(29 days)
Bard PTFE Mesh (Davol Inc.), Mersilene Mesh (Ethicon, Inc.), Bard Mesh (C.R. Bard, Inc.)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technology.
Yes
The device is described as "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," which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is a surgical mesh intended for repair and reinforcement of hernias and fascial defects, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a physical, non-absorbable, synthetic mesh made of knitted polypropylene filaments, which is a hardware component.
No, 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 mesh intended to assist in the repair and/or reinforcement of hernia and other fascial defects. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a non-absorbable, synthetic mesh made of polypropylene, designed to be implanted surgically.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The information provided describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
Proxy Biomedical VITAMESH™ surgical mesh 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
FTI, FTL
Device Description
The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ 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
Bench test data demonstrate that VITAMESH™ 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.
Key Metrics
Not Found
Predicate Device(s)
Bard PTFE Mesh (Davol Inc.), Mersilene Mesh (Ethicon, Inc.), Bard Mesh (C.R. Bard, Inc.)
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
MAR 2 8 2006
K060520
Page 1 of 1
SECTION 1 510(k) Summary
SUBMITTED FOR:
| Company Name: | Proxy Biomedical, Ltd. |
|---|---|
| Address: | 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: | Elaine Duncan |
| DATE PREPARED: | Feb 11, 2006 |
| TRADE NAME: | VITAMESH™ |
| COMMON NAME: | Surgical Mesh |
| REGULATORY CLASS: | This device is class II |
| DEVICE PANEL AND PRODUCT CODE: | General and Plastic Surgery |
| 21 CFR 878.330 FTI |
SUBSTANTIALLY EQUIVALENT TO: VITAMESH™ is substantially equivalent to the Bard PTFE Mesh. (Davol Inc.),Mersilene Mesh (Ethicon, Inc.), and the Bard Mesh (C.R. Bard, Inc.) a polypropylene mesh.
DESCRIPTION of the DEVICE:
The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
INDICATIONS FOR USE:
Proxy Biomedical VITAMESH™ surgical mesh 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 demonstrate that VITAMESH™ 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.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Proxy Biomedical, Ltd. c/o Paladin Medical, Inc. Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082
Re: K060520
Trade/Device Name: VITAMESH™ MacroPorous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 23, 2006 Received: February 27, 2006
Dear Ms. Duncan:
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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (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 such 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 docs 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC
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. 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 vours.
Hubert Lemmer MD
$
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KO60520 510(k) Number (if known):
Device Name: VITAMESH™ MacroPorous PP Surgical Mesh
Indications For Use:
Proxy Biomedical VITAMESH™ surgical mesh 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Lemons
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K060520
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