The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device 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® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device 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® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, 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® 10 cm 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 510(k) summary for the CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console does not contain information regarding detailed acceptance criteria or a specific study proving the device meets distinct performance thresholds.

Instead, the document states that the device is "substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics." It also mentions "Performance Testing" but provides no details about the tests performed, their results, or the acceptance criteria used.

Therefore, I cannot populate the requested table or provide the detailed information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's an analysis based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document.	Not specified in the document. The document only states "Information submitted in this premarket notification...is substantially equivalent to the predicate devices listed."

Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against pre-defined acceptance criteria for this particular device. It doesn't detail performance endpoints such as temperature reach, cryoablation zone size, success rate of blocking electrical conduction, or any other quantifiable metrics.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned.

Explanation: The document does not describe any specific "test set" or a study involving human subjects or data where performance was measured. The claim of "substantial equivalence" is typically supported by bench testing, non-clinical studies, and comparisons to the known performance of predicate devices, but the details of such tests are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

Explanation: Since no specific test set requiring expert ground truth is described, this information is absent. The regulatory approval process for these types of devices through 510(k) relies heavily on demonstrating similarity to already approved devices, rather than establishing new clinical effectiveness data requiring expert review of outcomes.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/Not mentioned.

Explanation: Without a described test set requiring human assessment or outcome review, an adjudication method is not relevant or not detailed in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: Not mentioned.
Effect Size of Human Reader Improvement with AI vs. without AI: Not applicable (as no AI component is described).

Explanation: This device is a cryosurgical system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Standalone Performance: Not applicable.

Explanation: As this is a physical medical device (cryosurgical system), the concept of "standalone (algorithm only)" performance does not apply. The device's performance is inherently linked to its physical operation and use by a clinician.

7. The Type of Ground Truth Used:

Type of Ground Truth: Not mentioned.

Explanation: Because no specific "test set" with performance outcomes is detailed, the type of ground truth used to evaluate performance is not discussed. For cryosurgical devices, ground truth for effectiveness would typically involve histological confirmation of cryonecrosis, electrophysiological evidence of conduction block, or clinical outcomes, but these are not specified as part of a formal performance study in this summary.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of a "training set" is not relevant.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of establishing ground truth for a "training set" is not relevant.

Summary of the Document's Approach:

The provided 510(k) summary document focuses on establishing substantial equivalence to already legally marketed predicate devices. This regulatory pathway typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive new clinical effectiveness studies with explicit acceptance criteria and performance statistics for the new device, unless significant technological differences or new intended uses are introduced. The statement "The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness" reinforces this approach.

Summary

{0}------------------------------------------------

510(k) Summary

CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device 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, Official Correspondent
Telephone:	514-694-1212

Date Prepared: March 12, 2004

2. Device Name

Device Trade Name:	SurgiFrost® 10 cm Cryosurgical Device plusFrostByte™ Clamp and Cryosurgical Console
Common/Usual Name:	Cryosurgical system
Classification Name:	Cryosurgical Unit and Accessories
Device Classification:	Class II

3. PREDICATE DEVICES

CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010)

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)

4. Device Description

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical

{1}------------------------------------------------

procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

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

The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, 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® 10 cm 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.

5. Intended Use

The SurgiFrost® 10 cm Cryosurgical Device 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.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational

{2}------------------------------------------------

KO40690 p.30f3

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® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices listed.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a bird-like figure wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040690

Trade Name: SurgiFrost® 10 cm Cryosurgical Device plus Frostbyte™ Clamp and Cryosurgical Console Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: April 14, 2004 Received: April 20, 2004

Dear Ms. Pilar Arana:

This letter corrects our substantially equivalent letter of April 29, 2004.

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 - Ms. Flor del Pilar Arana

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,

elmee

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): K0466 90

Device Name: SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console

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

Diuna Riaclune1

Jivision Sign-Off) Nivision of Cardiovascular Devices

Page 1 of

310(k) Number_K040690

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.