(77 days)
No
The summary describes a physical surgical mesh and its material properties and performance through bench testing. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.
Yes.
The device is intended for the "repair of hernias or other fascial deficiencies," which describes a therapeutic purpose.
No
The device is a surgical mesh intended for the repair of hernias or fascial deficiencies, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair of hernias or other fascial deficiencies that require the addition of a reinforcing material." This describes a surgical implant used directly in the body during a procedure.
- Device Description: The description details a "non-absorbable synthetic surgical mesh" made of polypropylene. This is a physical material implanted into a patient.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Parietene™ Macroporous Mesh is intended for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.
Intended use of the device: intended for the reinforcement of soft tissue where weakness exists during surgical repair. Indications for use: The Parietene™ Macroporous Mesh is indicated for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.
Product codes
FTL
Device Description
The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique.
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)
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the subject Parietene™ Macroporous Mesh. The following mesh 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 predicate PROLENE™ Soft (polypropylene) Mesh (K001122). Parietene™ Macroporous Mesh is made out of material that has been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-179). Parietene™ Macroporous Mesh shelf-life has been demonstrated by the stability results of the material and the ability of packaging to maintain product sterility per sealing. In conclusion, all testing demonstrates that the subject Parietene™ Macroporous Mesh is substantially equivalent to the predicate Prolene™ Soft Mesh.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROLENE™ Soft (Polypropylene) Mesh (K001122), Parietene™ Flat Sheet Mesh (K140941)
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Sofradim Production % Ms. Jennifer Brennan Covidien LLC Senior Manager, Regulatory Affairs 60 Middleton Avenue North Haven, Connecticut 06473
Re: K142091
Trade/Device Name: Parietene" Macroporous Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 1, 2014 Received: August 1, 2014
Dear Ms. Brennan:
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
1
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/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,
Jiyoung Dang -S
On behalf of 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K142091
Device Name
Parietene™ Macroporous Mesh
Indications for Use (Describe)
The Parietene™M Macroporous Mesh is intended for the repair of 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)
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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:
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FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740
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K142091
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: | Jennifer Brennan |
| Sr. Manager, Regulatory Affairs | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: (203) 492-5346 | |
| Fax: (203) 492-5029 | |
| Date prepared: | July 21st, 2014 |
| Name of device | |
| Trade or proprietary name: | Parietene™ Macroporous 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: PROLENE™ |
| Soft (Polypropylene) Mesh (K001122) Parietene™ | |
| Flat Sheet Mesh (K140941) | |
| Reason for 510(k) submission: | To obtain market clearance of the Parietene™ Macroporous Mesh. |
| Device description: | The Parietene™ Macroporous Mesh |
| is a non-absorbable synthetic surgical mesh made out of bi- | |
| dimensional monofilament polypropylene textile. The Parietene™ | |
| Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre- | |
| cut mesh facilitates the repair of inguinal hernias via the anterior | |
| approach using a tension free technique. |
4
Parietene™ Macroporous Mesh
Intended use of the device: intended for the reinforcement of soft tissue where weakness exists during surgical repair. Indications for use: The Parietene™ Macroporous Mesh is indicated for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material. Summary comparing the technological characteristics of the subject and predicate The subject Parietene™ Macroporous Mesh is substantially equivalent to the devices: predicate device PROLENE™ Soft (Polypropylene) Mesh (K001122) in terms of design for the following technological characteristics: - Indications - Polypropylene textile performance - Design: flat sheet meshes with similar shape and size. The subject Parietene™ Macroporous Mesh is substantially equivalent to the predicate device Parietene™ Flat Sheet Mesh (K140941) in terms of design for the following technological characteristics: - Polypropylene material - Design: flat sheet meshes with similar shape and size. Performance data: Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the subject Parietene™ Macroporous Mesh. The following mesh 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 predicate PROLENE™ Soft (polypropylene) Mesh (K001122). Parietene™ Macroporous Mesh is made out of material that has been evaluated for biocompatibility in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-179). Parietene™ Macroporous Mesh shelf-life has been demonstrated by the stability results of the material and the ability of packaging to maintain product sterility per sealing. In conclusion, all testing demonstrates that the subject Parietene™ Macroporous Mesh is substantially equivalent to the predicate Prolene™ Soft Mesh.