The Cryo1 cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

Device Description

The Cryo1 cryo-ablation probe is a sterile, single use, cryosurgical device to be used in conjunction with the frigitronics CCS-200 Cardiac Cryosurgical Console to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cryo1 cryo-ablation probe. While it details the device's indications for use, its equivalence to predicate devices, and regulatory approval, it does not contain information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the format requested.

The document states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, it does not provide details about what those specifications are, the methods used to test them, the results of the testing, or any statistical analysis that would typically be found in a study demonstrating such conformance.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, alongside the unavailable information:

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

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not specified.
Data provenance: Not specified. The document only mentions "Appropriate product testing was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study with ground truth establishment is described. The clearance is based on substantial equivalence to predicate devices, not on a novel clinical performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study with expert adjudication is described.

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

No MRMC comparative effectiveness study was done. This device is a cryo-ablation probe, not an AI diagnostic tool.

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

Not applicable. This device is a medical instrument, not an algorithm.

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

Not applicable, as no clinical study with ground truth establishment is described. The clearance is based on substantial equivalence to predicate devices.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that would have a "training set."

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

Not applicable, as this is not an AI/machine learning device.

Additional points from the document:

Type of Study: The clearance is based on a substantial equivalence claim to predicate devices (frigitronics CCS-200 Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436)). This means the manufacturer demonstrated that the new device is as safe and effective as the legally marketed predicate devices, rather than conducting new efficacy trials against specific performance criteria.
Material Testing: "All materials used in the manufacture of the Crvo-ablation probe are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials." This indicates biocompatibility testing was performed per a standard, which itself has implicit acceptance criteria. However, the specific criteria and results are not detailed.

Summary

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K082074
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CRYO1 CRYO-ABLATION PROBE 510(k) SUMMARY

General Information

Classification	Class II	MAR - 2 2009
Trade Name	Cryo1 cryo-ablation probe
Manufacturer	AtriCure, Inc
	6033 Schumacher Park Dr
	West Chester, OH 45069
Contact	James L. Lucky
	VP of Quality Assurance and Regulatory Affairs

Indications for Use

Predicate Devices

The predicate devices for the Cryo1 cryo-ablation probe are the frigitronics CCS-200 Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436).

Device Description

Materials

All materials used in the manufacture of the Crvo-ablation probe are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.

Summary of Substantial Equivalence

The Cryo1 cryo-ablation probe is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atricure Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

MAR - 2 2009

Re: K082074

Trade/Device Name: Cryo1 cryo-ablation probe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Code: GEH Dated: February 12, 2009 Received: February 13, 2009

Dear Mr. Job:

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 iddications for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the 1 (1 ) The general controls provisions of the Act include requirements for annual registrotion, 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 such additional controls. Existing major regulations affecting your devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDAAmount publish further announcements concerning your device in the Federal Register.

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

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Page 2 - Mr. Mark Job

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 begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Mark Tellem for

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) K082074

Device Name: Cryo1 cryo-ablation probe

Indications for Use:

Prescription Use × (Part 21 CRF 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Helin

Sigh-Off Division of Cardiovascular Devices K082074 510(k) Number

AtriCure, Inc.

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.