SurgiMend PRS Meshed, Revize-X

K171357 · Integra Lifesciences Corporation (Owner of Tei Biosciences) · OXH · Jun 7, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171357
• Device Name: SurgiMend PRS Meshed, Revize-X
• Applicant: Integra Lifesciences Corporation (Owner of Tei Biosciences)
• Product Code: OXH · General, Plastic Surgery
• Decision Date: Jun 7, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.

Device Story

SurgiMend Meshed is an acellular dermal tissue matrix derived from bovine dermis; supplied sterile. Device features a 2:1 fenestration pattern (meshing) allowing 2-fold area expansion and increased conformability upon hydration with 0.9% saline. Used by surgeons in clinical settings for soft tissue reinforcement and repair. Device provides a scaffold for host tissue revascularization and remodeling. Clinical benefit includes structural support for weakened or damaged soft tissue membranes.

Clinical Evidence

Bench testing included mechanical performance (burst strength, suture pull-out) and differential scanning calorimetry (DSC). Pre-clinical evidence included an acute/subacute animal model comparing meshed (test) vs. solid (control) configurations. Histological evaluation assessed revascularization and resorption/remodeling. Both configurations demonstrated a non-irritant bioreactivity score per modified ISO 10993-6, showing no significant difference in host biologic response.

Technological Characteristics

Acellular bovine dermal collagen matrix. Dimensions: variable sizes, 2:1 expansion ratio via meshing. Sterilized. Biocompatibility per ISO 10993. Mechanical properties evaluated per FDA Surgical Mesh guidance.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes in plastic and reconstructive surgery.

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

• SurgiMend Collagen Matrix for Soft Tissue Reconstruction (K083898)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2017

TEI Biosciences, Inc c/o Ms. Kavita Amin Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K171357

Trade/Device Name: SurgiMend PRS Meshed, Revize-X Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXH, FTM Dated: May 8, 2017 Received: May 9, 2017

Dear Ms. Amin:

This letter corrects our substantially equivalent letter of June 7, 2017.

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. 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 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Page 3 – Ms. Kavita Amin

## Change Control Table, Change History

## Change Control Table

| Version | Document Author | Document Approver | Date Approved |
|---------|---------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |

Complete Change Control Table (all versions) retained in SWIFT Docs.

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## Indications for Use

510(k) Number (if known) K171357

#### Device Name

SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction

#### Indications for Use (Describe)

Indications For Use: SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.

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

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) SUMMARY

## SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction

#### Submitter's name and address:

TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 USA

#### Contact person and telephone number:

Kavita Amin Specialist, Regulatory Affairs Telephone: [phone]

#### Date the Summary was prepared:

June 1, 2017 Name of the device:

| Trade name: | SurgiMend® PRS Meshed / Revize™-X Collagen Matrix for Soft<br>Tissue Reconstruction |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR 878.3300) |
| Product Code: | OXH, FTM |

#### Predicate Device:

SurgiMend Meshed is substantially equivalent in function and intended use to its predicate device as detailed in Table 1.

| 510(k)<br>Number | Product<br>Code | Trade Name | Manufacturer |
|------------------|-----------------|-------------------------------------------------------------|----------------------|
| K083898 | FTM | SurgiMend Collagen Matrix for<br>Soft Tissue Reconstruction | TEI Biosciences Inc. |

#### Table 1: Predicate Device

#### Device Description:

SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.

#### Indication for Use:

SurgiMend Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend Meshed is specifically indicated for plastic and reconstructive surgery.

#### Substantial Equivalence Comparison:

The modified device, SurgiMend Meshed, has the same manufacturing process as the predicate device, SurgiMend (K083898), with the addition of meshing, prior to packaging

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and sterilization. The modified device, SurgiMend Meshed, is manufactured with the same material, material specification, processing steps and chemical composition as the predicate device, SurgiMend (K083898). The modified device adds a 2:1 fenestration pattern to the design of the predicate device, through a meshing process prior to packaging. The addition of a defined mesh in this new configuration allows the device to expand approximately 2-fold in area and to be more conformable during application.

## Testing and Test Results:

The modified device, SurgiMend Meshed, is comprised of the same materials, processed, packaged and is sterilized by the same method as the predicate device (K083898). The biocompatibility testing conducted on the predicate device serves to confirm biocompatibility of the modified device, SurgiMend Meshed.

Performance testing for the modified device includes mechanical tests (burst strength, suture pull-out), conformability and differential scanning calorimetry (DSC) were conducted to be in compliance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 2, 1999. All test results were acceptable.

The modified device was characterized in a pre-clinical, acute/subacute animal model to evaluate the effect of meshing on the host biologic response after implantation. The study also evaluated implanted material histologically for revascularization and resorption/ remodeling of meshed (test) and solid (control) configurations. Gross, sub-gross and histological evaluation of explanted materials and surrounding tissues indicated no significant change in biological response with both materials exhibiting a bioreactivity score of Non-irritant in a modified ISO 10993-6 scoring system. The results of this study demonstrated that there were no significant differences between the predicate and modified device with respect to host biologic response and implant characteristics.

#### Conclusion:

The modified device, SurgiMend Meshed, is substantially equivalent to the commercially available marketed device, SurgiMend. The modifications expressed in this 510(k) Premarket Notification do not change the intended use, nor alter the fundamental scientific technology of the device. The modified device is as safe and as effective as the predicate device.