The MacroPore Surgi-Wrap MAST Bioresorbable 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. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

Device Description

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Surgi-Wrap MAST Bioresorbable Sheet to the desired shape or size. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore 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 MacroPore Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MacroPore manual instruments.

MacroPore 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. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MacroPore 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 MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a surgical mesh made from polylactic acid (PLA) intended for temporary wound support, soft tissue reinforcement, and repair of hernias or fascial defects.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Properties	Inherent Viscosity after Heating	Viscosity stayed within an appropriate range over 120 minutes when heated in saline at 60°C.
	Strength for Indications for Use	"Testing demonstrated that the MacroPore Surgi-Wrap MAST Bioresorbable Sheet is strong enough for the indications for use."
	Mechanical Strength (Compared to Predicates)	"Mechanical testing was performed on the MacroPore Surgi-Wrap MAST Bioresorbable Sheet which determined the MacroPore Surgi-Wrap MAST Bioresorbable Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
Biocompatibility/Safety	Safety and Efficacy (Animal Studies)	"The animal studies demonstrated that the MacroPore Surgi-Wrap MAST Bioresorbable Sheet materials are safe and efficacious for the indications for use."
Substantial Equivalence	Indications for Use (Compared to Predicates)	Shares identical indications for use principles with MacroPore Surgi-Wrap (TS) (K012025) and Sofradim Parietex Composite Mesh (K002699).
	Design & Material (Compared to Predicates)	Substantially equivalent physical designs (thin semi-rigid sheets, resorbable materials). MacroPore Surgi-Wrap MAST Bioresorbable Sheet and MacroPore Surgi-Wrap (TS) are made from identical material (PLA). Sofradim Parietex uses resorbable collagen. Both allow for contouring.
	Contouring Capability (Compared to Predicates)	MacroPore Surgi-Wrap MAST Bioresorbable Sheet and MacroPore Surgi-Wrap (TS) predicate are fully contourable when heated to approximately 55°C.
	Thickness (Compared to Predicates)	Thinnest MacroPore Surgi-Wrap MAST Bioresorbable Sheet (0.02mm) is identical to Surgi-Wrap (TS) predicate and virtually identical to thin film layer on Sofradim Parietex Composite Mesh (0.04mm).
	Dimensions (Compared to Predicates)	Comparable dimensions, provided in circular and rectangular sheets several centimeters in size.
	User Customization (Compared to Predicates)	Both the predicate devices and the MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be cut to specific shapes and sizes by the end user via the same methods (e.g., scissors, Power Pen).

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

The document describes several tests:

In Vitro Testing (Inherent Viscosity): No specific sample size is provided, but it states "testing was performed." The data provenance is not specified, but it's an in-house lab test ("in vitro").
In Vitro Testing (Strength): No specific sample size is provided, but it states "testing demonstrates." Data provenance is not specified.
In Vitro Testing (Mechanical Strength): No specific sample size is provided, but it states "mechanical testing was performed." Data provenance is not specified.
In Vivo Testing (Animal Studies): No specific species or number of animals are provided, only "Animal studies were conducted." Data provenance is typically internal to the manufacturer or a contract research organization. These are prospective studies on animals.
Equivalence to Marketed Product: This is a comparison to previously cleared devices (K012025, K002699) and relies on their established performance, not a new test set of patients for the MacroPore Surgi-Wrap MAST Bioresorbable Sheet.

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

The document does not mention the use of human experts to establish ground truth for a test set in the context of the device's performance. The "ground truth" for material properties and animal studies would be established by the results of the scientific tests and observations themselves, as interpreted by the researchers/scientists conducting those studies.

4. Adjudication Method for the Test Set:

No adjudication method is described for any test set, as this is not a study involving human interpretation of data where consensus or adjudication would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was conducted or described. This type of study is typically done for diagnostic imaging devices where human interpretation is a key factor. This device is a surgical implant.

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

Not applicable. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is primarily based on:

Empirical Measurement/Laboratory Data: For inherent viscosity, strength, and mechanical properties.
Biological Observation/Pathology: For the animal studies assessing safety and efficacy in vivo.
Established Performance of Predicate Devices: For demonstrating substantial equivalence, relying on the known performance and clearance of the MacroPore Surgi-Wrap (TS) and Sofradim Parietex Composite Mesh.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned for this type of device.

Summary

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MacroPore Surgi-Wrap MAST Bioresorbable Sheet K031955

ADMINISTRATIVE INFORMATION

Manufacturer Name:	MacroPore Biosurgery, Inc.6740 Top Gun StreetSan Diego, CA 92121
Official Contact:	Kenneth K. KleinhenzDirector of Regulatory Affairs
	Telephone (858) 458-0900
	Fax (858) 458-0994

DEVICE NAME

Classification Name:

Trade/Proprietary Name:

Surgical Mesh

MacroPore Surgi-Wrap MAST Bioresorbable Sheet

ESTABLISHMENT REGISTRATION NUMBER 2031733

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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DEVICE DESCRIPTION

Design Characteristics

Material Composition

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

In Vitro Testing

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

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

Mechanical testing was performed on the MacroPore Surgi-Wrap MAST Bioresorbable Sheet which determined the MacroPore 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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K031955

In Vivo Testing

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

EQUIVALENCE TO MARKETED PRODUCT

The MacroPore Surgi-Wrap 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: MacroPore Surgi-Wrap (TS) and the Sofradim Parietex Composite Mesh; Class II medical devices that were cleared for marketing in the United States under K012025, and K002699 respectively.

Indications For Use

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet shares identical indications for use principles with the predicate devices as both the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices are indicated for the same surgical procedures.

Design and Materials

The physical designs of MacroPore Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices (MacroPore Surgi-Wrap (TS) and the Sofradim Parietex Composite Mesh) are substantially equivalent, consisting of thin semi-rigid sheets that are fabricated from resorbable materials. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet and the MacroPore Surgi-Wrap (TS) predicate device are fabricated from the identical while the Sofradim Parietex predicate is fabricated from resorbable collagen. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet and the predicates also share of allowing for contouring. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet and the MacroPore Surgi-Wrap (TS) predicate are fully contourable when heated to approximately 55°C. The thickness of the predicate devices and the MacroPore Surgi-Wrap MAST Bioresorbable Sheet are substantially equivalent as the thinnest MacroPore Surgi-Wrap MAST Bioresorbable Sheet thickness is identical to the Surgi-Wrap (TS) predicate (0.02mm) and virtually identical to the thin film laver on the Sofradim Parietex Composite Mesh (0.04mm). The dimensions of the predicate devices are also comparable to the MacroPore Surgi-Wrap MAST Bioresorbable Sheet as both devices are provided in circular and rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet are substantially equivalent to the predicate devices with respect to mechanical strength. In addition to physical characteristics, both the predicate device and the MacroPore 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 & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2003

Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs MacroPore Biosurgery, Inc. 6740 Top Gun Street San Diego, California 92121

Re: K031955

Trade/Device Name: MacroPore Surgi-Wrap MAST Bioresorbable Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 20, 2003 Received: June 25, 2003

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.

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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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: MacroPore Surgi-Wrap MAST Bioresorbable Sheet

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSAR Y

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number _

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.