(89 days)
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.
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. The Mitek non absorbable "H" Fix is made from polypropylene.
The provided text describes the "Mitek Polypropylene 'H' Device" and its comparison to a predicate device, the Acufex "T" Fix device. The study described focuses on non-clinical pull tests, rather than clinical studies with human subjects or expert readers.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
| :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Implicit Criterion: The "H" Fix device should demonstrate mechanical strength suitable for its intended function (holding meniscal tissue in apposition during healing) and be at least equivalent to, or superior to, the predicate device. | The Mitek polypropylene non absorbable "H" Fix provided an average failure load of 16.29 pounds in bovine meniscus. |
| Implicit Criterion: The "H" Fix device should demonstrate a significantly greater failure force compared to the predicate device. | The Mitek "H" device showed a significantly greater failure force than the predicate Acufex "T" Fix device when tested in the bovine meniscus. |
Note: The document only provides the performance of the Mitek "H" Fix and states it was "significantly greater" than the predicate. It does not explicitly state the failure load of the Acufex "T" Fix or a specific numerical threshold for "significantly greater." The acceptance criteria are inferred from the comparative nature of the non-clinical test.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "an average failure load" which implies multiple tests were conducted, but the specific number of samples (e.g., number of "H" Fix devices tested, number of bovine menisci used) is not provided.
- Data Provenance: The tests were conducted on bovine meniscus. The country of origin is not specified, and it is a non-clinical (ex-vivo) study, not a human clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical, mechanical pull test. There were no human experts establishing ground truth in the context of diagnostic or clinical outcome assessment. The "ground truth" was the objective measurement of force required for failure.
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Adjudication method for the test set:
- Not Applicable. As a mechanical test, there was no subjective assessment requiring adjudication. The failure load was presumably measured by an instrument.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This was a non-clinical mechanical test, not a study involving human readers or AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This test did not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Failure Load Measurement: The ground truth was the objectively measured force (in pounds) at which the device failed when embedded in bovine meniscus.
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The sample size for the training set:
- Not Applicable. There was no "training set" as this was a non-clinical mechanical performance study, not an AI or machine learning model development.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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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.
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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) --
§ 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.