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

Device Description

The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST 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 Surgi-Wrap MAST 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 Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).

The MAST Biosurgery Surgi-Wrap MAST 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 Surgi-Wrap MAST 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 Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Surgi-Wrap MAST Bioresorbable Sheet." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a de novo approval or clinical trial for a novel device.

Therefore, many of the requested elements for acceptance criteria and study design are not explicitly available in this type of submission. This document primarily outlines the device description, intended use, and demonstrates equivalence to marketed products through physical characteristics, material composition, and intended uses.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: These are not explicitly stated as numerical performance targets (e.g., sensitivity, specificity, accuracy) like they would be for a diagnostic AI device. Instead, the "acceptance criteria" for a 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness. The criteria revolve around showing similar indications for use, design principles, material composition, and mechanical properties.
Reported Device Performance: The document describes testing performed to support substantial equivalence, but it doesn't present "performance" in terms of specific metrics like sensitivity or accuracy for a diagnostic device.

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (Summary from submission)
Safety:
Biocompatibility/Material Safety	Fabricated from polylactic acid (PLA). Animal studies demonstrated materials are safe.
Stability after heating (for shaping)	In vitro testing showed viscosity stayed within appropriate range over 120 minutes at 60℃ in saline.
Effectiveness/Functionality:
Mechanical Strength	Aging testing demonstrated strength for indications. Mechanical testing found substantial equivalence to predicates.
Ability to be shaped	Fully malleable when heated to ~55℃. Can be cut with scissors.
Resorbability	Bioresorbable (from device name and description).
Minimizes tissue attachment	Resorbable Protective Film minimizes tissue attachment (from Indications for Use).
Equivalence to Predicate Devices:
Indications for Use	Shares identical indications for use language with predicate devices.
Design principles (flexible, semi-rigid)	Substantially equivalent physical designs (flexible, semi-rigid, polymeric).
Material composition	Fabricated from PLA. Predicates are also bioresorbable.
Size/Thickness range	Shares similar size ranges (25x25mm to 500x500mm) and thickness (0.02mm to 1.0mm) with predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable or specified in the context of this 510(k) submission. The testing described (in vitro, animal studies) does not involve a "test set" in the sense of a dataset for AI evaluation.
Data Provenance: Not applicable or specified for this type of submission. The studies are described as "in vitro testing" and "animal studies" without further detail on origin or type.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical mesh, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a surgical mesh.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical mesh.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the in-vitro testing: Internal laboratory measurements (e.g., viscosity, mechanical strength) served as the "ground truth" for the material properties.
For the animal studies: Safety and efficacy observations in animals served as the "ground truth." The document states: "The animal studies demonstrated that the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet materials are safe and efficacious for the indications for use." The specific endpoints for "safety" and "efficacious" are not detailed.

8. The sample size for the training set

Not applicable. This is not an AI-based device and does not involve a training set in that context.

9. How the ground truth for the training set was established

Not applicable. This is not an AI-based device.

Summary

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K061473 Summary

Surgi-Wrap MAST Bioresorbable Sheet

Page 1 of 3

ADMINISTRATIVE INFORMATION

SEP 2 1 2006

MAST Biosurgery, Inc. 6749 Top Gun Street, Suite C San Diego, CA 92121

Official Contact:

Manufacturer Name:

Kenneth K. Kleinhenz Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994

DEVICE NAME

Classification Name:

Surgical Mesh, Polymeric

Trade/Proprietary Name:

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

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K061473 Page 2/3

K061473 Summary

Surgi-Wrap MAST Bioresorbable Sheet

Page 2 of 3

DEVICE DESCRIPTION

Design Characteristics

Material Composition

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

In Vitro Testing

The MAST Biosurgery Surgi-Wrap MAST 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 Surgi-Wrap MAST Bioresorbable Sheet is not expected to have a significant effect on its mechanical properties.

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

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

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K061473 Summary

Surgi-Wrap MAST Bioresorbable Sheet

In Vivo Testing

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

EQUIVALENCE TO MARKETED PRODUCT

The MAST Biosurgery SurgiWrap MAST 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: Integra LifeSciences Tendon Wrap (K053655) and MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332); Class II medical devices that were cleared for marketing in the United States under K053655.and K050332 respectively.

Indications For Use

The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares indications for use principles with the predicate devices as all devices are indicated for use in the same general surgery procedures. Furthermore, the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identical indications for use language with each of the predicate devices.

Design and Materials

The physical designs of MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the Integra LifeSciences Tendon Wrap (K053655) and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332) predicate devices are substantially equivalent as they are all fabricated from a bioresorbable material with physical properties of being flexible and semi-rigid. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and all predicates share fundamental design features of allowing for contouring as the semi-rigid polymeric design principles shared by the subject device and all predicates demonstrate substantial equivalence with respect to intraoperative contouring. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is substantially equivalent to the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332) 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 Surgi-Wrap MAST Bioresorbable Sheet are substantially equivalent to the predicate devices. In addition to physical characteristics, both the predicate device and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet can be cut to specific shapes and sizes by the end user.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract image of a human figure. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2006

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

Re: K061473

Trade/Device Name: Surgi-Wrap MAST Bioresorbable Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 29, 2006 Received: August 1, 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 (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 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 (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.

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Page 2 - Mr. Kenneth K. Kleinhenz

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

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 : K061473

Device Name: Surgi-Wrap MAST Bioresorbable Sheet

Indications for Use:

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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division' Si

Division of General, Restoration and Neurological Devices

Page 1 of

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.