(86 days)
Not Found
No
The description focuses on the material properties and physical manipulation of a resorbable implant, with no mention of AI or ML.
No.
The device is a pericardium replacement device, which acts as a structural implant rather than providing a therapeutic effect like drug delivery or direct physiological treatment.
No
The device is described as a "pericardium replacement device" and a "resorbable implant in sheet form," indicating its use as a therapeutic or reconstructive device, not for diagnosis.
No
The device is a physical implantable sheet made of poly lactic acid (PLA) and is described as a resorbable implant in sheet form. It is a hardware device, not software.
Based on the provided information, the MacroPore Cardio-Wrap (TS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is as a "pericardium replacement device in patients that may require re-operation within six months." This describes a device that is implanted directly into the body to perform a structural function.
- Device Description: The description details a resorbable implant made from poly lactic acid (PLA) in sheet form, designed to be cut, shaped, and implanted surgically. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Anatomical Site: The anatomical site is the "Pericardium," which is a part of the human body. IVDs are used to examine samples taken from the body (like blood, urine, tissue) or to analyze substances in vitro (in a lab setting).
- Intended User / Care Setting: The intended user is in a "Surgical suite," which is where surgical procedures are performed, not typically where IVD testing is conducted.
- Performance Studies: The performance studies described are "In Vitro Testing" (referring to testing of the material properties, not diagnostic testing of patient samples) and "In Vivo Testing" (animal studies), which are typical for implanted medical devices.
In Vitro Diagnostic devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The MacroPore Cardio-Wrap (TS) is a surgical implant used to replace a part of the body, not to perform diagnostic testing on samples.
N/A
Intended Use / Indications for Use
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
Product codes (comma separated list FDA assigned to the subject device)
DXZ, OMH
Device Description
MacroPore Cardio-Wrap (TS) is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) to the desired shape or size. MacroPore Cardio-Wrap (TS) 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 MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) and prevent dislocation. The MacroPore Cardio-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.
MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) is provided in sheets of 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Cardio-Wrap (TS) ranges from 0.05 mm to 1.0 mm according to the region to be treated. The MacroPore Cardio-Wrap (TS) 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
heart
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°C on inherent viscosity. Testing demonstrated that viscosity stayed within an appropriate range over 120 minutes. Aging testing was performed on MacroPore Cardio-Wrap (TS) which demonstrated it is strong enough for the indications for use. Mechanical testing determined the MacroPore Cardio-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 safety and efficacy of the MacroPore Cardio-Wrap (TS) material. The animal studies demonstrated that the MacroPore Cardio-Wrap (TS) materials are safe and efficacious for the indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K031785'. The characters are written in a bold, somewhat stylized manner, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier.
510(k) SUMMARY
MacroPore Cardio-Wrap (TS)
Page 1 of 3
ADMINISTRATIVE INFORMATION
Manufacturer Name: MacroPore Biosurgery, Inc. 6740 Top Gun Street San Diego, CA 92121 Official Contact: Kenneth K. Kleinhenz Director of Regulatory Affairs
DEVICE NAME
Classification Name:
Intracardiac Patch
Fax (858) 458-0994
Trade/Proprietary Name:
MacroPore Cardio-Wrap (TS)
Telephone (858) 458-0900
ESTABLISHMENT REGISTRATION NUMBER 2031733
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21CFR 870.3470, an Intracardiac Patch is a fabric device intended to be placed in the heart for use to repair septal defects, for patch grafting, and to repair tissue These devices are classified as Class II. Intracardiac Patches have been assigned Product Code DXZ.
INTENDED USE
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
1
DEVICE DESCRIPTION
Design Characteristics
MacroPore Cardio-Wrap (TS) is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) to the desired shape or size. MacroPore Cardio-Wrap (TS) 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 MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) and prevent dislocation. The MacroPore Cardio-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.
MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) is provided in sheets of 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Cardio-Wrap (TS) ranges from 0.05 mm to 1.0 mm according to the region to be treated. The MacroPore Cardio-Wrap (TS) is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
Material Composition
The MacroPore Cardio-Wrap (TS) is fabricated from polylactic acid (PLA).
In Vitro Testing
The MacroPore Cardio-Wrap (TS) 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 Cardio-Wrap (TS) is not expected to have a significant effect on its mechanical properties.
Aging testing was performed on MacroPore Cardio-Wrap (TS). Testing demonstrated that the MacroPore Cardio-Wrap (TS) is strong enough for the indications for use.
Mechanical testing was performed on the MacroPore Cardio-Wrap (TS) which determined the MacroPore Cardio-Wrap (TS) to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions,
2
In Vivo Testing
An animal study was conducted to demonstrate safety and efficacy of the MacroPore Cardio-Wrap (TS) material. The animal studies demonstrated that the MacroPore Cardio-Wrap (TS) materials are safe and efficacious for the indications for use.
EQUIVALENCE TO MARKETED PRODUCT
The MacroPore Cardio-Wrap (TS) shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to preamendment devices: Bio-Vascular Supple Peri-Guard. Sulzer Carbomedics Cardio Fix, and W.L. Gore Preclude Pericandial Membrane; Class II medical devices that were cleared for marketing in the United States under K983602, K993288, and K012098, respectively.
Indications For Use
The MacroPore Cardio-Wrap (TS) shares identical indications for use principles with the predicate devices as both the MacroPore Cardio-Wrap (TS) and the predicate devices are indicated for the same surgical procedures.
Design and Materials
The physical designs of MacroPore Cardio-Wrap (TS) and the predicate devices (Bio-Vascular Supple Peri-Guard, Sulzer Carbomedics Cardio Fix, and W.L. Gore Preclude Pericardial Membrane) are substantially equivalent, consisting of thin semi-rigid sheets. The MacroPore Cardio-Wrap (TS) and the predicates also share design features of allowing for contouring. The MacroPore Cardio-Wrap (TS) is fully contourable when heated to approximately 55℃. The thickness of the predicate devices and the MacroPore Cardio-Wrap (TS) are substantially equivalent as the thinnest MacroPore Cardio-Wrap (TS) thickness is virtually identical to the predicate (0.5mm vs 1.0mm). The dimensions of the predicate devices are also comparable to the MacroPore Cardio-Wrap (TS) as both devices are provided in rectangular sheets that are several centimeters in size. The mechanical characteristics of the MacroPore Cardio-Wrap (TS) are substantially equivalent to the predicate devices with respect to mechanical strength as measured by tensile and suture pull out testing. In addition to physical characteristics, both the predicate device and the MacroPore Cardio-Wrap (TS) can be cut to specific shapes and sizes by the end user.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.
FEB 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Macropore Biosurgery, Inc. c/o Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs 6740 Top Gun Street San Diego, CA 92121
Re: K031785
Trade Name: MacroPore Cardio-Wrap (TS) Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II (two) Product Code: OMH Dated: June 9, 2003 Received: June 10, 2003
Dear Mr. Kleinhenz:
This letter corrects our substantially equivalent letter of September 4, 2003.
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.
4
Page 2 - Mr. Kenneth K. Kleinhenz
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4646. 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 vours.
Dmna R. bohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: MacroPore Cardio-Wrap (TS)
Indications for Use:
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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Veleta
510(k) Num
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