(188 days)
No
The document describes a biological patch material and its performance characteristics, with no mention of AI or ML.
Yes.
The device is intended for repair of damaged or repaired cardiac structures and defects, indicating a therapeutic purpose.
No
Explanation: The device is a patch material intended for repair and reconstruction of cardiac structures, not for diagnosing conditions.
No
The device is described as a physical sheet of material (SIS-ECM) intended for surgical implantation, which is a hardware component, not software.
Based on the provided information, the CorMatrix® Tyke™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a material for surgical repair and reconstruction of cardiac structures in neonates and infants. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the material composition (SIS-ECM) and its form (lyophilized sheet) for use as a patch or covering during surgery. This aligns with a surgical implant or repair material.
- Performance Studies: The performance studies focus on the biomechanical properties (tensile strength, suture retention, burst strength) and in vivo performance (histological evaluation of tissue integration and remodeling) of the material when implanted. These are relevant to the structural and biological function of a surgical implant, not to diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
In summary, the CorMatrix® Tyke™ is a surgical implant intended for the physical repair and reconstruction of cardiac tissues, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defect and annulus repair, suture-line buttressing, and cardiac repair.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
CorMatrix® Tyke™ is derived from the same multi-laminate SIS-ECM material as the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix® Tyke™ will be supplied as a 2-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts, the device design and construction are identical to the FDA-cleared CorMatrix ECM for Cardiac Tissue Repair (K063349).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial structures, cardiac structures, intracardiac defects, septal defect and annulus, pericardium, aortic, pulmonary artery
Indicated Patient Age Range
neonates and infants, pediatric
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)
The CorMatrix® Tyke™ is intended for use as a reconstructive material for the repair and reconstruction of cardiac structures, including the pericardium. The performance testing conducted for the CorMatrix® Tyke™ includes tensile strength, suture retention, and burst strength testing. The testing demonstrated that the sterile CorMatrix® Tyke™ possesses adequate material properties for use in the indicated applications. The testing demonstrates that the material withstands the tension, and hemodynamic forces exerted on the material when used for pediatric cardiovascular repair, pericardial reconstruction, and venous cardiac outflow reconstruction.
A non-clinical investigational study was conducted to evaluate the in vivo performance of CorMatrix® Tyke™ patches. The CorMatrix Tyke (2-ply ECM material) was compared to the commercially available CorMatrix® ECM® for Cardiac Tissue Repair (4-ply ECM). Aortic and pulmonary artery implant sites were selected to correspond with the usual repair sites for which the CorMatrix® ECM® for Cardiac Tissue Repair is clinically used. Histological techniques were used to evaluate the structural integrity of both materials along with host cellular response during the remodeling process at 90 days and 180 days post-implantation.
Performance testing of the CorMatrix® Tyke™ (2-ply ECM material) demonstrated that it exceeds the biomechanical requirements for its intended use as well as the biomechanical requirements of the CorMatrix® ECM® for Cardiac Tissue Repair (4-ply ECM material). The nonclinical study data demonstrated optimal healing features in both the Control (Cardiac Tissue Repair) and Test (Tyke) groups. The structural integrity of the arteriotomy sites were restored through fibrocellular integration of the ECM implant and formation of a fully mature, stable, and endothelialized neointima in both groups, and there were no adverse changes recorded.
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.
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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 04, 2016
CorMatrix Cardiovascular, Inc. Mr. Andrew Green Executive Vice President of Operations 1100 Old Ellis Road Roswell, Georgia 30076
Re: K152127 Trade/Device Name: CorMatrix Tyke 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: January 6, 2016 Received: January 7, 2016
Dear Mr. Green:
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 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CorMatrix® Tyke™
Indications for Use (Describe)
The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defect and annulus repair, suture-line buttressing, and cardiac repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary: K152127
| Company Information | |
|---|---|
| Company Name: | CorMatrix Cardiovascular, Inc. |
| Contact Name: | Andrew Green |
| Contact Title: | President and COO |
| Address: | 1100 Old Ellis Rd. |
| Roswell, GA 30076 | |
| Phone: | 470-514-4019 |
| Fax: | 678-566-2860 |
| Date Prepared: | February 3, 2016 |
| Product Information | |
| Trade Name: | CorMatrix® Tyke™ |
| Common Name: | Patch, Pledget and Intracardiac |
| Classification Name: | Patch, Pledget and Intracardiac, 21 CFR 870.3470 |
| Product Code DXZ, Class II |
Predicate Devices
The CorMatrix® Tyke™ is substantially equivalent to CorMatrix® ECM® for Cardiac Tissue Repair, K063349.
