(78 days)
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.
The CryoGen Cardiac Cryosurgery System consists of three components: the Console, which contains the compressors and the dewar. The CryoGen Cardiac Cryosurgery System is a cryosurgical unit incorporating a gas cooled cryoprobe. Operation of the cryosurgical 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 to produce extreme cold. Temperatures of -100 to -120 °C are developed at the tip of the cryoprobe.
The provided text (K974320) does not contain information about studies conducted to prove device performance against acceptance criteria. It primarily focuses on the device description, intended use, technological characteristics, and its substantial equivalence to predicate devices for regulatory clearance.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This 510(k) summary is a premarket notification for a Class II medical device, and substantial equivalence to existing devices is typically the primary focus for clearance, rather than extensive clinical efficacy studies with predefined acceptance criteria as might be required for a Class III device or a novel technology. The "studies" mentioned refer to comparisons with predicate devices regarding design, materials, and principle of operation, rather than performance studies against specific clinical endpoints.
{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 | PremarketNotification |
|---|---|
| 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
.
§ 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.