(189 days)
Not Found
No
The summary describes a biological material envelope for holding implantable electronic devices and does not mention any AI/ML components or functionalities.
No
The device is described as an "ECM Envelope" intended to securely hold and create a stable environment for "implantable electronic devices" such as pacemakers or defibrillators. It does not directly treat a disease or condition itself, but rather supports other therapeutic devices.
No
The device, CorMatrix PROTECT ECM Envelope, is designed to securely hold and stabilize other implantable electronic devices like pacemakers and defibrillators. Its function is to provide a stable environment for these devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is constructed from physical materials (porcine small intestinal submucosa, PDS suture) and is intended to physically hold an implantable electronic device. It is a physical medical device, not software.
Based on the provided text, the CorMatrix PROTECT ECM Envelope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "securely hold an implantable electronic device to create a stable environment when implanted in the body." This describes a device used in vivo (within the living body) to support another implanted device.
- Device Description: The description details a physical envelope made from biological material (porcine small intestinal submucosa) designed to enclose an electronic device. This is a physical implantable device, not a reagent, instrument, or system intended for the examination of specimens derived from the human body in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health. The CorMatrix PROTECT ECM Envelope does not fit this description.
N/A
Intended Use / Indications for Use
The CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED) in order to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other CIEDs.
The CorMatrix PROTECT ECM (extracellular matrix) Envelope is constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using with violet 5-0 polydioxanone (PDS) suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
An animal study was performed to demonstrate the ability of the CorMatrix PROTECT ECM Envelope to isolate and stabilize a pacemaker in a model of bilateral, subcutaneous implant pockets of a New Zealand White rabbit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal study. The CorMatrix PROTECT ECM Envelope effectively isolated and stabilized the pacemaker with biocompatibility similar to the predicate device, TyRx AIGISRx Antibacterial Envelope.
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.
K063091, K130943, K063349, K980431, K062696, K062697, K073391
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three overlapping profiles of human faces, creating a sense of community and connection. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2014
Cormatrix Cardiovascular, Inc. Bryan Brosseau Regulatory Affairs Manager 1100 Old Ellis Road Roswell, GA 30076 US
Re: K140306
Trade/Device Name: Cormatrix protect ecm envelope Regulation Number: 21 CFR 870.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: July 15, 2014 Received: July 16, 2014
Dear Bryan Brosseau,
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. 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 affecting your device can be
1
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; medical device reporting (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Mitchell Stein
forBram Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
CorMatrix® PROTECT ECM® Envelope
Indications for Use (Describe)
The CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: K140306
| Company Information | |
|---|---|
| Company Name: | CorMatrix Cardiovascular, Inc. |
| Contact Name: | Bryan Brosseau |
| Contact Title: | Regulatory Affairs Manager |
| Address: | 1100 Old Ellis Rd. |
| Roswell, GA 30076 | |
| Phone: | 470-514-4036 |
| Fax: | 408-734-2629 |
| Date Prepared: | March 18, 2014 |
| Product Information | |
| Trade Name: | CorMatrix® PROTECT ECM® Envelope |
| Common Name: | Surgical Mesh Envelope |
| Classification Name: | Surgical Mesh, 21 CFR 878.3300, Product Code FTM, Class II |
Predicate Devices
The CorMatrix® PROTECT ECM® Envelope is substantially equivalent to the following devices:
- TyRx AIGISRx Antibacterial Envelope, K063091
- TyRx AIGISRx R Fully Resorbable Antibacterial Envelope, K130943
- CorMatrix ECM for Cardiac Tissue Repair, K063349
- Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696
- Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device, K062697 and K073391
Device Description
The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED) in order to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other CIEDs.
The CorMatrix PROTECT ECM (extracellular matrix) Envelope is constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using with violet 5-0 polydioxanone (PDS) suture.
Substantial Equivalence
The intended use of the CorMatrix PROTECT ECM Envelope to securely hold a CIED is identical to the TyRx AIGIS and TyRx AIGIS R envelopes. The device is manufactured from the same or
4
similar materials as the CorMatrix ECM for Cardiac Tissue Repair, Cook Biotech Surgical Mesh, and Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device.
Non-clinical Testing
An animal study was performed to demonstrate the ability of the CorMatrix PROTECT ECM Envelope to isolate and stabilize a pacemaker in a model of bilateral, subcutaneous implant pockets of a New Zealand White rabbit. The CorMatrix PROTECT ECM Envelope effectively isolated and stabilized the pacemaker with biocompatibility similar to the predicate device, TyRx AIGISRx Antibacterial Envelope.
Conclusion
The CorMatrix PROTECT ECM Envelope is substantially equivalent to the predicate devices.