(148 days)
Not Found
No
The summary describes a decellularized tissue patch and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for "repair of the right ventricular outflow tract," which implies a direct therapeutic intervention to address a medical condition.
No
The device is described as an allograft patch for repair, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is derived from human pulmonary artery tissue, indicating it is a physical tissue-based product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair of the right ventricular outflow tract." This is a surgical repair procedure performed directly on the patient's body.
- Device Description: The device is a "decellularized pulmonary artery patch allograft" derived from human tissue. This is a biological implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a therapeutic implant used for surgical repair.
N/A
Intended Use / Indications for Use
The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is derived from human pulmonary artery tissue and subsequently decellularized. The product is provided in multiple sizes for clinical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right ventricular outflow tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance and safety of the decellularized human pulmonary artery material used in the MatrACELLTM Decellularized Pulmonary Artery Patch Allograft was evaluated through extensive bench and animal testing in the female juvenile sheep model. The collective results have demonstrated that the MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is substantially equivalent to the respective predicate devices with regard to safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for LifeNet. The logo consists of a stylized figure with outstretched arms inside of a semi-circle. To the right of the figure is the word "LifeNet" in a sans-serif font. Below the word "LifeNet" is the phrase "Saving Lives. Restoring Health".
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 |
| Project Manager - LifeNet Health | |
| 1864 Concert Drive | |
| Virginia Beach, VA 23453 | |
| 757-609-4359 | |
| 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 |
| terephthalate, or polytetrafluoroethylene (21 CFR 870.3470, | |
| Product Code DXZ) | |
| 4. Predicate Devices | 1. CardioFixTM by CarboMedics - K993288 |
- CorMatrix Patch for Cardiac Tissue Repair -K063349
MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is |
| 5. Device Description | derived from human pulmonary artery tissue and subsequently
decellularized. The product is provided in multiple sizes for clinical
use. |
| 6. Intended Use of the
Device | The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft
is indicated for repair of the right ventricular outflow tract |
| 7. Technological
Characteristics | The proposed indications for use for the MatrACELLTM
Decellularized Pulmonary Artery Patch Allograft are substantially
equivalent to the indications for use for the predicate devices. Any
differences in the technological characteristics between the devices
do not raise any new issues of safety or efficacy. Thus, the
MatrACELLTM Decellularized Pulmonary Artery Patch Allograft is
substantially equivalent to the predicate devices. |
| 8. Non-clinical
Performance Data | Any differences in technological characteristics between the
MatrACELLTM Decellularized Pulmonary Artery Patch Allograft and
the predicate devices do not raise any new issues of safety or
efficacy. The performance and safety of the decellularized human
pulmonary artery material used in the MatrACELLTM Decellularized
Pulmonary Artery Patch Allograft was evaluated through extensive
bench and animal testing in the female juvenile sheep model. The
collective results have demonstrated that the MatrACELLTM
Decellularized Pulmonary Artery Patch Allograft is substantially
equivalent to the respective predicate devices with regard to safety
and efficacy. |
| 9. Summary | The MatrACELLTM Decellularized Pulmonary Artery Patch Allograft
is substantially equivalent to the predicate devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
2
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
3
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
Page 1 of 1
(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