The SurgiWrap FROST Bioresorbable Protective Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: colon and rectal prolapse. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures.

Device Description

The SurgiWrap FROST Bioresorbable Protective Sheet is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The SurgiWrap FROST Bioresorbable Protective Sheet is available in various sizes (50mm x 65mm to 200mm x 130mm with a thickness of 0.02mm to 0.04mm) for use in maintaining the relative position of healing tissues. The device is a solid, semi-transparent thin film sheet that is placed directly on the anatomy. The device has two surfaces, one surface is smooth and the opposite side of the device has a micro-texture. The textured surface of the device allows for controlled gripping with wet gloves. The textured surface of the device readily clings and conforms to surgical tissues. The textured surface also facilitates device placement by minimizing slippage of the device during handling as well as resisting movement of the device during the installation process. The SurgiWrap FROST Bioresorbable Protective Sheet can be cut with scissors to the desired shape and size according to the needs of the physician. The SurgiWrap FROST Bioresorbable Protective 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 SurgiWrap FROST Bioresorbable Protective Sheet and prevent dislocation. The implants maintain the stability of soft tissues during the healing period and are to avoid a second surgical procedure that may otherwise be necessary to remove permanent implants. The implants are not intended for use where permanent implants are required.

AI/ML Overview

This document is a 510(k) summary for the SurgiWrap FROST Bioresorbable Protective Sheet, a surgical mesh device. The provided text describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria for a specific study, nor does it detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, details of a study with performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC study results, or training set details) is not present in the provided text.

The closest information available related to "device performance" is:

"Performance testing was conducted on MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet. Testing demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet is strong enough for its intended use."
"Mechanical testing was performed on the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet which determined the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
"Biocompatibility studies were conducted per ISO 10993-6 to demonstrate safety and efficacy of the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet material. The biocompatibility studies demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet materials are safe for its intended use."

These statements indicate that testing was performed to demonstrate "strength enough for its intended use," "substantial equivalence to mechanical strengths," and "safety and efficacy" (biocompatibility), but they do not provide specific quantitative acceptance criteria or detailed results of these tests in a format that could be presented in the requested table or as part of a detailed study description.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to publish results of a performance study against predefined clinical metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 7, 2021

MAST Biosurgery % Kenneth Kleinhenz Regulatory Affairs Consultant OSR Consulting 10807 Dakota Ranch Rd. Santee, California 92071

Re: K200918

Trade/Device Name: SurgiWrap FROST Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: November 21, 2020 Received: November 25, 2020

Dear Kenneth 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200918

Device Name SurgiWrap FROST Bioresorbable Protective Sheet

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K200918 - 510(k) Summary SurgiWrap FROST Bioresorbable Protective Sheet Page 1 of 4

Date: 06 January 2021

510(k) Number: K200918

ADMINISTRATIVE INFORMATION

Manufacturer Name:	MAST Biosurgery, Inc.6749 Top Gun Street, Suite 108San Diego, CA 92121
Official Contact:	Kenneth K. KleinhenzRegulatory AffairsTelephone (619) 244-9573Fax (858) 550-8060

DEVICE NAME

Classification Name:	Surgical Mesh, Polymeric
Trade/Proprietary Name:	SurgiWrap FROSTBioresorbable Protective 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.

INTENDED USE

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K200918 - 510(k) Summary SurgiWrap FROST Bioresorbable Protective Sheet Page 2 of 4

DEVICE DESCRIPTION

Design Characteristics

Material Composition

The MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet is fabricated from polylactic acid (PLA).

NON-CLINICAL TESTING

Performance testing was conducted on MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet. Testing demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet is strong enough for its intended use.

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

Biocompatibility studies were conducted per ISO 10993-6 to demonstrate safety and efficacy of the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet material. The biocompatibility studies demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet materials are safe for its intended use.

EQUIVALENCE TO MARKETED PRODUCT

The MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet shares indications and design principles with the following predicate devices: MAST Biosurgery SurgiWrap MAST Bioresorbable Protective Sheet predicate device (K050332) and the Biomet Mesofol Reference device (K062558); Class II medical devices that were cleared for marketing in the United States under K050332 and K062558 respectively.

