The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

Device Description

The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).

In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.

The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

AI/ML Overview

The provided text is a 510(k) summary for the AtriCure cryoICE BOX (ACM) and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

However, based on the limited information available in the "V. Performance Data" section, here's what can be extracted and then what cannot be answered from the provided text:

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

The document provides a general statement in "V. Performance Data": "The AtriCure cryoICE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module."

It does not provide a specific table of acceptance criteria or detailed reported device performance. It only states that the device met the criteria.

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

This information is not provided in the document. The "Performance Data" section indicates "bench testing was conducted," but no details on sample size, data provenance, or whether it was retrospective or prospective are given.

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)

This information is not provided in the document. The device is a "Cryosurgical Unit And Accessories" and the testing mentioned is "bench testing," which typically does not involve expert-established ground truth in the context of medical image analysis or diagnostic performance.

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

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here for this device's performance testing.

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 information is not provided in the document. A MRMC study is relevant for assessing diagnostic performance, especially of AI/CAD systems that assist human readers. This device is a cryosurgical unit, not an AI or diagnostic imaging device, so such a study would not typically be applicable.

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

This information is not provided in the document. This concept is typically relevant for AI/algorithm performance. The device is hardware (a cryosurgical unit), and its performance would be assessed through functional bench tests, not as an "algorithm only" product.

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

This information is not provided in the document beyond the general statement that "predetermined acceptance criteria" were met during "bench testing." For a cryosurgical unit, "ground truth" would generally involve objective measurements against engineering specifications (e.g., temperature achieved, power output, flow rates) rather than clinical ground truth like pathology or outcomes data, which are more applicable to diagnostic or therapeutic devices where a direct clinical outcome is being measured against a gold standard.

8. The sample size for the training set

This information is not provided in the document. This is only relevant for machine learning or AI models, which is not applicable to the AtriCure cryoICE BOX as described.

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

This information is not provided in the document for the same reason as point 8.

Summary

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October 29, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

AtriCure, Inc. Ronit Shah Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K243157

Trade/Device Name: AtriCure cryoICE BOX (ACM) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: September 30, 2024 Received: September 30, 2024

Dear Ronit Shah:

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 (the 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 Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Adam D. Digitally signed by Adam D. Pierce -S Pierce - - - - Date: 2024.10.29
Pierce - - - 11:06:03 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243157

Device Name

AtriCure cryolCE BOX (ACM)

Indications for Use (Describe)

The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant Information l.

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason, Ohio 45040P: 513-755-4100
Contact Person:	Ronit ShahRegulatory Affairs Specialist
Date Prepared:	September 30, 2024
II. Device Information
Proprietary Name:	AtriCure® cryoICE® BOX
Common Name:	Cryo Surgical Unit and Accessories
Classification:	Unit, Cryosurgical, AccessoriesSurgical, General and Plastic Surgery, CFR 878.4350Class II, Product Code: GEHClassification Panel: General and Plastic Surgery
Predicate Device:	AtriCure Cryo Module (K142203, November 25, 2014)

lll. Device Description

In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.

The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

Intended Use / Indications for Use

The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

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#	Feature	Previously cleared AtriCureCryo Module (K142203)	Modified AtriCure cryolCEBOX (Subject)
1	Proprietary Name	AtriCure Cryo Module	AtriCure cryolCE Box
2	Device Classification	Device, Surgical CryogenicCryogenic Surgical Device, 21CFR 882.4250Product Codes: GEH, GXH	Unit, Cryosurgical,AccessoriesSurgical, General and PlasticSurgery, CFR 878.4350
3	Regulatory Class	Class II	Product Code: GEHClass II
4	FDA Division	Neurology	General and Plastic Surgery
5	Performance Standards	No performance standardsapplicable to this product havebeen promulgated by FDA	No performance standardsapplicable to this product havebeen promulgated by FDA
6	Indications for Use	The AtriCure Cryo Module is anonsterile, reusable devicewhich delivers cryogenic energy,namely nitrous oxide, toAtriCure's cryo-ablation probes.	The AtriCure cryoICE BOX is anon-sterile, reusable medicaldevice which deliverscryogenic energy, namelynitrous oxide, to AtriCure'scryo-ablation PROBES.
7	Operating Principle	Joule-Thompson Effect	Joule-Thompson Effect
8	Energy Used	Nitrous Oxide	Nitrous Oxide
9	Power Source	Mains Powered	Mains Powered
10	Power Specification	115 VAC, 50/60 Hz (nominal)	115 VAC, 50/60 Hz (nominal)
11	Typical MinimumOperating Steady StateProbe Temperature	Less than -55°C	Less than -55°C
12	Software version	V6.02	V6.10
13	Gas Purge System	Automatic	Automatic
14	Freeze Timer	Manual or Automatic	Manual or Automatic

IV. Comparison of Technological Characteristics with the Predicate Device (AtriCure Cryo Module – K142203)

The devices have the same intended use. ●

No changes were made to the operating principle. ●

No changes to the overall design or function of the devices. ●

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V. Performance Data

The bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriCure Cryo Module. The AtriCure cryolCE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module. No new safety or performance issues were raised during testing.

VI. Conclusions

AtriCure has demonstrated that the modifications made to the AtriCure cryolCE BOX are substantially equivalent in fundamental design, technology, function, device materials, packaging, operating principle, and intended use / indication for use as the previously cleared AtriCure Cryo Module per K142203.

Regulation Number and Section

§ 882.4250 Cryogenic surgical device.

(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).