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. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.

AI/ML Overview

This document is a 510(k) summary for VascuCel, a bovine pericardial patch. It does not describe a study proving a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study with specific metrics like accuracy, sensitivity, or specificity. Instead, it argues for "substantial equivalence" to a predicate device based on existing clinical literature and verification/validation testing.

Therefore, the following information, based on the provided text, will address the user's request in the context of a 510(k) submission for substantial equivalence. Many requested fields regarding specific performance metrics, sample sizes for test/training sets, expert consensus, and MRMC studies are not applicable or not provided in the context of this type of regulatory submission.

1. A table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence based on a predicate device and established clinical practice, the "acceptance criteria" are primarily related to general safety and effectiveness and comparative performance to the predicate. Specific quantitative performance metrics (like sensitivity/specificity for an AI device) are not present.

Acceptance Criterion (Implicit)	Reported Device Performance (VascuCel)
Biocompatibility	Made from glutaraldehyde-crosslinked bovine pericardium, similar to predicate. Verification and validation testing conducted on CardioCel (predicate) demonstrated safety.
Material Properties	Sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. Dimensions are 2 x 8 cm and 0.8 x 8 cm.
Sterility	"Sterile" (stated in device description).
Intended Use Equivalence	Indicated for great vessel repair, peripheral vascular reconstruction, and suture line buttressing, which is a subset of the predicate device's broader indications and aligns with established clinical practice for bovine pericardial patches.
Safety and Effectiveness	Safety and effectiveness of bovine pericardial patches for reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature. Verification and validation testing on CardioCel (predicate) demonstrated safety and effectiveness for proposed indications. Clinical data demonstrating acute safety of VascuCel is also provided.
Substantial Equivalence	The device is substantially equivalent to the currently marketed predicate device (K130872 CardioCel) based on technical information, intended use, laboratory verification tests, and clinical performance data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of an algorithm or statistical performance study. The submission refers to "clinical data demonstrating the acute safety of VascuCel" but does not give a sample size, provenance, or whether it was retrospective or prospective. For the predicate device, it mentions "clinical performance data that was performed on CardioCel."
Data Provenance: Not specified for the "clinical data demonstrating acute safety of VascuCel." The predicate device information (CardioCel) likely drew from various clinical studies and literature, which are not detailed here.

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)

Not applicable. This is not a study requiring expert-established ground truth in the context of image interpretation or diagnostic performance. The device is a patch for surgical repair. The "ground truth" for its safety and effectiveness relies on established medical understanding and clinical outcomes from surgical use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is typically relevant to studies involving multiple expert readers interpreting data for ground truth establishment.

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 is a medical device (surgical patch), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the claims of safety and effectiveness relies on:

Established Clinical Literature: The document states, "The safety and effectiveness of bovine pericardial patches for the reconstruction and repair of cardiac and vascular anatomy is well established in clinical literature and is the current standard of care in clinical practice." This implies a broad body of outcomes data and expert consensus over time.
Verification and Validation Testing: Performed on the predicate device (CardioCel), which would involve various laboratory and potentially animal studies to confirm material properties and biological response.
Acute Safety Clinical Data: Provided for VascuCel, suggesting actual patient outcome data, though details are absent.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Admedus Regen Pty Ltd % Ms. Mary Donlin Director Regulatory Affairs and Compliance Admedus Corporation 860 Blue Gentian Road, Ste 295 Eagan, Minnesota 55121

Re: K162579 Trade/Device Name: VascuCel 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: DXZ Dated: September 14, 2016 Received: September 15, 2016

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) 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 vours.

Mude Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162579 KHANKA

Device Name VascuCel

Indications for Use (Describe)

VascuCel is indicated as a patch in great vessel repair, 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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5. 510(k) SUMMARY of Safety and Effectiveness

(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

I. Applicant Information:

Date Prepared:Submitter:	September 14, 2016Admedus Regen Pty Ltd
Address:	26 Harris RoadMalaga, Western Australia 6090Australia
EstablishmentRegistration No.	3010805634
Contact Person:	Mary E. DonlinDirector Regulatory Affairs and Compliance
Telephone Number:Fax Number:	(651) 493-0606 Ext 1008(651) 528-8042

II. Device Information:

Trade Name:	VascuCel™
Common Name:	Cardiovascular Patch
Classification Name:	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE,POLYPROPYLENE
Classification:	Class II, 21 CFR § 870.3470
Product Code:	DXZ
Predicate Device:	K130872 CardioCel
Predicate DeviceIntended Use:	CardioCel is indicated for use as a patch in pericardialclosure and the repair of cardiac and vascular defects includingintracardiac defects; septal defects, valve and annulus repair; greatvessel reconstruction, peripheral vascular reconstruction and sutureline buttressing.
Device Description:	The VascuCel device is a bovine pericardial patch prepared fromglutaraldehyde-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 2 x 8cm size and a 0.8 x 8 cm size.
Intended Use:	VascuCel is indicated as a patch in great vessel repair, peripheralvascular reconstruction and suture line buttressing.
Contraindications:	VascuCel is not designed, sold or intended for use except asindicated.The use of a tissue bioprosthesis must be considered on anindividual patient basis.
Comparison toPredicate Device:	CardioCel was cleared by the FDA (K130872) for use as a patch inpericardial closure and the repair of cardiac and vascular defectsincluding intracardiac defects; septal defects, valve and annulusrepair; great vessel reconstruction, peripheral vascularreconstruction and suture line buttressing. The additional sizesadded to the existing CardioCel product line are within the currentproduct specification range for CardioCel. The minor change tothe dimensions of the device (from 5 cm x 8 cm to 2 cm x 8 cmand 0.8cm x 8 cm respectively) is also included in this submission.The purpose of the dimensional change is to manufacture a devicethat meets the current needs of the surgeon and to reduce the freehand trimming of the device during the surgical procedure. Theprimary purpose for this submission is to modify the indication foruse from a general to specific indication to denote the use as apatch for great vessel reconstruction, peripheral vascularreconstruction and suture line buttressing.
Test Data:	The safety and effectiveness of bovine pericardial patches for thereconstruction and repair of cardiac and vascular anatomy is wellestablished in clinical literature and is the current standard of carein clinical practice.The verification and validation testing conducted on CardioCel hasdemonstrated that the device is safe and effective for the proposedindication for use as a patch for peripheral vascular reconstructionand suture line buttressing. Clinical data demonstrating the acutesafety of VascuCel is also provided to support the proposedspecific indication.
Summary:	The accumulated technical information, intended use, laboratoryverification tests and clinical performance data that was performedon CardioCel as provided in K130872, demonstrates that VascuCelis substantially equivalent to the currently marketed predicatedevice.

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Regulation Number and Section

§ 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).