The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.

Device Description

The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CryoCor Model 1255 Surgical Probe, based on the provided text:

Acceptance Criteria and Device Performance

Criterion	Reported Device Performance
Met design and performance requirements	"Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements."
Biocompatibility with blood-contacting materials (ISO 10993-1)	"Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible."
Sterilization validation (E-beam radiation)	"The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document only mentions "Bench testing" and does not specify a numerical sample size for the test set.
- Data Provenance: Not explicitly stated, but "Bench testing" implies laboratory-controlled conditions, not human clinical trial data. The device is intended for use in cardiac surgery, but no clinical data is presented for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for bench testing would be predefined engineering specifications.
Adjudication method for the test set:
- This information is not provided as the disclosed testing is bench testing, not a clinical study requiring adjudication of expert interpretations.
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?
- No, an MRMC comparative effectiveness study was not done. This device is a surgical probe, not an AI-powered diagnostic tool that would typically involve human readers or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The device is a physical surgical probe, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" would be the engineering design specifications and performance requirements for the device. For biocompatibility, it would be the standards set by ISO 10993-1. For sterilization, it would be the validated E-beam radiation cycle parameters.
The sample size for the training set:
- This information is not applicable/not provided as the device is a physical surgical probe, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- This information is not applicable as the device is a physical surgical probe, not a machine learning algorithm.

Summary

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SEP 2 2 2004

K041890 p. 1 of 2

510(k) Summary of Substantial Equivalence

Date Prepared	September 16, 2004
SubmitterAddress	CryoCor, Inc.9717 Pacific Heights Blvd.San Diego, Ca 92121
ContactPhoneFaxE-Mail Address	Jami MillerRegulatory Affairs Specialist858-909-2231858-909-2350jmiller@cryocor.com
Device Trade Name/ Model Numbers	1255 Series Surgical Probe:Model 1255-15-12
Device Common Name	Cryosurgical Probe
Device Classification Name	Cryosurgical unit and accessories
Classification Regulation	Class II, C.F.R. Section 878.4350
Product Code	GEH

Device Description

Intended Use

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Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

Substantially Equivalent Devices

The physical characteristics, the intended use, and the mode of use of the Model 1255 Surgical Probe are similar to the predicate device.

Test Summary

Performance Testing

Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements.

Biocompatibility Information

Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.

Sterilization Validation

The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle.

Conclusion

CryoCor, Inc. considers the Model 1255-15-12 Surgical Probe to be substantially equivalent to their legally marketed predicate device based on the data and information presented within this application.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cryocor, Inc. c/o Ms. Jami Miller Regulatory Affairs Specialist 9717 Pacific Heights Blvd. SanDiego, CA 92121

Re: K041890

Trade Name: Cryocor Model 1250 ("Breva") Series Surgical Probes Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: August 05, 2004 Received: August 09, 2004

Dear Ms. Miller:

This letter corrects our substantially equivalent letter of September 22, 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.

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Page 2 - Ms. Jami Miller

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.

Eemee

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: K041890

Device Name: CryoCor Model 1250 ("Breva") Series Surgical Probes

Indications for Use:

The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bumima
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K041890

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.