(130 days)
Mersilene™ Polyester Fiber Mesh - Preamendment device, Symbotex™ Composite Mesh – K142908
Not Found
No
The document describes a physical mesh device and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The intended use and indications for use state that the mesh is intended for soft tissue reinforcement and repair of hernias and fascial deficiencies, which are therapeutic applications.
No
The device is a surgical mesh intended for soft tissue reinforcement and repair of hernias, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "macroporous three-dimensional monofilament polyester textile," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue reinforcement where weakness exists" and "repair of abdominal wall hernias or other fascial deficiencies". This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a physical mesh material made of polyester textile.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Versatex™ Monofilament Mesh is intended for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Versatex™ Monofilament Mesh is made out of a macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Bench testing has been conducted in accordance with FDA's Guidance for Performance data the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the Versatex™ Monofilament Mesh. The following mesh subject characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suture strength. The bench results demonstrate that the device is substantially equivalent to the primary predicate Mersilene™ Polyester Fiber Mesh (Preamendment device).
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.
Mersilene™ Polyester Fiber Mesh - Preamendment device, Symbotex™ Composite Mesh – K142908
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.
Not Found
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2015
Sofradim Production % Ms. Mary Mellows Surgical solutions, a global business unit of Covidien 60 Middletown Avenue North Haven, Connecticut 06473
Re: K150091
Trade/Device Name: Versatex™ Monofilament Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 21, 2015 Received: April 22, 2015
Dear Ms. Mellows:
This letter corrects our substantially equivalent letter of May 26, 2015.
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
1
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 (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known) K150091
Device Name Versatex™ Monofilament Mesh
Indications for Use (Describe)
Versatex™ Monofilament Mesh is intended for the repair of abdominal wail hemias or other fascial deficiencies that require the addition of a reinforcing material.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitter Information | |
|---|---|
| Name | Sofradim Production (subsidiary of Covidien LLC) |
| Address | 116, avenue du Formans |
| 01600 Trevoux, | |
| France | |
| Phone number | +33 (0) 4 74 08 90 00 |
| Fax number | +33 (0) 4 74 08 90 02 |
| Establishment Registration | 9615742 |
| Name of contact person | Mary Mellows |
| Senior Regulatory Specialist | |
| Covidien | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: (203) 492-5284 | |
| Fax: (203) 492-5029 | |
| Date prepared | January 15, 2015 |
| Name of device | |
| Trade or proprietary name | Versatex™ Monofilament Mesh |
| Common or usual name | Surgical Mesh |
| Classification name | Mesh, Surgical, Polymeric |
| Classification panel | General and Plastic Surgery (79) |
| Regulation | 21 CFR 878.3300 |
| Product Code | FTL |
| Legally marketed devices to | |
| which equivalence is claimed | Mersilene™ Polyester Fiber Mesh - Preamendment device |
| Symbotex™ Composite Mesh – K142908 | |
| Reason for 510(k) submission | To obtain market clearance of Versatex™ Monofilament Mesh. |
| Device description | Versatex™ Monofilament Mesh is made out of a macroporous three- |
| dimensional monofilament polyester textile. Largest sizes include a green | |
| dyed monofilament polyester (D&C Green No. 6) marking that is | |
| positioned in the center of the textile to help center and orient the mesh. | |
| Intended use of the device | Versatex™ Monofilament Mesh is intended for soft tissue reinforcement |
| where weakness exists. | |
| Indications for use | Versatex™ monofilament mesh is intended for the repair of abdominal wall |
| hernias or other fascial deficiencies that require the addition of a | |
| reinforcing material. |
4
comparing Summary devices
the The subject Versatex™ Monofilament Mesh is substantially equivalent to technological characteristics the predicate device Mersilene™ Polyester Fiber Mesh (Preamendment of the subject and predicate device) in terms of indications and design for the following technological characteristics:
- Polyester textile performance ।
- Design: flat sheet meshes with equivalent shapes and sizes.
The subject Versatex™ Monofilament Mesh is substantially equivalent to the predicate device Symbotex™ Composite Mesh (K142908) in terms of intended use and design for the following technological characteristics:
- -Same polyester materials and textiles
- -Design: flat sheet meshes with equivalent shapes and sizes.
Bench testing has been conducted in accordance with FDA's Guidance for Performance data the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the Versatex™ Monofilament Mesh. The following mesh subject characteristics were assessed: mesh thickness, pore size, surface density, bursting strength, bursting distension, breaking strength, elongation at break, tear strength, suture strength.
The bench results demonstrate that the device is substantially equivalent to the primary predicate Mersilene™ Polyester Fiber Mesh (Preamendment device).
Versatex™ Monofilament Mesh has the same intended use as the primary predicate Mersilene™ Polyester Fiber Mesh (Preamendment device).
Versatex™ Monofilament Mesh is made out of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-179).
VersatexTM Monofilament Mesh shelf-life has been demonstrated by the stability results of the material and the ability of packaging to maintain the sterile barrier.
In conclusion, all testing demonstrates that the subject VersatexTM Monofilament Mesh is substantially equivalent to the predicate devices.