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.

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).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the CorMatrix® Tyke™ device, a medical implant for cardiac repair in neonates and infants. The document focuses on demonstrating substantial equivalence to a predicate device, the CorMatrix® ECM® for Cardiac Tissue Repair.

However, the information provided does not contain details about acceptance criteria, a specific study proving the device meets those criteria in a typical clinical trial format (e.g., sample size for test set, expert qualifications, adjudication methods for ground truth, MRMC study, training set details, or standalone algorithm performance).

The document primarily discusses non-clinical testing of the material properties and a non-clinical investigational study in an animal model. It does not describe a study involving human subjects or a diagnostic AI/ML device where such details would be relevant.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the provided document:

1. Table of acceptance criteria and reported device performance:

The document describes performance testing for material properties and an in-vivo non-clinical study, but does not present a table of specific acceptance criteria with corresponding device performance values. It generally states that the device "exceeds the biomechanical requirements for its intended use" and that the in-vivo study showed "optimal healing features" and "no adverse changes recorded."

Acceptance Criteria	Reported Device Performance
Biomechanical Properties
Tensile Strength (implied, not quantified)	Device possesses "adequate material properties" and "exceeds biomechanical requirements."
Suture Retention (implied, not quantified)	Device possesses "adequate material properties" and "exceeds biomechanical requirements."
Burst Strength (implied, not quantified)	Device possesses "adequate material properties" and "exceeds biomechanical requirements."
Withstands Tension/Hemodynamic Forces (implied)	Material "withstands the tension, and hemodynamic forces exerted on the material when used for pediatric cardiovascular repair, pericardial reconstruction, and venous cardiac outflow reconstruction."
In-vivo Performance (Non-clinical Study)
Structural Integrity Restoration (implied)	"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."
Host Cellular Response/Remodeling (optimal)	"Optimal healing features in both the Control (Cardiac Tissue Repair) and Test (Tyke) groups."
Absence of Adverse Changes	"No adverse changes recorded."

2. Sample size used for the test set and the data provenance:

Sample Size: The document mentions a "non-clinical investigational study," which implies an animal study, not human patients. The specific number of animals or data points for this study is not provided.
Data Provenance: The study was "in vivo," meaning conducted in living organisms, likely animals, but the specific country of origin of the data is not specified. It was a prospective study in the sense that outcomes were observed after implantation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable/provided as the study described is a non-clinical/animal study examining material properties and biological responses, not a study requiring human expert interpretation for ground truth, like for an AI diagnostic device. Histological techniques were used for evaluation, which would involve pathologists/histologists, but their number and qualifications are not disclosed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable/provided. Adjudication methods are typically relevant for human reader studies or when establishing ground truth from multiple expert interpretations, which is not the type of study described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable/provided. The device is a medical implant, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study is not relevant to proving its effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable/provided. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical in-vivo study, the ground truth was established through histological techniques to evaluate structural integrity and host cellular response. This implies direct observation and analysis of tissue samples, which would typically be interpreted by veterinary pathologists or similar experts.

8. The sample size for the training set:

This is not applicable/provided. There is no mention of a "training set" as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established:

This is not applicable/provided. As above, no training set for an algorithm is described.

Summary

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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 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

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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

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Indications for Use

510(k) Number (if known)

K152127

Device Name CorMatrix® Tyke™

Indications for Use (Describe)

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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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 870.3470Product Code DXZ, Class II

Predicate Devices

The CorMatrix® Tyke™ is substantially equivalent to CorMatrix® ECM® for Cardiac Tissue Repair, K063349.

Device Description

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.

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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

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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.

Regulation Number and Section

§ 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).