(30 days)
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.
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.
This document is a 510(k) Pre-Market Notification from Admedus Regen PTY LTD for their ADAPT® Tissue device. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices (CardioCel and VascuCel) rather than presenting new performance data for the ADAPT® Tissue itself.
Therefore, many of the typical acceptance criteria and study details for an AI/ML device would not apply here. The key criteria for this submission are focused on demonstrating that "ADAPT® Tissue" is essentially the same device as the "CardioCel", with a minor labeling change (refining the indications for use).
However, I can extract the relevant information based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission based on an existing device (CardioCel), the "acceptance criteria" here are that the ADAPT® Tissue should be functionally equivalent to CardioCel. The reported performance refers to the nonclinical testing already performed for CardioCel.
| Acceptance Criteria (for ADAPT® Tissue to be SE to CardioCel) | Reported Device Performance (from CardioCel, applied to ADAPT® Tissue) |
|---|---|
| Device Description: Bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT® TEP technology; sterile, light yellow to beige colored, moist, pre-cut sheet, acellular collagen. | Identical. The ADAPT® Tissue device is stated to be identical in design and manufacturing to CardioCel. |
| Materials: Bovine Pericardium | Identical. Bovine Pericardium. |
| Design and Scientific Principles: Glutaraldehyde fixed bovine pericardium using ADAPT® TEP technology. | Identical. Glutaraldehyde fixed bovine pericardium using ADAPT® TEP technology. |
| Performance: Long-term implant for the repair of cardiac defects. | Substantially Equivalent. The nonclinical testing performed for CardioCel supports the specific ADAPT® Tissue indication. |
| Sterilization Method: Propylene oxide. | Identical. Propylene oxide. |
| Biocompatibility: Biocompatible; meeting the requirements of ISO 10993. | Substantially Equivalent. Biocompatible; meeting the requirements of ISO 10993. |
| Intended Use/Indications for Use: Subset of predicate device's indications. | Substantially Equivalent. The indication for use statement of the proposed device (repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair) is a subset of the predicate device (CardioCel) indication for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as no new human clinical study was performed for the ADAPT® Tissue's specific submission. The submission relies on "nonclinical testing performed in support of the general intended use for CardioCel." Details about the sample size, provenance, and type of study for the original CardioCel testing are not included in this summary.
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 is not applicable as this is not an AI/ML diagnostic or image analysis device relying on expert interpretation for ground truth. It's a biocompatibility and performance assessment of a surgical patch.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons stated above.
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
Not applicable. This device is a surgical patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical patch, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "performance" verification of such a device, the "ground truth" would typically involve:
- Biocompatibility testing: In vitro and in vivo studies (animal models) to assess tissue integration, immune response, and toxicity, with outcomes often measured by histological analysis, inflammatory markers, and gross observations.
- Mechanical property testing: Laboratory tests to evaluate tensile strength, elasticity, and suture retention.
- Degradation studies: In vitro and in vivo studies to assess how the material degrades over time in a physiological environment.
- Sterility testing: Laboratory verification of sterility.
These "truths" are established through standard scientific and regulatory testing methods, not expert consensus in the diagnostic sense. The document states "The nonclinical testing performed in support of the general intended use for CardioCel also demonstrates substantial equivalence." This implies a reliance on these types of scientific evaluations performed for the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. For the same reason as above.
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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.
