Tisgenx's Bovine Pericardial Tissue Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line during general surgical procedures.

Device Description

The Tisqenx Bovine Pericardial Tissue Patch is a bovine pericardium that is chemically crosslinked using a glutaraldehyde solution to impart stability. The device is provided terminally sterile, packaged in a sterile barrier jar filed with a liquid chemical sterilant. The device is intended for single patient use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency reconstruction and repair, and reinforcing the suture line during general surgical procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Bovine Pericardial Tissue Patch." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a study with human expert review or AI performance metrics.

Therefore, many of the requested details, such as MRMC studies, AI performance metrics, sample sizes for training/test sets for AI, expert qualifications, and ground truth methodologies, are not applicable or not present in this type of submission. This document describes a traditional medical device premarket submission, not an AI/ML device submission.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

Since this is a submission for a traditional medical device (a surgical mesh), not an AI/ML powered device, most of the questions relating to AI/ML specific performance studies (MRMC, standalone AI, training/test sets, expert adjudication for AI ground truth) are not relevant to this document. The "study" here refers to bench testing to demonstrate physical and chemical properties in comparison to a predicate device, not clinical performance studies involving human readers or AI.

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of specific acceptance criteria with numeric performance values from the testing in the same way one would expect for an AI/ML or diagnostic device. Instead, it states that "Performance Testing" was conducted to demonstrate "substantial equivalence" to the predicate device. The acceptable performance is therefore implied to be similar enough to the predicate device for all the mentioned characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Ultimate Tensile Strength	Similar to the predicate
% Elongation	Similar to the predicate
Suture Retention Strength	Similar to the predicate
Crosslinking Validation (DSC, Histology)	Validated
Glutaraldehyde Residuals	(Implicitly within acceptable limits)
Packaging Validation (Leak Test)	Validated
Sterility Test	Validated
Biocompatibility	Conducted in accordance with FDA Guidance for the Use of International Standard ISO 10993-1

Explanation: The document states that these tests were conducted to show that the device's mechanical properties, processing, and safety aspects are "similar to the predicate" or "validated." The exact numerical values for "acceptance criteria" and "reported performance" are not detailed in this public summary, as is common for 510(k) summaries which focus on demonstrating equivalence rather than publishing full test reports.

2. Sample sizes used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided summary. This would typically be detailed in the full test reports, not in the 510(k) summary.
Data Provenance: Not applicable in the context of clinical data. The tests are bench tests of the physical device. Therefore, there's no "country of origin" or "retrospective/prospective" designation for the test data in the sense of patient data.

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. The ground truth for this device (surgical mesh) is established through bench engineering and chemical tests (e.g., tensile testing, chemical analysis, sterility testing), not through human expert review of clinical images or data.

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

Not applicable. There is no human review or "adjudication" in the sense of interpreting outcomes for this type of device and its specific testing outlined.

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

Not applicable. This is not an AI/ML device, nor is it a diagnostic device that would involve human "readers."

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is based on established engineering and biological standards and test methods.

Mechanical Properties: Defined by established ASTM/ISO standards for tensile strength, elongation, suture retention.
Chemical Properties: Defined by methods for glutaraldehyde crosslinking validation and residuals (e.g., Differential Scanning Calorimetry, Histology).
Biocompatibility: Established by ISO 10993-1.
Sterility and Packaging: Established by relevant ISO/AAMI standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device. Device development involves R&D and prototyping, but not in the sense of "training data."

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

Not applicable. As there's no training set for an AI/ML model, there's no ground truth established in this context.

Summary

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June 18, 2019

Tisgenx Kris Kupumbati President 15615 Alton Parkway, Suite 450 Irvine, California 92618

Re: K182493

Trade/Device Name: Bovine Pericardial Tissue Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: May 6, 2019 Received: May 21, 2019

Dear Mr. Kupumbati:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Nina Mezu-Nwaba. PharmD., MPH., MSc. CAPT.. United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices 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) K182493

Device Name Bovine Pericardial Tissue Patch

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5.0: 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information

Name	Tisgenx, Inc.
Address	15615 Alton Parkway, Suite 450Irvine, CA 92618
Telephone	949-315-7157
Contact at Tisgenx Inc.	Kris Kupumbati
Contact Email Address	kris.kupumbati@tisgenx.com
Previous Correspondence	None

Device Information

Trade Name/ Product Name	Bovine Pericardial Tissue Patch
Common/ Usual Name	Surgical Mesh
Regulation Name	Mesh, Surgical
Review Panel	General & Plastic Surgery
Product Code(s)	FTM
Regulation Number	21 CFR 878.3300
Device Class	2

Predicate Device Information

Trade Name/ Product Name	Peripatch Sheet
Manufacturer	PM Devices, Inc.
Common Name	Surgical Mesh
Product Code(s)	FTM
Regulation Number	21 CFR 878.3300
Device Class	2
510(K) Number	K040835

This predicate device has not been subject to a recall.

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5.1 Device Description

5.2 Indications For Use

5.3 Comparison of Technological Characteristics With The Predicate Device

The proposed device has the same or similar material composition and design features as the noted predicate as follows:

Material Composition: Bovine pericardium; same as the predicate.
Processing: Glutaraldehyde crosslinking: same as the predicate, ●
Physical Form: Flat, square & rectangular patches; Same as the predicate. ●
Implant Sizes: Patches of various length & width: similar to the predicate ●
Packaging: Sealed sterile barrier container; Same as the predicate. ●
Sterilization: Liquid chemical sterilization; Similar to the predicate. .
Mechanical Properties: Tensile strength, suture retention strength & % elongation ● are similar to the predicate.

5.4 Performance Data

Biocompatibility Testing

The biocompatibility evaluation for the Bovine Pericardial Tissue Patch device was conducted in accordance with the FDA Guidance for the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016. Biocompatibility evaluation as required for Implant Devices, Circulating Blood Contact, Permanent Duration (>30 days) was considered in accordance with the cited guidance documents and standards.

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Performance Testing

The following bench testing was conducted to demonstrate the substantial equivalence of the Bovine Pericardial Tissue Patch to the predicate device.

Ultimate Tensile Strength, % Elongation ●
Suture Retention Strength .
Crosslinking Validation .
- Differential Scanning Calorimetry (DSC)
- Histology
Glutaraldehyde Residuals ●
Packaging Validation ●
- Leak Test
- ၊ Sterility Test

5.5 Conclusion

The testing conducted supports the Bovine Pericardial Tissue Patch being as safe and effective as the predicate and demonstrates that the device performs as intended. The performance testing conducted demonstrates that the Bovine Pericardial Tissue Patch performs substantially equivalent to the predicate device. Both the Bovine Pericardial Tissue Patch and the predicate device have the same intended use and technological characteristics.

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.