(106 days)
Not Found
No
The description focuses on the material properties and physical characteristics of a resorbable sheet for surgical support, with no mention of AI or ML.
Yes
The device is described as a "Bioresorbable Sheet" used for "temporary wound support," to "reinforce soft tissues where weakness exists," and for "repair of hernia or other fascial defects." These uses involve treating or supporting physiological functions, which aligns with the definition of a therapeutic device.
No
The provided text describes the Surgi-Wrap MAST Bioresorbable Sheet as a resorbable implant used for wound support, reinforcing soft tissues, and repairing hernias or fascial defects. Its purpose is to provide structural support, not to diagnose medical conditions or diseases.
No
The device is a physical, resorbable implant made from polylactic acid (PLA) in sheet form, intended for surgical use. It is 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 used in vivo (within the body) for surgical support and repair of soft tissues and fascial defects. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a resorbable implantable sheet made of polylactic acid, designed to be surgically placed within the body. This is consistent with an implantable medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.), using reagents, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used for structural support and repair within the body.
N/A
Intended Use / Indications for Use
The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, 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: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. 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. Laparoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
Product codes
FTL
Device Description
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 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.
The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is fabricated from polylactic acid (PLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological or gastroenterological anatomy, pelvic floor
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In Vitro Testing:
Testing was performed to determine the effect of prolonged heating in saline at 60℃ on inherent viscosity. The testing demonstrates that viscosity staved within an appropriate range over 120 minutes.
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.
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 efficacious for the indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031955, K012025, K031225, K010533
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
Surgi-Wrap MAST Bioresorbable Sheet 510(k) Summary
Page 1 of 3
ADMINISTRATIVE INFORMATION
MAY 2 7 2005
| Manufacturer Name: | MAST Biosurgery, Inc.
6749 Top Gun Street, Suite C
San Diego, CA 92121 |
|--------------------|------------------------------------------------------------------------------|
| Official Contact: | Kenneth K. Kleinhenz
Regulatory Affairs |
DEVICE NAME
Classification Name:
Trade/Proprietary Name:
Surgical Mesh, Polymeric
Telephone (858) 458-0900 Fax (858) 458-0994
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.
INTENDED USE
The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, 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: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. 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. Laparoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
1
DEVICE DESCRIPTION
Design Characteristics
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 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.
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 staved 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.
2
510(k) 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 efficacious for the indications for use.
EQUIVALENCE TO MARKETED PRODUCT
The MAST Biosurgery SurgiWrap MAST Bioresorbable 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 MAST Bioresorbable Sheet, MacroPore SurgiWrap (TS), GFE Medizintechnik TiMESH, and the InjecTx Biosling; Class II medical devices that were cleared for marketing in the United States under K031955, K012025, K031225, and K010533 respectively.
Indications For Use
The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identical indications for use principles with the predicate devices as the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices are indicated for the same surgical procedures.
Design and Materials
The physical designs of MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices (MacroPore Surgi-Wrap MAST Bioresorbable Sheet, MacroPore SurgiWrap (TS), and the InjecTx Biosling) are substantially equivalent, consisting of thin semi-rigid sheets that are fabricated from resorbable materials. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and MacroPore Surgi-Wrap (TS) predicate device are identical in fit, form, and function as all devices are manufactured with the same process and fabricated from the identical raw material. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the predicates also share design features of allowing for contouring. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the MacroPore SurgiWrap predicates are fully contourable when heated to approximately 55°C. The thickness, shapes, and sizes of the MacroPore SurgiWrap predicates and the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet are substantially equivalent as they are identical ranging in sizes from 25mm x 25mm to 500mm with thickness ranges from 0.02mm to 1.0mm. The dimensions of the GFE Medizintechnik TiMESH predicate devices are also comparable to the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet as both devices are provided in rectangular sheets that are several centimeters in size. 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.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Mr. Kenneth K. Kleinhenz Regulatory Affairs Mast Biosurgery Incorporated 6749 Top Gun Street, Suite C San Diego, California 92121
Re: K050332
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: April 27, 2005 Received: April 29, 2005
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 agencics. 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 sct 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.
4
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number : K050332
Device Name: Surgi-Wrap MAST Bioresorbable Sheet
Indications for Use:
The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, or costracters soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hemia 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: pubourethral support and bladder support and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. The resorbable Protective Film minizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures Laparoscopic 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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