(20 days)
No
The device description and performance studies focus on the physical and mechanical properties of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is a mesh indicated for tissue reinforcement and mechanical support in vaginal wall prolapse, which is a therapeutic intervention.
No
Explanation: The device, Mentor NovaSilk Mesh, is described as a permanent, synthetic knitted polypropylene mesh used for tissue reinforcement and bridging fascial defects. Its purpose is mechanical support in surgical treatment, not to diagnose a condition.
No
The device description clearly states it is a "permanent, synthetic knitted polypropylene mesh," which is a physical hardware component, not software.
Based on the provided information, the Mentor NovaSilk Mesh is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue reinforcement and long-lasting repair of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended." This describes a device used in vivo (within the body) during surgery, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a "permanent, synthetic knitted polypropylene mesh" that is surgically implanted. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
The device is a surgical mesh used for structural support, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Mentor NovaSilk Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Product codes (comma separated list FDA assigned to the subject device)
OTP, PAI, OTO, PAJ
Device Description
NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.
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
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)
The following characteristics were assessed for NovaSilk: overall product dimensions, including fiber and pore sizes; density and porosity; burst and tear strength; tensile morating the elongation; stiffness; suture pull strength; and edge integrity and curling.
The following biocompatibility testing was performed on NovaSilk: pyrogenicity, The forlowing orocompanentic toxicity. NovaSilk has been demonstrated to be nontoxic and non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
0
K053414/1/2
DEC 2 7 2005
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Donna A. Crawford Contact Person: Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111
805-879-6304 Telephone: 805-879-6015 FAX:
December 2, 2005 Date Prepared:
Device Name and Classification
| Proprietary Name: | Mentor NovaSilk™ Mesh |
|---|---|
| Common Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, polymeric |
| Class: | Class II |
| Product Code: | OTP, PAI, OTO, PAJ |
| CFR #: | §878.3300 |
Device Description
NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.
Substantial Equivalence Claim
The Mentor NovaSilk Mesh is substantially equivalent in material, function, performance and design to the Gynemesh Prolene Soft (Polypropylene) Mesh that was cleared under 510(k) K013718. Knitted polypropylene is currently used in Mentor's Aris Sling which was cleared under 510(k) K050148.
1
Image /page/1/Picture/0 description: The image shows a handwritten text string that appears to be an identifier or code. The text reads 'K.053411Y' with a subscript of '2/2' next to the 'Y'. The writing is in a dark ink, contrasting with the white background, and has a casual, handwritten style.
Indications for Use
The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.
Summary of Testing
The following characteristics were assessed for NovaSilk: overall product dimensions, including fiber and pore sizes; density and porosity; burst and tear strength; tensile morating the elongation; stiffness; suture pull strength; and edge integrity and curling.
The following biocompatibility testing was performed on NovaSilk: pyrogenicity, The forlowing orocompanentic toxicity. NovaSilk has been demonstrated to be nontoxic and non-pyrogenic.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111
SEP 2 8 2012
Re: K053414 Trade/Device Name: Mentor NovaSilk Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, OTO, PAJ Dated: December 2, 2005 Received: December 7, 2005
Dear Ms. Crawford:
This letter corrects our substantially equivalent letter of December 27, 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, Drug, 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
3
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 (OS) 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" (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.
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,
Sincerely yours,
Benjamin R. Weeks
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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Mentor NovaSilk™M Mesh
Indications for Use:
....
The Mentor NovaSilk Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical trealment 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)
Sartine BreuilD
and Ne
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510(k) Number K063414