(69 days)
Not Found
No
The summary describes a software-controlled system that uses a thermocouple for temperature monitoring and operates based on the Joule-Thompson principle. There is no mention of AI, ML, image processing, or any data-driven learning components.
Yes
The device is used for surgical treatment of cardiac arrhythmias, which involves a medical intervention to treat a disease or condition.
No
The device is described as a surgical system used for therapeutic procedures (freezing target tissue to block electrical conduction) rather than for diagnosing a condition. While it has a thermocouple for monitoring, this is for system operation during the procedure, not for diagnostic purposes.
No
The device description explicitly states it consists of a control unit and a disposable cryoprobe, both of which are hardware components. While the control unit is software-controlled, the system is not solely software.
Based on the provided information, the Cryocare Cardiac Surgical System is not an In Vitro Diagnostic (IVD) device.
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 "freeze the target tissue and block the electrical conduction pathway." This is a physical action applied to living tissue within the body.
- Device Description: The description details a surgical system with a control unit and cryoprobe designed for direct application to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cryocare Cardiac Surgical System directly treats tissue within the body, making it a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.
Product codes
OCL
Device Description
The modified Cryocare Cardiac Surgical system consists of a control unit that operates one single use, disposable cryoprobe. The control unit is software controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple.
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
In-vitro performance testing of the Endocare Modified Cryocare Cardiac Surgical System included dimensional inspection, flex tests, endurance tests, burst pressure tests, performance under simulated use conditions. All testing of the product yielded acceptable results.
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)
K011040 - Endocare Cryocare Cardiac Surgical System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Attachment 5
endocare.
Prepared March 28, 2002 Modified Cryocare Cardiac Surgical System TRADE NAME Class II (21 CFR 878.4350) CLASSIFICATION Eben Gordon CONTACT SUBMITTED BY Endocare, Inc. 7 Studebaker Regulatory Affairs (949) 595 5424 Irvine, CA 92618 K011040 - Endocare Cryocare Cardiac Surgical System. PREDICATE Decision date: 06/15/2001 DEVICE The modified Cryocare Cardiac Surgical system consists of a control unit that DEVICE operates one single use, disposable cryoprobe. The control unit is software DESCRIPTION controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple. The Cryocare Cardiac Surgical System is indicated for use in minimally INDICATIONS FOR invasive cardiac surgery procedures, including surgical treatment of cardiac USE arrhythmias. The Crvocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis In-vitro performance testing of the Endocare Modified Cryocare Cardiac TESTING Surgical System included dimensional inspection, flex tests, endurance tests, burst pressure tests, performance under simulated use conditions. All testing of the product yielded acceptable results. The Endocare Modified Cryocare Cardiac Surgical System is substantially SUMMARY OF equivalent to the predicate device in intended use and principles of operation. SUBSTANTIAL EQUIVALENCE
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 201 0003
Endocare, Inc. c/o Mr. Eben Gordon Director, Regulatory Affairs 7 Studebaker Irvine, CA 92618
Re: K021010
Trade/Device Name: Modified Cryocare Cardiac Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL Dated: May 8, 2002 Received: May 10, 2002
Dear Mr. Gordon:
This letter corrects our substantially equivalent letter of June 6, 2002.
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.
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Page 2 - Mr. Eben Gordon
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.
Elmoll
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Endocare, Inc. Special 510(k): Modified Cryocare Cardiac Surgical System
Attachment 2
Indications for Use Statement
510(k) Number (if known):
Modified Cryocare Cardiac Surgical System Device Name:
Indications for Use: The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes 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)
| Prescription Use | OR | Over the Counter Use | |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ---------------------- |
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021010 | Page 44 of 50 |
|---|---|---|
| --------------- | --------- | --------------- |