Lyograft

K192452 · B. Bruan Surgical, SA · FTM · Sep 3, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192452
• Device Name: Lyograft
• Applicant: B. Bruan Surgical, SA
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Sep 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.

Device Story

Lyograft is a biological surgical mesh composed of pure, acellular, non-crosslinked bovine pericardium; features 3D collagen fiber structure with large communicating pores created via lyophilization. Supplied sterile in various rectangular sizes (8x14cm to 20x30cm). Used in general and plastic surgery; clinician rehydrates mesh in physiological saline and cuts to size using aseptic technique before suturing into place. Long-term implant; incorporates into patient tissue over time. Benefits include soft tissue reinforcement; provides scaffold for tissue integration.

Clinical Evidence

Bench testing included tensile strength, burst strength, density, DSC, FTIR, and chemical purity tests. Animal study (n=16 female New Zealand White rabbits) compared Lyograft and TUTOMESH for abdominal wall reinforcement. Histological and macroscopic examination at 12 and 24 weeks demonstrated similar local tissue reaction and integration for both devices.

Technological Characteristics

Biological surgical mesh; material: acellular, non-crosslinked bovine pericardium. 3D collagen matrix with large pores. Supplied sterile (EtO). Dimensions: 8x14cm to 20x30cm. Single-use. Rehydrated in saline prior to implantation. No electronic or software components.

Indications for Use

Indicated for patients requiring surgical repair, reinforcement, or supplementation of soft tissue where weakness exists.

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

• TUTOMESH® (K091142)

Reference Devices

• Lyoplant (K970851)
• Lyoplant Onlay (K122791)

Submission Summary (Full Text)

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September 3, 2020

B. Bruan Surgical, SA % Robin Fatzinger Principle Consultant Oreg Consulting, LLC 2192 Martin Drive Gilbertsville, Pennsylvania 19525

Re: K192452

Trade/Device Name: Lyograft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: July 31, 2020 Received: August 3, 2020

Dear Robin Fatzinger:

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

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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 (OS) 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) K192452

Device Name Lyograft

Indications for Use (Describe)

Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.

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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# 5. 510(k) Summary as Required by 21 CFR 807.92(c).

## I. SUBMITTER

B. Braun Surgical, S.A. Carretera de Terrassa, 121 08191 Barcelona, Rubí Spain

Phone: [phone] Fax: [phone]

Contact Person: Pau Turon Dols, Ph.D Director of R&D, Regulatory, & Ouality

Date Prepared: 06 September 2019

### II. DEVICE

Name of Device: Lyograft®

Common or Usual Name: Mesh, Surgical

Classification Name: Surgical Mesh (21 CFR 878.3300)

Regulatory Class: II

Product Code: FTM

### III. PREDICATE DEVICE

TUTOMESH®, K091142 (B. Braun Surgical, S.A. is not aware of this predicate device being subject to a design-related recall. )

Lyoplant (K970851) and Lyoplant Onlay (K122791) will be used as reference devices to support product safety. Lyoplant and Lyoplant Onlay are dura substitutes (GXQ) which are manufactured from the identical bovine pericardium material by B. Braun Melsungen AG (Carl-Braun-Straße 1 -34212 Melsungen, Germany), the parent company of B. Braun Surgical, S.A.

### IV. DEVICE DESCRIPTION

Lyograft is a biological surgical mesh comprised of pure collagen made of bovine pericardium. It is a single layered membrane of connective tissue with the collagen fibers running in three dimensions. Lyophilization causes the formation of a mesh, free of non-collagenous components, with a loose fibrous structure and large communicating pores. Lyograft is a long-term implant that will be incorporated into the patient's tissue over time.

Lyograft is supplied in various sizes ranging from 8x14cm to 20x30cm. It is provided sterile within a double blister package and is for single use. Lyograft is rehydrated in a physiological saline solution and

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cut to size using aseptic technique prior to use. It is recommended to suture Lyograft in place using nonabsorbable sutures.

# V. INDICATIONS FOR USE

Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| | TUTOMESH® - Predicate | Lyograft® - Subject Device |
|----------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) Number | K091142 | TBD |
| Device Class | II | II |
| Product Code | FTM | FTM |
| Panel | 878.3300 | 878.3300 |
| Intended Use | General & Plastic Surgery<br>Implanted to reinforce soft<br>tissue or bone where weakness<br>exists. | General & Plastic Surgery<br>Implanted to reinforce soft<br>tissue where weakness exists. |
| Indications for Use | This device is intended for<br>implantation to repair, reinforce<br>and/or supplement soft tissue. | Lyograft® is intended for<br>implantation to repair, reinforce<br>and/or supplement soft tissue. |
| Material Source | Bovine Pericardium | Bovine Pericardium |
| Material Type | Acellular, non-crosslinked,<br>3-dimensional Collagen Matrix | Acellular, non-crosslinked,<br>3-dimensional Collagen Matrix |
| Resorbable | Yes | Yes |
| Shape(s) | Oval | Rectangular |
| Size(s) | 10 x 16cm & 13 x 22cm | 8 x 14cm to 20 x 30cm |
| How Supplied | Double Blister Package | Double Blister Package |
| Sterilization Method | Tutoplast® Tissue Sterilization<br>Process and Gamma Irradiation | EtO |
| Reusable | Single Use | Single Use |

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### VII. PERFORMANCE DATA

FDA Guidance for the Preparation of a Premarket Notification for a Surgical Mesh (March 2, 1999) was considered in determining the requirements for demonstrating substantial equivalence to the predicate device. The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for Lyograft was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Lyograft is considered a long term (>30 days) implant which comes in contact with tissue. The following tests have been considered per the standard:

- Cytotoxicity ●
- Sensitization
- Irritation .
- Acute Systemic toxicity ●
- Material Mediated Pyrogenicity
- Subchronic Toxicity
- Chronic Toxicity
- Hemolysis
- Genotoxicity ●
- Implantation ●

### Performance Testing - Bench

The following tests were conducted on both the subject and predicate devices to evaluate the performance characteristics and collagen purity:

- Tensile Strength
- Burst Strength ●
- Density Weight/Area ●
- DSC Analysis ●
- FTIR Analysis
- Acetic Acid Test
- Hydroxyproline Test ●
- Water Content ●

### Performance Testing - Animal

An animal study comparing the performance of Lyograft and Tutomesh for tissue reinforcement in the abdominal wall and tissue integration in a rabbit model was conducted. Sixteen (16) female New Zealand White rabbits were assigned to the following groups: Four (4) rabbits implanted with Lyograft for 12week explantation and four (4) rabbits implanted with Tutomesh for 12-week explantation; four (4) rabbits implanted with Lyograft for 24-week explantation and four (4) rabbits implanted with Tutomesh for 24week explantation. The test (Lyograft) and reference (Tutomesh) samples were cut to a defined size and sutured to the traumatized abdominal wall per standard procedure.

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The test and reference surgical sites were macroscopically examined after 12 and 24 post-operative weeks subsequently explanted for further histological examination. The results for Lyograft and Tutomesh at both the 12 and 24-week time points showed similar local tissue reaction and tissue integration.

## VIII. CONCLUSIONS

The subject device, Lyograft, and the predicate device, Tutomesh, are both biological surgical made from bovine pericardium and utilize the same technological characteristics and principles to reinforce soft tissue where weakness exists. The devices have the same biocompatibility safety profile and similar performance as demonstrated in bench and animal testing described above. Any minor differences in performance test results do not raise new issues of safety. Therefore, based on these similarities, Lyograft is considered substantially equivalent to Tutomesh.