(89 days)
Not Found
No
The description focuses on the material properties and physical characteristics of a resorbable sheet for surgical repair. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is used to reinforce soft tissues, repair hernias, and bridge fascial defects, which are therapeutic interventions.
No
This device is described as a resorbable implant used for temporary wound support and reinforcing tissues, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a resorbable implant in sheet form made from poly lactic acid (PLA), which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to provide temporary wound support, reinforce soft tissues, and repair hernias or fascial defects. This is a therapeutic and structural function within the body.
- Device Description: The description details a resorbable implant made of PLA, designed to be cut, shaped, and implanted surgically. This aligns with a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the living body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information contains no mention of analyzing biological specimens or providing diagnostic information.
- Performance Studies: The performance studies described are in vitro (testing material properties) and in vivo (animal studies), which are typical for implantable medical devices, not IVDs.
Therefore, the MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues, viscera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MacroPore Surgi-Wrap MAST Bioresorbable Sheet K031955
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | MacroPore Biosurgery, Inc.
6740 Top Gun Street
San Diego, CA 92121 |
|--------------------|--------------------------------------------------------------------------|
| Official Contact: | Kenneth K. Kleinhenz
Director 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
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.
1
DEVICE DESCRIPTION
Design Characteristics
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.
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:
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.
(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
ાર
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number _