ADAPT Tissue
Device Facts
| Record ID | K200566 |
|---|---|
| Device Name | ADAPT Tissue |
| Applicant | Admedus Regen Pty, Ltd. |
| Product Code | PSQ · Cardiovascular |
| Decision Date | Apr 3, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.
Device Story
ADAPT® Tissue is a sterile, bovine pericardial patch; prepared via glutaraldehyde-crosslinking using ADAPT® TEP technology. Device is an acellular collagen sheet; moist; light yellow to beige; 4cm² to 84cm² size; 0.25-0.80mm thickness. Intended for surgical implantation by physicians in hospital settings during cardiac procedures. Functions as a structural patch for defect repair; provides tissue reinforcement. Benefits patient by facilitating repair of cardiac/septal defects and valve/annulus structures.
Clinical Evidence
No new clinical data provided. Substantial equivalence is supported by design verification and validation studies previously performed for predicate devices CardioCel and VascuCel. Biocompatibility meets ISO 10993 requirements.
Technological Characteristics
Bovine pericardium; glutaraldehyde-crosslinked using ADAPT® TEP technology. Acellular collagen sheet. Sterilized via propylene oxide. Biocompatible per ISO 10993.
Indications for Use
Indicated for patients requiring repair of cardiac defects, including intracardiac defects, septal defects, and valve and annulus repair.
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
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 3, 2020
Admedus Regen Pty Ltd Diana Upp Sr. Regulatory Affairs Specialist 860 Blue Gentian Road, Suite 340 Eagan, Minnesota 55121
Re: K200566
Trade/Device Name: ADAPT® Tissue 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: February 21, 2020 Received: March 4, 2020
Dear Diana Upp:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K200566
Device Name ADAPT® Tissue
Indications for Use (Describe)
The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.
X 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}------------------------------------------------
# K200566 510(k) Summary
#### l. Applicant Information:
| Date Prepared: | March 27, 2020 |
|-----------------------------------|-------------------------------------------------|
| Submitter: | Admedus Regen PTY LTD |
| Address: | 26 Harris Road<br>Malaga Western Australia 6080 |
| Establishment<br>Registration No. | 3010805634 |
| Contact Person: | Kiran Bhirangi, MBBS FRCS (I) |
| Telephone Number: | +1 651-900-2151 |
# II. Device Information:
| Trade Name: | ADAPT® Tissue |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiovascular Patch |
| Classification Name: | Intracardiac Patch or Pledget, Biologically Derived |
| Classification: | Class II, 21 CFR § 870.3470 |
| Product Code: | PSQ |
| Predicate Devices: | CardioCel (K130872) and VascuCel (K162579) |
| Device Description: | The ADAPT® Tissue medical device is a bovine pericardial<br>patch prepared from glutaraldehyde-crosslinked bovine<br>pericardium using the ADAPT® TEP technology. It is a<br>sterile, light yellow to beige colored, moist, pre-cut sheet of<br>acellular collagen. The products range in size from 4cm² to<br>84cm² and can range in thickness from 0.25-0.80mm. |
| Intended Use: | The ADAPT® Tissue is indicated for use as a patch in the<br>repair of cardiac defects including intracardiac defects,<br>septal defects, valve and annulus repair. |
| Comparative<br>Analysis: | The proposed and predicate devices are identical in design<br>and manufacturing. The proposed device represents a<br>labeling change only. Both the subject and predicate devices<br>are manufactured from glutaraldehyde fixed bovine<br>pericardium using the ADAPT® TEP technology. |
{4}------------------------------------------------
Table 5-1 below reveals key similarities and is the basis for substantial equivalence of the ADAPT® Tissue to the predicate devices.
