(1556 days)
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 and acquired valvular lesions.
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.
The provided text describes a 510(k) summary for the CryoValve® SG Pulmonary Valve and Conduit, a human heart valve allograft. However, the document does not contain information regarding
acceptance criteria in the way it is typically described for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through preclinical bench, animal testing, and clinical evaluation.
Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text, as this medical device is a human tissue allograft, not an AI/ML driven device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable for this type of device in the context of AI/ML or specific quantitative performance metrics like sensitivity/specificity. | CryoValve SG was found to be comparable to the predicate CryoValve in terms of biocompatibility, integrity, and mechanical performance. This comparability provides reasonable assurance of device performance for its intended use and supports a determination of substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided document. The clinical evaluation is mentioned, but no details on sample size are given.
- Data Provenance: Not specified. The document mentions "clinical evaluation" but doesn't detail the nature, retrospective/prospective design, or geographic origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The "ground truth" for this device would likely be derived from a combination of clinical outcomes, histological analysis (for biocompatibility), and mechanical testing, rather than expert consensus on diagnostic images.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set:
- Not applicable/not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device, so an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
7. The type of ground truth used:
- Based on the general context of medical device approval for allografts, the "ground truth" or evidence demonstrating safety and effectiveness would likely include:
- Clinical Outcomes Data: From the "clinical evaluation" mentioned, demonstrating patient outcomes after implantation.
- Biocompatibility Testing: Ensuring the material does not cause adverse biological reactions.
- Integrity and Mechanical Performance Testing: Bench and animal testing to assess the structural soundness and functional performance of the valve under simulated physiological conditions.
- Histological and Microbiological Analysis: To confirm tissue quality, cell removal, and sterility.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device. The "training" here would refer to the historical data and experience with the predicate device (CryoValve) rather than a defined training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. Any "ground truth" related to the predicate device would have been established through its own preclinical and clinical evaluations, which preceded this 510(k) submission. The current submission focuses on demonstrating comparability between the new device and the existing predicate.
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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., NWKennesaw, GA 30144(770) 419-3355 |
|---|---|
| Contact Person: | David M. FronkVice President, Regulatory Affairs and Quality Assurance |
| Device Names: | Device Trade Name: CryoValve® SG Pulmonary ValveCryoValve® SG Pulmonary Valve and ConduitCommon/Usual Name: Human Heart ValveProposed 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 ValveAllograft - 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
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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
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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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(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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