criteria, study methodologies (like sample size), or results in the manner requested for an AI/diagnostic device.
To provide the requested table, I would need a document that presents specific quantitative performance metrics and the associated acceptance thresholds for the device.
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510(k) Summary
| Trade Name: | Mitek Mini Anchor |
|---|---|
| Sponsor: | Mitek Products60 Glacier DriveWestwood, MA 02090Registration #1221934 |
| Contact: | Paula E. BulgerManager, Regulatory AffairsMitek Products60 Glacier DriveWestwood, MA 02090Phone: (781) 251-2700Fax: (781) 461-9166 |
| Device Generic Name: | Staple, Fixation, Bone |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
| Product Code: | JDR (21 CFR 888.3030) |
| Predicate Devices: | K921873 - Mitek Mini AnchorK930892 - Mitek Mini AnchorK936311 - 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:
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| 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.
:
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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
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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
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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 stressurinary 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
.
§ 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.