(241 days)
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No
The summary describes a surgical mesh made of polypropylene and focuses on material and manufacturing process changes compared to a predicate device. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is a surgical mesh used for the repair and reinforcement of hernias and other fascial defects, which is a supportive role rather than directly therapeutic.
No
The device is a surgical mesh intended for repair and reinforcement of hernias and fascial defects, not for diagnosis.
No
The device description clearly states it is a "synthetic mesh constructed of knitted filaments of an alternative polypropylene resin," indicating 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 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 in vivo (within the body) during and after wound healing.
- Device Description: The description details a synthetic mesh constructed of knitted filaments of polypropylene resin. This is a physical implant material.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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
FTL
Device Description
The basis for this Traditional 510(k) submission is a material supplier change to the VitaMESH™ Macroporous PP Surgical Mesh. The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.
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
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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
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Summary of Performance Studies
Mechanical testing: The change of polypropylene used for manufacturing of VitaMESH™ does not introduce new risks to mechanical performance as shown by testing. All device specifications for the proposed VitaMESH™ are the same as for the predicate VitaMESH™. Mechanical testing and visual performance testing was performed on VitaMESH™ units manufactured using an alternative polypropylene resin to the predicate. This testing included:
- Aerial density
- Device stiffness
- Tensile strength
- Suture pullout strength
- Tear resistance
- Burst strength
- Pore size
- Mesh thickness
- Surface finish inspection
For product shelf life qualification, an aging study demonstrates that VitaMESH™ manufactured with the alternative polypropylene continues to meet specifications after 5 years accelerated aging both in physical characterization and performance testing. Additionally, a 5 year Real time aging study is in progress to support the above data.
Ethylene Oxide Residual Analysis: Ethylene oxide and ethylene chlorohydrin levels were found to be within limits specified in I.S. EN ISO 10993-7: 2008 'Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7: 2008)'.
Microbiological Testing: A microbiological evaluation was conducted to mitigate against any risks identified in changing from the fibre extruded with the original polypropylene of the predicate to the Bioburden testing carried out on the VitaMESH™ devices manufactured alternative polypropylene. with the alternative polypropylene met Proxy Biomedical Ltd. acceptance criteria. Routine pyrogen testing carried out on the VitaMESH™ devices manufactured with the alternative polypropylene using Linulus Amoebocyte Lysate (LAL) method met all acceptance criteria.
Biocompatibility testing: The change of polypropylene used for manufacturing of the device does not introduce new risks to biological safety. Conformance with biocompatibility requirements is shown in this submission.
The biocompatibility evaluation for the VitaMESH™ Macroporous PP Surgical Mesh manufactured using an alternative polypropylene resin to the predicate was conducted in accordance with I.S. EN ISO 10993-1: 2009 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process'. Testing included Cytotoxicity, irritation, sensitization, and chemical characterization of alternative polypropylene resin.
Chemical analysis: Testing demonstrated comparable chemical constitution.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 30, 2018
Proxy Biomedical Ltd. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K172636
Trade/Device Name: VitaMESH Macroporous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 26, 2018 Received: March 27, 2018
Dear Elaine 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172636
Device Name
VITAMESH™ MacroPorous PP Surgical Mesh
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
| Prescription Use (Ref. 21 CFR 201 Subpart D) | ☒ |
|---|---|
| Over-The-Counter Use (Ref. 21 CFR 201 Subpart C) | □ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SUBMITTER:
K172636, pg. 1 of 4
Submitted on behalf of:
| Proxy Biomedical Ltd. | |
|---|---|
| Coilleach | |
| Spiddal | |
| Galway | |
| Ireland | |
| Contact Person | Adrienne Tierney |
| Phone | 353 (0)91 896934 |
| Adrienne.Tierney@proxybiomedical.com |
by:
| Elaine Duncan, M.S.M.E., RAC | |
|---|---|
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
CONTACT PERSON for SUBMISSION: Elaine Duncan
DATE PREPARED:
August 29, 2017
| Device Trade Name | VitaMESH™ Macroporous PP Surgical Mesh |
|---|---|
| Common Name | Surgical Mesh |
| Classification reference | 21 CFR 878.3300 |
| Regulatory Class | II |
| Product Code | FTL |
| Predicate Device Name | VitaMESH™ Macroporous PP Surgical Mesh |
| Device 510(k) number | K060520 |
DEVICE DESCRIPTION:
The basis for this Traditional 510(k) submission is a material supplier change to the VitaMESH™ Macroporous PP Surgical Mesh. The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.
