(23 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of surgical mesh, with no mention of AI or ML.
Yes.
The device is described as a surgical mesh intended for the reinforcement of tissue during surgical repair and is indicated for hernia repair. These are therapeutic interventions.
No
This device is a surgical mesh intended for the reinforcement of tissue during surgical repair to fix hernias. It is used during surgery, not to diagnose a condition.
No
The device description clearly indicates that the device is a physical mesh made of polypropylene and polylactic acid, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "reinforcement of tissue during surgical repair" and specifically for "inguinal and incisional hernia repair," "inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair." This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details the physical composition of the mesh (polypropylene, polylactic acid hooks) and its function in providing structural support. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to physically repair tissue.
N/A
Intended Use / Indications for Use
PROGRIP™ Self-Gripping Polypropylene Mesh
PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
PROGRIP™ Self-Gripping Polypropylene Mesh
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue.
A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
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 for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the proposed devices.
Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.
Biocompatibility studies have been conducted on the proposed polypropylene devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)
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.
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
K140941 l of 4
510(k) SUMMARY
.
j
| 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: | Clare Santulli |
| Manager, Regulatory Affairs Covidien | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: | 203-492-7635 |
| Date prepared: | April 11, 2014 |
| Name of device: | |
| Trade or proprietary name: | PROGRIP™ Self-Gripping Polypropylene Mesh |
| Parietene™ Flat Sheet 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 |
1
Legally marketed devices to which equivalence is claimed:
PARIETENE™ PROGRIP™ Mesh (K101197)
PARIETENE™ Polypropylene Mesh (K991400)
Reason for 510(k) Submission:
The purpose of this 510(k) is to notify the agency of the addition of another formulation of raw material, polypropylene, from the yarn supplier who manufactures the monofilament yarns used in the proposed devices. Eventually the current polypropylene will no longer be available by the supplier.
Device description:
PROGRIP™ Self-Gripping Polypropylene Mesh
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue.
A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
Intended use of the device:
PROGRIP™ Self-Gripping Polypropylene Mesh
PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
No changes to the intended use have been made in this submission.
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
No changes to the intended use have been made in this submission
2
Indications for use:
PROGRIP™ Self-Gripping Polypropylene Mesh
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
No changes to the indication for use have been made in this submission
Parietene™ Flat Sheet Mesh
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.
No changes to the indication for use have been made in this submission
Summary comparing the technological characteristics of the subject and predicate devices:
The proposed PROGRIP™ Self-Gripping Polypropylene Mesh and Parietene™ Flat Sheet Mesh manufactured with another formulation of raw material, polypropylene, from the same yarn supplier as the current polypropylene are equivalent to predicate Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400) in terms of the following technological characteristics:
- Indication -
- Raw materials -
- Performance characteristics -
- -Biocompatibility
- Stability -
Performance data:
This change consists of the addition of another formulation of raw material, polypropylene, for the subject devices.
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of the proposed devices.
Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.
3
Biocompatibility studies have been conducted on the proposed polypropylene devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
Conclusion:
The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a stylized representation of the human form.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
Sofradim Production % Ms. Clare Santulli Regulatory Affairs Manager, Covidien 60 Middleton Avenue North Haven, Connecticut 06473
Re: K140941
Trade/Device Name: PROGRIP" Self-Gripping Polypropylene Mesh, Parietene™ Flat Sheet Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 11, 2014 Received: April 14, 2014
Dear Ms. Santulli:
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
5
Page 2 - Ms. Clare Santulli
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Binita S. Ashar 2014.05.07 17:12:16 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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) K 140941
Device Name
PROGRIP™ Self-Gripping Polypropylene Mesh
Parietene™ Flat Sheet Mesh
Indications for Use (Describe)
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh is inguinal hernias, parietal ereinforcement of tissue and abdominal wall hemai repair.
Type of Use (Select one or both, as applicable)
_ 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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