The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte" Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Device Description

The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp 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® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 7cm and 10cm Cryosurgical Probes 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

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CryoCath Technologies Inc. SurgiFrost® devices:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative or qualitative manner, nor does it present a table of device performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a pre-defined performance against specific, novel acceptance criteria.

The core of the submission is that: "The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness."

Therefore, the "acceptance criteria" are implicitly the characteristics and performance demonstrated by the predicate devices, and the "reported device performance" is a claim of equivalence to those predicates.

2. Sample size used for the test set and the data provenance

The document does not describe any specific clinical test set data (e.g., patient samples, data from a clinical trial). The approval is based on a demonstration of substantial equivalence through design and technological characteristics, not on a clinical performance study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no specific test set or clinical study is described, there is no information provided on experts establishing ground truth.

4. Adjudication method for the test set

Similarly, since no test set is discussed, there is no adjudication method mentioned.

5. 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 section is not applicable as the device is a cryosurgical system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable as the device is a cryosurgical system, not an algorithm. Its performance is inherent in its physical function and design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the submission (substantial equivalence for a physical medical device) and the absence of a defined clinical performance study, there is no mention of a specific ground truth methodology being applied to establish device performance for this particular 510(k) submission. The "ground truth", if it can be called that, is effectively the established safety and efficacy of the predicate devices.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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JAN 1 3 2006

510(k) Summary

CryoCath Technologies Inc.

SurgiFrost® 7cm, 10 cm Cryosurgical Devices plus FrostByte" Clamp 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: December 7th, 2005

2. Device Name

Device Trade Name:	SurgiFrost® 6cm, 7cm and 10cm SurgicalCryoAblation System plus FrostByte™ Clamp
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)

Endocare Inc. - CryoCare Cardiac Surgical System (K011040)

CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190)

Boston Scientific - Cobra Bipolar System (K023288)

Atricure Inc. - Atricure Bipolar Coagulation System (K020919)

Medtronic Inc. - Cardioblate™ Radiofrequency Ablation System (K013392)

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4. DEVICE DESCRIPTION

The Intended Use does not change as a result of this special 510(k) submission.

The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp 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® Cryosurgical Device (Single Use)
FrostByte™ Clamp (Single Use)
Footswitch (optional)

The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 7cm and 10cm Cryosurgical Probes 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.

5. INTENDED USE

The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive treatment of cardiac arrhythmias. The CryoCath SurgiFrost® System freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

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Technological Characteristics and Substantial Equivalence ୍.

The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness.

7. Performance Testing

Information submitted in this premarket notification for the SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices listed.

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Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

CryoCath Technologies. Inc. c/o Ms. Flor del Pilar Arana, MBA Director, Regulatory Affairs 16771 Chemin Ste-Marie Kirkland, Quebec Canada H9H 5H3

Re: K053436

Trade Name: SurgiFrost® 6 cm, 7 cm and 10 cm CryoSurgical Devices plus FrostByte™ Clamp Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: December 8, 2005 Received: December 9, 2005

Dear Ms. Arana:

This letter corrects our substantially equivalent letter of January 13, 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 - Ms. Flor del Pilar Arana, MBA

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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 ome

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

K053436

510(k) Number (if known):

Device Name: SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console

Indications For Use: The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte" Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp 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)

Bhumman

Ilvision Sign-Off) Alvision of Cardiovascular Devices 510(k) Number k. 253736

Page 1 of_____________________________________________________________________________________________________________________________________________________________________

Special 510(k) Confidential CryoCath Technologies Inc., December 7th, 2005 Page vi SurgiFrost® Surgical Cryoablation System

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.