(89 days)
ACUFEX "T" FIX DEVICE NON ABSORBABLE SUTURE
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No
The summary describes a mechanical fastener for meniscal repair and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the repair of torn meniscal tissue and separation of the meniscus from the synovium, which describes a therapeutic purpose.
No
The device is described as a "meniscal fastener" intended for the "repair of torn meniscal tissue." This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description clearly states it is a physical implant made of polypropylene, intended for surgical placement. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the "H" Fix is a physical device made of polypropylene intended for the surgical repair of torn meniscal tissue in the knee. It is surgically placed.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples or performing any kind of test on bodily fluids or tissues.
This device is a surgical implant/fastener, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Mitek meniscal fasteners ( "H" Fix) are intended for the repair of torn meniscal tissue as well as the repair of a separation of the meniscus from the synovium.
Product codes
MBI, HRX
Device Description
FUNCTION: To hold (meniscal) soft tissue in apposition during the healing tirne period. DEVICE DESIGN: The "H" Fix is cylindrical in cross section and configured to have one leg of the letter "H" in a 90 degree opposed position to the other. MATERIALS USED: The Mitek non absorbable "H" Fix is made from polypropylene. INTENDED USE: The device is surgically placed across (through) a tear in the meniscal tissue of the knee with a needle applicator and released. The released "H" Fix produces a holding (compressive) force across the tear causing tissue apposition, which allows the natural healing process (at the tear) to occur.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
meniscal tissue of the knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Mitek polypropylene non absorbable "H" Fix pull tests from bovine meniscus provided an average failure load of 16.29 pounds. The Mitek "H" device showed a significantly greater failure force than the predicate Acufex "T" Fix device when tested in the bovine meniscus.
Key Metrics
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Predicate Device(s)
ACUFEX "T" FIX DEVICE NON ABSORBABLE SUTURE
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/0 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, sans-serif font on the top line. The word "PRODUCTS" is in a smaller, sans-serif font on the bottom line.
Image /page/0/Picture/2 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, bold, sans-serif font. Below the company name is the text "a Johnson Johnson company" in a smaller, serif font. The logo is simple and professional, reflecting the company's focus on medical devices and supplies.
60 GI ACIER DRIVE . WESTWOOD . M OLACIEN DHIVE - WESTVLL-FREE (800) 356-4835 • FAX (617) 461-9166
NOV I O
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK POLYPROPYLENE "H"DEVICE
CONTACT
Edward F. Kent Vice President Requlatory Affairs & Quality Assurance August 11 1997
DATE
NAME OF DEVICE
CLASSIFICATION NAME COMMON NAME PROPRIETARY NAME
产 MITÊK POLYPROPYLENE "H" DEVICE
PREDICATE DEVICE
ACUFEX "T" FIX DEVICE NON ABSORBABLE SUTURE
DESCRIPTION OF DEVICE
FUNCTION
To hold (meniscal) soft tissue in apposition during the healing tirne period.
DEVICE DESIGN
The "H" Fix is cylindrical in cross section and configured to have one leg of the letter "H" in a 90 degree opposed position to the other.
::
MATERIALS USED
The Mitek non absorbable "H" Fix is made from polypropylene.
INTENDED USE
The device is surgically placed across (through) a tear in the meniscal tissue of the knee with a needle applicator and released. The released "H" Fix produces a holding (compressive) force across the tear causing tissue apposition, which allows the natural healing process (at the tear) to occur.
COMPARISON TO PREDICATE DEVICE(S)
The Mitek polypropylene"H" Fix device is similar to the Acufex T-Fix device in function and material, non absorbable biocompatible polymers. The T-Fix is surgically placed through a tear in the knee meniscus, toggled and then tied with sutures over external tissues to hold the "T" in place. The "H" Fix is placed through the tear in a cannulated needle and extended into the tissue, the spring forces in the material are induced by proper placement in the tissue and by the device length.
000025
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DESCRIPTION OF NON CLINICAL TESTS
The Mitek polypropylene non absorbable "H" Fix pull tests from bovine meniscus provided an average failure load of 16.29 pounds. The Mitek "H" device showed a significantly greater failure force than the predicate Acufex "T" Fix device when tested in the bovine meniscus.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. 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 1 0 1997
Mr. Edward F. Kent Vice President, Regulatory Affairs Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts
K973009 Re : Mitek Non Absorbable "H" Fix Trade Name: Requlatory Class: II Product Codes: MBI and HRX Dated: August 12, 1997 Received: August 13, 1997
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 regulations affecting your device can be found in the Code of Federal Requlations, 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 Requlation {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 requlations.
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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 diaqnostic 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.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Mitek meniscal fasteners ( "H" Fix) are Indications For Use:
)
intended for the repair of torn meniscal tissue as well as the repair of a separation of the meniscus from the synovium.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature of
(Divisiah Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use X) (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96) --