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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
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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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K200566 510(k) Summary
l. Applicant Information:
| Date Prepared: | March 27, 2020 |
|---|---|
| Submitter: | Admedus Regen PTY LTD |
| Address: | 26 Harris RoadMalaga Western Australia 6080 |
| EstablishmentRegistration 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 pericardialpatch prepared from glutaraldehyde-crosslinked bovinepericardium using the ADAPT® TEP technology. It is asterile, light yellow to beige colored, moist, pre-cut sheet ofacellular collagen. The products range in size from 4cm² to84cm² and can range in thickness from 0.25-0.80mm. |
| Intended Use: | The ADAPT® Tissue is indicated for use as a patch in therepair of cardiac defects including intracardiac defects,septal defects, valve and annulus repair. |
| ComparativeAnalysis: | The proposed and predicate devices are identical in designand manufacturing. The proposed device represents alabeling change only. Both the subject and predicate devicesare manufactured from glutaraldehyde fixed bovinepericardium using the ADAPT® TEP technology. |
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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(ProposedDevice) | VascuCel(PredicateDevice) | CardioCel(PrimaryPredicate Device) | Comparison |
|---|---|---|---|---|
| RegulatoryClass | II | II | II | Substantiallyequivalent |
| 510(k) No. | New | K162579 | K130872 | |
| ClassificationName | Intracardiac Patchor Pledget | Intracardiac Patchor Pledget | Intracardiac Patchor Pledget | Substantiallyequivalent |
| CFR Section | 21 CFR 870.3470 | 21 CFR 870.3470 | 21 CFR 870.3470 | |
| Device Name | ADAPT® Tissue | VascuCel | CardioCel | |
| Trade/CommonName | ADAPT® Tissue | VascuCel | CardioCel | |
| Manufacturer | Admedus RegenPTY LTD | Admedus RegenPTY LTD | Admedus RegenPTY LTD | Same |
| DeviceDescription | The ADAPT®Tissue medicaldevice is a bovinepericardial patchprepared fromglutaraldehyde-crosslinked bovinepericardium usingthe ADAPT® TEPtechnology. It is asterile, light yellowto beige colored,moist, pre-cutsheet of acellularcollagen. | The VascuCeldevice is a bovinepericardial patchprepared fromglutaraldehyde-crosslinked bovinepericardium usingthe ADAPT® TEPtechnology. It is asterile, light yellowto beige colored,moist, pre-cutsheet of acellularcollagen. | The CardioCeldevice is acardiovascularpatch preparedfromglutaraldehyde-crosslinked bovinepericardium usingthe ADAPT® TEPtechnology. It is asterile, light yellowor beige colored,moist, pre-cut, flatsheet of acellularcollagen. | Substantiallyequivalent |
| Intended Use /Indications forUse | The ADAPT®Tissue is indicatedfor use as a patchin the repair ofcardiac defectsincludingintracardiacdefects, septaldefects, valve andannulus repair. | VascuCel isindicated as apatch in greatvessel repair,peripheral vascularreconstruction andsuture linebuttressing. | CardioCel isindicated for useas a patch inpericardial closureand the repair ofcardiac andvascular defectsincludingintracardiacdefects; septaldefects, valve andannulus repair;great vesselreconstruction,peripheralvascularreconstruction andsuture line | Substantiallyequivalent –the indicationfor usestatement ofthe proposeddevice is asubset of thepredicatedeviceindication foruse |
| Table 5-1: Predicate Device(s) Comparison Chart |
|---|
| ------------------------------------------------- |
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| Description | ADAPT® Tissue(Proposed Device) | VascuCel(Predicate Device) | CardioCel(Primary Predicate Device) | Comparison |
|---|---|---|---|---|
| IntendedPopulation | Patients whorequire repair ofcardiac defectsincludingintracardiacdefects, septaldefects, valve andannulus repair. | Patients whorequire greatvessel repairs;vascularreconstruction andsuture-linebuttressing | Patients withintracardiac andcardiovasculardefects requiringrepair (pediatricand adult groups) | Substantiallyequivalent |
| Clinical Setting | In-hospital(bioimplant that issurgicallyimplanted) | In-hospital(bioimplant that issurgicallyimplanted) | In-hospital(bioimplant that issurgicallyimplanted duringopen heartsurgery) | |
| AnatomicalSites | Cardiovascular | PeripheralVasculature | Cardiovascular | |
| Materials | Bovine Pericardium | BovinePericardium | BovinePericardium | |
| Design andScientificPrinciples | Glutaraldehydefixed bovinepericardium usingADAPT® TEPtechnology | Glutaraldehydefixed bovinepericardium usingADAPT® TEPtechnology | Glutaraldehydefixed bovinepericardium usingADAPT® TEPtechnology | |
| Performance | A long-term implantfor the repair ofcardiac defects | A long-termimplant for thegreat vessel repairand peripheralvascularreconstruction | A long-termimplant for therepair ofcardiovasculardefects | Substantiallyequivalent |
| SterilizationMethod | Propylene oxide | Propylene oxide | Propylene oxide | |
| Biocompatibility | Biocompatible;meeting therequirements ofISO 10993 | Biocompatible;meeting therequirements ofISO 10993 | Biocompatible;meeting therequirements ofISO 10993 | Substantiallyequivalent |
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.
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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.
§ 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).