CardioCel is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.

Device Description

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut, flat sheet of acellular collagen. CardioCel has a shelf life of 24 months when stored between 2°C - 25°C. CardioCel is supplied in three sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm.

AI/ML Overview

The acceptance criteria for the CardioCel device, a cardiovascular patch, are implicitly established by demonstrating substantial equivalence to predicate devices (Edwards Bovine Pericardial Patch K082139 and CV Peri-Guard Cardiovascular Patch K971726) through various studies. The device aims to meet performance characteristics related to mechanical strength, biocompatibility, and clinical safety and efficacy in cardiac repair.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria (e.g., minimum burst strength in MPa) are not explicitly stated, the criteria are inferred from the need to be "substantially equivalent" to predicate devices. The reported performance suggests the device meets these inferred criteria.

Acceptance Criterion (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance
Bench Testing
Burst strength comparable to predicates	CardioCel functional testing, including burst strength, has demonstrated it is a "consistent, stable patch material suitable for cardiovascular repair in high pressure environments." Side-by-side studies demonstrated substantial equivalence to predicate devices.
Suture retention strength comparable to predicates	Demonstrated (mentioned as part of functional testing).
Tensile strength comparable to predicates	Demonstrated (mentioned as part of functional testing).
Crosslink stability comparable to predicates	Demonstrated. Side-by-side studies showed substantial equivalence.
Pronase digestion comparable to predicates	Demonstrated. Side-by-side studies showed substantial equivalence.
Biocompatibility
Favorable biocompatibility meeting ISO 10993 requirements	Biocompatibility testing according to ISO 10993 confirmed that CardioCel exhibited favorable biocompatibility characteristics, "in common with the predicate devices." Implied equivalent to predicate devices.
Non-Clinical Studies (Animal Models)
Effective and durable repair of defects in relevant models	Pivotal studies in sheep models demonstrated that CardioCel provided "effective and durable repair of jugular vein defects and both mitral and pulmonary heart valve defects."
Tissue remodeling and preservation of valve function without calcification	The biocompatible properties allowed "tissue remodeling in and around the implant and preservation of valve function. without calcification."
Safety and performance in high-pressure hemodynamic environment comparable to predicates	"The safety and performance characteristics of CardioCel in a high pressure hemodynamic environment compare favorably with published animal studies using predicate devices."
Clinical Studies
Safety and efficacy in human patients	A clinical study demonstrated "durability, efficacy and favorable hemodynamic properties."
No graft-related morbidity or mortality	"There was no graft related morbidity or mortality."
No evidence of calcification up to 36 months post-surgery	"No evidence of calcification up to 36 months after surgery."
Clinical performance comparable to predicate devices	"The clinical performance of CardioCel compares favorably with clinical studies using predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Clinical Study: 30 pediatric patients.
- Non-Clinical Studies (Animal): Information on the exact number of animals in the sheep model for pivotal studies is not provided, but it states "small and large animal models."
Data Provenance:
- Clinical Study: Not explicitly stated, but the sponsor is Australian (Admedus Regen Pty Ltd). This suggests the study might have been conducted in Australia or internationally, but the country of origin of the data is not specified.
- Clinical Study Type: Prospective (implied by "A clinical study... was undertaken to assess the safety and efficacy").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document describes a clinical study of 30 pediatric patients but does not specify the number of experts used to establish ground truth (e.g., for assessing outcomes, efficacy, or adverse events).
Qualifications of Experts: Not specified. Decisions in such clinical studies would typically be made by medical professionals (e.g., cardiac surgeons, cardiologists) involved in the care of the patients and evaluation of the device.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set in either the clinical or non-clinical studies. Outcomes would have been assessed by the clinical investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. This type of study is more common for diagnostic imaging devices rather than implantable patches. The comparison is made against existing predicate devices and literature.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant (cardiovascular patch), not an algorithm or software. Therefore, no standalone algorithm-only performance study was conducted. Performance is assessed through bench tests, animal studies, and human clinical trials.

7. Type of Ground Truth Used

Clinical Study: The "ground truth" for the clinical study would be based on clinical outcomes data (e.g., successful repair, absence of complications, sustained hemodynamic properties, absence of calcification), assessed by medical professionals during follow-up (up to 36 months).
Non-Clinical (Animal) Studies: Pathology (e.g., tissue remodeling, calcification assessment) and physiological outcomes data (e.g., durability, preservation of valve function in the specific defect models) would serve as ground truth, observed and evaluated by veterinary researchers and pathologists.
Bench Testing: Direct measurement against engineering specifications and comparative data from predicate devices.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. Since this is a medical device (implantable patch), there isn't a traditional "training set" in the computational sense.
The development and optimization of the CardioCel device and its ADAPT® TEP technology (which likely involved iterative testing and refinement) would represent an analogous "training" phase, but specific sample sizes for this development process are not provided in the summary. For instance, the number of bovine pericardial samples processed or animals used in early-stage development is not detailed.

