FOR ADULT PATIENTS
AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

FOR ADOLESCENT PATIENTS
The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age.

*Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

Device Description

The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are sterile, single use devices that achieve cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX device is offered in two probe length configurations: approximately 11" and 17" long. At the distal end, the ryoICE cryoSPHERE+ and cryoICE cryoSPHERE MAX probe features an 8mm or 10mm diameter ball tip shape for each length configuration. The flexible region of the probe is malleable and is capable of being bent by the end user using an included forming tool.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the AtriCure cryoICE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria. As such, information regarding many of the requested points (like sample size for test sets, number of experts for ground truth, MRMC studies, or training set details) is not present.

However, I can extract the available information regarding acceptance criteria and the type of study conducted to support the equivalence claim.

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were predetermined, and the device met these criteria, ensuring substantial equivalence. While specific numerical acceptance criteria are not detailed in the provided text, the criteria implicitly refer to demonstrating equivalence in performance, features, and safety compared to the predicate device.

Feature / Test Category	Acceptance Criteria (Implied)	Reported Device Performance
General Equivalence	Substantial equivalence to predicate device in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use/indication for use.	Demonstrated equivalence; no new safety or performance issues raised.
Reliability	Met predetermined reliability standards.	Met predetermined acceptance criteria.
Transit	Maintained integrity and function after transit simulations.	Met predetermined acceptance criteria.
Shelf-life	Maintained sterility and functionality throughout shelf-life.	Met predetermined acceptance criteria.
Cryogen Performance/Thermal Insulation	Similar thermal performance and insulation efficiency to predicate.	Met predetermined acceptance criteria.
Mechanical Integrity	Maintained structural and functional integrity under mechanical stress.	Met predetermined acceptance criteria.
Biocompatibility	Biocompatible patient-contacting materials.	Biocompatible patient-contacting materials (Same as predicate).
Sterility	Achieved and maintained sterility.	Sterile - single use, disposable device (Same as predicate); Gamma Irradiation (Same as predicate).
Electromagnetic Compatibility (EMC)	Compliant with EMC standards.	Met predetermined acceptance criteria.
Operating Temperature	Below -40°C.	Below -40°C (Same as predicate).
Intended Use / Indications for Use	Identical to predicate device.	Identical to predicate device.
Operating Principle	Joule-Thompson Effect.	Joule-Thompson Effect (Same as predicate).
Energy Used	Nitrous Oxide.	Nitrous Oxide (Same as predicate).
Human Factors	Hand-held device connected to a console, closed-loop system, activation by button or footswitch.	Same as predicate.
Ball Tip Material/Construction	Aluminum Alloy; smooth spherical ball.	Aluminum Alloy; smooth spherical ball (construction changed from welded to threaded with epoxy, but considered equivalent).
Ball Tip Diameter	8mm.	8mm (CRYOSP, CRYOSP-L) and 10mm (CRYOSMAX, CRYOSMAX-L) - modification allowing for differing body habitus and surgeon preference.
Shaft Material/Construction	Rigid Region: Makrolon Polycarbonate; Smooth. Flexible Region: Clear LDPE sheath with black braids; Smooth Aluminum.	Rigid Region: Double Wall Vacuum Insulated Stainless Steel with Shrink Tube; Smooth. Flexible Region: Double Wall Vacuum Insulated Stainless Steel with Shrink Tube; Corrugated Stainless Steel.
Exposed Shaft Length	Standard: 28cm (11"); Long: 46cm (18").	Standard: 28cm (11"); Long: 43cm (17") (CRYOSP-L and CRYOSMAX-L).
Nose Cone	Overall Length: Less than 1 inch; Material: Polycarbonate Resin; Color: Translucent Blue.	Overall Length: Less than 2 inches; Material: Polycarbonate Resin; Color: Blue.
Device Flow Rate	Minimum flow rate value.	Specified flow rate range.
Probe Thermocouple	Material: Cu-Constantan w/Kapton; Location: Distal end of Rigid Shaft.	Material: Type t (cu-constantan); Location: Distal Cap, proximal to ball tip.

