(109 days)
CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosihetic 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 SG) is a human hent valvai The Cryolitie, fice C. you ve 35 Friman I. The valve is dissected, treated with an antimierobial solution, and asepted to remove the cells and cellular debris that has not already been removed during the posimorlem treated to renove the centual deenses. The valve is cryopreserved in a tissue vulture medium. period. hervesting, and the antitional process. The thee pouch packaging system. The packaging containing a cryqptolection, within the meether allows for aseptic introduction of the valve into the system not only while the lemperatures, our in begin prior to crystallization to feel have arm operating tolin. Supercenting of informations are transferred to a liquid nitrogen freezer for long-lerm storage at -- 135°C to -196°C.
Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA chass Implantion of the CTS varve SCF Camend Reactive Amibody measured at up to one year. Compared to the I and citiss II and mobile is misser on theat valve. Data have not been provided to evaluate the effect of standard-processed punnolary in the United United Online Form durability, or long-term resistance to rejection by the patient, of the CryoValve SG.
The provided document is a 510(k) summary for the CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit, a human heart valve. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.
The "Analysis Supporting Substantial Equivalence" section states: "A Clinical Data Analysis provides the needed assessment to support the product claim. The Analysis reviews A Cinnell Dall Analysis provides the necesses scientific rationale needed to make this change to the labeling." This vague statement implies a clinical data analysis was performed, but no details of this analysis are provided in the document. The document primarily focuses on regulatory clearance based on substantial equivalence to a previously cleared predicate device (K033484).
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document is about a heart valve, not an AI/ML device with performance metrics like sensitivity/specificity.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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: Not applicable as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document is a regulatory submission for a medical device (human heart valve) which is substantially different from an AI/ML software device that would typically undergo performance evaluation against specific acceptance criteria.
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510(K) SUMMARY (K083106)
This 510(k) Summary is 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: | John D. FerrosDirector, Regulatory Affairs |
| Device Names: | Device Trade Name: CryoValve® SG Pulmonary ValveCryoValve® SG Pulmonary Valve and ConduitCommon/Usual Name: Human Heart ValveProposed Classification Name: Allograft Heart Valve (Product Code: OHA) |
Intended Use:
.
CryoValve SC Pulmonary Human Heart Valves are indicated for the replacement of diseased, damsuged, malformed, or malfunctioning native or prostherie pulmonary valves. They may also be used in the reparences we infiatively of martinenting marve of procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.
Predicate Devices:
| Device | Company | 510 (k) Number(s),Clearance Date | ProductCode |
|---|---|---|---|
| CryoValve® SGPulmonary Valve | CryoLife. Inc.1655 Roberts Blvd., NWKennesaw, GA 30014 | K033484 - February 07, 2008 | OHA |
| CryoValve® SGPulmonary Valve andConduit |
Device Description:
The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve SG) is a human hent valvai The Cryolitie, fice C. you ve 35 Friman I. The valve is dissected, treated with an antimierobial solution, and asepted to remove the cells and cellular debris that has not already been removed during the posimorlem treated to renove the centual deenses. The valve is cryopreserved in a tissue vulture medium. period. hervesting, and the antitional process. The thee pouch packaging system. The packaging containing a cryqptolection, within the meether allows for aseptic introduction of the valve into the system not only while the lemperatures, our in begin prior to crystallization to feel have arm operating tolin. Supercenting of informations are transferred to a liquid nitrogen freezer for long-lerm storage at -- 135°C to -196°C.
Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA chass Implantion of the CTS varve SCF Camend Reactive Amibody measured at up to one year. Compared to the I and citiss II and mobile is misser on theat valve. Data have not been provided to evaluate the effect of standard-processed punnolary in the United United Online Form durability, or long-term resistance to rejection by the patient, of the CryoValve SG.
Analysis Supporting Substantial Equivalence:
A Clinical Data Analysis provides the needed assessment to support the product claim. The Analysis reviews A Cinnell Dall Analysis provides the necesses scientific rationale needed to make this change to the labeling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
FEB = 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CryoLife, Inc. c/o Mr. John Ferros 1655 Roberts Boulevard, NW Kennesaw, GA 30144
Re: K083106
CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit Regulatory Class: unclassified
Product Code: OHA Dated: January 5, 2009 Received: January 6, 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 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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Page 2 - Mr. John Ferros
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 vours,
y
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
510(k) Number (if known): K083106
Device Name: CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit
Indications For Use: CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosihetic 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.
V 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)
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Division of Cardiovascular Devices
| 510(k) Number | K683106 |
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