(32 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical characteristics of a synthetic mesh, with no mention of AI or ML technologies.
No
The device is a synthetic mesh for tissue reinforcement, acting as a structural support rather than directly treating a medical condition or disease.
No
The device is a synthetic mesh indicated for tissue reinforcement and stabilization, serving as mechanical support or bridging material. It is implanted to treat fascial defects and does not diagnose disease or conditions.
No
The device description clearly states it is a "Synthetic Mesh" manufactured from "monofilament polypropylene fibers," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a "synthetic mesh" made of "monofilament polypropylene fibers" that is "supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon." This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, Polyform™ Synthetic Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Product codes
OTO
Device Description
Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 Polyform™ Synthetic Mesh 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 nonsensitizing to biological tissues consistent with their intended use.Updated test data on the bench and the rodent, as summarized in the updated product brochure, shows comparable technical properties to the more contemporary material properties like those in the Gynemesh PS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
SUBMITTED FOR:
| Company Name: | Proxy Biomedical, Ltd. |
|---|---|
| Address: | Coilleach, Spiddal |
| Galway, IRELAND | |
| Caitriona Conneely, Quality Assurance Manager |
Tel: 353 91 896900
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: PROCODE CLASS/REGULATION: FDA REVIEW PANEL:
Elaine Duncan September 4, 2012 (revised) Polyform™ Synthetic Mesh Surgical Mesh OTO Class II/21 CFR878.3300 Obstetrics/Gynecology
SUBSTANTIALLY EQUIVALENT TO: Polyform™ Synthetic Mesh is substantially equivalent to the Mersilene Mesh (Ethicon, Inc.), the Prolene Soft Mesh (Ethicon, Inc.), and the Bard Mesh (C.R. Bard, Inc.) a polypropylene mesh.
DESCRIPTION of the DEVICE:
Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.
INDICATIONS FOR USE:
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
SUMMARY of TESTING:
Bench test data reveal Polyform™ Synthetic Mesh 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 nonsensitizing to biological tissues consistent with their intended use.Updated test data on the bench and the rodent, as summarized in the updated product brochure, shows comparable technical properties to the more contemporary material properties like those in the Gynemesh PS.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
OCT 25 2012
Proxy BioMedical, Ltd. % Elaine Duncan, M.S.M.E., RAC President Paladin Medical Incorporated P.O. Box 560 STILLWATER MN 55082-0560
Re: K051245
Trade/Device Name: Polyform™ Synthetic Mesh Regulation Number: 21 CFR § 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTO Dated (Date on orig SE Itr): May 11, 2005 Received (Date on orig SE ltr) : May 16, 2012
Dear Ms. Duncan:
This letter corrects our substantially equivalent letter of June 17, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drue. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
2
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hubert Humphrey
Image /page/2/Picture/7 description: The image shows a handwritten signature. The signature is in cursive and appears to be a single word or name. The writing is dark and bold against a white background. The signature has a loop at the beginning and a flourish at the end.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Polyform™ Synthetic Mesh Device Name:
Indications for Use:
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harlan Leess
4
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ਕਾ ਹੈ ਰਿਹੜ੍ਹ ਸਾਹਿਤ . . . .
j lei feroda ling Bellimanyo de la comment in suvelle
ਸਾਰ ਸਾਰ ਦੀ ਇੱਕ ਪਾਕਾਬਕ ਸਿੰਘ ਸ
അമേരിക്കുന്നു. അവിടെ പ്രവാലങ്ങൾ
പ്രവാന്യ വാഹ്യമായിരുന്നും വാഹ്യമായിരു
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(TTO-npi2 noiziviO) ນັກຣ໌ ໄຣຕອ
SEAN FRINGER MACH A PECIL A SACHING ACCREACH A CON CARA SE : : : : :
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Urologiical Devices 10(1/1) Murphs: --------------------------------------------------------------------------------------------------------------------------------------------------------------