9. How the Ground Truth for the Training Set Was Established

Again, since this is not an AI/ML device, the concept of "ground truth for a training set" as it applies to algorithms is not directly relevant.
However, the development and refinement of the ADAPT® TEP technology itself would have been guided by extensive R&D, where the "ground truth" would have been established through:
- Biochemical and mechanical characterization: Lab experiments to optimize crosslinking, removal of cellular components, and achieve desired physical properties.
- Early animal studies: To assess initial biocompatibility, degradation, and performance, leading to iterative improvements in the manufacturing process.
- These iterations would inform the "training" (i.e., optimization) of the manufacturing process to produce the final device.

Summary

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510(k) Summary for K130872

SUBMITTED BY:

Admedus Regen Pty Ltd Level.1, 197 Adelaide Terrace Perth, Western Australia 6000 Australia

CONTACT IN AUSTRALIA:

Dr. Julian Chick Chief Operating Officer Admedus Ltd Tel: +61 3 9620 5454 Tel +61 417 137 291 Fax: +61 8 9266 0199 Email: jchick@admedus.com

OFFICIAL CORRESPONDENT: Mr. Christopher Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 (301) 272 3114 Tel: Fax: (301) 272 3181 Email: chris.sloan@quintiles.com

DATE PREPARED:

January 14, 2014

CardioCel® TRADE NAME:

COMMON NAME: Intracardiac Patch

CLASSIFICATION NAME:

Intracardiac Patch or Pledget (21 CFR 870.3470; Product Code DXZ)

Edwards Bovine Pericardial Patch (K082139) PREDICATE DEVICE(S): CV Peri-Guard Cardiovascular Patch (K971726)

DEVICE DESCRIPTION:

JAN 30 2014

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CardioCel has a shelf life of 24 months when stored between 2°C - 25°C.

CardioCel is supplied in three sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm.

INDICATIONS FOR USE:

COMPARATIVE ANALYSIS:

CardioCel is manufactured from glutaraldehyde crosslinked bovine pericardium, which is the same material used for the predicate devices. CardioCel is considered to be substantially equivalent to the predicates for the following reasons:

Same raw material. .
Same intended use. .
Used in the same patient population. .
Used in the same clinical environment. .
. Manufactured using the same principles of crosslinking with glutaraldehyde.
Used in the same anatomical region (cardiovascular system). .
t Intended to perform as a long term implant, maintaining the integrity of the area repaired.
. Operates using the same fundamental scientific technology.
. Supplied in several sizes.
Similar manufacturing process .
Similar sterilisation method to one predicate. .
Similar packaging and labeling. .

Please see Table 1 for a comparison of CardioCel to the Edwards Bovine Pericardial Patch (K082139) and the CV Peri-Guard Cardiovascular Patch (K971726).

The safety and effectiveness of glutaraldehyde-crosslinked bovine pericardium patches for cardiovascular reconstruction and repair is well established. Cardiovascular patches have proved to be effective in achieving the desired results and are well tolerated by the host tissue.

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SUBSTANTIAL EQUIVALENCE INFORMATION:

Bench testing

CardioCel functional testing including burst strength, suture retention strength, tensile strength, crosslink stability and pronase digestion testing has demonstrated that CardioCel is a consistent, stable patch material suitable for cardiovascular repair in high pressure environments. Side by side studies of burst strength, crosslink stability and pronase digestion have demonstrated that CardioCel is substantially equivalent the predicate devices.

Biocompatibility

The biocompatibility of gluraldehyde-crosslinked bovine pericardium patches is wellestablished by a long history of clinical use in cardiovascular applications. Biocompatibility testing according to the requirements of ISO 10993 confirmed that CardioCel exhibited favorable biocompatibility characteristics in common with the predicate devices.

Non-clinical studies

CardioCel has been evaluated in small and large animal models for biocompatibility, safety and performance. Pivotal studies in sheep models demonstrated that CardioCel provided effective and durable repair of jugular vein defects and both mitral and pulmonary heart valve defects. The biocompatible properties of CardioCel allowed tissue remodeling in and around the implant and preservation of valve function. without calcification. The safety and performance characteristics of CardioCel in a high pressure hemodynamic environment compare favorably with published animal studies using predicate devices.

Clinical studies

A clinical study of 30 pediatric patients requiring surgical repair of a range of congenital cardiac anomalies was undertaken to assess the safety and efficacy of CardioCel as an intracardiac repair patch. CardioCel showed durability, efficacy and favorable hemodynamic properties. There was no graft related morbidity or mortality and no evidence of calcification up to 36 months after surgery. The clinical performance of CardioCel compares favorably with clinical studies using predicate devices.

Information from bench testing, biocompatibility testing, non-clinical studies and clinical studies support the claim that Cardiovascular patch is substantially equivalent to marketed devices including the Edwards Bovine Pericardial Patch (K082139) and the CV Peri-Guard Cardiovascular Patch (K971726).

