(177 days)
No
The summary describes a physical mesh device for hernia repair and does not mention any computational or data-driven components.
No
The device is a surgical mesh intended for reinforcing soft tissue, not for providing therapy. Its purpose is mechanical support and reinforcement.
No
The device is a surgical mesh intended for the reinforcement of abdominal wall soft tissue, not for diagnosing conditions.
No
The device description clearly states it is a "three-dimensional device made out of polypropylene monofilament textile knitted in one-piece," indicating it is a physical mesh, 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 the "reinforcement of abdominal wall soft tissue where a weakness exists" and "open repair of groin hernia defects." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "three-dimensional device made out of polypropylene monofilament textile knitted in one-piece" designed for "extraperitoneal placement by open approach." This is a physical mesh intended for surgical implantation.
- 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 outside the body to analyze samples. This device is used inside the body as a surgical implant.
N/A
Intended Use / Indications for Use
Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Duatene™ Bilayer Mesh is designed to be placed in an extraperitoneal site by open approach. Duatene™ Bilayer Mesh is a three-dimensional device made out of polypropylene monofilament textile knitted in one-piece. The three-dimensional textile is composed of: a posterior textile layer which is circular or elliptic in shape (for preperitoneal placement) an anterior textile layer which is oblong in shape (for onlay placement) The two textile layers are designed with differentiated knitting patterns, adapted to the function of each layer. The two layers are linked by crossing threads from both textiles. The mesh is designed to be placed over the groin region to ensure long term reinforcement of soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, groin region
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: 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 Duatene™ Bilayer Mesh in comparison with the predicate Prolene™ (Polypropylene) Hernia System (K984220). The mesh characteristics assessed were: Pore size, Thickness, Surface density, Bursting strength, Bursting distension, Breaking strength, Elongation at break, Tear strength, Suture pull-out strength. The reference device Parietene™ Macroporous Mesh (K142091) was introduced to confirm no issues associated with mechanical differences. Connector dimensions and breaking strength were compared and found substantially equivalent.
- In vivo pre-clinical tests: Conducted on a representative animal model in comparison with the predicate Prolene™ (Polypropylene) Hernia System (K984220) to evaluate tissue integration. Results demonstrate that no difference was observed.
- Stability study: Conducted and the proposed device shelf-life was demonstrated.
- Biocompatibility evaluation: Performed and confirmed that Duatene™ Bilayer Mesh and its constitutive components are compliant with ISO Standard 10993-1. A chemical and toxicological assessment was performed. Biocompatibility data of the reference device Parietene™ Macroporous Mesh (K142091) was leveraged for genotoxicity and systemic toxicity. Cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogen and implantation studies were performed on the subject device.
- Usability tests: Conducted and demonstrated that the subject Duatene™ Bilayer Mesh is safe and effective for the intended users, uses and use environments.
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.
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.
K142091, K071249, K991400, K140941
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
February 1, 2018
Covidien (Sofradim Production) % Ms. Mary Mellows Regulatory Affairs Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K172395
Trade/Device Name: Duatene™ Bilayer mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: January 2, 2018 Received: January 3, 2018
Dear Ms. Mellows:
We have reviewed vour 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 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.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172395
Device Name Duatene™ Bilayer Mesh
Indications for Use (Describe)
Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) Summary
| Date Prepared: | August 4, 2017 |
|---|---|
| Submitter: | Sofradim Production (subsidiary of Covidien llc) |
| 116, avenue du Formans | |
| 01600 Trevoux, France | |
| Telephone: +33 (0)4 74 08 90 00 | |
| Fax: +33 (0) 4 74 08 90 02 | |
| Contact: | Jose Marquez |
| Regulatory Affairs Manager | |
| Covidien | |
| 60 Middletown Avenue | |
| North Haven, CT 06473, USA | |
| Telephone: (203) 492-7290 | |
| Fax: (203) 492-5029 | |
| Email: jose.a.marquez@medtronic.com | |
| Name of device: | Duatene™ Bilayer Mesh |
| Trade/Proprietary name: Surgical Mesh | |
| Common name: Mesh, Surgical, Polymeric | |
| Classification name: Panel number and product code: 79 FTL | |
| Regulation number: 21 CFR 878.3300 | |
| Predicate Device: | Prolene™ (Polypropylene) Hernia System |
| Trade/Proprietary name: Surgical Mesh | |
