(65 days)
No
The device description focuses on the biological and processing aspects of a human tissue patch. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for "repair or reconstruction of the right ventricular outflow tract," which describes a therapeutic purpose.
No
The device is described as a patch for repair or reconstruction, derived from human tissue, and implanted. Its primary function is to replace or repair tissue, not to diagnose a condition.
No
The device description clearly describes a physical tissue patch derived from human tissue, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "repair or reconstruction of the right ventricular outflow tract." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "human cardiac patch derived from human pulmonary valve and artery tissue." It is a biological tissue product intended for implantation.
- Lack of Diagnostic Function: The description focuses on the physical properties, processing, and implantation of the patch. There is no mention of it being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to test samples like blood, urine, or tissue to provide diagnostic information. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
The CryoPatch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period. harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.
CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.
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)
CryoPatch SG has undergone biomechanical, histological, DNA content, and decellularization evaluation. In addition, a large animal study and clinical data support the substantial equivalence of the device to previously marketed devices.
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.
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
CryoPatch® SG Pulmonary Human Cardiac Patch 510(k) Submission CryoLife, Inc.
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accord MIG Mill (2009 requirements of 21 C.F.R. § 807.92.
| Submitter: | CryoLife, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30144
(770) 419-3355 | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Ferros
Director, Regulatory Affairs | |
| Device Names: | Device Trade Name:
Common/Usual Name:
Classification Name: | CryoPatch® SG Pulmonary Human Cardiac Patch
Allograft Patch
Intracardiac patch or pledget |
| Intended Use: | CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction
of the right ventricular outflow tract. | |
Predicate Devices:
| Device | Company | 510 (k) Number(s),
Clearance Date | Product
Code |
|----------------------------------------------------|--------------------------------------|--------------------------------------------|-----------------|
| MatrACELLTM
Pulmonary Artery Patch
Allograft | LifeNet Health
Virginia Beach, VA | K081438 - 10/17/2008 | DXZ |
| CryoValve® SG
Pulmonary Valve (and
Conduit). | CryoLife, Inc.
Kennesaw, GA | K033484 - 02/07/2008
K083106-02/06/2009 | OHA |
Device Description:
The CryoPatch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period. harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.
CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.
Testing Supporting Substantial Equivalence:
CryoPatch SG has undergone biomechanical, histological, DNA content, and decellularization evaluation. In addition, a large animal study and clinical data support the substantial equivalence of the device to previously marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 0 7 2009
CryoLife, Inc. c/o Mr. John D. Ferros Director, Regulatory Affairs 1655 Roberts Boulevard, NW Kennesaw, GA 30144
Re: K091626
Trade/Device Name: CryoPatch® SG Pulmonary Human Cardiac Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class: II (two) Product Code: DXZ Dated: June 1, 2009 Received: June 3, 2009
Dear Mr. Ferros:
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 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 - Mr. John D. Ferros
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Anna R. Vicker
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
510(k) Number (if known): K091626
Device Name: CryoPatch® SG Pulmonary Human Cardiac Patch
Indications For Use: Indicated for repair or reconstruction of the right ventricular outflow tract.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Dune D. Lachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 09162