(49 days)
Not Found
No
The summary describes a mechanical bone anchor and suture system with no mention of AI or ML components or functions.
Yes.
The device is used for rotator cuff repair and includes a bone anchor with suture, indicating its role in surgically restoring tissue function.
No
This device is a bone anchor used for rotator cuff repair, which is a therapeutic intervention, not a diagnostic one. The performance studies mentioned also relate to mechanical properties of the anchor rather than diagnostic capabilities.
No
The device description clearly states it is a sterile, disposable bone anchor made of titanium alloy and nickel-titanium, supplied with an inserter and suture, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Rotator cuff repair." This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a bone anchor with sutures, designed to be implanted in the body. This is a surgical implant, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
This device is clearly a surgical implant used for a specific repair procedure.
N/A
Intended Use / Indications for Use
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.
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 and PANACRYL, Poly (L-Lactide/Glycolide) synthetic absorbable] suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing: Arc span test, Insertion force, PullOut force, and Suture/Suture Hole interface.
Key Metrics
Not Found
Predicate Device(s)
K915889 - Mitek Anchor
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
| SEP 22 1999 | 510(k) Summary | K992611 |
|---|---|---|
| Trade Name: | Mitek Rotator Cuff QuickAnchor® Plus | |
| Sponsor: | Mitek Products | |
| 60 Glacier Drive | ||
| Westwood, MA 02090 | ||
| Registration #1221934 | ||
| Contact: | Christine Kuntz-Nassif | |
| Telephone: (781) 461-9700 | ||
| Fax: (781) 461-9166 | ||
| Device Generic Name: | Smooth or threaded metallic bone fixation fastener | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. | ||
| Product Code: | HWC (21 CFR 888.3040) | |
| Predicate Devices: | K915889 - Mitek 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 and PANACRYL, Poly (L-Lactide/Glycolide) synthetic absorbable] suture.
Indications for Use:
Mitek RC Anchors have been found substantially equivalent in previous Premarket Notifications for Rotator Cuff repair.
This current 510(k) allows modification of the RC Anchor design in order to accommodate the line extension, which includes the Mitek Rotator Cuff 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 RC Anchor for the design modification:
Performance testing: Arc span test, Insertion force, PullOut force, and Suture/Suture Hole interface.
Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Rotator Cuff 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 Department of Health & Human Services - USA. The logo features a stylized design of three human figures connected together, possibly representing unity or collaboration. The figures are arranged in a diagonal line, with the heads facing towards the upper right corner of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figures.
SEP 2 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek® Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K992611
Trade Name: Mitek Rotator Cuff QuickAnchor® Plus Regulatory Class: II Product Code: HWC Dated: August 03, 1999 Received: August 04, 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 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 requirement, 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 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.
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) 594-4659. 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/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 _
510(k) Number (if known): 上9926 リ
Device Name: __ Mitek Rotator Cuff QuickAnchor® Plus_
Indications for Use:
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________ OR Prescription Use _> (Per 21 CFR 801.109)
Division Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992611