AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Q: Who is the manufacturer of AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

AtriCure, Inc. filed the 510(k) submission for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697).

Q: What is the FDA product code for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-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 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

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

Q: What are the predicate devices for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

AtriCure cryoICE cryoablation probe (Cryo2) (K180138); AtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K182565).

Q: Who can help prepare an FDA 510(k) submission like AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-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.

K200697 · AtriCure, Inc. · GXH · Dec 23, 2020 · Neurology

Device Facts

Record ID	K200697
Device Name	AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
Applicant	AtriCure, Inc.
Product Code	GXH · Neurology
Decision Date	Dec 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4250
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

For Adult Patients AtriCure's Cryo2 cryo2 cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. For Adolescent Patients The Cryo2 cryolCE 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. 1 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. For Adult Patients AtriCure's cryolCE 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 Adolescent Patients The cryolCE 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. 1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation drectly or with assistance from a camera, endoscope or other similar optical technology.

Device Story

Hand-held, single-use cryosurgical probes (Cryo2, CryoS, CryoS-L) utilize high-pressure nitrous oxide (N2O) via Joule-Thompson effect to achieve rapid cooling (down to -50°C to -70°C). Probes feature malleable aluminum alloy tips (cylindrical for Cryo2; 8mm ball for CryoS/CryoS-L) to reach target anatomy. Operated by surgeons in clinical settings; connected to AtriCure Cryo Module (ACM) console. Freezing creates cryonecrosis, blocking electrical conduction in cardiac tissue or temporarily blocking pain signals in peripheral/intercostal nerves. Direct visualization required for adolescent intercostal procedures. Benefits include targeted tissue destruction/nerve block with controlled temperature monitoring via console-integrated thermocouples.

Clinical Evidence

Clinical evidence based on literature review conducted with UCSF Stanford Pediatric Device Consortium. Evaluated safety and effectiveness of intercostal nerve cryoanalgesia in patients ≥12 years compared to adult procedures. Endpoints included intraoperative/post-operative complications, adverse events, cryoablation-associated numbness, neuropathic pain, chest wall numbness, and post-operative pneumothorax. Results demonstrated no new safety or effectiveness concerns for the adolescent population.

Technological Characteristics

Cryosurgical probes using Joule-Thompson effect with N2O gas. Materials: aluminum alloy cryotip, insulated rigid shaft. Dimensions: 4mm cylindrical tip (Cryo2), 8mm ball tip (CryoS/CryoS-L). Malleable design. Energy: mains-powered console. Sterilization: gamma irradiation. Single-use. Thermocouple-based temperature monitoring.

Indications for Use

Indicated for adult patients for cryosurgical treatment of cardiac arrhythmias or temporary pain block via peripheral nerve ablation; also indicated for adolescent patients (≥12 years) for temporary pain block via intercostal nerve ablation 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

AtriCure cryoICE cryoablation probe (Cryo2) (K180138)
AtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K182565)

