(78 days)
Not Found
No
The document describes a cryosurgical system based on the Joule-Thomson principle for freezing tissue. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to freeze target tissue and block electrical conduction pathways to treat cardiac arrhythmias, which is a therapeutic purpose.
No
The device description states its purpose is to produce extreme cold for freezing target tissue and blocking electrical conduction pathways, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines hardware components like a Console, compressors, dewar, and a gas-cooled cryoprobe, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias." This describes a surgical intervention performed directly on the patient's tissue.
- Mechanism of Action: The device works by freezing tissue to block electrical conduction pathways. This is a physical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a cryosurgical unit with a cryoprobe that produces extreme cold. This is a surgical tool, not a diagnostic instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The CryoGen Cardiac Cryosurgery System, as well as the other predicate devices, are intended for use in minimally invasive surgical procedures, including the treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block in the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
The CryoGen Cardiac Cryosurgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The CryoGen Cardiac Cryosurgery System consists of three components: the The Oryouth Caraldo Oryect good ond the Console, which contains the disposuressors and the dewar. The CryoGen Cardiac Cryosurgery System is a comproboto and and anomorating a gas cooled cryoprobe. Operation of the cryosurglour do noo incorporainly .
System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended are oxpandod through a extreme cold. Temperatures of -100 to -120 °C are developed at the tip of the cryoprobe. These temperatures are within the range of the predicate devices and are sufficient to achieve the desired tissue effect. None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no cooling along the shaft of the probe nor at the handle that is held by the user during treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
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)
Not Found
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.
K972662, K811390, K874367, K970496
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
CryoGen, Inc. San Diego, CA Premarket Notification November 14, 1997
FEB - 3 1998
510(k) Summary
Name of Device
| Trade name: | CryoGen Cardiac Cryosurgery System |
|---|---|
| Common name: | Cryosurgical Unit and Accessories |
| Classification name: | Cryosurgical Unit and Accessories (21 CFR 878.4350) |
Predicate devices
| Device | Premarket
Notification |
|-----------------------------------------|---------------------------|
| Frigitronics CCS 100 | K811390 |
| Spembly Cardiac Cryounit and Cryoprobes | K874367 |
| Heartport Maze System: Cryoprobe Set | K970496 |
| CryoGen Cryosurgical System | K972662 |
Device description & Principle of Operation
The CryoGen Cardiac Cryosurgery System consists of three components: the The Oryouth Caraldo Oryect good ond the Console, which contains the disposuressors and the dewar. The CryoGen Cardiac Cryosurgery System is a comproboto and and anomorating a gas cooled cryoprobe. Operation of the cryosurglour do noo incorporainly .
System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended are oxpandod through a extreme cold. Temperatures of -100 to -120 °C are developed at the tip of the cryoprobe. These temperatures are within the range of the predicate devices and are sufficient to achieve the desired tissue effect. None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no cooling along the shaft of the probe nor at the handle that is held by the user during treatment.
1
CryoGen, Inc. San Diego, CA Premarket Notification November 14, 1997
Intended use
The CryoGen Cardiac Cryosurgery System, as well as the other predicate devices, are intended for use in minimally invasive surgical procedures, including the treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block in the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
Technological characteristics
The technological characteristics of the CryoGen Cardiac Cryosurgical System are the same as those of the predicate CryoGen Cryosurgical System. These devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization.
Summary
By virtue of design, materials, function and intended use, the CryoGen Cardiac Cryosurgical System is substantially equivalent to the CryoGen Cryosurgical System which is cleared under K972662. It is also equivalent to the predicate devices cleared via the Premarket Notification process, which have been included in this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of a person with outstretched arms embracing another person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the image.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cryogen, Incorporated c/o Ms. Cheryl L. Shea Vice President, Regulatory Affairs and Quality Assurance 6199 Cornerstone Court East, Suite 106 San Diego, CA 92121
Re: K974320 Trade Name: Cryogen Cardiac Cryosurgical System Regulatory Class: II (two) Product Code: OCL Dated: November 14, 1997 Received: November 17, 1997
Dear Ms. Shea:
This letter corrects our substantially equivalent letter of February 3, 1998.
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 (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.
3
Page 2 - Ms. Cheryl L. Shea
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 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 continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely vours.
elime
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CryoGen, Inc. San Diego, California Premarket Notification November 14, 1997
Indications Statement
CryoGen Cardiac Cryosurgical System Device Name: 510(k) Number:
Indications for use:
The CryoGen Cardiac Cryosurgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
bcocla
(Division Sign-Off)
| Division of General Restorative Devices | K974320 |
|---|---|
| 510(k) Number |
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
.