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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device seeking substantial equivalence to existing devices. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The document states:

Intended 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."

Regarding "Performance Testing," the document only says:

"Information submitted in this premarket notification for the SurgiFrost® XL information of Olyosurgical Console is substantially equivalent to the predicate devices listed."

This indicates that the submission relies on the device's substantial equivalence to predicate devices rather than providing new performance testing data against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred from the text, and where information is missing:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission hinges on substantial equivalence to predicate devices, not on meeting new, specified performance criteria with new data.
Sample size used for the test set and the data provenance: This information is not provided. The document does not describe any specific testing with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no test set is described, no ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable/not provided. The device is a cryosurgical system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable/not provided. The device is a cryosurgical system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
The sample size for the training set: This information is not provided. The document does not describe any machine learning or AI components that would require a training set.
How the ground truth for the training set was established: This information is not provided.

In conclusion, the 510(k) submission for the SurgiFrost® XL Cryosurgical Device and Cryosurgical Console does not describe specific acceptance criteria and a study to meet them. Instead, it argues for substantial equivalence to existing predicate devices, implying that the safety and effectiveness are established by comparison to already approved devices.

Summary

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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

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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. ·

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.

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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.

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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.

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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

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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

Page 1 of_

Special 510(k) CrvoCath Technologies Inc., SurgiFrost® Surgical Cryoablation System

Confidential July 25", 2006 Page vi

Regulation Number and Section

§ 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.