ORTHO-WRAP BIORESORBABLE SHEET

K072190 · Mast Biosurgery · FTL · Jan 16, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072190
• Device Name: ORTHO-WRAP BIORESORBABLE SHEET
• Applicant: Mast Biosurgery
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. MAST Biosurgery Ortho-Wrap is NOT intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The MAST Biosurgery Ortho-Wrap reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue. The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Device Story

Ortho-Wrap Bioresorbable Sheet is a resorbable implant manufactured from polylactic acid (PLA). Provided as solid sheets (25mm x 25mm to 500mm x 500mm; 0.02mm to 1.0mm thickness). Device is malleable when heated to ~55°C (e.g., in sterile hot water), allowing 3D conformation to anatomical structures. Used in open or laparoscopic/endoscopic orthopedic surgeries by surgeons to manage/protect tendon injuries and reinforce soft tissue repairs. Can be cut to size and fixated with sutures. Acts as a remodelable scaffold replaced by patient's own tissue; minimizes tissue attachment. Does not provide primary biomechanical strength; used in conjunction with sutures or bone anchors. Benefits include tissue protection and reinforcement during healing.

Clinical Evidence

No clinical data. Safety and efficacy supported by bench testing (viscosity stability under heat, aging tests, mechanical strength testing) and animal studies.

Technological Characteristics

Material: Polylactic acid (PLA). Form: Resorbable, malleable sheet. Dimensions: 25mm x 25mm to 500mm x 500mm; 0.02mm to 1.0mm thickness. Principle: Thermal malleability at ~55°C for anatomical conformation. Sterilization: Not specified. Connectivity: None (implantable).

Indications for Use

Indicated for management and protection of tendon injuries without substantial tissue loss and reinforcement of soft tissues repaired by suture/anchors during tendon repair surgery (e.g., flexor/extensor tendons of fingers, thumb, wrist, rotator cuff, patellar, Achilles, biceps, quadriceps). Not for replacing body structure or providing primary biomechanical strength. Indicated for open and laparoscopic/endoscopic 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

• MAST Biosurgery Surgi-Wrap MAST Tendon Sheet (K063648)
• S. Jackson Supra FOIL Smooth Nylon foil Sheets (K973379)
• Avanta Orthopaedics Tendon Spacer (K964359)
• MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K061473)

Submission Summary (Full Text)

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# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | MAST Biosurgery, Inc.<br>6749 Top Gun Street, Suite 108<br>San Diego, CA 92121 | JAN 16 2008 |
|--------------------|----------------------------------------------------------------------------------------------|-------------|
| Official Contact: | Kenneth K. Kleinhenz<br>Regulatory Affairs<br>Telephone [phone]<br>Fax [phone] | |

# DEVICE NAME

| Classification Name: | Surgical Mesh, Polymeric |
|-------------------------|--------------------------------|
| Trade/Proprietary Name: | Ortho-Wrap Bioresorbable Sheet |

# ESTABLISHMENT REGISTRATION NUMBER 3004661493

# DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 878.3300, Surgical Mesh are polymeric screens intended to be implanted to reinforce soft tissues. These devices are classified as Class II. Surgical Mesh have been assigned Product Code FTL and FTM.

### INTENDED USE

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues.

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. MAST Biosurgery Ortho-Wrap is NOT intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the The MAST Biosurgery Ortho-Wrap reinforces soft tissue and provides a tendon repair. remodelable scaffold that is replaced by the patients own soft tissue.

The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Ko72190

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#### 510(k) Summary Ortho-Wrap Bioresorbable Sheet

K072190 2/3

### DEVICE DESCRIPTION

### Design Characteristics

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Ortho-Wrap Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Ortho-Wrap Bioresorbable Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Ortho-Wrap Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Ortho-Wrap Bioresorbable Sheet and prevent dislocation.

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

# Material Composition

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is fabricated from polylactic acid (PLA).

### In Vitro Testing

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures. Therefore, testing was performed to determine the effect of prolonged heating in saline at 60℃ on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. The relatively brief exposure anticipated during the surgical preparation of MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is not expected to have a significant effect on its mechanical properties.

Aging testing was performed on MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. Testing demonstrated that the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is strong enough for the indications for use.

Mechanical testing was performed on the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet which determined the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.

### In Vivo Testing

Animal studies were conducted to demonstrate safety and efficacy of the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet material. The animal studies demonstrated that the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet materials are safe and efficacious for the indications for use.

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### EQUIVALENCE TO MARKETED PRODUCT

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MAST Biosurgery Surgi-Wrap MAST Tendon Sheet (K063648), S. Jackson Supra FOIL Smooth Nylon foil Sheets (K973379), and Avanta Orthopaedics Tendon Spacer (K964359); Class II medical devices that were cleared for marketing in the United States under K063648, K973379, and K964359 respectively.

#### Indications For Use

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet shares indications for use principles with the predicate devices as all devices are indicated for use in the same orthopedic surgery procedures involving tendons and tendon repair. Furthermore, the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet shares identical indications for use language with each of the predicate devices.

#### Design and Materials

The physical designs of the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K061473), the S. Jackson Supra FOIL Smooth Nylon foil Sheets (K973379), and the Avanta Orthopaedics Tendon Spacer (K964359) predicate devices are substantially equivalent as they are all flexible and malleable implants fabricated from a polymeric material and provided in various sizes that they can be cut to shape intra-operatively and subsequently placed on, under, and around tendon anatomy. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet and the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet predicate (K063648) share the common design feature of being bioresorbable sheets as they are both made from the identical bioresorbable polylactic acid (PLA) material and they are both fully contourable when heated to approximately 55℃. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is substantially equivalent to the S. Jackson Supra FOIL Smooth Nylon foil Sheets (K973379) and MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K061473) predicates as they are all thin, semi-rigid sheets provided in sizes ranging from 25mm x 25mm and 500mm x 500mm with various thicknesses ranging from 0.02mm to 1.0mm. The mechanical characteristics of the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet are substantially equivalent to the predicate devices with respect to mechanical characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol of medicine and healing, with three figures intertwined.

JAN 16 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAST Biosurgery, Inc. % Mr. Kenneth K. Keinhenz Regulatory Affairs 6749 Top Gun Street, Suite C San Diego, California 92121

Re: K072190

Trade/Device Name: Ortho-Wrap Bioresorbable Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 3, 2008 Received: January 7, 2008

Dear Mr. Keinhenz:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kenneth K. Keinhenz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number : K072190

#### Device Name: Ortho-Wrap Bioresorbable Sheet

#### Indications for Use:

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues.

The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is also indicated for reinforcement of soft tisssues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. MAST Biosurgery Ortho-Wrap is NOT intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The MAST Biosurgery Ortho-Wrap reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue.

The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**
Division of General, Restorative,
and Neurological Devices

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510(k) Number /
$$2072190$$