(8 days)
No
The device description and performance studies focus on the material properties and mechanical characteristics of a surgical mesh, with no mention of AI or ML technology.
Yes
The device is described as assisting in the repair and/or reinforcement of hernia and other fascial defects, which directly addresses a health condition.
No
The device is a surgical patch intended to repair and/or reinforce hernia and other fascial defects, not to diagnose medical conditions.
No
The device description clearly states it is a "non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical patch intended to assist in the repair and reinforcement of hernia and other fascial defects. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant made of expanded polytetrafluoroethylene, designed to be surgically placed to reinforce tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for structural support and repair.
N/A
Intended Use / Indications for Use
MOTIFMESH ™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Product codes
FTL
Device Description
Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench test data reveal MOTIFMESH TM Soft Tissue Patch has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
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AUG 1 1 2005
SECTION 1 510(k) Summary
SUBMITTED FOR:
Proxy Biomedical, Ltd.
Unit 6D, Mervue Business Park Galway, IRELAND Contact Person: Peter Mulrooney, Quality Assurance Manager
Tel: +353 (0)91 709161 Fax: +353 (0)91 709162
Submitted by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
CONTACT PERSON: DATE PREPARED: TRADE NAME: COMMON NAME:
Elaine Duncan August 1, 2005 MOTIFMESHTM Soft Tissue Patch urgical Mesh
SUBSTANTIALLY EQUIVALENT TO: MOTIFMESH™ Soft Tissue Patch with the sinusoidal cell opening is substantially equivalent to the MOTIFMESH™ Soft Tissue Patch with the hexagonal shape previously cleared under K050678.
DESCRIPTION of the DEVICE:
Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.
INDICATIONS FOR USE:
MOTIFMESH ™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
SUMMARY of TESTING:
Bench test data reveal MOTIFMESH TM Soft Tissue Patch has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with their intended use.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
AUG 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Proxy Biomedical, Ltd. c/o Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082-0560
Re: K052100
Trade/Device Name: Modification to Motif Mesh Soft Tissue Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 1, 2005 Received: August 3, 2005
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave acterimerally marketed predicate devices marketed in interstate for use stated in the clerosure) to regarly nameted to of the Medical Device American procession of to conniferee prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassinod in accerative who f a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that to not require appt to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to suell additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods of reacts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr o locality a your device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must of any I cacial statuted and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 81equirements, and manufacturing practice requirements as set CFR Part 877, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Ms. Elaine Duncan, M.S.M.E., RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Brigham
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):_____K052100
Modification to Motif Mesh Soft Tissue Patch Device Name:
'
Indications For Use:
Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
تتخذ بدر
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saulare Buchus
Division of General, Restorative. and Neurological Devices
510(k) Number K052100
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