(28 days)
Not Found
No
The summary describes a bovine pericardial patch and its physical properties and testing, with no mention of AI or ML technology.
No
The device description indicates it is a patch used for repair and reconstruction of cardiac and vascular defects, and the intended use is as a patch in pericardial closure and repair/reconstruction. This suggests it is a structural repair device, not one that treats a disease or condition for therapeutic purposes.
No
The device description and intended use clearly state that it is a surgical patch used for repair and reconstruction, not for identifying or diagnosing diseases or conditions.
No
The device description clearly states it is a bovine pericardial patch, 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 describes the device as a patch for surgical repair of cardiac and vascular defects. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical patch made from bovine pericardium. IVDs are typically reagents, kits, or instruments used to examine specimens from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide diagnostic information about a patient's condition.
- Anatomical Site: The anatomical sites listed are where the device is implanted, not where samples are taken for analysis.
IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
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.
Product codes
PSQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardial, cardiac, vascular, intracardiac, septal, valve, annulus, great vessel, peripheral vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Verification and validation testing was conducted on CardioCel 3D including dimensional verification, crosslink stability, tensile testing, and burst pressure testing. A risk assessment included evaluation of biocompatibility, sterility, packaging, and shelf life. The results demonstrated that the design outputs of the modified device meet the design inputs in conformance with established design controls.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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) |
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I. Applicant Information
| Date Prepared | March 30, 2017 |
|---|---|
| Submitter | Admedus Regen Pty Ltd |
| Address | 26 Harris Road |
| Malaga, Western Australia 6090 | |
| Australia | |
| Establishment Registration | 3010805634 |
| Contact Person | Mary E. Donlin |
| Vice President Regulatory Affairs and Compliance | |
| Telephone Number | |
| Fax 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 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. | |
| Indications for Use | 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. |
4
| Comparison to
Predicate Device | The predicate device, CardioCel (K130872), was cleared by the
FDA 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 identical to the predicate device with respect
to intended use, raw materials, tissue processing, sterilization,
packaging and principles of operation. Whereas CardioCel is offered
in a flat sheet configuration, the manufacturing change implemented
during crosslinking enables CardioCel 3D to hold a curved shape. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Verification and
Validation | Verification and validation testing was conducted on CardioCel 3D
including dimensional verification, crosslink stability, tensile testing,
and burst pressure testing. A risk assessment included evaluation of
biocompatibility, sterility, packaging, and shelf life. The results
demonstrated that the design outputs of the modified device meet the
design inputs in conformance with established design controls. |
| Conclusion | The accumulated technical information, intended use, and laboratory
verification tests demonstrate that CardioCel 3D is substantially
equivalent to the currently marketed predicate device. |