(109 days)
Not Found
No
The summary describes a cryopreserved human heart valve allograft and its processing, storage, and intended use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a replacement heart valve, which is used to treat diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, fitting the definition of a therapeutic device.
No
The device is a human heart valve allograft intended for replacement of diseased or malfunctioning pulmonary valves, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical human heart valve that undergoes processing, cryopreservation, and packaging. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a human heart valve allograft, which is a biological tissue intended for implantation.
- Lack of Diagnostic Function: The description focuses on the physical characteristics, processing, and storage of the valve for implantation. There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a replacement part.
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 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.
Product codes
OHA
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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., NW
Kennesaw, GA 30144
(770) 419-3355 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Ferros
Director, Regulatory Affairs |
| Device Names: | Device Trade Name: CryoValve® SG Pulmonary Valve
CryoValve® SG Pulmonary Valve and Conduit
Common/Usual Name: Human Heart Valve
Proposed 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 | Product
Code |
|-------------------------------------------------|----------------------------------------------------------------|--------------------------------------|-----------------|
| CryoValve® SG
Pulmonary Valve | CryoLife. Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30014 | K033484 - February 07, 2008 | OHA |
| CryoValve® SG
Pulmonary Valve and
Conduit | | | |
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.
1
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
2
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 Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K683106 |
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