(77 days)
Not Found
No
The device description and performance studies focus on the material properties and physical design of a surgical mesh with resorbable pins, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a mesh used for anatomical repair (hernia repair) and does not actively treat or prevent disease or otherwise restore function in a therapeutic manner.
No
Explanation: The device is a surgical mesh used for hernia repair, which is a therapeutic intervention, not a diagnostic one. It functions by mechanically supporting tissue, not by detecting or identifying a medical condition.
No
The device description clearly states it is a physical mesh made of knitted monofilament polyester with polylactic acid pins, indicating it is a hardware medical device, 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 inguinal and incisional hernia repair." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a mesh with resorbable pins designed for physical implantation to repair hernias.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
Parietex Progrip™ Mesh is indicated for inguinal and incisional hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Parietex Progrip™ TEM2015G and TEM3015G are rectangular meshes made of knitted monofilament polyester with polylactic acid (PLA) resorbable pins on one of the sides. The PLA pins facilitate placement, positioning and fixation of the mesh to the surrounding tissue.
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)
No additional bench testing has been conducted. The materials of the new Parietex Progrip™ references are identical to the predicate Parietex Progrip™ and therefore, the performance data submitted in the predicate Parietex Progrip™ Traditional 510k (K081050) applies to the two additional sizes.
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.
Parietex Progrip™ Mesh (K081050)
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
Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Sofradim Production
116, avenue du formans
01600 Trevoux, France
Phone: 33 04 74 08 90 00 | MAR - 4 201 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | James McMahon
Manager, Regulatory Affairs
Covidien
15 Crosby Avenue
Bedford, MA 01730
Phone: 781-839-1787 | |
| DATE PREPARED: | December 16th, 2010 | |
| TRADE/PROPRIETARY NAME: | Parietex Progrip™ Mesh (TEM2015G and TEM3015G) | |
| COMMON/USUAL NAME: | Surgical Mesh | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | |
| PREDICATE DEVICE(S): | Parietex Progrip™ Mesh (K081050) | |
| DEVICE DESCRIPTION: | Parietex Progrip™ TEM2015G and TEM3015G are rectangular
meshes made of knitted monofilament polyester with polylactic
acid (PLA) resorbable pins on one of the sides. The PLA pins
facilitate placement, positioning and fixation of the mesh to the
surrounding tissue. | |
| INDICATION: | Parietex Progrip™ mesh is indicated for inguinal and incisional
hernia repair. | |
| TECHNOLOGICAL
CHARACTERISTICS: | Parietex Progrip™ meshes are made with knitted monofilament
polyester and monofilament polylactic acid resorbable pins. The
intended use and fundamental technology of the two additional
sizes, of Parietex Progrip™ Mesh are equivalent to that of the
predicate Parietex Progrip™mesh. | |
| MATERIALS: | Parietex Progrip™ mesh is comprised of biocompatible materials
that are in compliance with ISO 10993-1 standard. | |
| PERFORMANCE DATA: | No additional bench testing has been conducted. The materials of
the new Parietex Progrip™ references are identical to the
predicate Parietex Progrip™ and therefore, the performance data
submitted in the predicate Parietex Progrip™ Traditional 510k
(K081050) applies to the two additional sizes. | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford; Masschusetts 01730
MAR - 4 2011
Re: K103682
Trade/Device Name: Parietex ProGrip™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: February 15, 2011 Received: February 16, 2011
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
2
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 yours,
Aling B. R.te
fa
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references P
Indications For Use
K103682 510(k) Number (if known):
Parietex Progrip™ Mesh Device Name:
Indications For Use:
Parietex Progrip™ Mesh is indicated for inguinal and incisional hernia repair.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kromefh MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number