(158 days)
SupraFOIL, Dexon, Biosling, Vicryl Mesh, Vipro Mesh
Not Found
No
The description focuses on the material properties and physical manipulation of a resorbable implant, with no mention of AI or ML capabilities.
Yes
The device is described as a resorbable implant used to reinforce soft tissues and repair defects, which are therapeutic actions.
No
The device is described as a resorbable implant used for reinforcing soft tissues and repairing defects, not for diagnosing conditions.
No
The device description clearly states it is a resorbable implant in sheet form made from polylactic acid (PLA), which is a physical material, not software. It also mentions being cut with scissors, heated, and fixated with sutures, all physical manipulations of a tangible product.
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 defects like hernias and prolapses. 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 fixated within the body. This is consistent with a surgical implant, not a diagnostic test performed outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely mechanical and supportive.
- Performance Studies: The performance studies focus on mechanical strength, aging, and in vivo biocompatibility – all relevant to an implantable surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MacroPore Surgi-Wrap (TS) does not fit this definition.
N/A
Intended Use / Indications for Use
The MacroPore Surgi-Wrap (TS) 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: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Product codes
FTM
Device Description
MacroPore Surgi-Wrap (TS) is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MacroPore Surgi-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or weld the MacroPore Surgi-Wrap (TS) to itself. MacroPore Surgi-Wrap (TS) is fully malleable when heated to approximately 55°C (for example, by the use of hot water), and thus can be conformed to the desired shape or size. MacroPore Surgi-Wrap (TS) can be rolled into a tube or used as a flat sheet. It can be sewn to adjacent tissues or used with, or without, tissue fixation devices such as resorbable sutures, which also serve to fixate the MacroPore Surgi-Wrap (TS). MacroPore Surgi-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.
MacroPore Surgi-Wrap (TS) is provided in sheets of 10mm to 120mm x 120mm and will be provided in other shapes and sizes in the future. The thickness of the MacroPore Surgi-Wrap (TS) is provided with and without macroporous holes. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and are provided in a variety of patterns. The holes in 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, 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
Because the MacroPore Surgi-Wrap (TS) is intended to be heated in the surgical theatre to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C. In these studies, testing was performed to demonstrate that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical procedure is not expected to have a significant effect on its mechanical properties.
Aging testing was performed on MacroPore Surgi-Wrap (TS). Testing demonstrated that the MacroPore Surgi-Wrap (TS) is strong enough for the indications for use.
Mechanical testing was performed on the MacroPore Surgi-Wrap (TS) which determined the MacroPore Surgi-Wrap (TS) to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.
In Vivo Testing
An animal study was conducted to demonstrate that the MacroPore Surgi-Wrap (TS) materials are appropriate for the indications for use. The animal studies demonstrated that the MacroPore Surgi-Wrap (TS) material:
- causes the appropriate tissue responses.
- promotes appropriate tissue ingrowth.
- resorbs over a period compatible with tissue healing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SupraFOIL, Dexon, Biosling, Vicryl Mesh, Vipro Mesh
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
(P.1 OF 3)
DEC 0 3 2001
K012025 SUMMARY
MacroPore Surgi-Wrap (TS)
Page 1 of 3
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Official Contact:
MacroPore, Inc. 6740 Top Gun Street San Diego, CA 92121
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 (TS)
ESTABLISHMENT REGISTRATION NUMBER 2031733
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21 CFR 878.3300, Surgical Mesh are polymeric seceens intended to be implanted to As shown in 21CFK of 6.7500, Surgical Mesurale por yillant of Surgical Mesh have been assigned Product Code FTM.
INTENDED USE
The MacroPore Surgi-Wrap (TS) is to be used wherever temporary wound support is required, to I de Macror Suff tissues where weakness exists, or for the repair of hernit or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired sain and this includes, but is not limited to the following procedures: vaginal prolonal prolonages and This includes, but is not ministration of the pelvic floor and sacral colposuspension.
