(1556 days)
Distributed before June 26, 1991; therefore, no 510(k) or PMA on record
Not Found
No
The device description focuses on the biological and preservation aspects of a human heart valve allograft. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is clearly indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, which is a therapeutic intervention aimed at restoring proper heart function.
No
Explanation: The device is a human heart valve replacement, intended for therapeutic purposes (replacement of diseased or damaged valves), not for diagnosing conditions.
No
The device description clearly details a physical human heart valve that undergoes processing, packaging, and cryopreservation, indicating it is a hardware medical device, 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 the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a human heart valve allograft, which is a biological tissue intended for implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
The device is a medical device, specifically a tissue-based implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CryoValve SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valye allografts are used to repair both congenital and acquired valvular lesions.
Product codes (comma separated list FDA assigned to the subject device)
74MIE, OHA
Device Description
The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial · solution, and treated to remove the cellular debris that has not already been removed during the postmortem period, harvesting, and the antimicrobial process. The valve 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 ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary valves
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)
Cryo Valve SG was subjected to preclinical bench and animal testing, as well as clinical evaluation, to assess biocompatibility, integrity, and mechanical performance of CryoValve SG was comparable to the predicate Cryo Valve, providing reasonable assurance of device performance for its intended use, and supporting a determination of substantial equivalence.
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.
Distributed before June 26, 1991; therefore, no 510(k) or PMA on record
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
N/A
0
Ko33484
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.
| Submitter: | CryoLife, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30144
(770) 419-3355 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David M. Fronk
Vice President, Regulatory Affairs and Quality Assurance |
| Device Names: | Device Trade Name: CryoValve® SG Pulmonary Valve
CryoValve® SG Pulmonary Valve and Conduit
Common/Usual Name: Human Heart Valve
Proposed Classification Name: Heart Valve, Allograft (Product Code: 74MIE) |
FEB - 7 2008# Intended Use:
Cryo Valve SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valye allografts are used to repair both congenital and acquired valvular lesions.
Predicate Devices:
| Device | Company | 510 (k) Number, Concurrence Date | Product Code |
|---|---|---|---|
| Human Heart Valve | |||
| Allograft - CryoValve | CryoLife, Inc. | ||
| (Kennesaw, GA) | Distributed before June 26, 1991; | ||
| therefore, no 510(k) or PMA on record | 74 MIE |
Device Description:
The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial · solution, and treated to remove the cellular debris that has not already been removed during the postmortem period, harvesting, and the antimicrobial process. The valve 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 ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.
Testing Supporting Substantial Equivalence:
Cryo Valve SG was subjected to preclinical bench and animal testing, as well as clinical evaluation, to assess biocompatibility, integrity, and mechanical performance of CryoValve SG was comparable to the predicate Cryo Valve, providing reasonable assurance of device performance for its intended use, and supporting a determination of substantial equivalence.
Substantial Equivalence:
The CryoLife, Inc. CryoValve SG Human Heart Valve (CryoValve SG) is substantially equivalent to the predicate devices and predicate human tissue for implantation in commercial distribution, having similar indications for use, material composition, method of processing/manufacture, technological characteristics, and final packaging. This determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act is not intended to have any bearing on the resolution of intellectual property infringement litigation or other matters related to intellectual property.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David M. Fronk Vice President, Regulatory Affairs and Quality Assurance CryoLife, Inc. 1655 Roberts Boulevard, NW Kennesaw, Georgia 30144
FEB 7 2008
Re: K033484
Trade/Device Name: CryoValve® SG Pulmonary Human Heart Valve and CryoValve® SG Pulmonary Human Heart Valve and Conduit Regulatory Class: Unclassified Product Code: OHA Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Fronk:
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.
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
2
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 Biometric's (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.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
3
Indications for Use
CryoValve® SG Pulmonary Valve, and
and acquired valvular lesions.
CryoValve® SG Pulmonary Valve and Conduit
510(k) Number (if known):
коззива
Device Name:
Indications For Use:
CryoValve SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital
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| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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Over-The-Counter Use . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
ardiovascular Devices
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