Study Details Based on Provided Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only lists "Reliability Testing," "Transit," "Shelf-life," "Cryogen Performance/Thermal Insulation," "Mechanical testing," "Biocompatibility," "Sterility," and "EMC" as types of tests.
- Data Provenance: Not specified, but these are typically bench tests performed in a laboratory setting by the manufacturer. These are non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical bench testing study, not a clinical study involving experts defining a medical ground truth for diagnostic accuracy.
Adjudication method for the test set:
- Not applicable. This was a non-clinical bench testing study.
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. This device is a cryoablation probe (surgical instrument), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical bench tests, the "ground truth" would be established engineering specifications, performance standards, material properties, and regulatory requirements (e.g., sterilization efficacy, biocompatibility standards).
The sample size for the training set:
- Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This information is not relevant to this device type.

Summary

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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 26, 2023

AtriCure, Inc. Erica Schwab Senior Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K233170

Trade/Device Name: cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH Dated: September 27, 2023 Received: September 27, 2023

Dear Erica Schwab:

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.

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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).

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.

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 mediation-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).

Sincerely,

Image /page/1/Picture/7 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.10.26, and the time is 11:59:12 -04'00'.

Adam D. Pierce. Ph.D. Assistant Director DHT5A: Division of Neurosurgical,

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233170

Device Name

cryolCE cryoSPHERE+ Cryoablation Probe (CRYOSP): cryolCE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX);

cryolCE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

Indications for Use (Describe)

FOR ADULT PATIENTS

AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

FOR ADOLESCENT PATIENTS

The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Applicant Information

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason Ohio 45040P: 513-755-4100
Contact Person:	Erica SchwabSenior Regulatory Affairs SpecialistPhone: 513-755-4100
Date Prepared:	October 26, 2023
Device Information
Proprietary Name:	cryoICE cryoSPHERE+ cryoablation probe (CRYOSP)cryoICE cryoSPHERE+ cryoablation probe (CRYOSP-L)cryoICE cryoSPHERE MAX cryoablation probe (CRYOSMAX)cryoICE cryoSPHERE MAX cryoablation probe (CRYOSMAX-L)
Common Name:	Cryosurgical Probe
Classification:	Cryogenic surgical deviceRegulatory Class: Class II; per 21 CFR 878.4250Product Code: GXHClassification Panel: Neurodiagnostic and Neurosurgical Devices
Predicate Device:	cryoICE cryoSPHERE cryoablation probe (CRYOS and CRYOS-L)(K200697, December 23, 2020)

Device Description

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Intended Use / Indications for Use

FOR ADULT PATIENTS

AtriCure's cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

FOR ADOLESCENT PATIENTS

The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.

1Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

Comparison of Technological Characteristics

. The devices include the same intended use and indications for use, and;
. No changes were made in operating principle, or specifications of performance, and;
. The results of the verification and validation testing:
- Demonstrated equivalency in performance о
- Did not raise any new issues of safety o

Modifications included in the cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX probe end-effectors were for differing body habitus and surgeon preference for the device specifically intended to blocking pain.