1
l2025 (P.2 of 3)
MacroPore Surgi-Wrap (TS)
Page 2 of 3
DEVICE DESCRIPTION
Design Characteristics
Design Characteristics
MacroPore Surgi-Wrap (TS) is a resorbable implant in sheet form manufactured from by lards include MacroPore Surgi-Wrap (TS) is a resordio ministrations to the desired shape and size.
avid (PLA). MacroPore Surgi-Wrap (TS) can be cut with seissors to the MaroPore Surgi-Wra acid (PLA). MacroPore Surgi-Wrap (13) Can or vitars the MacroPore Surgi-Wap (13) to The MacroPore Power Pen can also be used to car or can is fully malleable when heated to the desired shape or size. Macrorole Surgewill (19) water), and thus can be oonformed approximately 55°C (for example, by tie use or section for MacroPore Surgi-Wrep (TS) can be rolled into a tube or used as a flat sheet. It can be seen serve to fixate the MacroPore tissue fixation devices such as resorbable sumres, which also care server to fixate the MacroPore tissue fixation devices such as resoludies suratore Surgi-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.
MacroPore Surgi-Wrap (TS) is provided in sheets of 10mm to 120mm x 120mm and MacroPore Surgic Wrap (115) is provided in show in the arrance 20 mm according to the will be provided in other shapes and sizes in old mores from 0.02 mm to 2.0 mm according to the thickness of the Macrorede Surgi-Wiap (TS) innovided with and with and without macroporous in diameter and region to be treated. The Macrorole Sugl-Way (10) in province 3,000 microns in diameter and holes. The macroporous noles fange in size from 50 increas to the sheets may be aligned with holes to attach suture material.
Material Composition
Material Composition
The MacroPorc Surgi-Wrap (TS) is fabricated from polylactic acid (PLA).
In Vitro Testing
Because the MacroPore Surgi-Wrap (TS) is intended to be heated in the sure to exatomic temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C studios, testing was periorined to decomments that viseosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical over 120 minutes. Therefore, the Telanely of the expected to have a significant effect on its mechanical propertics.
Aging testing was performed on MacroPore Surgi-Wrap (TS). Testing demonstrated that the Againg Tore Surgi-Wrap (TS) is strong enough for the indications for use.
Mcchanical testing was performed on the MacroPore Surgi-Wrap (TS) which determined the MacroPore Surgi-Wrap (TS) to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.
2
Kol 2025 (P. 7 . P. 7 . P 3)
K012025 SUMMARY
MacroPore Surgi-Wrap (TS)
Page 3 of 3
In Vivo Testing
An animal study was conducted to demonstrated that the MacroPore Surgi-Wrap (TS) materials are An animal study was conducted to demonstrated that the MacroPore Surgi-Wrap (TS) materials are
(TS) material. The animal sudies demonstrated that the MacroPore Surgi-Wrap (TS (13) matorial:
appropriate for the indications for use.
EQUIVALENCE TO MARKETED PRODUCT
MacroPore Surgisters (TS) shares indications and design principles with the following pre-MacroPore Surgi-Wrap (TS) shares indications and design printiples with and prodevices, which have been determined by FDA to be substantially equivalent o the following pre devices, which have been determined by FDA to be subsidians + 1
amendment devices: SupraFOIL, Dexon, Biosling, Vicryl Mesh, and Vipro Mesh.
Supraces: SupraFOIL, Dexon, Bi
Indications For Use
The MacroPore Surgi-Wrap Surgi Wran (TS) and the predicate devices with the predicated for the The MacroPore Surgi-Wrap (TS) shares identical matchiopic in the predicate devices are indicated for the same surgical procedures.