INDICATION FOR USE:
VitaMESH™ Macroporous PP 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.
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510(k) SUMMARY
BASIS FOR SUBSTANTIAL EQUIVALENCE
K172636, pg. 2 of 4
The predicate VitaMESH™ Macroporous PP Surgical Mesh which was cleared under 510(k) number K060520 is a non-absorbable, synthetic mesh, constructed of knitted filaments of polypropylene. As shown in this submission, the VitaMESH™ with the resin change is the same product as the predicate. The following demonstrates substantial equivalence.
Comparison of VitaMESH™ with alternative material device to predicate device
| Characteristic | VitaMESH™ | VitaMESH™ |
|---|---|---|
| Proposed | Predicate | |
| 510(K) | K172636 | K060520 |
| Material: Chemically, | ||
| Physically, and Biologically | ||
| equivalent. | Alternative Polypropylene | Polypropylene |
- There have been no changes made to the fiber extrusion process.
- No changeshave been made to the manufacturing process (including sterilization) of the finished mesh device.
- . There is no change to the proposed clinical use of the device.
- . No changes have been made to the sterilization method of this device.
- There is no change to the packaging shelf life qualification as a result of this material change to VitaMESH™.
- . The product catalogue range has increased since the original VitaMESH™ submission. The current product sizes are still within the original range of the predicate. . Minor changesto the packaging and labelling since the original submission for the predicate are unrelated to the material change and are summarized in the submission for information only
PERFORMANCE DATA:
The proposed VitaMESH™ has been manufactured with an alternative polypropylene resin to the predicate VitaMESH™ cleared under 510(k) number K060520. This alternative polypropylene has been shown to be substantial equivalent to the polypropylene used in the manufacturing of the predicate. This change was necessitated by the discontinuation of the original raw material polypropylene resin by the supplier. The following evaluations were provided in support of the substantial equivalence determination:
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510(k) SUMMARY
K172636, pg. 3 of 4
Mechanical testing: The change of polypropylene used for manufacturing of VitaMESH™ does not introduce new risks to mechanical performance as shown by testing. All device specifications for the proposed VitaMESH™ are the same as for the predicate VitaMESH™. Mechanical testing and visual performance testing was performed on VitaMESH™ units manufactured using an alternative polypropylene resin to the predicate. This testing included:
- Aerial density
- Device stiffness
- Tensile strength
- Suture pullout strength
- Tear resistance
- Burst strength
- Pore size
- Mesh thickness
- Surface finish inspection
For product shelf life qualification, an aging study demonstrates that VitaMESH™ manufactured with the alternative polypropylene continues to meet specifications after 5 years accelerated aging both in physical characterization and performance testing. Additionally, a 5 year Real time aging study is in progress to support the above data.
Ethylene Oxide Residual Analysis: Ethylene oxide and ethylene chlorohydrin levels were found to be within limits specified in I.S. EN ISO 10993-7: 2008 'Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals (ISO 10993-7: 2008)'.
Microbiological Testing: A microbiological evaluation was conducted to mitigate against any risks identified in changing from the fibre extruded with the original polypropylene of the predicate to the Bioburden testing carried out on the VitaMESH™ devices manufactured alternative polypropylene. with the alternative polypropylene met Proxy Biomedical Ltd. acceptance criteria. Routine pyrogen testing carried out on the VitaMESH™ devices manufactured with the alternative polypropylene using Linulus Amoebocyte Lysate (LAL) method met all acceptance criteria.
Biocompatibility testing: The change of polypropylene used for manufacturing of the device does not introduce new risks to biological safety. Conformance with biocompatibility requirements is shown in this submission.
The biocompatibility evaluation for the VitaMESH™ Macroporous PP Surgical Mesh manufactured using an alternative polypropylene resin to the predicate was conducted in accordance with I.S. EN
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510(k) SUMMARY
K172636, pg. 4 of 4
ISO 10993-1: 2009 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process'. Testing included Cytotoxicity, irritation, sensitization, and chemical characterization of alternative polypropylene resin..
Chemical analysis: Testing demonstrated comparable chemical constitution.
CONCLUSIONS:
Mechanical test data and the determination of biocompatibility as well as chemical characterization demonstrates that the VitaMESH™ Macroporous PP Surgical Mesh manufactured using the alternative polypropylene performs as intended use conditions. In additon, VitaMESH™ devices manufactured using the alternative polypropylene proposed in this substantially equivalent to the predicate device.