(22 days)
VitaMesh™ Blue Lightweight 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.
VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.
The provided document is a 510(k) premarket notification for a medical device, VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive clinical study with specified acceptance criteria and detailed performance metrics as would be found in a clinical trial report.
Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of regulatory submission. The document primarily describes design verification and comparative testing to a predicate device.
Here's an attempt to extract relevant information based on the prompt, with clarifications where data is not present:
Acceptance Criteria and Device Performance Study (VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh)
The submission describes the VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh as a modification of a previously cleared device (VitaMesh™ surgical mesh, K060520). The primary and overall "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device. This is achieved by showing that the modifications (addition of a blue colorant and physical property adjustments for lighter/more drapeable mesh) do not introduce new risks and that the fundamental performance remains comparable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Safety: No new risks introduced by modifications. | Biocompatibility: Qualification testing included biocompatibility, showing "comparable safety performance" to the predicate product. |
| Effectiveness/Performance: Fundamental performance not affected by modifications; comparable properties to predicate. | Design Verification Tests: Performed according to 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, March 2, 1999'. These tests "showed comparable properties to the VitaMesh" (predicate). Details of specific metrics (e.g., tensile strength, pore size, burst strength) and their comparative values are not provided in this summary. Animal Implant Comparative Study: Showed "equivalent healing properties" when compared to the predicate product. Specific outcome measures (e.g., tissue integration, adhesion formation) and quantitative results are not detailed. |
| Indications for Use: Same as predicate. | Indications for Use: Identical to the predicate device: "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." |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The submission mentions "design verification tests" and an "animal implant comparative study" but does not give specific numbers of samples or animals used.
- Data Provenance: The studies appear to be pre-market regulatory tests conducted by the manufacturer, Proxy Biomedical Ltd., located in Ireland.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not specified. This type of 510(k) submission does not typically involve expert review panels to establish clinical ground truth in the way a diagnostic AI device might. The "ground truth" here is based on physical property testing and animal study observations, which would be interpreted by qualified laboratory personnel and veterinary pathologists, respectively, but their specific numbers or qualifications are not detailed.
4. Adjudication Method
- Not applicable/Not specified. Adjudication methods (e.g., 2+1) are typically used in clinical studies where multiple human readers interpret data. This submission relies on objective engineering tests and animal study observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a study assessing human reader performance with or without AI assistance. This is a submission for a surgical mesh device.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an AI/algorithm-based device. It is a physical surgical mesh.
7. Type of Ground Truth Used
- For the design verification tests: Objective physical and mechanical properties measured in a laboratory setting (e.g., mesh porosity, weight, tensile strength, drapeability). The detailed metrics and their measurement methodologies would be defined in quality system documents, though not provided in this summary.
- For the animal implant study: Histopathological and macroscopic observations from animal tissue after implantation, comparing healing responses to the predicate device.
8. Sample Size for Training Set
- Not applicable. This medical device is not an AI/machine learning algorithm, so there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
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K 11 1121
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MAY 1 3 2011
SPECIAL 510(k)
Submitter- Manufacturer: Proxy Biomedical Ltd.,
Denise Kennedy ,Quality Assurance Manager
Coilleach, Spiddal, Galway, Ireland. Tel: + 353 91 896900 30048-59928
Submitted by and Contact Person
Elaine Duncan Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
CONTACT PERSON:
Elaine Duncan
DATE PREPARED:
April 14, 2011
TRADE NAME: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh (and as also known by various other trade names)
Surgical Mesh COMMON NAME: Surgical Mesh Polymeric CLASSIFICATION NAME: 21 CFR 878.330D REGULATION General and Plastic Surgery, FTL: Class II PROCODE and CLASS
SUBSTANTIALLY EQUIVALENT TO: VitaMesh™ Blue Lightweight Macroporous PP Mesh is a modification of and is therefore substantially equivalent to VitaMesh™ surgical mesh, cleared under K060520. The addition of a colorant (blue) and modifications to the mesh physical properties do not introduce new risks nor do they affect the fundamental performance of the predicate product.
DESCRIPTION of the DEVICE: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.
INDICATIONS FOR USE: VitaMesh™ Blue Lightweight 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.
SUMMARY of TESTING: Design verification tests were per the requirements of 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, March 2, 1999' and showed comparable properties to the VitaMesh. Additional qualification testing included biocompatibility and animal implant comparative study which showed comparable safety performance and equivalent healing properties when compared to predicate product.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and the USA. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Proxy Biomedical, Ltd. % Paladin Medical, Inc. Ms. Elaine Duncan P.O. Box 560 Stillwater, Minnesota 55082
1 3 2011 MAY
Re: K111121
Trade/Device Name: VitaMesh" Blue Lightweight Macroporous PP Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2011 Received: April 21, 2011
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. 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
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Page 2 - Ms. Elaine Duncan
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/ReportaProblem/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,
Thy B. Rh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K111121 . 510(k) Number (if known):
Device Name: VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh
Indications for Use:
VitaMesh™ Blue Lightweight 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.
Prescription Use _ 2
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kume for MXM
(Division Sign-Off)
Division S (Division of Surgical, Orthopedic, d Restorative Devices
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510(k) Number K11121
§ 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.