(156 days)
No
The device description and performance studies focus on the physical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is indicated for the "reinforcement of soft tissues during repair of groin hernia defects," which is a therapeutic intervention.
No
Explanation: The device, PARIETEX™ Plug and Patch, is described as a surgical implant for reinforcing soft tissues during hernia repair. Its function is to reinforce tissue, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a kit composed of physical components (patch and disk made of polyester and polylactic acid monofilament), indicating it is a hardware medical device, not software-only.
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 groin hernia defects by open approach." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The device is described as a "kit composed of... a pre-cut non absorbable patch made out of polyester monofilament" and a "semi-absorbable disk." These are physical materials implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device and its intended use do not involve the analysis of such specimens.
Therefore, the PARIETEX™ Plug and Patch is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
Product codes
FTL
Device Description
PARIETEX™ Plug and Patch is a kit composed of:
• A pre-cut non absorbable patch made out of polyester monofilament.
• A semi-absorbable disk made from the assembly of two textile layers. This disk is composed of polyester monofilament and polylactic acid monofilament.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
groin 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)
Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ Plug and Patch. Testing has shown that the PARIETEX™ Plug and Patch is equivalent in performance characteristics to the predicates PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh and BARD® Mesh PerFix® Plug.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K922916, K081050, K090858, K081126
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
510(k) Summary of Safety and Effectiveness
NOV - 5 2010
| SUBMITTER: | Sofradim Production
116, avenue du formans
01600 Trevoux, France
Phone: 33 0 4 74 08 90 00 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James McMahon
Manager, Regulatory Affairs
Covidien
15 Crosby drive
Bedford, MA 01730 USA
Phone: (781) 839 1787 |
| DATE PREPARED: | May 28, 2010 |
| TRADE/PROPRIETARY NAME: | PARIETEX™ Plug and Patch |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric |
| PREDICATE DEVICE(S): | BARD® MESH PERFIX® PLUG (K922916)
PARIETEX PROGRIP™ Mesh (K081050)
PARIETEX™ Lightweight Monofilament Polyester Mesh (K090858)
PARIETEX™ PARASTOMAL MESH (K081126) |
| DEVICE DESCRIPTION: | PARIETEX™ Plug and Patch is a kit composed of:
• A pre-cut non absorbable patch made out of polyester monofilament.
• A semi-absorbable disk made from the assembly of two textile layers. This disk is composed of polyester monofilament and polylactic acid monofilament. |
| INTENDED USE: | PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach. |
| TECHNOLOGICAL
CHARACTERISTICS: | The technological characteristics of PARIETEX™ Plug and Patch are similar to those of the predicate devices. The patch and the disk of the PARIETEX™ Plug and Patch are manufactured with knitted monofilament polyester and monofilament polylactic acid threads. |
| MATERIALS: | PARIETEX™ Plug and Patch is comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards. |
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ Plug and Patch. Testing has shown that the PARIETEX™ Plug and Patch is equivalent in performance characteristics to the predicates PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh and BARD® Mesh PerFix® Plug. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Covidien Mr. James McMahon Manager, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
Re: K101519
Trade/Device Name: PARIETEX™ Plug and Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: October 29, 2010 Received: November 02, 2010
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.
NOV - 5 2010
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.
2
Page 2 - Mr. James McMahon
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 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/ReportalProblem/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,
Mark N Millam
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
NOV - 5 2010
510(k) Number (if known): K101519
PARIETEX™ Plug and Patch Device Name:
Indications For Use:
PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
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 Keene for MXM
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101519