Bovine Pericardial Tissue Patch

K182493 · Tisgenx · FTM · Jun 18, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K182493
• Device Name: Bovine Pericardial Tissue Patch
• Applicant: Tisgenx
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Bovine pericardial tissue patch; chemically crosslinked with glutaraldehyde for stability. Provided terminally sterile in liquid chemical sterilant. Used by surgeons in OR for cardiac/vascular reconstruction, soft tissue repair, and suture line reinforcement. Acts as structural reinforcement material. Benefits patient by providing stable, biocompatible tissue scaffold for surgical repair.

Clinical Evidence

Bench testing only. Testing included ultimate tensile strength, % elongation, suture retention strength, crosslinking validation (DSC, histology), glutaraldehyde residuals, and packaging/sterility validation. Biocompatibility evaluation performed per ISO 10993-1 for permanent duration, blood-contacting implant devices.

Technological Characteristics

Material: Bovine pericardium. Processing: Glutaraldehyde crosslinking. Form: Flat, square, and rectangular patches. Sterilization: Liquid chemical. Mechanical properties: Tensile strength, suture retention strength, and elongation. No software or electronic components.

Indications for Use

Indicated for patients requiring cardiac and vascular reconstruction and repair, soft tissue deficiency repair, or suture line reinforcement during general surgical procedures.

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

• Peripatch Sheet (K040835)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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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# 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 450<br>Irvine, CA 92618 |
| Telephone | 949-315-7157 |
| Contact at Tisgenx Inc. | Kris Kupumbati |
| Contact Email Address | [e-mail] |
| 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

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.

#### 5.2 Indications For Use

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.

#### 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.