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ADMEDUS

'able 1: Comparison of CardioCel with Edwards Bovine Pericardial Patch and CV Peri-Guard™ Cardiovascular Patch

Regulatory Class		Edwards Bovine Pericardial Patch	CV Peri-Guard™ Cardiovascular Patch
510(k) number	II	K082139	II	K971726
Classification Name		Intracardiac Patch or Pledget	Intracardiac Patch or Pledget
CFR Section		870.3470	870.3470
Product Code andClassification Panel		DXZ-Panel 74	DXZ-Panel 74
Device Name	CardioCel	Edwards Bovine Pericardial Patch withXenoLogiX Treatment	CV Peri-Guard™ Cardiovascular Patch
Trade/Common Name	CardioCel	Edwards Bovine Pericardial Patch	Cardiovascular Patch
Manufacturer	Admedus Pty Ltd	Edwards LifeSciences LLC	Bio-Vascular Inc.
Description	The CardioCel device is a cardiovascular patchprepared from bovine pericardium using theADAPT® TEP technology. It is a sterile, lightyellow to beige colored, moist, pre-cut, flat sheetof acellular collagen and is supplied in threesizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm, whichmay be tailored to size during surgery.	The Edwards Bovine Pericardial Patch iscomprised of a rectangular sheet of bovinepericardium that has been preserved in a bufferedglutaraldehyde solution.The pericardial patch is in the form of a 10 cm x15 cm size, and may be tailored during surgery tomeet the specific configuration needs ofindividual circumstances.	CV Peri-guard is composed of bovinepericardium, cross-linked with glutaraldehyde.Available in configurations ranging from 1 cm x1 cm to 14 cm x 16 cm.
Intended Use	For closure following open-heart surgery;intracardiac defects; septal defects and annulusrepairs; cardiac and vascular reconstruction andrepairs; peripheral vascular reconstruction andrepairs; great vessel reconstruction and repairs;and suture-line buttressing.	To assist in closure following open-heart surgery;intracardiac defects; septal defects and annulusrepairs; cardiac and vascular reconstruction andrepairs; peripheral vascular reconstruction andrepairs; great vessel reconstruction and repairs;and suture-line buttressing.	May be used for repair of ventricular septaldefect (VSD) using either a single patch orreinforced patch technique. May also be used inother applications exposed to peak systolicpressure using a reinforced patch technique (i.e.ventricular aneurysm patch, aortic graft sutureline buttress).
	CardioCel	vards Bovine Pericardial Patc	Peri-Guard™ Cardiovascular Pat
ications for	rdioCol is indicated for use in pericardial Forts and the repair of cardiac and veseular Forts including intraction and veseuding Forts including intractarias research as are	க்கடாச செய்த கார்க்கார்களில் சேவை மாந்து பார்க்க வாய்க்க வரதில் வருகின்ற வருகின்றன. பாய்க்க வரதில் வருகின்ற வருகின்றன. பால்க்குவிட்ட அரச்சியின் விளக்குறிப்புகள் பால்: நகரம்	Peri-guard is indicated for use as a patch for acardiac defects. great vessel, valve repaire repairen ure line buttressing essel, valve reparter SD) patch, atrial patch, aor
tended populatio	ients with intracardiac and cardiovascula ects requiring repair (paediatric and adulgroups)	tients with intracardiac and cardiovascu fects requiring repair (paediatric and admgroups)	tients with intracardiac and cardiovascugroups)
linical settir	lanted durinn-hospital (bioimplant surgical imp) pen heart surgery)	In-hospital (bioimplant surgical implanted durin open heart surgery)	ospital (bioimplant surgical implanted duopen heart surgery
natomical site	rdiovascul	ardiovascul	ardiovascula
Material	ovine pericardiu	ovine pericardiui	ovine pericardiu
Design and scienti orinciples	rdiunutaraldehyde fixed bovine perica	utaraldehyde fixed bovine pericard	utaraldehyde fixed bovine pericardi
erformanc	long term implant for the repair o1 diovascular defects	ong term implant for the repair diovascular defects	ong term implant for the repai diovascular defects
erilization metho	erilised using propylene o	erilised using formalin-glutaraldehyd	erilised using ethanol and propylene oxid
ocompatibili	ments of ISCocompatible; meeting the require0993	iocompatible; meeting the requirements of0993	ocompatible; meeting the requirements of10993

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ADMEDUS

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2014

Admedus Regen Pty Ltd Christopher Sloan 1801 Rockville Pike, Suite 300 Rockville. MD 20852

Re: K130872

Trade/Device Name: CardioCel 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: December 30, 2013 Received: December 30, 2013

Dear Christopher Sloan:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Christopher Sloan

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/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Melissa A. Torres -S

Bram D. Zuckerman, M.D. For Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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510(k) Premarket Notification Indication For Use

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INDICATION FOR USE

510(k) Number (if known):	K130872
Device Name:	CardioCel®
Indication For Use:	CardioCel is indicated for use as a patch in pericardialclosure and the repair of cardiac and vascular defectsincluding intracardiac defects; septal defects, valve andannulus repair; great vessel reconstruction, peripheralvascular reconstruction and suture line buttressing.

AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpan D) (21 CFR 801 Subpar1 C)) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Melissa A. Date: Concurrence of CDRH, Office of Device Evaluation (ODE) TOYTES -S - 2014.01.30

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).