(90 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of an extracellular matrix patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a patch material for vascular reconstruction and repair of the carotid artery, which is a physical repair rather than a therapeutic treatment in the conventional sense (e.g., drug delivery, radiation, or other active medical intervention).
No
The device is described as a "patch material for vascular reconstruction and repair," indicating its use in treatment rather than diagnosis. The provided text details its composition, sizes, and performance studies related to its physical properties and biological compatibility, none of which involve diagnostic capabilities.
No
The device description clearly states it is a physical scaffold derived from porcine tissue, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "vascular reconstruction and repair of the carotid artery," which is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a "patch material" made from "extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS)." This is a material designed to be implanted or used directly on tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the living body) to analyze samples. This device is clearly intended for in vivo use during surgery.
N/A
Intended Use / Indications for Use
The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
The CorMatrix ECM for Carotid Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). SIS is developed from a select layer of tissue that is recovered from porcine small intestine. During processing, the inner and outer muscle layers of the material are removed, leaving an intact submucosa with a portion of the tunica propria layer attached to the outer surface. Following processing, the remaining acellular ECM material is cut to specific shapes and sizes, lyophilized, and terminally sterilized using Ethylene Oxide gas.
The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, lyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid artery
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)
All necessary bench and animal testing was conducted on the CorMatrix ECM for Carotid Repair to support a determination of substantial equivalence to the predicate devices.
Nonclinical Testing Summary:
The nonclinical testing assessed the following aspects of the device:
- Suture retention strength.
- Probe burst strength.
- Tensile strength.
- Biocompatibility.
- Sterilization validation.
- Packaging and shelf-life.
Animal testing examined the safety and performance, as well as burst pressures of repaired vessels at various time points. The collective results of the nonclinical testing demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use. The collective nonclinical testing demonstrates that the CorMatrix ECM for Carotid Repair does not raise new questions of safety or efficacy for carotid artery repair.
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.
K063349, K001785, K983602, K963611
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
CORMATRIX CARDIOVASCULAR, INC.
CORMATRIX® EC 510(k) Premarket Not.
JUL 26 2011
SECTION 5
510(k) SUMMARY (CONT.)
510(k) Notification K
GENERAL INFORMATION
Applicant:
CorMatrix Cardiovascular, Inc. 155-A Moffett Park Dr., Suite 240 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-734-2628 FAX: 408-734-2629
Contact Person:
Heather Lake Regulatory Consultant Experien Group, LLC 155-A Moffett Park Dr., Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: 408-400-0856 FAX: 408-400-0865
Date Prepared: April 26, 2011
DEVICE INFORMATION
Classification:
21 CFR§870.3470, Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluroethylene
Product Code:
DXZ
Trade Name:
CorMatrix® ECM® for Carotid Repair
Generic/Common Name:
Patch, Pledget and Intracardiac
1
SECTION 5 510(k) SUMMARY (CONT.).
PREDICATE DEVICES
- CorMatrix® ECM® for Cardiac Tissue Repair (K063349) .
- Cook® Biotech Surgisis® Peripheral Vascular Patch (K001785) .
- Bio-Vascular/Synovis® Vascu-Guard® Peripheral Vascular Patch (K983602) ●
- Carbomedics Vascutek Thin Wall Carotid Patch (K963611) .
INTENDED USE
The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.
PRODUCT DESCRIPTION
The CorMatrix ECM for Carotid Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). SIS is developed from a select layer of tissue that is recovered from porcine small intestine. During processing, the inner and outer muscle layers of the material are removed, leaving an intact submucosa with a portion of the tunica propria layer attached to the outer surface. Following processing, the remaining acellular ECM material is cut to specific shapes and sizes, lyophilized, and terminally sterilized using Ethylene Oxide gas.
The CorMatrix ECM for Carotid Repair is derived from the same SIS-ECM material as CorMatrix's two commercially available products, the CorMatrix ECM for Pericardial Closure and the CorMatrix ECM for Cardiac Tissue Repair. The CorMatrix ECM for Carotid Repair will be supplied as a multilaminate, Iyophilized, sterilized sheet of SIS-ECM. The CorMatrix ECM will be provided in four sizes: 1x10cm, 1x15cm, 2x10cm and 2x15cm sheets.
SUBSTANTIAL EQUIVALENCE
The indications for use for the CorMatrix ECM for Carotid Repair are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the CorMatrix ECM for Carotid Repair is substantially equivalent to the predicate devices.
2
6111187
SECTION 5 510(k) SUMMARY (CONT.)
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench and animal testing was conducted on the CorMatrix ECM for Carotid Repair to support a determination of substantial equivalence to the predicate devices.
Nonclinical Testing Summary:
The nonclinical testing assessed the following aspects of the device:
- Suture retention strength .
- Probe burst strength .
- Tensile strength .
- Biocompatibility .
- Sterilization validation .
- Packaging and shelf-life .
Animal testing examined the safety and performance, as well as burst pressures of repaired vessels at various time points. The collective results of the nonclinical testing demonstrate that the CorMatrix ECM for Carotid Repair meets the established specifications necessary for consistent performance for its intended use. The collective nonclinical testing demonstrates that the CorMatrix ECM for Carotid Repair does not raise new questions of safety or efficacy for carotid artery repair.
SUMMARY
The CorMatrix ECM for Carotid Repair is substantially equivalent to the predicate devices.
3
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 depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CorMatrix Cardiovascular, Inc. c/o Kit Cariquitan 155 Moffett Park Dr., Suite 210 Sunnyvale, CA 94089
JUL 26 2011
Re: K111187
Trade/Device Name: CorMatrix® ECM® for Carotid Repair Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: April 26, 2011 Received: April 27, 2011
Dear Mr. Cariquitan:
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 (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations offecting 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. Kit Cariquitan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
KL
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CORMATRIX CARDIOVASCULAR, INC.
CORMATRIX® ECM® FOR CAROTID REPAIR 510(k).PREMARKET NOTIFICATION
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K ( | | | 8-7
Device Name: CorMatrix® ECM® for Carotid Repair
Indications For Use:
The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Oi
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
ion Slan-Off) ion of Cardiovascular Devices
510(k) Number K111187