(30 days)
No
The summary describes a biological tissue patch and its manufacturing process. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for use in the repair of cardiac defects, which is a therapeutic purpose.
No
The device is described as a "bovine pericardial patch" for the repair of cardiac defects, indicating it is an implantable therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a bovine pericardial patch, which is a physical, implantable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "use as a patch in the repair of cardiac defects." This is a surgical implant used in the body to repair tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "bovine pericardial patch" that is "surgically implanted." This is a physical device for surgical repair.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
PSQ
Device Description
The ADAPT® Tissue medical 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. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In-hospital (bioimplant that is surgically implanted)
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
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.
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.
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/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)
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3
K200566 510(k) Summary
l. Applicant Information:
| Date Prepared: | March 27, 2020 |
|---|---|
| Submitter: | Admedus Regen PTY LTD |
| Address: | 26 Harris Road |
| Malaga Western Australia 6080 | |
| Establishment | |
| 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 |
| 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. The products range in size from 4cm² to | |
| 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 |
| repair of cardiac defects including intracardiac defects, | |
| septal defects, valve and annulus repair. | |
| Comparative | |
| Analysis: | The proposed and predicate devices are identical in design |
| and manufacturing. The proposed device represents a | |
| labeling change only. Both the subject and predicate devices | |
| are manufactured from glutaraldehyde fixed bovine | |
| 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
(Proposed
Device) | VascuCel
(Predicate
Device) | CardioCel
(Primary
Predicate Device) | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Class | II | II | II | Substantially
equivalent |
| 510(k) No. | New | K162579 | K130872 | |
| Classification
Name | Intracardiac Patch
or Pledget | Intracardiac Patch
or Pledget | Intracardiac Patch
or Pledget | Substantially
equivalent |
| CFR Section | 21 CFR 870.3470 | 21 CFR 870.3470 | 21 CFR 870.3470 | |
| Device Name | ADAPT® Tissue | VascuCel | CardioCel | |
| Trade/Common
Name | ADAPT® Tissue | VascuCel | CardioCel | |
| Manufacturer | Admedus Regen
PTY LTD | Admedus Regen
PTY LTD | Admedus Regen
PTY LTD | Same |
| Device
Description | The ADAPT®
Tissue medical
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. | The VascuCel
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. | The CardioCel
device is a
cardiovascular
patch prepared
from
glutaraldehyde-
crosslinked bovine
pericardium using
the ADAPT® TEP
technology. It is a
sterile, light yellow
or beige colored,
moist, pre-cut, flat
sheet of acellular
collagen. | Substantially
equivalent |
| Intended Use /
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. | VascuCel is
indicated as a
patch in great
vessel repair,
peripheral vascular
reconstruction and
suture line
buttressing. | 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 | Substantially
equivalent –
the indication
for use
statement of
the proposed
device is a
subset of the
predicate
device
indication for
use |
| Table 5-1: Predicate Device(s) Comparison Chart |
|---|
| ------------------------------------------------- |
5
| Description | ADAPT® Tissue
(Proposed Device) | VascuCel
(Predicate Device) | CardioCel
(Primary Predicate Device) | Comparison |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended
Population | Patients who
require repair of
cardiac defects
including
intracardiac
defects, septal
defects, valve and
annulus repair. | Patients who
require great
vessel repairs;
vascular
reconstruction and
suture-line
buttressing | Patients with
intracardiac and
cardiovascular
defects requiring
repair (pediatric
and adult groups) | Substantially
equivalent |
| Clinical Setting | In-hospital
(bioimplant that is
surgically
implanted) | In-hospital
(bioimplant that is
surgically
implanted) | In-hospital
(bioimplant that is
surgically
implanted during
open heart
surgery) | |
| Anatomical
Sites | Cardiovascular | Peripheral
Vasculature | Cardiovascular | |
| Materials | Bovine Pericardium | Bovine
Pericardium | Bovine
Pericardium | |
| Design and
Scientific
Principles | Glutaraldehyde
fixed bovine
pericardium using
ADAPT® TEP
technology | Glutaraldehyde
fixed bovine
pericardium using
ADAPT® TEP
technology | Glutaraldehyde
fixed bovine
pericardium using
ADAPT® TEP
technology | |
| Performance | A long-term implant
for the repair of
cardiac defects | A long-term
implant for the
great vessel repair
and peripheral
vascular
reconstruction | A long-term
implant for the
repair of
cardiovascular
defects | Substantially
equivalent |
| Sterilization
Method | Propylene oxide | Propylene oxide | Propylene oxide | |
| Biocompatibility | Biocompatible;
meeting the
requirements of
ISO 10993 | Biocompatible;
meeting the
requirements of
ISO 10993 | Biocompatible;
meeting the
requirements of
ISO 10993 | Substantially
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.