(65 days)
Not Found
Not Found
No
The description focuses on the material properties and mechanical characteristics of a surgical mesh, with no mention of AI or ML.
No
The device is a surgical patch intended to repair and/or reinforce fascial defects, providing structural support rather than delivering a therapeutic agent or performing a therapeutic action itself to treat a disease.
No
The device is a surgical patch intended to assist in the repair and/or reinforcement of hernias and other fascial defects. It is used in treatment and repair, not for diagnosing conditions.
No
The device description clearly states it is a physical soft tissue patch made from polytetrafluoroethylene, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing." This describes a surgical implant used directly on the body for structural support.
- Device Description: The description details a "nonabsorbable, inert, sterile, macro porous surgical soft tissue patch" made from polytetrafluoroethylene. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural 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 (comma separated list FDA assigned to the subject device)
FTL
Device Description
MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. 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''+/-.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong 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 the applicant device has mechanical characterisation values, which are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device are 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): 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.
Not Found
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
§ 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
510(k) Summary K05 0678
SUBMITTED FOR:
Company Name: Address:
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 March 14, 2005 MOTIFMESHTM Soft Tissue Patch Surgical Mesh
SUBSTANTIALLY EQUIVALENT TO: MOTIFMESH™ Soft Tissue Patch is substantially equivalent to the Bard PTFE Mesh. (Davol Inc.), Mersilene Mesh (Ethicon) and the Bard Mesh (Davol Inc.), a polypropylene mesh.
DESCRIPTION of the DEVICE:
MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. 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''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
INDICATIONS FOR USE:
MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
SUMMARY of TESTING:
Bench test data reveal the applicant device has mechanical characterisation values, which are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device are 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
MAY 2 0 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. P.O. Box 560 Stillwater, Minnesota 55082
Re: K050678
K050678
Trade/Device Name: MOTIFMESH™ Soft Tissue Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 14, 2005 Received: March 16, 2005
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > I o(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is subserverketed in interst referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Amendments for use stated in the enclosure) to regally manced to career and cal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Registions of the Federal F commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what as provisions of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the gentlal registration, listing of
general controls provisions of the Act include requirements for any provisionaling and general controls provisions of the Act mende requirements as and the submit misbranding and adulteration.
, I
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See and C) mich and (opregulations affecting your device
it may be subject to such additional controls. Existing major regulation FDA it may be subject to such additional controls: Existing major vegan to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Peris 800 to Registe can be found in the Code of Federal Regalations, The C-77 in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substantity of the requirements of the Act
that FDA has made a determination that your device addression . You must that FDA has made a determination hial your de reas by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administers of other was included to: registration and listing (21 l
comply with all the Act's requirements, including, but not assess comply with all the Act s requirements, mendams, our not turing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end 800); end familicable, the electro CFR Part 807); labeling (21 CFR 1 at 601); good manage (200); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
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)
The same of the support of aling of a list of the spivalence of your device to a This letter will allow you to begin hiaketing your active as usesnese of your device to a legally
premarket notification. The FDA finding of substantial equivales of tyour premarket notification. The FDA Iniding of Subscantal organ 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
rs the real and the many of 10, 276, 0115 - Alancelone note the regulation If you desire specific advice for your de not our our our our our one note the regulation entitled, contact the Office of Compliance at (240) 270 - 1 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by reference to prematics nonification (ne Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638– other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance findex html Manufacturers, International and Consumer 713.555ant of the loved in and 10 minuters html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. -Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
05067 8
510(k) Number (if known):
MOTIFMESH™ Soft Tissue Patch
Device Name:
Indications For Use:
MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of a nonabsorbable implant MOTIFMESH™ Soft Tissue Patch is intended to assist in the Icpar and of reason of a nonabsorbable implant
hemia and other fascial defects requiring the additional support of a nerma and after wound healing.
Prescription Use __ × (Part 21 CFR 801 Subpart D)
الد م
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Fart F ST WEET PAGE OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
estorative
12