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. December 23, 2020 AtriCure Inc. Melissa Smallwood Senior Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040 Re: K200697 Trade/Device Name: AtriCure CryoICE cryo-ablation probe (Cryo2), AtriCure CryoICE CryoSPHERE cryoablation probe (CryoS, CryoS-L) Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH Dated: March 13, 2020 Received: March 17, 2020 Dear Melissa Smallwood: 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 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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200697 #### Device Name AtriCure® cryoICE® cryoablation probe (Cryo2) # Indications for Use (Describe) For Adult Patients AtriCure's Cryo2 cryo2 cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. ### For Adolescent Patients The Cryo2 cryolCE 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. 1 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) X 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." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200697 #### Device Name AtriCure® cryoICE® cryoSPHERE™ cryoablation probe (CryoS, CryoS-L) ## Indications for Use (Describe) For Adult Patients AtriCure's cryolCE 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 Adolescent Patients The cryolCE 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. 1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation drectly or with assistance from a camera, endoscope or other similar optical technology. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ #### 510(k) Summary #### l. Submitter | Manufacturer: | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 P: 513-644-4736 F: 513-755-4108 | |---------------------------|---------------------------------------------------------------------------------------------------------------------| | Contact Person: | Melissa Smallwood, MHA Senior Regulatory Affairs Specialist | | Alternate Contact Person: | Mary Galeano, RAC Senior Regulatory Affairs Specialist | | Date Submitted: | 11/23/2020 | | II. Device | | | Name of Devices: | AtriCure® cryolCE® cryoablation probe (Cryo2) AtriCure® cryolCE® cryoSPHERE™ cryoablation probe (CryoS, CryoS-L) | | Common Name: | Cryosurgical Probe | | Classification Name: | Cryogenic Surgical Device (21 CFR 878.4250) | | Regulatory Class: | Class II | | Product Code: | GXH | #### lll. Predicate Device Predicate Device: K180138 AtriCure® cryolCE® cryoablation probe (Cryo2) K182565 AtriCure® cryolCE® cryoSPHERE™ cryoablation probe (CryoS, CryoS-L) #### IV. Device Description #### Cryo2 The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac surgery; it is also intended for use in blocking pain by temporarily ablatinq peripheral nerves. The cryosurgical handpiece uilizes a high-pressure cryogen (nitrous oxide, N20) to freeze target tissues, creating an inflammatory response, and ultimately, cryonerosis. The cryosurgical handpiece provides below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitous oxide is supplied to the cryprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryolip, of the probe is malleable to allow access to varying anatomy and anatomical sites. The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three infices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be cryotip into the desired form. The cryolip is attached to an insulated rigid shaft that allows the surgeon to adjust the exposed cryolip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM). The cryoICE PROBE is a sterile, single-use cryosurgical instrument. The form tool facilitates bending of the malleable tip. {5}------------------------------------------------ This PROBE was designed for treatment of cardieving controlled temperatures down to -50° to -70°C; it can also be used to temporarily block pain by ablating peripheral nerves in adolescent patients of at least 12 years of aqe. ### CryoS, CryoS-L The cryolCE cryoSPHERE cryoablation (CRYOS/CRYOS-L) probe is a single use cryablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe. The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the supplied TOOL. The PROBE features a spherical 8mm cryoablation tip. ### PACKAGE CONTENTS - 1.One (1) PROBE #### 2.One (1) TOOL The PROBE and TOOL are supplied STERILE and NON-PYROGENIC in unopened package. For single use only. Do not resterilize. Do Not Re-Use. #### V. Indications for Use #### Cryo2 #### For Adult Patients AtriCure's Cryo2 cryolCE cryablation probes are steriles intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. #### For Adolescent Patients The Cryol cryolCE cryo-ablation probes are intention intercostal nerves under 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. # CryoS, CryoS-L ### For Adult Patients AtriCure's cryolCE 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 Adolescent Patients The cryolCE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by abilating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age. 'Direct visualization, in this context, requires that the see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology. #### VI. Comparison of Technological Characteristics with the Predicate Device AltiCure's cryolCE cryoablation probes (CryoS-L) have no changes in technological characteristics as compared to the predicate. Modifications included in the cryolCE crycabation probes included indication for use in addescent patients to temporarily block pain by ablating intercostal nerves under direct visualization. {6}------------------------------------------------ | Summary of Technical Characteristics | | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CRYO2 | CRYOS/CRYOS-L | | Market Product Name | cryolCE cryoablation probe | cryolCE cryoSPHERE cryoablation probe | | Intended Use | For Adult Patients AtriCure's Cryo2 cryolCE cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. For Adolescent Patients The Cryo2 cryolCE 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 Adult Patients AtriCure's cryolCE 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 Adolescent Patients The cryolCE 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. | | Operating Principle | Joule-Thompson Effect | Joule-Thompson Effect | | 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. | | Energy Used | Nitrous Oxide | Nitrous Oxide | | Operating Temperature | -50°C to 70°C | -50°C to 70°C | | Human Factors | Hand-held device containing cryogen with activation button on console or footswitch. | Hand-held device containing cryogen with activation button on console or footswitch. | | Cryotip | Material: aluminum alloy Construction: smooth malleable cylindrical linear probe Diameter: 4 mm | Material: aluminum alloy Construction: smooth spherical ball welded to a malleable cylindrical aluminum shaft. Diameter: ball - 8mm; aluminum shaft - 5mm | | | Length: 10cm | Length: reference the "end-effector" length | | End-effector Length - Shaft and Cryotip | 28 cm | 28cm (CRYOS) 46cm (CRYOS-L) | | Biocompatibility | Biocompatible patient contacting materials. | Biocompatible patient contacting materials. | | Probe Packaging | Sterile - Single Use disposable device | Sterile - Single Use disposable device | | Sterilization | Gamma Irradiation | Gamma Irradiation | | Power Source | Mains Powered | Mains Powered | {7}------------------------------------------------ #### VII. Performance Data ### Clinical Evidence AtriCure partnered with UCSF Stanford Pediatic Device Consortium (PDC) to evaluate Clinical Evidence in support of the cryolCE cryoablation probes (Cryo2, CryoS and CryoS-L) Indication for Use. The clinical publications demonstrated that use of the cryol CE cryoablation probes (Cryo2, CryoS and CryoS-L) in intercostal nerve ablation for temporarily pain block was as safe and effective when used in patients aged ≥ 12 years as compared to use of the cryolCE cryo2, CryoS and CryoS-L) for equivalent procedures in adults, based on the following endpoints: - Intraoperative or post-operative complications for patients receiving cryoanalgesia during Nuss procedure . - . Adverse events observed for patients receiving cryoanalgesia - Cryoablation associated numbness - Neuropathic pain - . Chest wall numbness - . Post-operative pneumothorax #### VIII. Conclusions The Clinical Evidence reviewed in the 510(k) submission demonstrates that AtriCure's cryolCE cryos, CryoS-L), as labeled per the Indication for Use do not present any new or additional questions of safety and effectiveness.

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

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AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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