(29 days)
No
The description focuses on the mechanical and thermal aspects of the device, with no mention of AI or ML capabilities.
Yes
The device is intended for the "cryosurgical treatment of cardiac arrhythmias," which is a medical treatment.
No
The device is described as a cryo-ablation probe used for the treatment of cardiac arrhythmias by freezing target tissues, not for diagnosis.
No
The device description clearly details physical hardware components such as handpieces, probes, shafts, handles, thermocouples, tubes, and a cryotip made of aluminum or stainless steel, which are used to physically interact with and treat cardiac tissue. This is not a software-only device.
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 by freezing target tissues." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument (cryo-ablation probe) used to physically freeze tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The cryosurgical handpieces, or cryo-ablation probes, utilized in the AtriCure Cryosurgical System are hand held, single use, cryosurgical instruments intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery. The cryosurgical handpieces utilize a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpieces provide 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 cryoprobes via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probes are 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 or stainless-steel 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 the cryotip into 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Bench Testing
- Mechanical Reliability .
- Transit
- Shelf-life
- Cryogen Performance/Thermal Insulation
The results of the verification and validation testing:
- Demonstrated equivalency in performance
- Did not raise any new issues of safety
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
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February 15, 2018
AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K180137
Trade/Device Name: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CR YOF) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH 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 (QS) regulation (21 CFR Part 820);
1
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 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.G. Willemann
for 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) K180137 Subject of this Special 510(k) submission
Device Name AtriCure® cryoICE® cryo-ablation probe (CRYO3), and AtriCure® cryoICE® cryoFORM® cryo-ablation probe (CRYOF)
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.
| 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
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 (CRYO3)
AtriCure® cryoICE® cryoFORM® cryo-ablation probe (CRYOF) |
| Common Name: | Cryosurgical Probe |
| Classification Name: | Unit, Cryosurgical, Accessories
Surgical, General and Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | GEH |
lll. Predicate Device
The device proposed for modification in this submission is the AtriCure cryolCE cryo-ablation probe cleared via K142441 on October 29, 2014, and the AtriCure cryolCE cryoFORm cryo-ablation probe cleared via K152337 on March 22, 2016.
The following reference device was also used in this submission:
- K142203 AtriCure cryoICE cryoablation probe
IV. Device Description
The cryosurgical handpieces, or cryo-ablation probes, utilized in the AtriCure Cryosurgical System are hand held, single use, cryosurgical instruments intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery. The cryosurgical handpieces utilize a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpieces provide 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 cryoprobes via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probes are malleable to allow access to varying anatomy 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 or stainless-steel 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 the cryotip into 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.
Comparison Of Technological Characteristics With The Predicate Device VI.
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 CRYO3, and CRYOF probes 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 cryo-ablation probe are intended to 1.) align components with the previously cleared cryolCE cryoFORM cryo-ablation probe, 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 cryo-ablation probe (CRYO3) and AtriCure cryolCE cryoFORM cryoablation probe are equivalent to the previously cleared CRYOF probes as there is no change to intended use, operating principals, or function of the devices.