SURGI-WRAP MAST TENDON SHEET
Device Facts
| Record ID | K063648 |
|---|---|
| Device Name | SURGI-WRAP MAST TENDON SHEET |
| Applicant | Mast Biosurgery USA, Inc. |
| Product Code | FTL · General, Plastic Surgery |
| Decision Date | Mar 7, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the 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 Surgi-Wrap MAST Tendon Sheet 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
Resorbable implant in sheet form; manufactured from poly (L-lactide-co-D,L-lactide) 70:30 (PLA). Device is malleable when heated to ~55°C; cut to shape intra-operatively; placed on, under, or around tendon anatomy. Used alone or with soft tissue fixation devices (sutures/anchors). Provides remodelable scaffold for soft tissue reinforcement; minimizes tissue attachment. Used in open and laparoscopic/endoscopic surgical procedures by physicians. Benefits patient by reinforcing repair site and reducing adhesions; replaced by patient's own tissue over time.
Clinical Evidence
Animal studies conducted to demonstrate safety and efficacy. Bench testing included aging studies and mechanical strength testing, confirming performance under indicated conditions. Thermal testing at 60°C confirmed viscosity stability for intra-operative shaping.
Technological Characteristics
Resorbable sheet; poly (L-lactide-co-D,L-lactide) 70:30 (PLA). Thickness 0.02mm to 1.0mm. Malleable when heated to ~55°C. Provided in various shapes/sizes (25mm x 25mm to 500mm x 500mm). Non-electronic, mechanical implant.
Indications for Use
Indicated for management and protection of tendon injuries without substantial tissue loss; reinforcement of soft tissues repaired by suture/anchors during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps, etc.). 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 Bioresorbable Sheet (K061473)
- Integra LifeSciences Tendon Wrap (K053655)
- TEI Biosciences TissueMend Soft Tissue Repair Matrix (K060989)
- S. Jackson Supra FOLL Smooth Nylon foil Sheets (K973379)
Submission Summary (Full Text)
{0}------------------------------------------------
510(k) Summarv Surgi-Wrap MAST Tendon Sheet
# ADMINISTRATIVE INFORMATION
Manufacturer Name:
Official Contact:
MAST Biosurgery, Inc.
MAR 0 7 2007
Page 1 of 3
6749 Top Gun Street, Suite C San Diego, CA 92121
Kenneth K. Kleinhenz Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994
DEVICE NAME
Classification Name:
Trade/Proprietary Name:
Surgical Mesh, Polymeric
Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the 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 Surgi-Wrap MAST Tendon Sheet 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.
{1}------------------------------------------------
#### Surgi-Wrap MAST Tendon Sheet 510(k) Summary
Page 2 of 3
# DEVICE DESCRIPTION
#### Design Characteristics
The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is a resorbable implant in sheet form manufactured from poly (L-lactide-co-D,L-lactide) 70:30 (PLA). The Surgi-Wrap MAST Tendon Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Tendon Sheet 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 Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet and prevent dislocation. The Surgi-Wrap MAST Tendon Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).
The MAST Biosurgery Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is fabricated from polylactic acid (PLA).
#### In Vitro Testing
The MAST Biosurgery Surgi-Wrap MAST Tendon 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°C 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 Surgi-Wrap MAST Tendon Sheet is not expected to have a significant effect on its mechanical properties.
Aging testing was performed on MAST Biosurgery Surgi-Wrap MAST Tendon Sheet. Testing demonstrated that the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is strong enough for the indications for use.
Mechanical testing was performed on the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet which determined the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.
{2}------------------------------------------------
#### Surgi-Wrap MAST Tendon Sheet 510(k) Summary
Page 3 of 3
### In Vivo Testing
Animal studies were conducted to demonstrate safety and efficacy of the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet material. The animal studies demonstrated that the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet materials are safe and efficacious for the indications for use.
# EQUIVALENCE TO MARKETED PRODUCT
The MAST Biosurgery Surgi-Wrap MAST Tendon 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 Bioresorbable Sheet (K061473). Integra LifeSciences Tendon Wrap (K053655), TEI Biosciences TissueMend Soft Tissue Repair Matrix, (K060989) and S. Jackson Supra FOLL Smooth Nylon foil Sheets (K973379); Class II medical devices that were cleared for marketing in the United States under K061473, K053655, K060989 and K973379 respectively.
#### Indications For Use
The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet shares indications for use principles with the predicate devices as all devices are indicated for use in the same surgical procedures involving tendons. Furthermore, the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet shares identical indications for use language with each of the predicate devices.
### Design and Materials
The physical designs of the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K061473), Integra LifeSciences Tendon Wrap (K053655), TEI Biosciences Tissue Repair Matrix, (K060989) and S. Jackson Supra FOIL Smooth Nylon foil Sheets (K973379) predicate devices are substantially equivalent as they are all flexible and malleable sheets 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 Surgi-Wrap MAST Tendon Sheet and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K061473), Integra LifeSciences Tendon Wrap (K053655), and TEI Biosciences TissueMend Soft Tissue Repair Matrix, (K060989) predicates all share the common design feature of being bioresorbable. The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is substantially equivalent to the S. Jackson Supra FOLL 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 and 500mm x 500mm with various thicknesses ranging from 0.02mm to 1.0mm. The mechanical characteristics of the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet are substantially equivalent to the predicate devices with respect to mechanical characteristics.
{3}------------------------------------------------
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAST Biosurgery, Inc. % Mr. Kenneth K. Kleinhenz Regulatory Affairs 6749 Top Gun Street, Suite C San Diego, California 92121
MAR 0 7 2007
Re: K063648
Trade/Device Name: Surgi-Wrap MAST Tendon Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 4, 2006 Received: December 7, 2006
Dear Mr. Kleinhenz:
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.
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.
{4}------------------------------------------------
# Page 2 -- Mr. Kenneth K. Kleinhenz
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 Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
K0653648
# Indications for Use
# 510(k) Number :
# Device Name: Surgi-Wrap MAST Tendon Sheet
# Indications for Use:
The Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the 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 Surgi-Wrap MAST Tendon Sheet 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 Exaluation (ODE)
(Division Sign-off)
Division of General, Restorative,
and Neurological Devices
K013648
Page 1 of 1
70(k) Number K065678
