(381 days)
ACUFEX "T" FIX DEVICE, PDS II SUTURE
Not Found
No
The device description and intended use focus on a physical implant for meniscal repair, with no mention of software, data processing, or AI/ML terms.
Yes.
The device is described as "intended for use in the repair or torn meniscal tissue" and secures "edges of a tear in the meniscus," which are actions that restore or improve a body function, thus making it a therapeutic device.
No
The device is a meniscal fastener, which is an implant used for repairing tears in the meniscus. Its intended use is therapeutic (repairing torn tissue), not for diagnosing conditions.
No
The device description clearly states it is a molded polymeric implant, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of torn meniscal tissue and synovial separation within the body. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a molded polymeric implant designed to secure tissue edges. This is a physical repair mechanism, not a tool for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for physical repair.
N/A
Intended Use / Indications for Use
Mitek meniscal fasteners "H" Fix PDS are intended for use in the repair or torn meniscal tissue in the red/red zone of the meniscus (outer 1/3 ) as well as the repair of a separation of a synovium.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
To hold outer 1/3 (meniscal) soft tissue in apposition during the healing time period.
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 absorbable "H" Fix is made from PDS (polydioxanone) polymer.
Mitek Meniscal Fasteners are molded polymeric implants used to repair tears in the meniscus. Fasteners provide the means for firmly securing together the edges of a tear in the meniscus or across the synovial meniscal junction. The fasteners are available in absorbable PDS (polydioxanone).
Mitek instruments - Applicator, probe and rasp used to assist in the procedure of measuring, preparing and inserting the Mitek Meniscal Fastener.
A Meniscal Fastener secured in a delivery needle is supplied sterile unless the package is damaged or opened.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscal tissue of the knee, meniscus, synovial meniscal junction
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)
The Mitek absorbable "H" Fix pull tests from cadaver meniscus provided an average failure load of 12.06 pounds.
Studies of the polydioxanone polymer have found it to be nonantigenic, nonpyrogenic, and it elicits only a slight tissue response during healing.
The absorption characteristics of polydioxanone have been extensively studied. The general mechanism by which in vivo degradation of polydioxanone occurs is hydrolysis. The in vivo hydrolysis of polydioxanone cleaves the ester linkages and initially results in the loss of tensile strength. Ultimately the hydrolyzed polymer is eliminated from the body, primarily in urine.
Studies conducted on devices made from polydioxanone polymer indicate minimal absorption until about the 90th post-implantation day.
The results of implantation studies of polydioxanone molded articles in animals indicate that approximately 85% of its original strength remains 5 weeks after implantation. At 7 weeks post implantation approximately 12% of its original strength is retained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACUFEX "T" FIX DEVICE, PDS II SUTURE
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK ABSORBABLE "H" DEVICE
SUBMITTER
NAME ADDRESS
TEL #
CONTACT
DATE
NAME OF DEVICE
CLASSIFICATION NAME COMMON NAME PROPRIETARY NAME
MITEK ABSORBABLE "H" DEVICE
60 Glacier Drive, Westwood, MA 02090
Edward F. Kent Vice President Regulatory
Mitek Products
617-461-9700
January 10, 1997
Affairs
PREDICATE DEVICE
ACUFEX "T" FIX DEVICE PDS II SUTURE
DESCRIPTION OF DEVICE FUNCTION
To hold outer 1/3 (meniscal) soft tissue in apposition during the healing time 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 absorbable "H" Fix is made from PDS (polydioxanone) polymer.
INTENDED USE
The device is surgically placed across (through) a tear in the meniscal tissue of the knee with a needle applicator and 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. The tear in the meniscus for repair with the "H" PDS device should be located in the outer 1/3 zone of the meniscus,i.e., red/red zone.
COMPARISON TO PREDICATE DEVICE(S)
The Mitek absorbable "H" Fix device is similar to the Acufex T-Fix device in function. 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-Fix 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 device length.
DESCRIPTION OF NON CLINICAL TESTS
The Mitek absorbable "H" Fix pull tests from cadaver meniscus provided an average failure load of 12.06 pounds.
1
MITEK MENISCAL FASTENER
Catalog No. XXXXXX Catalog No. YYYYYYY
DESCRIPTION
Mitek Meniscal Fasteners are molded polymeric implants used to repair tears in the meniscus. Fasteners provide the means for firmly securing together the edges of a tear in the meniscus or across the synovial meniscal junction. The fasteners are available in absorbable PDS (polydioxanone).
Studies of the polydioxanone polymer have found it to be nonantigenic, nonpyrogenic, and it elicits only a slight tissue response during healing.
Mitek instruments - Applicator, probe and rasp used to assist in the procedure of measuring, preparing and inserting the Mitek Meniscal Fastener.
ACTIONS
PDS (Polydioxanone)
The absorption characteristics of polydioxanone have been extensively studied. The general mechanism by which in vivo degradation of polydioxanone occurs is hydrolysis. The in vivo hydrolysis of polydioxanone cleaves the ester linkages and initially results in the loss of tensile strength. Ultimately the hydrolyzed polymer is eliminated from the body, primarily in urine.
Studies conducted on devices made from polydioxanone polymer indicate minimal absorption until about the 90th post-implantation day.
The results of implantation studies of polydioxanone molded articles in animals indicate that approximately 85% of its original strength remains 5 weeks after implantation. At 7 weeks post implantation approximately 12% of its original strength is retained.
CONTENTS
A Meniscal Fastener secured in a delivery needle is supplied sterile unless the package is damaged or opened. Do not re-sterilize PDS (polydioxanone).
INDICATIONS
Mitek Meniscal Fasteners are intended for the repair of torn meniscal tissue in the red/red zone of the meniscus (outer 1/3) as well as the repair of a separation of the meniscus from the synovium.
CONTRAINDICATIONS
These fasteners (being absorbable) are not to be used where prolonged ( beyond 6 weeks) approximation of tissue under stress is required.
PRECAUTIONS
- Care should be taken to avoid damage when handling the fasteners. Avoid the crushing of 1. the fasteners by the application of needle holders or forceps.
- A surgeon should not attempt clinical use of the Mitek Meniscal Fasteners before reviewing 2. instructions for use and rehearsing the installation procedure.
- Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. 3.
- Discard used needles in sharps containers. 4.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Edward F. Kent · Vice President, Regulatory Affairs Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090
K970119 Re: Mitek Absorbable Polydioxanone "H" Device Regulatory Class: II Product Code: MBI Dated: January 8, 1998 Received: January 9, 1998
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 and and in
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. ਬੋ 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 described in your sia (x) puivalence of your device to a legally marketed predicate device results in a classification for your markets problems, 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 Other general information on your responsibilities under the Act may be Information on your copyon of Small Manufacturers Assistance obtained from the briver (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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Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Mitek meniscal fasteners "H" Fix PDS
are intended for use in the repair or torn
meniscal tissue in the red/reed zone of the meniscal tissue in the red/red bonbe repair
meniscus (outer 1/3 ) as well as the repair meniscus (Outer 175 ) as well as a separation of a separation of a synovium
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970119
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)