K Number
K163212
Device Name
Parietene DS Composite Mesh
Date Cleared
2017-06-29

(225 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.
Device Description
Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh. -The macroporous textile is knitted from a permanent monofilament polypropylene yarn. - The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide. - The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking. - The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures. The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.
More Information

Not Found

No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML.

Yes
The device is a surgical mesh intended for the reinforcement of abdominal wall soft tissue, which qualifies it as a therapeutic device.

No

The device is a surgical mesh intended for reinforcing abdominal wall soft tissue, not for diagnosing medical conditions.

No

The device description clearly details a physical mesh made of various materials (polypropylene, synthetic copolymer, etc.) and includes information about bench and animal testing, indicating it is a physical medical device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "reinforcement of abdominal wall soft tissue where a weakness exists" and "repair of ventral hernias or other abdominal fascial deficiencies." This describes a surgical implant used directly on the patient's body.
  • Device Description: The description details a physical mesh composed of textiles and films, designed for surgical implantation ("placed in an intraperitoneal site by a laparoscopic or open approach").
  • 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 compatibility testing.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support.

N/A

Intended Use / Indications for Use

Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.

Product codes (comma separated list FDA assigned to the subject device)

FTL

Device Description

Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh.

The macroporous textile is knitted from a permanent monofilament polypropylene yarn.
The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide.
The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking.
The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures.

The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal wall

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)

In vitro (bench) tests were performed in accordance with the "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999 to evaluate the performance characteristics of the subject Parietene™ DS Composite Mesh in comparison with the predicate Proceed™ Surgical Mesh (K060713). The following mesh characteristics were assessed: Pore size, Thickness, Surface density, Bursting strength, Bursting distension, Breaking strength, Elongation at break, Tear strength, Suture pull-out strength.

Knot-pull tensile strength and suture pull-out tests were performed on the pre-placed sutures of the subject Parietene™ DS Composite Mesh to demonstrate conformity to USP monograph for non-absorbable surgical suture and to assess the strength of the textile/suture assembly.

Trocar passage testing was conducted to demonstrate that the integrity of the mesh is preserved when used by laparoscopy.

In vivo pre-clinical tests on representative animal models were conducted in comparison with the predicate Proceed™ Surgical Mesh (K060713) to evaluate the tissue integration and to demonstrate the minimizing tissue attachment performance in case of contact with viscera.

Stability study was conducted and the proposed device shelf life was demonstrated.

Biocompatibility tests were performed to confirm that Parietene™ DS Composite Mesh and its constitutive components are compliant with ISO Standard 10993-1 for their intended patient contact profile.

Usability tests were conducted and demonstrate that the subject Parietene™ DS Composite Mesh is safe and effective for the intended users, uses and use environments.

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

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.

K060713

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 29, 2017

Sofradim Production % Ms. Mary Mellows Regulatory Affairs Manager Covidien 60 Middletown Avenue North Haven, Connecticut 06473

Re: K163212

Trade/Device Name: Parietene Ds Composite Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 29, 2017 Received: June 5, 2017

Dear Ms. Mellows:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

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)

K163212

Device Name

Parietene™ DS Composite Mesh

Indications for Use (Describe)

Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.

Type of Use (Select one or both, as applicable)

2 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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510(k) Summary of Safety and Effectiveness

Date Prepared:

November 14, 2016

Submitter:

Sofradim Production (subsidiary of Covidien IIc) 116, avenue du Formans 01600 Trevoux, France +33 (0)4 74 08 90 00 Telephone: +33 (0) 4 74 08 90 02 Fax:

Contact:

Mary Mellows Regulatory Affairs Manager

Covidien 60 Middletown Avenue North Haven, CT 06473, USA

(203) 492-5284 Telephone: (203) 492-5029 Fax: Email: mary.e.mellows@medtronic.com

Name of device:

Trade/Proprietary name:Parietene™ DS Composite Mesh
Common name:Surgical Mesh
Classification name:Mesh, Surgical, Polymeric
• Panel number and product code: 7
  • 9 FTL • Regulation number: 21 CFR 878.3300

Predicate Device:

Trade/Proprietary name:Proceed™ Surgical Mesh
Common name:Surgical Mesh
Classification name:Mesh, Surgical, Polymeric
• Panel number and product code: 79 FTL
• Regulation number: 21 CFR 878.3300
510(k) Number:K060713
Manufacturer:Ethicon
Reason for 510(k) Submission:To obtain market clearance for the Parietene™ DS Composite Mesh.
Device Description:Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the

4

mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh.

-The macroporous textile is knitted from a permanent monofilament polypropylene yarn.

  • The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide.

  • The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking.

  • The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures.

The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.

Intended Use: Parietene™ DS composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists.

Parietene™ DS composite mesh is intended for the reinforcement Indications for use: of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.

Summary comparing The subject Parietene™ DS Composite Mesh is substantially equivalent to the predicate device Proceed™ Surgical Mesh the (K060713) in terms of indications and design for the following characteristics of the subject and predicate technological characteristics: device:

  • Polypropylene textile performance
  • Minimizing tissue attachment layer ●
  • Design: composite mesh with equivalent shapes and sizes ●

Materials: Parietene™ DS composite mesh and its constitutive components have been evaluated and found compliant with ISO Standard 10993-1.

  • Performance data: The following performance data is provided in support of the substantial equivalence determination:
    In vitro (bench) tests have been performed in accordance with the "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999 to evaluate the performance characteristics of the subject Parietene™ DS Composite Mesh in comparison with the predicate Proceed™ Surgical Mesh (K060713). The following mesh characteristics were assessed:

5

  • Pore size
  • · Thickness
  • Surface density .
  • Bursting strength .
  • . Bursting distension
  • . Breaking strength
  • Elongation at break .
  • · Tear strength
  • Suture pull-out strength .

Knot-pull tensile strength and suture pull-out tests were performed on the pre-placed sutures of the subject Parietene™ DS Composite Mesh to demonstrate conformity to USP monograph for non-absorbable surgical suture and to assess the strength of the textile/suture assembly.

Trocar passage testing was conducted to demonstrate that the inteqrity of the mesh is preserved when used by laparoscopy.

  • . In vivo pre-clinical tests on representative animal models were conducted in comparison with the predicate Proceed™ Surqical Mesh (K060713) to evaluate the tissue integration and to demonstrate the minimizing tissue attachment performance in case of contact with viscera.
  • . Stability study was conducted and the proposed device shelf life was demonstrated.
  • . Biocompatibility tests were performed to confirm that Parietene™ DS Composite Mesh and its constitutive components are compliant with ISO Standard 10993-1 for their intended patient contact profile.
  • . Usability tests were conducted and demonstrate that the subject Parietene™ DS Composite Mesh is safe and effective for the intended users, uses and use environments.

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Conclusion:

All testing demonstrates that the subject Parietene™ DS Composite Mesh is substantially equivalent to the predicate device, Proceed™ Surgical Mesh (K060713).