(91 days)
No
The device description and performance studies focus on the physical properties and biological integration of a surgical mesh, with no mention of AI or ML capabilities.
Yes
The device, Dextile™ Anatomical Mesh, is intended for the reinforcement of soft tissues during repair of inguinal hernia. This acts to treat a medical condition and restore function, classifying it as a therapeutic device.
No
The device is a surgical mesh intended for reinforcement of soft tissues during hernia repair, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a physical mesh made of polypropylene textile, intended for surgical implantation. It is a hardware 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 the "reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a physical mesh made of polypropylene textile, designed for surgical placement.
- Lack of In Vitro Testing: While there are "in vitro (bench) tests" mentioned, these are tests performed on the device itself (like pore size, strength, etc.) and not tests performed on biological samples (like blood, urine, tissue) to diagnose or monitor a condition.
- No Mention of Biological Samples: There is no indication that this device interacts with or analyzes biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.
Product codes
FTL
Device Description
Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (during repair of inguinal hernia by laparoscopic approach)
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)
The following performance data is provided in support of the substantial equivalence determination: In vitro (bench) tests have been performed in accordance with the FDA Guidance "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 Dextile™ Anatomical Mesh in comparison with the predicate 3DMAX™ Light Mesh (K091659). The following mesh characteristics were assessed: Pore size, Surface density, Thickness, Bursting strength, Bursting deflection, Tensile breaking strength, Elongation at break, Tear strength, Suture pull-out strength. Trocar passage testing was conducted to demonstrate that the mesh integrity is preserved when used by laparoscopy. In vivo pre-clinical tests on representative animal model were conducted in comparison with the predicate 3DMAX™ Light Mesh (K091659) to evaluate the tissue integration. Results demonstrate that no difference was observed between the subject Dextile™ Anatomical Mesh and the predicate 3DMAX™ Light Mesh (K091659) in terms of tissue integration. Stability study was conducted, and the proposed device shelf life was demonstrated. Biocompatibility evaluation was performed and confirmed that Dextile™ Anatomical 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 Dextile™ Anatomical Mesh is acceptable 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)
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
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December 6, 2019
Sofradim Production % Angela Arsdale Regulatory Affairs Manager Covidien 60 Middletown Avenue North Haven, Connecticut 06473
Re: K192443
Trade/Device Name: Dextile Anatomical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 4, 2019 Received: September 6, 2019
Dear Angela Arsdale:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192443
Device Name Dextile Anatomical Mesh
Indications for Use (Describe)
Dextile Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repar of inguinal hernia by laparoscopic approach.
Type of Use (Select one or both, as applicable)
| Transactional Use (Per 31 CFR 30.2, Subpart B) |
|---|
| Customer Service Use (Per 31 CFR 30.2, Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | November 26, 2019 |
|---|---|
| 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: | Angela Van Arsdale |
| Regulatory Affairs Manager | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: (203) 492-5787 | |
| Fax: (203) 492-5029 | |
| Email: angela.vanarsdale@medtronic.com | |
| Name of device: | Dextile™ Anatomical 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: | 3DMAX™ Light 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: | K091659 |
| Manufacturer: | Davol Inc., Subsidiary of C.R. Bard, Inc Route 22 West |
| Device Description: | Dextile™ Anatomical Mesh is designed to be placed in a pre- |
| peritoneal site by laparoscopic approach. | |
| The device has an anatomical shape with sealed edges allowing | |
| coverage of inguinal hernia defects and facilitating laparoscopic | |
| mesh deployment and handling. | |
| The mesh is made of a non-absorbable macroporous | |
| monofilament polypropylene textile. | |
| A green marking is placed on the medial side of the mesh to help | |
| positioning and orienting the mesh: "ML" letters designate Medial | |
| Line. The green marking is made of monofilament polyester yarn. | |
| The "D&C Green No. 6" dye is used for the marking. | |
| Intended Use: | Dextile™ Anatomical Mesh is intended for the reinforcement of |
| soft tissue where weakness exists. | |
| Indications for use: | Dextile™ Anatomical Mesh is intended to be used for the |
| reinforcement of soft tissues where weakness exists during repair | |
| of inguinal hernias by laparoscopic approach. | |
| Summary comparing | |
| the technological | |
| characteristics of the | |
| subject and predicate | |
| device: | The subject Dextile™ Anatomical Mesh is substantially equivalent |
| to the predicate device 3DMAX™ Light Mesh (K091659) in terms | |
| of indications and design for the following technological | |
| characteristics: | |
| Design: anatomical shape of the mesh with sealed edges, | |
| presence of a medial marker, three mesh sizes Polypropylene textile performance | |
| Materials: | Dextile™ Anatomical Mesh has 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 FDA Guidance "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 Dextile™ Anatomical Mesh in comparison with the | |
| predicate 3DMAX™ Light Mesh (K091659). The following | |
| mesh characteristics were assessed: Pore size Surface density Thickness Bursting strength Bursting deflection Tensile breaking strength Elongation at break Tear strength Suture pull-out strength Trocar passage testing was conducted to demonstrate that the | |
| mesh integrity is preserved when used by laparoscopy. In vivo pre-clinical tests on representative animal model were | |
| conducted in comparison with the predicate 3DMAX™ Light | |
| Mesh (K091659) to evaluate the tissue integration. Results | |
| demonstrate that no difference was observed between the | |
| subject Dextile™ Anatomical Mesh and the predicate | |
| 3DMAX™ Light Mesh (K091659) in terms of tissue integration. Stability study was conducted, and the proposed device shelf | |
| life was demonstrated. Biocompatibility evaluation was performed and confirmed that | |
| Dextile™ Anatomical Mesh and its constitutive components |
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are compliant with ISO Standard 10993-1 for their intended patient contact profile.
- . Usability tests were conducted and demonstrate that the subject Dextile™ Anatomical Mesh is acceptable 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 Dextile™ Anatomical Mesh is substantially equivalent to the predicate device, 3DMAX™ Light Mesh (K091659).