Device Description
CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
CorMatrix® Tyke™ is derived from the same multi-laminate SIS-ECM material as the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix® Tyke™ will be supplied as a 2-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts, the device design and construction are identical to the FDA-cleared CorMatrix ECM for Cardiac Tissue Repair (K063349).
Indications for Use
The CorMatrix Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
4
CorMatrix Cardiovascular, Inc.
CorMatrix® Tyke™ 510(k) Premarket Notification
Substantial Equivalence
The device is constructed from the identical ECM material used for construction of the CorMatrix® ECM® for Cardiac Tissue Repair (K063349). The device differs from the CorMatrix® ECM® for Cardiac Tissue Repair only in the number of ECM layers from which each device is constructed.
The CorMatrix® Tyke™ is a two-layer ECM material and the CorMatrix® ECM® for Cardiac Tissue Repair is a 4-layer ECM material. Due to the handling and remodeling characteristics of the 2ply material, the CorMatrix® Tyke™ is well-suited for pediatric, lower-pressure applications. The Indications for Use are specific for the thinner ECM material by limiting use to lower-pressure applications. Due to the pediatic populations for which the CorMatrix® Tyke™ is intended, the device is provided in a maximum size of 4 cm x 7 cm whereas the predicate device (CorMatrix® ECM® for Cardiac Tissue Repair) is provided in sizes up to 7 cm x 20 cm.
Each layer of the device is identical to the ECM layers in the predicate device. However, the 2ply CorMatrix® Tyke™ was designed to address the needs of surgeons requesting a thinner ECM material.
The Indications for Use for the CorMatrix® Tyke™ also include pericardial closure. The CorMatrix RegeneSIS Pericardial Patch (K051405) is identical to the CorMatrix® ECM® for Cardiac Tissue Repair and was a predicate device for clearance of the CorMatrix® ECM® for Cardiac Tissue Repair.
Non-clinical Testing
The CorMatrix® Tyke™ is intended for use as a reconstructive material for the repair and reconstruction of cardiac structures, including the pericardium. The performance testing conducted for the CorMatrix® Tyke™ includes tensile strength, suture retention, and burst strength testing. The testing demonstrated that the sterile CorMatrix® Tyke™ possesses adequate material properties for use in the indicated applications. The testing demonstrates that the material withstands the tension, and hemodynamic forces exerted on the material when used for pediatric cardiovascular repair, pericardial reconstruction, and venous cardiac outflow reconstruction.
A non-clinical investigational study was conducted to evaluate the in vivo performance of CorMatrix® Tyke™ patches. The CorMatrix Tyke (2-ply ECM material) was compared to the commercially available CorMatrix® ECM® for Cardiac Tissue Repair (4-ply ECM). Aortic and pulmonary artery implant sites were selected to correspond with the usual repair sites for which the CorMatrix® ECM® for Cardiac Tissue Repair is clinically used. Histological techniques were used to evaluate the structural integrity of both materials along with host cellular response during the remodeling process at 90 days and 180 days post-implantation.
Conclusion
Performance testing of the CorMatrix® Tyke™ (2-ply ECM material) demonstrated that it exceeds the biomechanical requirements for its intended use as well as the biomechanical
5
CorMatrix Cardiovascular, Inc.
CorMatrix® Tyke™
510(k) Premarket Notification requirements of the CorMatrix® ECM® for Cardiac Tissue Repair (4-ply ECM material). The nonclinical study data demonstrated optimal healing features in both the Control (Cardiac Tissue Repair) and Test (Tyke) groups. The structural integrity of the arteriotomy sites were restored through fibrocellular integration of the ECM implant and formation of a fully mature, stable, and endothelialized neointima in both groups, and there were no adverse changes recorded.
The CorMatrix® Tyke™ is substantially equivalent to the CorMatrix® ECM® for Cardiac Tissue Repair.