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 Description

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and efficacy criteria through a clinical study with acceptance criteria in the typical sense for AI/software devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this submission is for a medical device (surgical mesh), not an AI/software device. Therefore, the concept of "acceptance criteria" and "reported device performance" as typically applied to AI models (e.g., accuracy, sensitivity, specificity thresholds) is not applicable here. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices.

The device's performance is demonstrated through in-vitro and in-vivo testing, primarily to show that it functions as intended and is comparable to its predicates.

Acceptance Criterion (Implied by Substantial Equivalence to Predicates)	Reported Device Performance
Material Composition Equivalence	Fabricated from polylactic acid (PLA), identical to MAST Biosurgery Surgi-Wrap MAST Tendon Sheet (K063648) predicate.
Design Characteristics Equivalence	Flexible, malleable sheet form, cuttable, 3D conformable when heated (approx. 55°C), provided in various shapes/sizes (25x25mm to 500x500mm, 0.02-1.0mm thickness), similar to predicate devices (K063648, K973379, K964359).
Intended Use Equivalence	Indicated for management/protection of tendon injuries and reinforcement of soft tissues during tendon repair, sharing identical indications for use language with predicate devices.
In Vitro Performance (Heating Effect)	Viscosity stayed within appropriate range over 120 minutes when heated in saline at 60°C. Brief surgical exposure not expected to significantly affect mechanical properties.
In Vitro Performance (Aging)	Demonstrated to be strong enough for the indications for use after aging.
In Vitro Performance (Mechanical Strength)	Substantially equivalent to the mechanical strengths of predicate devices under indication for use conditions.
In Vivo Performance (Safety & Efficacy)	Animal studies demonstrated that the materials are safe and efficacious for the indications for use.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a 510(k) for a physical medical device. The "tests" are described as in-vitro and in-vivo (animal) studies, not a human clinical test set for AI performance.
Data Provenance:
- In Vitro Testing: Performed with the device itself.
- In Vivo Testing: Conducted via "Animal studies." No country of origin is specified for these studies, but they were likely conducted under controlled laboratory conditions.
- Retrospective/Prospective: The in-vitro and in-vivo tests would be considered prospective as they were specifically designed and executed for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of expert consensus, which is common for AI evaluation, is not relevant here. The ground truth for the in-vitro tests relies on objective measurements and established scientific principles. For in-vivo animal studies, efficacy and safety endpoints are determined by veterinary and scientific protocols, not human expert consensus on diagnostic images or data interpretations.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of resolving disagreements among human readers or experts for device performance data for this type of submission. Performance is assessed through direct physical, chemical, and biological testing.

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 is a physical medical device (surgical mesh), not an AI or software device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for this physical device relies on:

Objective measurements and chemical/physical properties: For in-vitro tests (e.g., viscosity, mechanical strength, aging properties). These are based on established scientific measurement techniques.
Animal study results: For in-vivo safety and efficacy. These outcomes are typically assessed through histological analysis, gross observations, and potentially functional assessments in the animal models, ultimately interpreted by veterinary pathologists and researchers.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no AI model, there's no training set or associated ground truth establishment process.

Summary

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ADMINISTRATIVE INFORMATION

Manufacturer Name:	MAST Biosurgery, Inc.6749 Top Gun Street, Suite 108San Diego, CA 92121	JAN 16 2008
Official Contact:	Kenneth K. KleinhenzRegulatory AffairsTelephone (858) 458-0900Fax (858) 458-0994

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 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

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 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 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

Page 1 of 1

510(k) Number /
$$2072190$$

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.