CARDIOCEL

K130872 · Celxcel Pty, Ltd. · DXZ · Jan 30, 2014 · Cardiovascular

Device Facts

• Record ID: K130872
• Device Name: CARDIOCEL
• Applicant: Celxcel Pty, Ltd.
• Product Code: DXZ · Cardiovascular
• Decision Date: Jan 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K130872 · Jan 30, 2014	CARDIOCEL	Celxcel Pty, Ltd.	Clinical study of pediatric patients	A clinical study of 30 pediatric patients was used to assess the safety and efficacy of the CardioCel patch for intracardiac repair, demonstrating durability, hemodynamic properties, and lack of calcification over 36 months.	Pediatric; Congenital cardiac anomalies; Intracardiac repair; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical study; Follow-up/Duration: Up to 36 months	30 pediatric patients requiring surgical repair of congenital cardiac anomalies; Sample Size: 30	Not applicable for this study	Safety, efficacy, durability, hemodynamic properties, calcification

Indications for Use

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 Story

CardioCel is a sterile, pre-cut, flat sheet of acellular bovine pericardium; processed via ADAPT® TEP technology using glutaraldehyde crosslinking. Used in hospital settings during open-heart surgery by surgeons for cardiovascular reconstruction and repair. Implanted as a long-term patch to maintain structural integrity of repaired tissue; supports tissue remodeling without calcification. Benefits include durable repair of cardiac/vascular defects and favorable hemodynamic performance in high-pressure environments.

Clinical Evidence

Clinical study of 30 pediatric patients with congenital cardiac anomalies demonstrated safety and efficacy. Primary endpoints included durability, hemodynamic properties, and absence of calcification. Results showed no graft-related morbidity or mortality up to 36 months post-surgery. Non-clinical evidence includes pivotal sheep model studies showing effective repair of jugular vein and heart valve defects with tissue remodeling and no calcification. Bench testing confirmed functional stability (burst/tensile strength) and biocompatibility per ISO 10993.

Technological Characteristics

Material: Glutaraldehyde-crosslinked bovine pericardium. Form: Sterile, moist, pre-cut flat sheet (4x4 cm, 5x8 cm, 14x7 cm). Principle: ADAPT® TEP technology for crosslinking. Sterilization: Propylene oxide. Biocompatibility: ISO 10993 compliant. Intended as a long-term implant for cardiovascular repair.

Indications for Use

Indicated for pediatric and adult patients requiring surgical repair of pericardial, cardiac, and vascular defects, including intracardiac, septal, valve, annulus, great vessel, and peripheral vascular defects, and for suture line buttressing.

Regulatory Classification

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.

Predicate Devices

• Edwards Bovine Pericardial Patch (K082139)
• CV Peri-Guard Cardiovascular Patch (K971726)

Submission Summary (Full Text)

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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: [phone] Tel [phone] Fax: [phone] Email: [e-mail]

OFFICIAL CORRESPONDENT: Mr. Christopher Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 [phone] Tel: Fax: [phone] Email: [e-mail]

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:

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.

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:

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.

### 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

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'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 and<br>Classification Panel | | DXZ-Panel 74 | DXZ-Panel 74 | |
| Device Name | CardioCel | Edwards Bovine Pericardial Patch with<br>XenoLogiX 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 patch<br>prepared from bovine pericardium using the<br>ADAPT® TEP technology. It is a sterile, light<br>yellow to beige colored, moist, pre-cut, flat sheet<br>of acellular collagen and is supplied in three<br>sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm, which<br>may be tailored to size during surgery. | The Edwards Bovine Pericardial Patch is<br>comprised of a rectangular sheet of bovine<br>pericardium that has been preserved in a buffered<br>glutaraldehyde solution.<br><br>The pericardial patch is in the form of a 10 cm x<br>15 cm size, and may be tailored during surgery to<br>meet the specific configuration needs of<br>individual circumstances. | CV Peri-guard is composed of bovine<br>pericardium, cross-linked with glutaraldehyde.<br>Available in configurations ranging from 1 cm x<br>1 cm to 14 cm x 16 cm. | |
| Intended Use | For closure following open-heart surgery;<br>intracardiac defects; septal defects and annulus<br>repairs; cardiac and vascular reconstruction and<br>repairs; peripheral vascular reconstruction and<br>repairs; great vessel reconstruction and repairs;<br>and suture-line buttressing. | To assist in closure following open-heart surgery;<br>intracardiac defects; septal defects and annulus<br>repairs; cardiac and vascular reconstruction and<br>repairs; peripheral vascular reconstruction and<br>repairs; great vessel reconstruction and repairs;<br>and suture-line buttressing. | May be used for repair of ventricular septal<br>defect (VSD) using either a single patch or<br>reinforced patch technique. May also be used in<br>other applications exposed to peak systolic<br>pressure using a reinforced patch technique (i.e.<br>ventricular aneurysm patch, aortic graft suture<br>line 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 adul<br>groups) | tients with intracardiac and cardiovascu fects requiring repair (paediatric and adm<br>groups) | tients with intracardiac and cardiovascu<br>groups) | |
| linical settir | lanted durin<br>n-hospital (bioimplant surgical imp) pen heart surgery) | In-hospital (bioimplant surgical implanted durin open heart surgery) | ospital (bioimplant surgical implanted du<br>open heart surgery | |
| natomical site | rdiovascul | ardiovascul | ardiovascula | |
| Material | ovine pericardiu | ovine pericardiui | ovine pericardiu | |
| Design and scienti orinciples | rdiun<br>utaraldehyde 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 ISC<br>ocompatible; meeting the require<br>0993 | iocompatible; meeting the requirements of<br>0993 | ocompatible; meeting the requirements of<br>10993 | |

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ADMEDUS

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.

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

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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 [phone] or [phone] 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 [phone] or [phone] 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 pericardial<br>closure and the repair of cardiac and vascular defects<br>including intracardiac defects; septal defects, valve and<br>annulus repair; great vessel reconstruction, peripheral<br>vascular 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