(29 days)
No
The description focuses on the mechanical and thermal aspects of the device, with no mention of AI or ML.
Yes
The device is described as being "intended for use in the cryosurgical treatment of cardiac arrhythmias" and "for use in blocking pain by temporarily ablating peripheral nerves," which are therapeutic applications.
No
This device is a therapeutic device used for cryosurgical treatment by freezing tissues, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly details a physical probe with various hardware components (cryotip, shaft, handle, thermocouple, tubes) that performs a physical action (freezing tissue). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cryosurgical treatment of cardiac arrhythmias and blocking pain by temporarily ablating peripheral nerves. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument (cryo-ablation probe) used to freeze tissue. It is applied externally or internally to the patient during surgery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical device used for therapeutic purposes, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
AtriCure’s cryoICE cryo-ablation 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 probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.
Product codes
GXH
Device Description
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 arrhythmias during cardiac surgery; it is also intended for use in blocking pain by temporarily ablating peripheral nerves. The cryosurgical handpiece utilizes a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpiece provides probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probe is malleable to allow access to varying 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 internal inlet orifices 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 used to bend the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Bench Testing
- Mechanical Reliability
- Transit
- Shelf-life
- Cryogen Performance/Thermal Insulation
Results: Demonstrated equivalency in performance and did not raise any new issues of safety.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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February 15, 2018
AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K180138
Trade/Device Name: AtriCure cryoICE cryo-ablation probe (CRYO2) Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH Dated: January 15, 2018 Received: January 17, 2018
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemen
for
Bram 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)
Subject of this Special 510(k) submission
Device Name
AtriCure cryoICE cryo-ablation probe (CRYO2)
Indications for Use (Describe)
AtriCure's cryolCE cryo-ablation 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 probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.
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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Image /page/3/Picture/1 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".
510(k) Summary
l. Submitter
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 1 (513) 755-4100 |
|----------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Melissa Smallwood
Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee
Manager, Regulatory Affairs |
| Date Prepared: | 01/12/2018 |
| II.
Device | |
| Name of Device: | AtriCure cryoICE cryo-ablation probe |
| Common Name: | Cryosurgical Probe |
| Classification Name: | Unit, Cryosurgical, Accessories
Surgical, General and Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | GXH |
lll. Predicate Device
The device proposed for modification in this submission is the AtriCure cryolCE cryo-ablation probe cleared via K142203 on November 25, 2014.
The following reference devices were also used in this submission:
IV. Device Description
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 arrhythmias during cardiac surgery; it is also intended for use in blocking pain by temporarily ablating peripheral nerves. The cryosurgical handpiece utilizes a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpiece provides probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probe is malleable to allow access to varying and anatomical sites.
4
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 internal inlet orifices 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 used to bend the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time 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).
V. Indications For Use
AtriCure's cryolCE cryo-ablation 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 probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.
VI. Comparison Of Technological Characteristics With The Predicate Device
Minor modifications were made to the non-patient contacting tube-sets of the cryo-ablation probes. The packaging was modified to align with AtriCure's current product lines.
- . The devices have the same intended use, and;
- No changes were made in operating principle, or specifications of performance, and;
- Both the previously cleared and proposed CRYO2 probe use the same patient contacting materials, ● and:
- . The results of the verification and validation testing:
- o Demonstrated equivalency in performance
- Did not raise any new issues of safety o
The modifications to the proposed AtriCure cryolCE cryoablation probe are intended to 1.) align components with the previously cleared cryolCE cryoFORM cryoablation probe, improve manufacturability, and 2.) align the device packaging with AtriCure's commercial product lines.
VII. Performance Data
Non-clinical Bench Testing
- Mechanical Reliability
- Transit ●
- Shelf-life ●
- Cryogen Performance/Thermal Insulation ●
VIII. Conclusions
The modified AtriCure cryolCE cryoablation probe (CRYO2) is equivalent to the previously cleared AtriCure cryolCE cryoablation probe (CRYO2) as there is no change to intended use, operating principals, or function of the device.