(307 days)
Not Found
No
The summary describes a biological patch material and its performance characteristics, with no mention of AI or ML technology.
Yes
A therapeutic device is one that treats or prevents a disease or condition. This device is used as a patch for the repair of cardiac and vascular defects, clearly indicating a therapeutic purpose.
No
CardioCel is a cardiovascular patch used for the repair of cardiac and vascular defects, not for diagnosing conditions.
No
The device description clearly states it is a "cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium," which is a physical, implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of CardioCel is as a patch for surgical repair of cardiac and vascular defects. This is a therapeutic and structural function within the body.
- Device Description: The device is a sterile, pre-cut sheet of acellular collagen for implantation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. CardioCel does not perform this function. It is a surgically implanted material.
Therefore, CardioCel is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular
Indicated Patient Age Range
Paediatric and adult groups
Intended User / Care Setting
In-hospital (bioimplant surgical implanted during open heart surgery)
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)
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 well-established 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.
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.
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
§ 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).
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Image /page/0/Picture/0 description: The image shows the word "ADMEDUS" in bold, black letters. The "A" is shaped like a triangle with a small square inside. The other letters are standard block letters, with the "M" having a pointed top and the "D" and "U" being rounded.
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:
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).
3
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 and | ||||
| Classification Panel | DXZ-Panel 74 | DXZ-Panel 74 | ||
| Device Name | CardioCel | Edwards Bovine Pericardial Patch with | ||
| 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 | |||
| prepared from bovine pericardium using the | ||||
| ADAPT® TEP technology. It is a sterile, light | ||||
| yellow to beige colored, moist, pre-cut, flat sheet | ||||
| of acellular collagen and is supplied in three | ||||
| sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm, which | ||||
| may be tailored to size during surgery. | The Edwards Bovine Pericardial Patch is | |||
| comprised of a rectangular sheet of bovine | ||||
| pericardium that has been preserved in a buffered | ||||
| glutaraldehyde solution. |
The pericardial patch is in the form of a 10 cm x
15 cm size, and may be tailored during surgery to
meet the specific configuration needs of
individual circumstances. | CV Peri-guard is composed of bovine
pericardium, cross-linked with glutaraldehyde.
Available in configurations ranging from 1 cm x
1 cm to 14 cm x 16 cm. | |
| Intended Use | For closure following open-heart surgery;
intracardiac defects; septal defects and annulus
repairs; cardiac and vascular reconstruction and
repairs; peripheral vascular reconstruction and
repairs; great vessel reconstruction and repairs;
and suture-line buttressing. | To assist in closure following open-heart surgery;
intracardiac defects; septal defects and annulus
repairs; cardiac and vascular reconstruction and
repairs; peripheral vascular reconstruction and
repairs; great vessel reconstruction and repairs;
and suture-line buttressing. | May be used for repair of ventricular septal
defect (VSD) using either a single patch or
reinforced patch technique. May also be used in
other applications exposed to peak systolic
pressure using a reinforced patch technique (i.e.
ventricular aneurysm patch, aortic graft suture
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
groups) | tients with intracardiac and cardiovascu fects requiring repair (paediatric and adm
groups) | tients with intracardiac and cardiovascu
groups) | |
| linical settir | lanted durin
n-hospital (bioimplant surgical imp) pen heart surgery) | In-hospital (bioimplant surgical implanted durin open heart surgery) | ospital (bioimplant surgical implanted du
open heart surgery | |
| natomical site | rdiovascul | ardiovascul | ardiovascula | |
| Material | ovine pericardiu | ovine pericardiui | ovine pericardiu | |
| Design and scienti orinciples | rdiun
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
ocompatible; meeting the require
0993 | iocompatible; meeting the requirements of
0993 | ocompatible; meeting the requirements of
10993 | |
4
ADMEDUS
5
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
6
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
7
510(k) Premarket Notification Indication For Use
・、 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
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 |
| 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. |
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