The 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 or sub lay approach in adults (greater than 21 years of age).

Device Description

The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established 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 Meshare 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 swaged 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.

AI/ML Overview

This FDA 510(k) summary does not describe a study involving a medical device with acceptance criteria and performance results in the way one would typically expect for a diagnostic or AI-driven device. Instead, it concerns a surgical mesh (T-Line Hernia Mesh) and its substantial equivalence to previously cleared versions of the same product.

The primary goal of this submission (K232924) was to add a smaller size of the T-Line Hernia Mesh to its product line, based on customer feedback. Therefore, the "study" described is a performance evaluation to demonstrate that this new size meets the same safety and effectiveness standards as the existing, cleared mesh products.

Here's the breakdown based on your request, with an emphasis on how it applies to this specific submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on prior clearances)	Reported Device Performance (for the new, smaller size)
Safety	No new risks associated with the modified (smaller) T-Line Hernia Mesh. Biocompatibility, sterility, mechanical properties (e.g., tensile strength, tear strength, burst strength), and material characteristics (e.g., pore size, density) comparable to predicate.	A risk analysis was conducted, confirming no new risks. The modified T-Line Hernia Mesh continues to meet pre-determined functional and performance requirements and external standard requirements.
Effectiveness/Function	Maintenance of intended function for reinforcement of soft tissue for ventral hernia repair. Performance comparable to predicate devices in surgical use.	The modified T-Line Hernia Mesh continues to meet pre-determined functional and performance requirements and external standard requirements.
Technological Characteristics	Material (polypropylene monofilament yarn), manufacturing process (knitting and heat pressing), design (continuous, uninterrupted, seamless extensions with swaged needles) remain consistent with predicate, differing only in physical dimensions.	The device's technological characteristics are identical to the predicate in terms of intended use, indications for use, function, technology, safety, performance, and procedural steps, with the only change being the addition of a smaller size.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a distinct "test set" in the context of clinical data for the new, smaller mesh size. The performance evaluation likely involved bench testing of the new mesh size. The "sample size" for such tests would refer to the number of physical mesh samples subjected to various mechanical and material property tests. This information is not provided in this summary.
Data Provenance: Not applicable in the context of clinical trial data. The device is manufactured by Deep Blue Medical Advances, Inc. in Durham, NC, USA. The performance data would originate from their internal testing.
Retrospective or Prospective: Not applicable for a device modification of this nature, which primarily relies on bench testing and comparison to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a diagnostic device where expert ground truth on medical images or patient conditions is required. The assessment is based on engineering and material science principles, and comparison to existing, cleared products.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. The evaluation focuses on physical and material properties and risk analysis.

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. This is not an AI-driven or diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is implied by the established performance specifications and material properties of the previously cleared predicate T-Line Hernia Mesh devices (K230227, K221556, K193144), as well as relevant external standards for surgical mesh. The new, smaller mesh size must demonstrate that it meets these same pre-determined physical, chemical, and mechanical requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device submission.

In summary: K232924 is a submission for a minor modification (addition of a smaller size) to an already cleared surgical mesh. The "study" involves performance testing and risk analysis to confirm that the new size maintains the same safety and effectiveness profile as the predicate devices, rather than a clinical study establishing new efficacy or diagnostic performance. The acceptance criteria are essentially that the modified device's performance, material characteristics, and risk profile are equivalent to its previously cleared versions and comply with relevant standards.

Summary

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October 18, 2023

Deep Blue Medical Advances, Inc. % Diana Degregorio Regulatory Affairs Consultant Lince Consulting, LLC 111 Deerwood Road Suite 200 San Ramon, California 94583

Re: K232924

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: September 19, 2023 Received: September 19, 2023

Dear Diana Degregorio:

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 (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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Tek N. Digitally signed by Tek N. Lamichhane -S Lamichhane -S Date: 2023.10.18 22:28:45 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K232924

Device Name T-Line Hernia Mesh

Indications for Use (Describe)

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

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	October 18, 2023
SUBMITTER	Deep Blue Medical Advances, Inc.701 W Main Street, Suite 410Durham, NC 27701Phone: (919) 914-6039Establishment Registration No.: 3017492634
CONTACT PERSON	Diana DeGregorioLincé Consulting, LLCPhone: (925) 980-8047Email: ddegregorio@linceconsulting.com
DEVICE	T-Line® Hernia MeshCommon Name: Surgical MeshProduct Code(s): FTLCFR Classification and Name: 21 CFR§878.3300Mesh, Surgical, Polymeric
PREDICATE DEVICE	T-Line Hernia Mesh (K230227, K221556, K193144)Product Code(s): FTLCFR Classification and Name: 21 CFR§878.3300Mesh, Surgical, Polymeric
DEVICE DESCRIPTION	The T-Line Hernia Mesh is manufactured by knitting and heat pressingstandard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture othercommercially available hernia meshes. Mesh extensions are used toapply the device to the abdominal wall. The extensions of the T-LineHernia Meshare incorporated directly into the mesh body. The meshdesign incorporates continuous, uninterrupted, seamless extensions fromthe mesh body to facilitate mesh securement to tissue. After knitting,needles are swaged onto the ends of the extensions to allow theextensions to be sewn into the abdominal fascia by surgeons akin to howsutures are sewn into fascia.
INTENDED USE	The T-Line Hernia Mesh is indicated for the reinforcement of soft tissuewhere weakness exists for the repair of ventral hernias performed via anopen onlay or sublay approach in adults (greater than 21 years of age).
COMPARISON TOPREDICATETECHNOLOGICALCHARACTERISTICS	The T-Line Hernia Mesh is substantially equivalent to the T-Line HerniaMesh cleared under K230227, K221556 and K193144. The subject andpredicate devices are identical in terms of intended use, indications foruse, function, technology, safety, performance as well as proceduralsteps and labeling. This 510(k) was limited to the addition of a smaller

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size of the T-Line Hernia Mesh based on customer feedback.

PERFORMANCE A risk analysis was conducted and confirmed there are no new risks associated with the subject T-Line Hernia Mesh. Appropriate evaluations DATA have demonstrated that the modified T-Line Hernia Mesh continues to meet the same pre-determined functional and performance requirements and external standard requirements as the predicate device and do not raise any new questions of safety or effectiveness.

CONCLUSION Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate and reference devices, substantial equivalence of the modified T-Line Hernia Mesh has been demonstrated.

Regulation Number and Section

§ 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.