(156 days)
PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
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.
The provided document is a 510(k) summary for the PARIETEX™ Plug and Patch surgical mesh. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies with specific performance metrics for acceptance criteria in the way a new drug or novel AI device would.
Based on the provided text, there is no detailed information about specific acceptance criteria or an analytical or clinical study designed to prove the device meets such criteria in terms of outcomes or effectiveness on patients. The submission relies on demonstrating technological characteristics equivalency and bench testing.
Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility | In compliance with ISO 10993-1 and/or USP standards. |
| Technological Characteristics | Similar to predicate devices: BARD® MESH PERFIX® PLUG (K922916), PARIETEX PROGRIP™ Mesh (K081050), PARIETEX™ Lightweight Monofilament Polyester Mesh (K090858), PARIETEX™ PARASTOMAL MESH (K081126). |
| Performance Characteristics | Equivalent to predicate devices: PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh, and BARD® Mesh PerFix® Plug (demonstrated via bench testing). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for bench testing.
- Data Provenance: The "Performance Data" section mentions "Bench testing has been conducted," implying laboratory-based testing rather than clinical data from human subjects. No country of origin is specified for this testing. It is inherently retrospective in the sense that it's pre-market testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The evaluation is based on material properties and mechanical performance, not expert-adjudicated clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. No clinical adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This is a medical device (surgical mesh), not an AI diagnostic or assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to ISO 10993-1 and/or USP standards.
- For technological characteristics: Direct comparison to predicate device specifications (e.g., materials, knitted structure).
- For performance characteristics: Results from bench testing (likely mechanical strength, tear resistance, burst strength, etc., though specific metrics are not detailed). The "ground truth" here is the established mechanical properties of the predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a "training set."
Summary of the Study Proving Acceptance Criteria:
The "study" described in this 510(k) summary is primarily focused on bench testing and demonstrating substantial equivalence to already legally marketed predicate devices. The submission indicates that:
- The PARIETEX™ Plug and Patch is made of biocompatible materials that comply with recognized standards (ISO 10993-1, USP).
- Its technological characteristics (e.g., construction from knitted polyester monofilament and polylactic acid) "are similar to those of the predicate devices."
- "Bench testing has been conducted to evaluate the performance characteristics" and has shown the device to be "equivalent in performance characteristics to the predicates PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh and BARD® Mesh PerFix® Plug."
The document does not detail the specific parameters or results of this bench testing, but the FDA's clearance implies satisfaction with this evidence for substantial equivalence. The "acceptance criteria" here are implicitly that the new device's material properties and mechanical performance attributes are within the acceptable range or "equivalent" to the established performance of the predicate devices.
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510(k) Summary of Safety and Effectiveness
NOV - 5 2010
| SUBMITTER: | Sofradim Production116, avenue du formans01600 Trevoux, FrancePhone: 33 0 4 74 08 90 00 |
|---|---|
| CONTACT PERSON: | James McMahonManager, Regulatory AffairsCovidien15 Crosby driveBedford, MA 01730 USAPhone: (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. |
| TECHNOLOGICALCHARACTERISTICS: | 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. |
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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.
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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
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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
§ 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.