| Description | ADAPT® Tissue<br>(Proposed<br>Device) | VascuCel<br>(Predicate<br>Device) | CardioCel<br>(Primary<br>Predicate Device) | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Class | II | II | II | Substantially<br>equivalent |
| 510(k) No. | New | K162579 | K130872 | |
| Classification<br>Name | Intracardiac Patch<br>or Pledget | Intracardiac Patch<br>or Pledget | Intracardiac Patch<br>or Pledget | Substantially<br>equivalent |
| CFR Section | 21 CFR 870.3470 | 21 CFR 870.3470 | 21 CFR 870.3470 | |
| Device Name | ADAPT® Tissue | VascuCel | CardioCel | |
| Trade/Common<br>Name | ADAPT® Tissue | VascuCel | CardioCel | |
| Manufacturer | Admedus Regen<br>PTY LTD | Admedus Regen<br>PTY LTD | Admedus Regen<br>PTY LTD | Same |
| Device<br>Description | The ADAPT®<br>Tissue medical<br>device is a bovine<br>pericardial patch<br>prepared from<br>glutaraldehyde-<br>crosslinked bovine<br>pericardium using<br>the ADAPT® TEP<br>technology. It is a<br>sterile, light yellow<br>to beige colored,<br>moist, pre-cut<br>sheet of acellular<br>collagen. | The VascuCel<br>device is a bovine<br>pericardial patch<br>prepared from<br>glutaraldehyde-<br>crosslinked bovine<br>pericardium using<br>the ADAPT® TEP<br>technology. It is a<br>sterile, light yellow<br>to beige colored,<br>moist, pre-cut<br>sheet of acellular<br>collagen. | The CardioCel<br>device is a<br>cardiovascular<br>patch prepared<br>from<br>glutaraldehyde-<br>crosslinked bovine<br>pericardium using<br>the ADAPT® TEP<br>technology. It is a<br>sterile, light yellow<br>or beige colored,<br>moist, pre-cut, flat<br>sheet of acellular<br>collagen. | Substantially<br>equivalent |
| Intended Use /<br>Indications for<br>Use | The ADAPT®<br>Tissue is indicated<br>for use as a patch<br>in the repair of<br>cardiac defects<br>including<br>intracardiac<br>defects, septal<br>defects, valve and<br>annulus repair. | VascuCel is<br>indicated as a<br>patch in great<br>vessel repair,<br>peripheral vascular<br>reconstruction and<br>suture line<br>buttressing. | CardioCel is<br>indicated for use<br>as a patch in<br>pericardial closure<br>and the repair of<br>cardiac and<br>vascular defects<br>including<br>intracardiac<br>defects; septal<br>defects, valve and<br>annulus repair;<br>great vessel<br>reconstruction,<br>peripheral<br>vascular<br>reconstruction and<br>suture line | Substantially<br>equivalent –<br>the indication<br>for use<br>statement of<br>the proposed<br>device is a<br>subset of the<br>predicate<br>device<br>indication for<br>use |
| Table 5-1: Predicate Device(s) Comparison Chart |
|-------------------------------------------------|
|-------------------------------------------------|
{5}------------------------------------------------
| Description | ADAPT® Tissue<br>(Proposed Device) | VascuCel<br>(Predicate Device) | CardioCel<br>(Primary Predicate Device) | Comparison |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended<br>Population | Patients who<br>require repair of<br>cardiac defects<br>including<br>intracardiac<br>defects, septal<br>defects, valve and<br>annulus repair. | Patients who<br>require great<br>vessel repairs;<br>vascular<br>reconstruction and<br>suture-line<br>buttressing | Patients with<br>intracardiac and<br>cardiovascular<br>defects requiring<br>repair (pediatric<br>and adult groups) | Substantially<br>equivalent |
| Clinical Setting | In-hospital<br>(bioimplant that is<br>surgically<br>implanted) | In-hospital<br>(bioimplant that is<br>surgically<br>implanted) | In-hospital<br>(bioimplant that is<br>surgically<br>implanted during<br>open heart<br>surgery) | |
| Anatomical<br>Sites | Cardiovascular | Peripheral<br>Vasculature | Cardiovascular | |
| Materials | Bovine Pericardium | Bovine<br>Pericardium | Bovine<br>Pericardium | |
| Design and<br>Scientific<br>Principles | Glutaraldehyde<br>fixed bovine<br>pericardium using<br>ADAPT® TEP<br>technology | Glutaraldehyde<br>fixed bovine<br>pericardium using<br>ADAPT® TEP<br>technology | Glutaraldehyde<br>fixed bovine<br>pericardium using<br>ADAPT® TEP<br>technology | |
| Performance | A long-term implant<br>for the repair of<br>cardiac defects | A long-term<br>implant for the<br>great vessel repair<br>and peripheral<br>vascular<br>reconstruction | A long-term<br>implant for the<br>repair of<br>cardiovascular<br>defects | Substantially<br>equivalent |
| Sterilization<br>Method | Propylene oxide | Propylene oxide | Propylene oxide | |
| Biocompatibility | Biocompatible;<br>meeting the<br>requirements of<br>ISO 10993 | Biocompatible;<br>meeting the<br>requirements of<br>ISO 10993 | Biocompatible;<br>meeting the<br>requirements of<br>ISO 10993 | Substantially<br>equivalent |
## Performance
Evaluation:
The nonclinical testing performed in support of the general intended use for CardioCel also demonstrates substantial equivalence of the specific ADAPT® Tissue indication for the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair. The CardioCel and ADAPT Tissue devices are identical in design and manufacturing. No additional testing was conducted to support the labeling change that is the purpose of this submission.
{6}------------------------------------------------
Summary: The results from design verification and design validation studies performed in support of CardioCel and VascuCel have been found to directly support performance of the ADAPT® Tissue. Therefore, the ADAPT® Tissue is substantially equivalent to the predicate devices.
