(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and materials of the mesh, with no mention of AI or ML technologies.
No.
The device is indicated for the "reinforcement of soft tissues during repair of inguinal hernia defects," which describes a surgical repair and not a therapeutic function.
No
The device is a surgical mesh used to reinforce soft tissues during hernia repair, which is a treatment or repair function, not a diagnostic one.
No
The device description clearly describes a physical mesh made of polyester, polylactic acid, and collagen, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a mesh made of materials like polyester, polylactic acid, and collagen, designed for physical fixation and support within the body.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for direct surgical implantation in vivo.
N/A
Intended Use / Indications for Use
The PROGRIP™ Laparoscopic Self-Fixating Mesh is used for the reinforcement of tissues during surgical repair. No changes to the intended use have been made in this submission. PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach. No changes to the indication for use have been made in this submission.
Product codes
FTL
Device Description
The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes. The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inguinal hernia defects
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 removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance. The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use. The change in specification does not alter the performance specifications of the PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) and does not require additional performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897)
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
PROGRIP™ Laparoscopic Self-fixating Mesh
Covidien
DEC 1 1 2012
、510(K) SUMMARY
This 510(k) summary of information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
Submitter Information .
| Name: | Sofradim Production |
|---|---|
| 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: | James McMahon (US Agent) |
| Associate Director, Regulatory Affairs | |
| Covidien | |
| 15 Hampshire Street | |
| Mansfield, MA 02048 USA | |
| Phone: 508-452-1545 | |
| Date prepared: | December 4, 2012 |
| Name of device | |
| Trade or proprietary name: | PROGRIP™ Laparoscopic Self-fixating 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 |
Page 1 of 3
1
Covidien
PROGRIP™ Laparoscopic Self-fixating Mesh
Legally marketed devices to
which equivalence is claimed: PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897)
Reason for 510(k) Submission:
To propose the removal of a final product specification (lower specification of extractible pH). This change is supported by a final product specification (gripping points test). The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use. This change does not impact the intended use and does not alter the fundamental scientific technology of the device.
Device description:
The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes.
The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.
Intended use of the device:
The PROGRIP™ Laparoscopic Self-Fixating Mesh is used for the reinforcement of tissues during surgical repair. No changes to the intended use have been made in this submission
Indications for use:
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach. No changes to the indication for use have been made in this submission
Page 2 of 3
2
Covidien
PROGRIP™ Laparoscopic Self-fixating Mesh
Summary comparing the technological characteristics
of the subject and predicate
devices:
The subject PROGRIP™ Laparoscopic Self-Fixating Mesh is identical to the predicate device PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) in terms of its physical, technological characteristics and performance characteristics.
and predicate (K120897) PROGRIP™ proposed The Laparoscopic Self-Fixating Mesh is a monofilament polyester knit with monofilament polylactic acid resorbable grips on one of the sides. The grips allow positioning and fixation of the mesh to surrounding tissue.
Performance data:
The removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance. The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use.
The change in specification does not alter the performance specifications of the PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) and does not require additional performance data.
3
Image /page/3/Picture/0 description: The image shows the 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 entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Sofradim Production % Covidien LLC, Soft Tissue Implants Mr. James McMahon Associate Director, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
December 11, 2012
Re: K123479
Trade/Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh
· Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical mesh
Regulatory Class: II Product Code: FTL Dated: November 09, 2012 Received: November 19, 2012
Dear Mr. McMahon:
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
4
Page 2 - Mr. James McMahon
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 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 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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Peter D. Rumm -S
- Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh
Indications for Use:
PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
Prescription Use_ X (21 CFR 801 Subpart D)
AND/OR
Over-the -Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123479