(25 days)
Not Found
Not Found
No
The summary describes a mechanical suture anchor and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the surgical repair of the rotator cuff, which is a therapeutic intervention.
No
Explanation: The device description states its purpose is for "fixation of two strands of #2 suture to bone" and "surgical repair of the rotator cuff," indicating a therapeutic rather than diagnostic function. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a "threaded titanium alloy suture anchor" which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Mitek FASTIN® RC anchor is a surgical implant used to fix suture to bone during rotator cuff repair. It is a physical device implanted in the body, not used to test samples from the body.
- Intended Use: The intended use is "Rotator cuff repair," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Mitek FASTIN® RC anchor is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing. Rotator cuff repair
Product codes
MBI, HWC, GAM, and GAS
Device Description
The Mitek FASTIN® RC threaded titanium alloy suture anchor is preloaded on a disposable inserter assembly intended for fixation of two strands of #2 suture to bone. The Mitek FASTIN® RC Anchor is designed to be used in the surgical repair of the rotator cuff.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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
Based upon mechanical tests done and contained in the literature, it can be stated that the holding power of the Mitek FASTIN® RC Anchor is equal to or greater than the Mitek FASTIN®.
Key Metrics
Not Found
Predicate Device(s)
Mitek FASTIN® 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.
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Image /page/0/Picture/1 description: The image shows the date "NOV 2 3 1998" on the left side. To the right of the date is the logo for "mitek PRODUCTS". The logo is in bold, black font. The image appears to be a scan of a document.
60 GLACIER DRIVE . WESTWOOD . MA . 02090 00 GEAOIEN DHIVE - 1281778 FREE (800) 356-4835 • FAX (781) 461-9166
510(k) SUMMARY FOR MITEK FASTIN® RC ANCHOR
SUBMITTER
NAME ADDRESS
CONTACT
Mitek Products 60 Glacier Drive Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs October 2, 1998
NAME OF DEVICE
TEL
DATE
| CLASSIFICATION NAME | Staple, Fixation, bone |
|---|---|
| COMMON NAME | Appliance for reconstruction of bone to soft tissue |
| PROPRIETARY NAME | Mitek FASTIN® RC Anchor |
Mitek FASTIN® Anchor PREDICATE DEVICE
The Mitek FASTIN® RC threaded titanium alloy suture anchor DESCRIPTION OF DEVICE is preloaded on a disposable inserter assembly intended for fixation of two strands of #2 suture to bone. The Mitek FASTIN® RC Anchor is designed to be used in the surgical repair of the rotator cuff.
INTENDED USE
The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing.
COMPARISON TO PREDICATE DEVICE
The Mitek FASTIN® RC is the same design as the predicate device, Mitek FASTIN®.
DESCRIPTION OF NON CLINICAL TESTS
Based upon mechanical tests done and contained in the literature, it can be stated that the holding power of the Mitek FASTIN® RC Anchor is equal to or greater than the Mitek FASTIN®.
ASSESSMENT OF PERFORMANCE DATA
The Mitek FASTIN® RC is the same device as the Mitek FASTIN® which was legally cleared for marketing in March 95.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Mr. Edward F. Kent Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090
K983818 Re: Mitek Fastin RC Anchor Trade Name: Requlatory Class: II Product Codes: MBI, HWC, GAM, and GAS Dated: October 27, 1998 October 29, 1998 Received:
Dear Mr. Kent:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 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 regulations.
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Page 2 - Mr. Edward F. Kent
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,
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): _K9838|8
Mitek FASTIN® RC Anchor Device Name:
Rotator cuff repair Indications For Use:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH , Office of Device Evaluation (ODE)
Prescription Use_ X OR
Over -The-Counter Use_________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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