(22 days)
Not Found
No
The summary describes a surgical mesh made of synthetic material with a blue colorant. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device is a surgical mesh intended for repair and reinforcement of fascial defects, which is a supportive role rather than a direct therapeutic function to treat a disease or condition.
No
The device, VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, is described as a surgical mesh intended to assist in the repair and/or reinforcement of hernia and other fascial defects. Its function is to provide physical support and reinforcement during wound healing, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "non-absorbable, synthetic mesh," which is a physical hardware component, not software.
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 for the repair and/or reinforcement of hernia and other fascial defects. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a surgical mesh, a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVDs are devices used to perform tests on samples taken from the human body to provide information for medical purposes. This surgical mesh does not fit that description.
N/A
Intended Use / 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.
Product codes
FTL
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 11 1121
page 1 of 1
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.
1
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
2
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
3
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