#	Feature	Predicate Device - CRYOS and CRYOS-L perK200697	Proposed Device - CRYOSP, CRYOSP-L,CRYOSMAX and CRYOSMAX-L
1	MarketedProduct Name	cryoICE cryoSPHERE cryoablation probe	cryoICE cryoSPHERE+ cryoablation probecryoICE cryoSPHERE MAX cryoablation probe
2	Intended Use	FOR ADULT PATIENTSAtriCure's cryoICE cryoSPHERE cryoablationprobes are sterile, single use devices intended foruse performed by freezing target tissues, creatingan inflammatory response (cryonecrosis) forblocking pain by temporarily ablating peripheralnerves.	FOR ADULT PATIENTSAtriCure's cryoICE cryoSPHERE+ andcryoSPHERE MAX cryoablation probes areintended for use to temporarily block pain byablating peripheral nerves performed by freezingtarget tissues, creating an inflammatory response(cryonecrosis).
		FOR ADOLESCENT PATIENTSThe cryoICE cryoSPHERE cryo-ablation probesare intended for use to temporarily block pain byablating intercostal nerves under directvisualization¹ in adolescent patients of at least 12years of age.¹Direct visualization, in this context, requires thatthe surgeon is able to see the targeted tissue forcryoablation directly or with assistance from acamera, endoscope or other similar opticaltechnology.	FOR ADOLESCENT PATIENTSThe cryoICE cryoSPHERE cryo-ablation probesare intended for use to temporarily block pain byablating intercostal nerves under directvisualization¹ in adolescent patients of at least 12years of age.¹Direct visualization, in this context, requires thatthe surgeon is able to see the targeted tissue forcryoablation directly or with assistance from acamera, endoscope or other similar opticaltechnology.
#	Feature	Predicate Device - CRYOS and CRYOS-L perK200697	Proposed Device - CRYOSP, CRYOSP-L,CRYOSMAX and CRYOSMAX-L
3	OperatingPrinciple	Joule-Thompson Effect	Joule-Thompson Effect
4	Technology	The system consists of cryoprobes that are usedfor freezing target tissue. A console is used tocontrol the supply of gas to the cryoprobe.	The system consists of cryoprobes that are usedfor freezing target tissue. A console is used tocontrol the supply of gas to the cryoprobe.
5	Energy Used	Nitrous Oxide	Nitrous Oxide
6	OperatingTemperature	Below -40°C	Below -40°C
7	Human Factors	Hand-held device connected to a console whichcirculates the cryogen through the device in aclosed loop system via the activation button orfootswitch.	Hand-held device connected to a console whichcirculates the cryogen through the device in aclosed loop system via the activation button orfootswitch.
5	Ball Tip	Material: Aluminum Alloy	Material: Aluminum Alloy
		Construction: smooth spherical ball welded ontothe shaft.	Construction: smooth spherical ball threaded(with epoxy adhesive) onto the shaft.
		Diameter: Ball Tip - 8mm (CRYOS and CRYOS-L)	Diameter: Ball Tip - 8mm (CRYOSP andCRYOSP-L) and 10mm (CRYOSMAX andCRYOSMAX-L)
6	Insulative Shaft	Rigid Region:Material: Makrolon Polycarbonate (black)Construction: smooth rigid shaft	Rigid Region:Material: Double Wall Vacuum InsulatedStainless Steel covered with Shrink Tube (black)Construction: smooth rigid shaft
		Flexible Region:Material: Clear LDPE sheath with black braids)Construction: Smooth Aluminum	Flexible Region:Material: Double Wall Vacuum InsulatedStainless Steel covered with Shrink Tube (black)Construction: Corrugated Stainless Steel
7	Exposed ShaftLength	Standard: 28cm (11") (CRYOS)Long: 46cm (18") (CRYOS-L)	Standard: SameLong: 43cm (17") (CRYOSP-L andCRYOSMAX-L)
8	Nose Cone	Overall Length: Less than 1 inchMaterial: Polycarbonate ResinColor: Translucent Blue	Overall Length: Less than 2 inchesMaterial: Polycarbonate Resin,Color: Blue
9	Device FlowRate	Minimum flow rate value	Specified flow rate range
10	ProbeThermocouple	Material: Cu-Constantan w/KaptonLocation: Distal end of the Rigid Shaft	Material: Type t (cu-constantan)Location: Distal Cap, proximal to ball tip.
11	Biocompatibility	Biocompatible patient contacting materials	Biocompatible patient contacting materials
12	Packaging	Sterile - single use, disposable device	Sterile - single use, disposable device
13	Sterilization	Gamma Irradiation	Gamma Irradiation
14	Power Source	Mains Powered	Mains Powered

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Performance Data

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared crvoICE cryoSPHERE devices. The cryolCE cryoSPHERE+ and cryoICE cryoSPHERE MAX devices met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared cryolCE cryoSPHERE devices. No new safety or performance issues were raised during testing.

Non-clinical Bench Testing:

Reliability Testing ●
Transit ●
Shelf-life
. Cryogen Performance/Thermal Insulation
Mechanical testing ●
Biocompatibility .
Sterility
EMC ●

Conclusions

AtriCure has demonstrated that the cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use as the previously cleared devices: cryoICE cryoSPHERE cryoablation probes.

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).