(28 days)
CardioCel 3D 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.
The CardioCel 3D device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 4 x 6 cm size with a 60° curve.
The provided document is a 510(k) premarket notification for a medical device called CardioCel 3D. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information typically found in studies designed to establish device performance against predefined acceptance criteria for AI algorithms.
Here's an analysis based on the information provided, highlighting why certain questions cannot be answered from this document:
1. A table of acceptance criteria and the reported device performance:
This document does not specify "acceptance criteria" in the sense of performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it describes verification and validation testing performed on the physical device.
| Test Type | Reported Device Performance |
|---|---|
| Dimensional | Met design inputs. (Exact details of acceptance criteria for dimensions are not provided, but the statement indicates successful verification). |
| Crosslink Stability | Met design inputs. (Specific criteria not detailed). |
| Tensile Testing | Met design inputs. (Specific criteria not detailed). |
| Burst Pressure | Met design inputs. (Specific criteria not detailed). |
| Biocompatibility | Evaluated in a risk assessment and met requirements (implying compliance with ISO standards or similar). |
| Sterility | Evaluated in a risk assessment and met requirements. |
| Packaging | Evaluated in a risk assessment and met requirements. |
| Shelf Life | Evaluated in a risk assessment and met requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable and therefore not provided. The document describes laboratory verification and validation testing of the physical properties and characteristics of the CardioCel 3D device. It is not presenting data from a "test set" in the context of an AI study.
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 question is not applicable to this document. "Ground truth" and "experts" in this context typically refer to establishing diagnostic certainty for an AI algorithm's performance, which is not what this document addresses. The "ground truth" for the device's physical properties would be established by validated measurement standards and laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to this document as no expert adjudication of diagnostic outcomes is involved.
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 to this document. An MRMC study is relevant for evaluating the impact of AI on human interpretation of medical images or data, which is not the purpose of this 510(k) submission for a tissue patch.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this document. There is no algorithm being evaluated in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the physical device would be established through scientific measurement standards and validated laboratory methodologies (e.g., precise calipers for dimensional verification, standardized tensile testing equipment and protocols for tensile strength, calibrated burst pressure testers, etc.). This is implicitly assumed for "verification and validation testing."
8. The sample size for the training set:
This is not applicable to this document as no AI algorithm is being trained or evaluated.
9. How the ground truth for the training set was established:
This is not applicable to this document as no AI algorithm is being trained or evaluated.
Summary of the document's content regarding device performance:
The document indicates that the CardioCel 3D device underwent "Verification and validation testing" which included:
- Dimensional verification
- Crosslink stability
- Tensile testing
- Burst pressure testing
Additionally, a risk assessment evaluated:
- Biocompatibility
- Sterility
- Packaging
- Shelf life
Conclusion: The results of these tests and the risk assessment "demonstrated that the design outputs of the modified device meet the design inputs in conformance with established design controls." This forms the basis for the FDA's determination of substantial equivalence to the predicate device (CardioCel K130872). The key difference from the predicate is that CardioCel 3D holds a curved shape due to a manufacturing change during crosslinking, while maintaining identical intended use, raw materials, tissue processing, sterilization, packaging, and principles of operation.
{0}------------------------------------------------
Image /page/0/Picture/2 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 a stylized image of three 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
April 28, 2017
Admedus Regen Pty Ltd % Mary Donlin Vice President Regulatory Affairs and Compliance 860 Blue Gentian Road, Ste 295 Eagan, Minnesota 55121
Re: K170951
Trade/Device Name: CardioCel 3D 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: PSQ Dated: March 30, 2017 Received: March 31, 2017
Dear Ms. Donlin:
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
{1}------------------------------------------------
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 the quality systems (OS) 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,
M.A. Wilhelmsen
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) K170951
Device Name CardioCel 3D
Indications for Use (Describe)
CardioCel 3D 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
I. Applicant Information
| Date Prepared | March 30, 2017 |
|---|---|
| Submitter | Admedus Regen Pty Ltd |
| Address | 26 Harris RoadMalaga, Western Australia 6090Australia |
| Establishment Registration | 3010805634 |
| Contact Person | Mary E. DonlinVice President Regulatory Affairs and Compliance |
| Telephone NumberFax Number | (651) 493-0606 Ext 1008(651) 528-8042 |
II. Device Information
| Trade Name | CardioCel® 3D |
|---|---|
| Common Name | Cardiovascular Patch |
| Classification Name | Intracardiac Patch or Pledget, Biologically Derived |
| Classification | Class II, 21 CFR § 870.3470 |
| Product Code | PSQ |
| Predicate Device | CardioCel (K130872) |
| Device Description | The CardioCel 3D device is a bovine pericardial patch preparedfrom glutaraldehyde-crosslinked bovine pericardium using theADAPT® TEP technology. It is a sterile, light yellow to beigecolored, moist, pre-cut sheet of acellular collagen. It is offered in a 4x 6 cm size with a 60° curve. |
| Indications for Use | CardioCel 3D is indicated for use as a patch in pericardial closureand the repair of cardiac and vascular defects including intracardiacdefects; septal defects, valve and annulus repair; great vesselreconstruction, peripheral vascular reconstruction and suture linebuttressing. |
{4}------------------------------------------------
| Comparison toPredicate Device | The predicate device, CardioCel (K130872), was cleared by theFDA for use as a patch in pericardial closure and the repair ofcardiac and vascular defects including intracardiac defects; septaldefects, valve and annulus repair; great vessel reconstruction,peripheral vascular reconstruction and suture line buttressing. TheCardioCel 3D device is identical to the predicate device with respectto intended use, raw materials, tissue processing, sterilization,packaging and principles of operation. Whereas CardioCel is offeredin a flat sheet configuration, the manufacturing change implementedduring crosslinking enables CardioCel 3D to hold a curved shape. |
|---|---|
| Summary ofVerification andValidation | Verification and validation testing was conducted on CardioCel 3Dincluding dimensional verification, crosslink stability, tensile testing,and burst pressure testing. A risk assessment included evaluation ofbiocompatibility, sterility, packaging, and shelf life. The resultsdemonstrated that the design outputs of the modified device meet thedesign inputs in conformance with established design controls. |
| Conclusion | The accumulated technical information, intended use, and laboratoryverification tests demonstrate that CardioCel 3D is substantiallyequivalent to the currently marketed predicate device. |
§ 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).