MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT

K081438 · Lifenet Health · DXZ · Oct 17, 2008 · Cardiovascular

Device Facts

• Record ID: K081438
• Device Name: MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
• Applicant: Lifenet Health
• Product Code: DXZ · Cardiovascular
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.

Device Story

MatrACELL Decellularized Pulmonary Artery Patch Allograft is a human-derived pulmonary artery tissue patch. The tissue undergoes a decellularization process to create a scaffold for clinical use. It is provided in multiple sizes for surgical application. Used by surgeons in cardiac procedures to repair the right ventricular outflow tract. The patch serves as a structural graft to facilitate tissue repair. Benefits include providing a biological scaffold for surgical reconstruction of cardiac structures.

Clinical Evidence

No clinical data. Performance and safety evaluated through extensive bench testing and animal testing in a female juvenile sheep model.

Technological Characteristics

Decellularized human pulmonary artery tissue. Provided in multiple sizes. Biological scaffold material. Non-synthetic.

Indications for Use

Indicated for repair of the right ventricular outflow tract in patients requiring cardiac tissue 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

• CardioFixTM by CarboMedics (K993288)
• CorMatrix Patch for Cardiac Tissue Repair (K063349)

Submission Summary (Full Text)

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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., RAC<br>Project Manager - LifeNet Health<br>1864 Concert Drive<br>Virginia Beach, VA 23453<br>757-609-4359<br>eFAX: 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, polyethylene<br>terephthalate, or polytetrafluoroethylene (21 CFR 870.3470,<br>Product Code DXZ) |
| 4. Predicate Devices | 1. CardioFixTM by CarboMedics - K993288<br>2. CorMatrix Patch for Cardiac Tissue Repair -K063349<br>MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is |
| 5. Device Description | derived from human pulmonary artery tissue and subsequently<br>decellularized. The product is provided in multiple sizes for clinical<br>use. |
| 6. Intended Use of the<br>Device | The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft<br>is indicated for repair of the right ventricular outflow tract |
| 7. Technological<br>Characteristics | The proposed indications for use for the MatrACELLTM<br>Decellularized Pulmonary Artery Patch Allograft are substantially<br>equivalent to the indications for use for the predicate devices. Any<br>differences in the technological characteristics between the devices<br>do not raise any new issues of safety or efficacy. Thus, the<br>MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is<br>substantially equivalent to the predicate devices. |
| 8. Non-clinical<br>Performance Data | Any differences in technological characteristics between the<br>MatrACELLTM Decellularized Pulmonary Artery Patch Allograft and<br>the predicate devices do not raise any new issues of safety or<br>efficacy. The performance and safety of the decellularized human<br>pulmonary artery material used in the MatrACELLTM Decellularized<br>Pulmonary Artery Patch Allograft was evaluated through extensive<br>bench and animal testing in the female juvenile sheep model. The<br>collective results have demonstrated that the MatrACELLTM<br>Decellularized Pulmonary Artery Patch Allograft is substantially<br>equivalent to the respective predicate devices with regard to safety<br>and efficacy. |
| 9. Summary | The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft<br>is 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 [phone]. 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 [phone] or [phone] 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)

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