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

Q: Who is the manufacturer of cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

AtriCure, Inc. filed the 510(k) submission for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) (K233170).

Q: What is the FDA product code for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

GXH. It is classified under 21 CFR 882.4250 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K233170 · AtriCure, Inc. · GXH · Oct 26, 2023 · Neurology

Device Facts

Record ID	K233170
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)
Applicant	AtriCure, Inc.
Product Code	GXH · Neurology
Decision Date	Oct 26, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.4250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Sterile, single-use cryoablation probes; used with AtriCure Cryo Module (ACM) console. Input: nitrous oxide cryogenic agent. Principle: Joule-Thompson effect; probe tip freezes target tissue to create cryonecrosis. Output: localized tissue freezing. Used in clinical settings by surgeons; probe tip placed on target nerve via incision. Malleable shaft allows bending for anatomical access. Surgeon monitors via direct visualization (camera/endoscope). Output affects clinical decision-making by providing temporary nerve block for pain management. Benefits patient through temporary pain relief.

Clinical Evidence

Bench testing only. Testing included reliability, transit, shelf-life, cryogen performance/thermal insulation, mechanical testing, biocompatibility, sterility, and EMC. All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Aluminum alloy ball tip, double-wall vacuum-insulated stainless steel shaft. Energy: Nitrous oxide (Joule-Thompson effect). Dimensions: 11" or 17" lengths; 8mm or 10mm ball tips. Connectivity: Connects to external console. Sterilization: Gamma irradiation. Software: None (mechanical/thermal device).

Indications for Use

Indicated for adult patients to temporarily block pain via peripheral nerve cryoablation (cryonecrosis). Indicated for adolescent patients (≥12 years) to temporarily block pain via intercostal nerve cryoablation under direct visualization.

Regulatory Classification

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.

Predicate Devices

cryoICE cryoSPHERE cryoablation probe (CRYOS and CRYOS-L) (K200697)

Related Devices

K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe · AtriCure, Inc. · Nov 9, 2018
K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2) · AtriCure, Inc. · Feb 15, 2018
K102021 — CRYO-TOUCH II · Myoscience, Inc. · Sep 17, 2010
K250371 — cryoICE cryoXT cryoablation probe (cryoXT) · AtriCure, Inc. · Apr 10, 2025
K120415 — CRYO-TOUCH III · Myoscience, Inc. · Jun 22, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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, {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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. *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. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### Applicant Information | Manufacturer: | AtriCure, Inc. 7555 Innovation Way Mason Ohio 45040 P: 513-755-4100 | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Erica Schwab Senior Regulatory Affairs Specialist Phone: 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 device Regulatory Class: Class II; per 21 CFR 878.4250 Product Code: GXH Classification Panel: Neurodiagnostic and Neurosurgical Devices | | Predicate Device: | cryoICE cryoSPHERE cryoablation probe (CRYOS and CRYOS-L) (K200697, December 23, 2020) | #### 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. {5}------------------------------------------------ ### 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 per K200697 | Proposed Device - CRYOSP, CRYOSP-L, CRYOSMAX and CRYOSMAX-L | |----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Marketed Product Name | cryoICE cryoSPHERE cryoablation probe | cryoICE cryoSPHERE+ cryoablation probe cryoICE cryoSPHERE MAX cryoablation probe | | 2 | Intended Use | FOR ADULT PATIENTS AtriCure's cryoICE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves. | FOR ADULT PATIENTS AtriCure's cryoICE 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 cryoICE cryoSPHERE cryo-ablation 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. | FOR ADOLESCENT PATIENTS The cryoICE cryoSPHERE cryo-ablation 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. | | # | Feature | Predicate Device - CRYOS and CRYOS-L per K200697 | Proposed Device - CRYOSP, CRYOSP-L, CRYOSMAX and CRYOSMAX-L | | 3 | Operating Principle | Joule-Thompson Effect | Joule-Thompson Effect | | 4 | Technology | The system consists of cryoprobes that are used for freezing target tissue. A console is used to control the supply of gas to the cryoprobe. | The system consists of cryoprobes that are used for freezing target tissue. A console is used to control the supply of gas to the cryoprobe. | | 5 | Energy Used | Nitrous Oxide | Nitrous Oxide | | 6 | Operating Temperature | Below -40°C | Below -40°C | | 7 | Human Factors | Hand-held device connected to a console which circulates the cryogen through the device in a closed loop system via the activation button or footswitch. | Hand-held device connected to a console which circulates the cryogen through the device in a closed loop system via the activation button or footswitch. | | 5 | Ball Tip | Material: Aluminum Alloy | Material: Aluminum Alloy | | | | Construction: smooth spherical ball welded onto the 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 and CRYOSP-L) and 10mm (CRYOSMAX and CRYOSMAX-L) | | 6 | Insulative Shaft | Rigid Region: Material: Makrolon Polycarbonate (black) Construction: smooth rigid shaft | Rigid Region: Material: Double Wall Vacuum Insulated Stainless 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 Insulated Stainless Steel covered with Shrink Tube (black) Construction: Corrugated Stainless Steel | | 7 | Exposed Shaft Length | Standard: 28cm (11") (CRYOS) Long: 46cm (18") (CRYOS-L) | Standard: Same Long: 43cm (17") (CRYOSP-L and CRYOSMAX-L) | | 8 | 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 | | 9 | Device Flow Rate | Minimum flow rate value | Specified flow rate range | | 10 | Probe Thermocouple | Material: Cu-Constantan w/Kapton Location: 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 | {6}------------------------------------------------ {7}------------------------------------------------ # 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.