(258 days)
Not Found
No
The summary describes a surgical mesh, a physical implant, and the performance studies focus on material properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is a surgical mesh indicated for the repair of hernia or other fascial defects, which are conditions that require treatment to restore health. Therefore, it serves a therapeutic purpose.
No
The device, PREMIUM, is a surgical mesh used for repairing hernias or other fascial defects, acting as a reinforcing or bridging material. It is an implant used for structural support during surgery, not for diagnosing medical conditions.
No
The device description explicitly states it is a surgical mesh, which is a physical implant, 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 the device is for the "repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description further clarifies that PREMIUM devices are "surgical meshes" and "parietal reinforcement implants." These are terms associated with surgical devices, not devices used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. The testing mentioned (Tensile strength, Stiffness, etc.) are performance tests for the physical properties of the mesh, not diagnostic tests.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to physically repair defects within the body.
N/A
Intended Use / Indications for Use
PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PREMIUM devices are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product codes
FTL
Device Description
PREMIUM medical devices are surgical meshes with light polypropylene. They are non resorbable parietal reinforcement implants.
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)
PREMIUM conforms to the special control "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh". Testing include: Tensile strength, Stiffness, Suture pullout strength, Burst strength and Tear resistance. No clinical data has been presented.
Non clinical performance testing according to special control demonstrates that PREMIUM is as safe, as effective, and performs as safety and effectively as its predicate devices.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and 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. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
Cousin Biotech Mr. Frank Pelletier Regulatory Affairs Director 8 Rue de L'Abbé Bonpain F 59117 Wervicq-Sud, France
Re: K133889
Trade/Device Name: Premium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 31, 2014 Received: August 4, 2014
Dear Mr. Pelletier:
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 (reporting of medical
1
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/Resourcesfor You/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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Abbreviated 510k PREMIUM
Image /page/2/Picture/1 description: The image shows the word "COUSIN" in large, white, block letters with a black outline. The word is centered over a green diamond shape. Below the word "COUSIN" is a smaller, faded word that appears to be "baseball".
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: PREMIUM Indications for Use:
PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
| Prescription Use
✓ | AND/OR | Over-The-Counter Use
__________ |
|-----------------------------|--------|------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Abbreviated 510k
TOUSIN
PREMIUM
510(k) SUMMARY
As required by section 807.92(c)
| Submitter | COUSIN BIOTECH | |||
|---|---|---|---|---|
| 8 rue de l'Abbé Bonpain | ||||
| F59117 WERVICQ SUD FRANCE | ||||
| Contacts | Franck PELLETIER Regulatory Affairs Director | |||
| f.pelletier@cousin-biotech.com | ||||
| Preparation date | 18 December 2013 | |||
| Trade Name | PREMIUM | |||
| Common Name | POLYMERIC SURGICAL MESH | |||
| Classification Name | MESH SURGICAL POLYMERIC | |||
| Regulation number | 878.3300 | |||
| Product code | FTL | |||
| Class | II | |||
| Legally marketed | ||||
| predicate devices | PREMIUM is compared to PROLENE SOFT (K001122) | |||
| manufactured by ETHICON, INC. | ||||
| Description | PREMIUM medical devices are surgical meshes with | |||
| light polypropylene. They are non resorbable parietal | ||||
| reinforcement implants. | ||||
| Intended Use | PREMIUM devices are surgical meshes that are | |||
| indicated for the repair of hernia or other fascial | ||||
| defects that require the addition of a reinforcing or | ||||
| bridging material to obtain the desired surgical result. | ||||
| Performance data | PREMIUM conforms to the special control "Guidance | |||
| for the Preparation of a Premarket Notification | ||||
| Application for a Surgical Mesh". Testing include: | ||||
| Tensile strength, Stiffness, Suture pullout strength, | ||||
| Burst strength and Tear resistance. | ||||
| No clinical data has been presented. |
4
Abbreviated 510k PREMIUM
Image /page/4/Picture/1 description: The image shows the word "COUSIN" in a stylized font. The word is white with a black outline, and it is set against a green diamond shape. The diamond shape is slightly blurred, and the word "COUSIN" is the main focus of the image.
| Substantial
| equivalence | |
|---|---|
| PREMIUM is substantially equivalent to its predicated | |
| devices in terms of intended use, material, design, | |
| mechanical properties and function. Non clinical | |
| performance testing according to special control | |
| demonstrates that PREMIUM is as safe, as effective, | |
| and performs as safety and effectively as its predicate | |
| devices. |