(57 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical applications of a bone anchor, with no mention of AI or ML.
Yes.
The device is used for reconstruction and repair of various anatomical structures, including for relief of Stress Urinary Incontinence, which are therapeutic interventions.
No
Explanation: The device description indicates it is a bone anchor used for surgical repairs and reconstruction of various ligaments and structures. It does not mention any function related to diagnosing a condition or disease. The "Intended Use" also describes therapeutic applications, not diagnostic ones.
No
The device description clearly states it is a sterile, disposable bone anchor made of titanium alloy and nickel-titanium, supplied pre-loaded on an inserter with a polyester suture. This describes a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for repairing ligaments and tissues in various parts of the body. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a bone anchor with a suture, designed to be implanted into bone. This is a physical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Mitek Mini QuickAnchor® Plus is indicated for:
shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).
Product codes
HWC
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 on an inserter 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, hand, wrist, pubis
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: Insertion force, PullOut force, Suture Hole interface and Off-axis insertion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Mitek® Products
Mini QuickAnchor® Plus
510(k) Premarket Notification July 23, 1999
510(k) Summary
Mitek Mini QuickAnchor® Plus Trade Name: Sponsor: Mitek Products 60 Glacier Drive Westwood, MA 02090 Registration #1221934 Christine Kuntz-Nassif Contact: Telephone: (781) 461-9700 Fax: (781) 461-9166 Smooth or threaded metallic bone fixation fastener Device Generic Name: According to Section 513 of the Federal Food, Drug, and Classification: Cosmetic Act, the device classification is Class II. HWC (21 CFR 888.3040) Product Code: K921873 - Mitek GII Mini QuickAnchor Predicate Devices: 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 on an inserter 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 design in order to accommodate the line extension which includes the Mini QuickAnchor® Plus, providing a pre-loaded single use anchor on a disposable inserter.
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of the Mini Anchor for the design modification:
Insertion force, PullOut force, Suture Hole interface and Off-axis insertion. Performance testing:
Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Mini QuickAnchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.
SEP 2 1 19999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek Products 60 Glacier Dr. Westwood, Massachusetts 02090
Re: K992487
Trade Name: Mitek Mini QuickAnchor® Plus Regulatory Class:II Product Code: HWC Dated: July 23, 1999 Received: July 26, 1999
Dear Ms. Kuntz-Nassif:
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, Drug, 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 Regulations, Title 21, Parts 800 to 895. A 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 Drug 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou 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.
2
Page 2 - Ms. Christine Kuntz-Nassif
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) 594-4639. 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/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten. Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page . of
510(k) Number (if known):长ብዓ 24 ۶ 7
Device Name: __ Mitek Mini QuickAnchor® Plus
Indications for Use:
The Mitek Mini QuickAnchor® Plus is indicated for:
shoulder (Bankart repair) ankle (Mid-foot reconstruction) foot (Hallux valgus reconstruction) hand (Ulnar or lateral collateral ligament reconstruction) wrist (Scapholunate ligament reconstruction) pubis (For relief from Stress Urinary Incontinence due to urethral or bladder neck hypermobility with minimal or no cystocele).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992487 |
|---|---|
| --------------- | --------- |
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