(28 days)
No
The summary describes a cryosurgical system that freezes tissue using argon gas and a probe, controlled by a console. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis that would indicate the use of AI/ML technology. The description focuses on the mechanical and control aspects of the device.
Yes
Explanation: The device is intended to treat cardiac arrhythmias by freezing target tissue to block electrical conduction pathways, which is a therapeutic action.
No
Explanation: The device is described as a cryosurgical device intended for treatment (freezing target tissue to block electrical conduction pathways), not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a console, probes, gas tank, and footswitch, indicating it is a hardware-based system with potential software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias." This describes a surgical intervention performed directly on the patient's tissue.
- Mechanism of Action: The device "freezes the target tissue and blocks the electrical conduction pathways." This is a physical action on the tissue, not an analysis of a sample taken from the body.
- Device Description: The description details a system that delivers cold temperatures to tissue using a probe and console. This aligns with a surgical device, not a diagnostic test performed on a sample.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Product codes
OCL
Device Description
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console and accessories act together as a System. The system is composed of the following components:
- Cryosurgical Control Panel and Power Cord
- Cryosurgical Console .
- Tank Carrier .
- Gas Tank Regulator and Wrench .
- Gas Hose •
- SurgiFrost® XL Cryosurgical Device (Single Use)
- Footswitch (optional)
The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® XL Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost Cryosurgical Probe.
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)
Information submitted in this premarket notification for the SurgiFrost® XL information of Olyosurgical Console is substantially equivalent to the predicate devices listed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021010, K040690, K053436, K011040, K973190
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
K062140
p. 1 /3
510(k) Summary
AUG 2 4 2006
CryoCath Technologies Inc. SurgiFrost® XL Cryosurgical Device and Cryosurgical Console
1. SPONSOR
| CryoCath Technologies Inc. | |
|---|---|
| 16771 Chemin Ste-Marie | |
| Kirkland, Quebec | |
| H9H 5H3, CANADA | |
| Contact Person: | Flor del Pilar Arana, |
| Director Regulatory Affairs and Official Correspondent | |
| Telephone: | 514-694-2380 ext 358 |
Date Prepared: July 25th, 2006
2. Device Name
| Device Trade Name: | SurgiFrost® XL Surgical CryoAblation System |
|---|---|
| Common/Usual Name: | Cryosurgical system |
| Classification Name: | Cryosurgical Unit and Accessories |
| Device Classification: | Class II |
3. PREDICATE DEVICES
CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010, K040690 and K053436)
Endocare Inc. - CryoCare Cardiac Surgical System (K011040)
CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190)
4. Device Description
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
1
The Intended Use does not change as a result of this special 510(k) submission.
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console and accessories act together as a System. The system is composed of the following components:
- Cryosurgical Control Panel and Power Cord
- Cryosurgical Console .
- Tank Carrier .
- Gas Tank Regulator and Wrench .
- Gas Hose •
- SurgiFrost® XL Cryosurgical Device (Single Use)
- Footswitch (optional)
The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® XL Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost Cryosurgical Probe.
INTENDED USE 5. ·
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Technological Characteristics and Substantial Equivalence 6.
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, technological, and operational characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness.
2
Performance Testing 7.
Information submitted in this premarket notification for the SurgiFrost® XL information of Olyosurgical Console is substantially equivalent to the predicate devices listed.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cryocath Technologies, Inc. c/o Mr. Fred Milder US Agent Applied Physics 204 Clinton Rd Brookline, MA 02445
Re: K062140
Trade/Device Name: SurgiFrost XL Cryosurgical Device, Model 60SFXL Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: July 25, 2006 Received: July 27, 2006
Dear Dr. Milder:
This letter corrects our substantially equivalent letter of August 24, 2006.
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.
4
Page 2 - Mr. Fred Milder
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 yours.
el.gmell.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: SurgiFrost® XL Cryosurgical Device and Cryosurgical Console
Indications For Use: The SurgiFrost® XL Cryosurgical Device and Cryosurgical Mansole is intended for minimally invasive cardiac surgical procedures, including the Onsolo in incendou for model for the SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Prescription Use X
AND/OR
Over-The-Counter Use_ (21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Jackson
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K062140
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Special 510(k) CrvoCath Technologies Inc., SurgiFrost® Surgical Cryoablation System
Confidential July 25", 2006 Page vi