T-Line Hernia Mesh

K193144 · Deep Blue Medical Advances, Inc. · FTL · Mar 30, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193144
• Device Name: T-Line Hernia Mesh
• Applicant: Deep Blue Medical Advances, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

T-LINE™ HERNIA MESH is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay approach.

Device Story

T-Line Hernia Mesh is a surgical mesh designed for ventral hernia repair. It consists of a polypropylene mesh body with integrated, continuous, seamless extensions. During open onlay surgery, surgeons use needles swaged onto these extensions to sew the mesh directly into the abdominal fascia, similar to suture placement. This design aims to reduce stress at the mesh-tissue-suture interface. The device is intended for use by surgeons in an operating room setting. By providing integrated fixation, the mesh facilitates securement to the abdominal wall, promoting bioincorporation of tissue while reinforcing the weakened area.

Clinical Evidence

Bench testing and in vivo porcine model study. The study compared T-Line Hernia Mesh to the Bard Soft Mesh control in Yucatan pigs over 6 months. Endpoints included histological evaluation of inflammation, bioincorporation, fibrosis, and mesh contraction. Results showed no biologically significant differences between the test and control devices; both elicited equivalent tissue responses and demonstrated stable bioincorporation with no adverse local or systemic effects.

Technological Characteristics

Material: medical grade polypropylene monofilament yarn. Design: large-pore structure, knit mesh with integrated, seamless extensions. Fixation: needles swaged onto extensions for direct fascial suturing. Sterilization: not specified. Connectivity: N/A. Software: N/A.

Indications for Use

Indicated for reinforcement of soft tissue in patients with ventral hernias requiring repair via an open onlay approach.

Regulatory Classification

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.

Predicate Devices

• Bard Soft Mesh (K052155)

Reference Devices

• Ethicon, Inc. PROLENE Polypropylene Suture (K133356)

Submission Summary (Full Text)

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March 30, 2020

Deep Blue Medical Advances, Inc. % Nancy Lince Regulatory Affairs Consultant Lince Consulting, LLC 111 Deerwood Road. Suite 200 San Ramon, California 95483

Re: K193144

Trade/Device Name: T-Line Hernia Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: November 11, 2019 Received: November 13, 2019

Dear Ms. Lince:

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 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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K193144

Device Name T-Line Hernia Mesh

Indications for Use (Describe)

T-LINE™ HERNIA MESH is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay approach.

| 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)

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#### 510(k) Summary

- November 11, 2019 Date Prepared
- SUBMITTER Deep Blue Medical Advances, Inc. 701 W Main Street. Suite 410 Durham, NC 27701 Phone: [phone] Establishment Registration No.: TBD

### Contact Person Nancv Lincé Lincé Consulting, LLC Phone: [phone] Email: [e-mail]

- T-Line™ Hernia Mesh DEVICE COMMON NAME: Surgical Mesh Product Code(s): FTL CFR CLASSIFICATION AND NAME: 21 CFR§878.3300 Mesh, Surgical, Polymeric
- Predicate Device K052155 Bard Soft Mesh Reference Device: K133356 Ethicon, Inc. PROLENE Polypropylene Suture
- DEVICE The T-Line Hernia Mesh is manufactured by knitting and heat pressing DESCRIPTION standard medical grade polypropylene monofilament yarn using wellestablished standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Mesh are incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaqed onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
- T-LINE™ HERNIA MESH is indicated for the reinforcement of soft tissue INTENDED USE where weakness exists for the repair of ventral hernias performed via an open onlay approach.

Comparison to The T-Line Hernia Mesh is substantially equivalent to the Bard Soft Mesh (K052155), which is the primary predicate device. This 510(k) also PREDICATE references the Ethicon, Inc. PROLENE Polypropylene Suture (K133356) to TECHNOLOGICAL address the technological difference (i.e. extensions versus suture fixation) CHARACTERISTICS between the subject and predicate device. The T-Line Hernia Mesh has the same intended use and similar technological characteristics as the predicate surgical mesh device. Specifically, both devices are intended for use in soft tissue reinforcement with similar materials and design characteristics. The characteristics evaluated such as knit, thickness, and filament diameter are within the same ranges. Both devices are designed with a large-pore

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structure to promote bioincorporation of tissue. The primary difference is that the subject device is designed with extensions that are incorporated (sewn) into the fascia to reduce the stresses currently placed on the mesh, tissue. suture interface. The T-Line Hernia Mesh extensions are made from the same polypropylene material as the mesh body and are knit by the loom as part of the mesh knit. The extension surface area is approximately 15 times qreater than the surface area of #0 polypropylene suture.

Based on the results of in vivo testing, the T-Line Hernia Mesh demonstrated PERFORMANCE DATA substantially equivalent safety and performance characteristics when compared to the predicate mesh when performing open hernia repair in a simulated use porcine model. There were no biologically significant differences between histologic and gross findings for up to 6 months postoperatively. All animals showed good bioincorporation and there was no evidence of adverse local or systemic effects of either mesh in any animal. The results revealed a normal inflammatory response to the polypropylene meshes.

> At 1-, 3-, and 6- month post-operative endpoints, histological evaluation of inflammation, bioincorporation and fibrosis at the T-Line Hernia Mesh and Bard Mesh control sites was conducted and associated cellular populations were scored and compared. Additionally, potential mesh contraction was assessed for both test and control mesh over time. Results showed no biologically significant differences between the T-Line Hernia Mesh and predicate Bard Soft Mesh throughout the duration of the study. No clinical observations, changes in clinical pathology parameters, or changes in body weights were linked to either the test or control meshes during the study. Microscopically, the same tissue reactions were seen with both the T-Line and the Control reference mesh, consisting of both inflammatory and reparative processes. From a biological standpoint, the T-Line and Control Reference mesh samples elicited an equivalent overall tissue response. Finally, there were no differences in mesh stability between the T-Line and Control reference mesh at any time point. Results therefore demonstrated equivalent safety and performance between the T-Line Hernia Mesh and predicate Bard Soft Mesh when surgically implanted into Yucatan pigs for up to 6 months.

> Performance specifications for the subject device were derived from a variety of design inputs; including procedural characteristics and requirements, clinical input from physicians, review of predicate device characteristics and labeling, user interface considerations, relevant external standards, and outputs from the company's risk management process. The data showed the T-Line Hernia Mesh functions as intended and does not raise any new issues of safety and effectiveness when compared to the predicate device.

CONCLUSION Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the T-Line Hernia Mesh is substantially equivalent to the currently marketed predicate device.