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Indications For Use

The SurgiWrap FROST Bioresorbable Protective Sheet, the MAST Biosurgery SurgiWrap MAST Bioresorbable Protective Sheet predicate device (K050332), and the Biomet Mesofol (K062558) Reference device are substantially equivalent with respect to their indications for use as they are all indicated for the same intended use of soft tissue support in various abdominal anatomy.

Design and Materials

The design principles of the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet and the MAST Biosurgery SurgiWrap MAST Bioresorbable Protective Sheet predicate devices (K050332) and Reference device [Biomet Mesofol (K062558)] are substantially equivalent, consisting of sterile, single-use devices that are flexible and malleable implants fabricated from a thin sheet resorbable polymeric material and are provided in various sizes that they can be cut to shape intra-operatively and subsequently placed on, under or and around pelvic and abdominal anatomy. All devices also share the common design principles of being 100% composed of the same resorbable polymeric material that is used to reinforce soft tissues. All devices share substantially equivalent thickness, shapes, and sizes. The devices also share substantially equivalent mechanical strength.

	Subject Device	Predicate Device	Reference Device
	MAST BiosurgerySurgiWrap FROSTBioresorbable ProtectiveSheet	MAST BiosurgerySurgi-Wrap MASTBioresorbable Sheet(K050332)	BiometMesofol(K062558)
Intended Use	The SurgiWrap FROSTBioresorbable Protective Sheetis to be used wherevertemporary wound support isrequired, to reinforce softtissues where weakness existsor for the repair of hernia orother fascial defects that requirethe addition of a reinforcing orbridging material to obtain thedesired surgical result. Thisincludes, but is not limited tothe following procedures: colonand rectal prolapse. Theresorbable protective filmminimizes tissue attachment tothe device in case of directcontact with the viscera. Thedevice is indicated for open andlaparoscopic procedures.	The SurgiWrap MAST BioresorbableSheet is to be used wherever temporarywound support is required, to reinforcesoft tissues where weakness exists orfor the repair of hernia or other fascialdefects that require the addition of areinforcing or bridging material toobtain the desired surgical result. Thisincludes, but is not limited to thefollowing procedures: colon and rectalprolapse. The resorbable ProtectiveFilm minimizes tissue attachment to thedevice in case of direct contact with theviscera. The device is indicated foropen and laparoscopic procedures.Laparoscopic procedures are limited tosizes from 0.02mm - 0.2mm inthickness.	Mesofol® Surgical Sheet isindicated when temporarywound support is requiredto reinforce soft tissueswhere weakness exists, orin conjunction with herniarepair or other fascialdefects that require theaddition of a reinforcing orbridging material to obtainthe desired surgical result.The resorbable protectivesheet minimizes tissueattachment to the device incase of direct contact withthe viscera.

The SurgiWrap FROST Bioresorbable Protective Sheet is substantially equivalent to the predicate and Reference devices in the following respects:

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K200918 - 510(k) Summary SurgiWrap FROST Bioresorbable Protective Sheet Page 4 of 4

	Subject Device	Predicate Device	Reference Device
	MAST BiosurgerySurgiWrap FROSTBioresorbable ProtectiveSheet	MAST BiosurgerySurgi-Wrap MASTBioresorbable Sheet(K050332)	BiometMesofol(K062558)
Design	Sheets ranging in size from65mm x 50mm to200mm x 130mmwith thickness of0.02mm – 0.04mm	Sheets ranging in size from25mm x 25mm to500mm x 500mmwith thickness of0.02mm – 1.0mm	Sheets ranging in size from40mm x 40mm to200mm x 250mmwith thickness of0.04mm
Material	Polylactic acid	Polylactic acid	Polylactic acid andCaprolactone
ResorbableMaterial	Yes	Yes	Yes
SheetThickness	0.02 – 0.04mm	0.02 – 1.0mm	0.04mm
Sterilization	eBeam Irradiation	eBeam Irradiation	eBeam Irradiation
Embossed witha Micropattern	Yes	No	No
Product Code	FTL	FTL	FTL
CFR Section	878.3300	878.3300	878.3300

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.