This document is a 510(k) summary for the MatrACELL™ Decellularized Pulmonary Artery Patch Allograft. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not present any specific acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, or AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary pathway for 510(k) clearance. The "performance data" mentioned is not about meeting specific numerical thresholds for diagnostic accuracy, but rather about showing that the device is as safe and effective as its predicates.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices for safety and efficacy.	Differences in technological characteristics do not raise new issues of safety or efficacy. Performance and safety evaluated through extensive bench and animal testing in the female juvenile sheep model. Collective results demonstrated substantial equivalence in safety and efficacy.

Missing from the document: Specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or precision) for diagnostic/classification performance, as this is not an AI/ML diagnostic device being cleared.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of an AI/ML device. The "test set" here refers to the data used in bench and animal testing. The document mentions a "female juvenile sheep model" for animal testing, but does not specify the number of animals or the specific details of the bench tests.
Data Provenance: The animal study was conducted using a "female juvenile sheep model." The location of this study (e.g., country of origin) is not specified. It is a prospective study as it involves new animal testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not stated: Ground truth in the context of this device (a tissue allograft) would likely relate to histological analysis, tissue integration, mechanical properties, and functional outcomes in the animal model. The document does not specify the number or qualifications of experts involved in analyzing the results of the bench and animal tests.

4. Adjudication Method for the Test Set

Not applicable / Not stated: Adjudication methods are typically used to resolve discrepancies among experts when establishing ground truth for diagnostic AI/ML models. This type of formal adjudication process is not described for the evaluation of this tissue allograft.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, not performed: An MRMC comparative effectiveness study is used to assess human reader performance with and without AI assistance. This device is a tissue allograft, not an AI/ML diagnostic or assistive device, so such a study would not be relevant.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, not applicable: This device is a tissue allograft, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used

The implicit "ground truth" for demonstrating substantial equivalence for this device would likely be:
- Histology/Pathology: Assessment of tissue integration, cellular infiltration, inflammation, and degradation in the animal model.
- Mechanical Properties: Bench testing to ensure the patch's physical properties (e.g., tensile strength, flexibility) are suitable and comparable to native tissue or predicate devices.
- Functional Outcomes Data: In the animal model, this would involve assessing the long-term patency, remodeling, and hemodynamic performance of the patched right ventricular outflow tract.
- Safety Data: Assessment of adverse events, host immune response, and complications in the animal model.

8. The Sample Size for the Training Set

Not applicable: This device is not an AI/ML model that requires a training set. The "development" of the decellularization process might involve various experimental runs, but this is distinct from an AI/ML training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable: As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The development of the decellularization process would be based on established scientific principles and experimental results to achieve the desired tissue properties.

Summary

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OCT 1 7 2008

510(k) Summary

510(k) Summary in Accordance with 21CFR §807.92

Date Summary Prepared: October 14, 2008

1. 510(k) Owner	LifeNet Health
2. Contact Information	Alyce Linthurst Jones, M.S., RACProject Manager - LifeNet Health1864 Concert DriveVirginia Beach, VA 23453757-609-4359eFAX: 1-866-813-1302
3. Name of the Device
Trade Name:	MatrACELLTM Decellularized Pulmonary Artery Patch Allograft
Common Name:	Patches and Pledgets
Classification Name:	Intracardiac patch or pledget made of polypropylene, polyethyleneterephthalate, or polytetrafluoroethylene (21 CFR 870.3470,Product Code DXZ)
4. Predicate Devices	1. CardioFixTM by CarboMedics - K9932882. CorMatrix Patch for Cardiac Tissue Repair -K063349MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is
5. Device Description	derived from human pulmonary artery tissue and subsequentlydecellularized. The product is provided in multiple sizes for clinicaluse.
6. Intended Use of theDevice	The MatrACELLTM Decellularized Pulmonary Artery Patch Allograftis indicated for repair of the right ventricular outflow tract
7. TechnologicalCharacteristics	The proposed indications for use for the MatrACELLTMDecellularized Pulmonary Artery Patch Allograft are substantiallyequivalent to the indications for use for the predicate devices. Anydifferences in the technological characteristics between the devicesdo not raise any new issues of safety or efficacy. Thus, theMatrACELLTM Decellularized Pulmonary Artery Patch Allograft issubstantially equivalent to the predicate devices.
8. Non-clinicalPerformance Data	Any differences in technological characteristics between theMatrACELLTM Decellularized Pulmonary Artery Patch Allograft andthe predicate devices do not raise any new issues of safety orefficacy. The performance and safety of the decellularized humanpulmonary artery material used in the MatrACELLTM DecellularizedPulmonary Artery Patch Allograft was evaluated through extensivebench and animal testing in the female juvenile sheep model. Thecollective results have demonstrated that the MatrACELLTMDecellularized Pulmonary Artery Patch Allograft is substantiallyequivalent to the respective predicate devices with regard to safetyand efficacy.
9. Summary	The MatrACELLTM Decellularized Pulmonary Artery Patch Allograftis substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2008

LifeNet Health c/o Ms. Alyce Linthurst Jones Project Manager 1864 Concert Drive Virginia Beach, VA 23453

Re: K081438

MatrACELL™ Pulmonary Artery Patch Allograft Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: DXZ Dated: September 12, 2008 Received: September 15, 2008

Dear Ms. Jones:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Alyce Linthurst Jones

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); good manufacturing practice requirements as set forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M

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

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Indications for Use

510(k) Number (if known): ___

Device Name: MatrACELL™ Decellularized Pulmonary Artery Patch Allograft

Indications for Use: The MatrACELL™ Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Device Evaluation (ODE) Concurrence of CDRH, C

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numbe

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(Posted November 13, 2003)

1864 Concert Drive, Virginia Beach, VA 23453 - 961 - 757-464-4761 - 144 - 1-757-464-5721 - 1997 - 1-800-847-7831 www.lifene

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).