| Common name: Mesh, Surgical, Polymeric | |
| Classification name: Panel number and product code: 79 FTL | |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Number: K984220 | |
| Manufacturer: Ethicon | |
| Reference Device: | Parietene™ Macroporous Mesh |
| Trade/Proprietary name: Surgical Mesh | |
| Common name: Mesh, Surgical, Polymeric | |
| Classification name: Panel number and product code: 79 FTL | |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Number: K142091 | |
| Manufacturer: Sofradim Production |
4
| Reference Device: Trade/Proprietary name: | Ultrapro™ Hernia System |
|---|---|
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| 510(k) Number: | Panel number and product code: 79 FTL |
| Regulation number: 21 CFR 878.3300 | |
| Manufacturer: | K071249 |
| Ethicon | |
| Reference Device: | Parietene™ Polypropylene Mesh (modified into Parietene™ Flat Sheet Mesh) |
| Trade/Proprietary name: | Surgical Mesh |
| Common name: | Mesh, Surgical, Polymeric |
| Classification name: | Panel number and product code: 79 FTL |
| Regulation number: 21 CFR 878.3300 | |
| 510(k) Numbers: | K991400, K140941 |
| Manufacturer: | Sofradim Production |
| Reason for 510(k) Submission: | To obtain market clearance for the Duatene™ Bilayer Mesh. |
| Device Description: | Duatene™ Bilayer Mesh is designed to be placed in an extraperitoneal site by open approach. Duatene™ Bilayer Mesh is a three-dimensional device made out of polypropylene monofilament textile knitted in one-piece. The three-dimensional textile is composed of: a posterior textile layer which is circular or elliptic in shape (for preperitoneal placement)an anterior textile layer which is oblong in shape (for onlay placement) The two textile layers are designed with differentiated knitting patterns, adapted to the function of each layer. The two layers are linked by crossing threads from both textiles. The mesh is designed to be placed over the groin region to ensure long term reinforcement of soft tissues. |
| Intended Use: | Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. |
| Indications for use: | Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects. |
| Summary comparing the technological characteristics of the subject and predicate device: | The subject Duatene™ Bilayer Mesh is substantially equivalent to the predicate device Prolene™ (Polypropylene) Hernia System (K984220) in terms of: IndicationsDesign: bilayer mesh linked with connector and equivalent in regards of shapes and sizes of the reference devices Parietene™ Macroporous Mesh (K142091) and Ultrapro™ Hernia System (K071249) |
5
- Polypropylene textile performance, including in regards of mechanical performance of the reference device Parietene™ Macroporous Mesh (K142091)
Duatene™ Bilayer Mesh has been evaluated and found compliant with ISO Standard 10993-1.
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 Duatene™ Bilayer Mesh in comparison with the predicate Prolene™ (Polypropylene) Hernia System (K984220).The following mesh characteristics were assessed:
- Pore size -
Materials:
Performance data:
- -Thickness
- -Surface density
- -Bursting strength
- -Bursting distension
- Breaking strength -
- -Elongation at break
- -Tear strength
- Suture pull-out strength -
The reference device Parietene™ Macroporous Mesh (K142091) is introduced in this submission to confirm that there are no issues associated with the mechanical differences identified in terms of bursting strength, bursting distension, breaking strength, elongation at break, tear strength and suture pull-out strength between the subject Duatene™ Bilayer Mesh and the predicate Prolene™ (Polypropylene) Hernia System (K984220) (refer to section 21 Performance Testing - Bench).
Connector dimensions and breaking strength were compared between the subject device Duatene™ Bilayer Mesh and the predicate device Prolene™ (Polypropylene) Hernia System (K984220) and found to be substantially equivalent.
- In vivo pre-clinical tests on representative animal model were conducted in comparison with the predicate Prolene™ (Polypropylene) Hernia System (K984220) to evaluate the tissue integration. Results demonstrate that no difference was observed between the subject Duatene™ Bilayer Mesh and the predicate Prolene™ (Polypropylene) Hernia System (K984220) in terms of tissue integration.
- Stability study was conducted and the proposed device shelf ●
6
life was demonstrated.
- Biocompatibility evaluation was performed and confirmed that . Duatene™ Bilayer Mesh and its constitutive components are compliant with ISO Standard 10993-1 for their intended patient contact profile. A chemical and toxicological assessment was performed. The biocompatibility data of the reference device Parietene™ Macroporous Mesh (K142091) has been leveraged for genotoxicity and systemic toxicity. Cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogen and implantation studies have been performed on the subject device.
- . Usability tests were conducted and demonstrate that the subject Duatene™ Bilayer 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 demonstrate that the subject Duatene™ Bilayer Mesh is substantially equivalent to the predicate device, Prolene™ (Polypropylene) Hernia System (K984220).