Design and Materials
The physical designs of MacroPore Surgi-Wrap (TS) and the predicate devices (Suprailent, consisting of a thin Designical designs of MacroPore Surgi-Nrap (15) and Tire Dremote Constitute of a thin
Dexon, Biosling, Vicry Mesh, and Vipro Mesh) are substantilly equivale Surgi-Dexon, Biosling, Jicry) Mesh, and Vipt Mesh) are Substantaly clarmers Semi-rigid sheet that allows for contouring. The Macrore Surgi-Wrap (TS) and the predicates
Wrap (TS) have a semi-rigid construction. The MacroPore Surgi-Wrap (TS) is fully Wrap (TS) have a semi-rigid contructing. The MacroPore Surgi-Wraper Surgi-Wrap (TS) is fully
also share design features of allowing for controuring. The MacoPore Surgi also share design features of allowing the continues of the thickness of the predices and this contourable when heated to approximately 55°C. Lte MacroPore Surgi-Wrap (TS)
MacroPore Surgi-Wrap (TS) are substantially equivate Surgi-Wrap (TS) MacroPore Surgi-Wrap (TS) are substantially equivalent as Ine MacroPore Surgi-Wrap (TS)
thickness ranges arc essentially a substantially equivalent to the predicate thickness ranges are essentially a subset of the predically equivalent to be predicate device device device device device are also has a thickness from 0.05mm – 2.0mm – 2.0mm – 2.0mm – The predicate device are also that ranges in thickness from 0.05mm - 2.0mm. The omelisons of the provided in recentular sheets
comparable to the Macroler The mechanical characteristics of the MacroPore S comparable to the MacroPore Surgi-Wrap (TS) as out devices in of the MacroPore Surgi-Wrap, Mrgi-Wrap, Mrgi-Wrap, Mrgi-Wrap, Mrgi-Wrap, Mrgi-Wrap, Mrsi-Wrap, Mrsi-Wrap, Surgi-(TS) are also substantially equivalent to the predicate dovices. In addition to physical characteristics, both the predicate device and the MacroPore Surgi-Wrap (TS) can be cut to
characteristics, both the predicate device and the MacroPore Surgi-Wrap (TS) can be characteristicos, or sizes by the end user.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs Macropore, Inc. 6740 Top Gun St. San Diego, California 92121
Re: K012025
Trade Name: Macropore Surgi-Wrap (TS) Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: September 28, 2001 Received: October 1, 2001
Dear Mr. Kleinhenz:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) promatially equivaluated in intereste commerce m referenced above and we have determined the actived in interstate commerce prior to
indications for use stated in the enclosure) (o devices America, or to devices that have indications for use stated in the enclosure) to useries Amendments, or to devices that have
May 28, 1976, the enactment date of the Medical Device Amend Drug, and Cosmetic A May 28, 1976, the enactment date of the Medical Define Federal Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Featuresion (PMA) You m been reclassified in accordance with the proval application (PMA). You may,
(Act) that do not require approval of a premarket approval application of the Act. The on (Act) that do not require approval of a promazer a controls provisions of the Act. The general therefore, market the device, subject to the general registration, listing of devices, controls provisions of the Act mende requirements sees as a misbranding and adulteration.
good manufacturing practice, labeling, and prohibitions against misbranding and adul
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) movement major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controllar controls. Extrang migris In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Books of be found in the Couc of Federal Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a subscribe only other requirements of the Act
that FDA has made a determination that your device complies . You must that IDA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations administration not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not answering req comply with an the Act stequirements, moradian and actual manufacturing practice requirements as setting CFK Part 807), labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 1050 forth in the quality systems (QB) regulations 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Kenneth Kleinhenz
This letter will allow you to begin marketing your device as described in your Section 5 (0(k) I his letter will anow you to ocgin maxeding your manoling of your device to a legally premarket notification. The PDA miding of backand 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 and If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CFK Patroof. 10 for the visions on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertisin Compliance at (301) 594-4057. Tuditionally) None at (301) 594-4639. Also, please note the your device, picase connect to other of remarket notification (21CFR Part 807.97).
regulation entitled, «Misbranding by reference to premarket absorbrad from the fegulation entitled, "Mitted, Million on your responsibilities under the Act may be obtained from the Other general mionnation on your responsional 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,
Neil R.P. Ogden
Celia M. Witten, Ph.D., N 1.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
0/2025
Device Name: MacroPore Surgi-Wrap (TS)
Indications for Use:
The MacroPore Surgi-Wrap (TS) is to be used wherever temporary wound support is
t the support of the areast tissues where weakness exists, or for the repair to The MacroPore Surgi-Wray (TS) is to be used weakness exists, or for the repair of hemia of
required, to reinforce soft tissues where weakness exists, or for themal of required, to reinforce solt tissues where waktes, of tor tipe of bridging material to
other fascial defects that require the addition of a reinforcing material to
beller fasc other fascial directs that require the addition of a femiloted, but is not limited to the following
obtain the description of mesult. This includes, but is not limited to the ottain the desired surgical result. This includes, but is not minitur to the counting of
orocedures: prolapse repair, colon and rectal prolapse repair, reconstruction of the procedures. Vagania prosuspension.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSAR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
| Susan Walker (Division Sign-Off) Division of General, Restorative and Neurologic Devices | OR | Over-The-Counter Use _______ | |
|---|---|---|---|
| -- | ---------------------------------------------------------------------------------------------------------------------- | ---- | ------------------------------ |
| 510(k) Number | K012025 |
|---|---|
| --------------- | --------- |