Who is the manufacturer of CardioCel 3D?

Admedus Regen Pty, Ltd. filed the 510(k) submission for CardioCel 3D (K170951).

What is the FDA product code for CardioCel 3D?

PSQ. It is classified under 21 CFR 870.3470 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CardioCel 3D?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CardioCel 3D?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CardioCel 3D

K170951 · Admedus Regen Pty, Ltd. · PSQ · Apr 28, 2017 · Cardiovascular

Device Facts

Record ID	K170951
Device Name	CardioCel 3D
Applicant	Admedus Regen Pty, Ltd.
Product Code	PSQ · Cardiovascular
Decision Date	Apr 28, 2017
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.3470
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

CardioCel 3D is a sterile, bovine pericardial patch used in cardiac and vascular surgical procedures. It is manufactured from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. The device is an acellular collagen sheet, 4 x 6 cm, featuring a 60° pre-formed curve. It is intended for use by surgeons in clinical settings to repair defects or reinforce suture lines. The curved configuration is designed to facilitate surgical application compared to flat patches. The device functions as a structural patch; it is implanted during surgery to provide tissue support and closure. Benefits include biocompatibility and structural integrity for cardiac and vascular repair.

Clinical Evidence

Bench testing only. Verification and validation included dimensional verification, crosslink stability, tensile testing, and burst pressure testing. Risk assessment covered biocompatibility, sterility, packaging, and shelf life. Results demonstrated that design outputs meet design inputs.

Technological Characteristics

Bovine pericardium tissue; glutaraldehyde-crosslinked; ADAPT TEP technology; acellular collagen; 4 x 6 cm dimensions with 60° curve; sterile; moist, light yellow to beige sheet.

Indications for Use

Indicated for patients requiring pericardial closure or 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.

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

CardioCel (K130872)

Related Devices

K130872 — CARDIOCEL · Celxcel Pty, Ltd. · Jan 30, 2014
K200566 — ADAPT Tissue · Admedus Regen Pty, Ltd. · Apr 3, 2020
K162579 — VascuCel · Admedus Regen Pty, Ltd. · Oct 14, 2016
K040835 — PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 · Pm Devices, Inc. · Jun 15, 2004
K172660 — Duravess bovine pericardial vascular patch · Edwards Lifesciences, LLC · Nov 17, 2017

Submission Summary (Full Text)

{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) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 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. |