(106 days)
No
The document describes a cryosurgical system that uses cryogenic energy to ablate tissue. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on the mechanical, electrical, and performance aspects of the hardware and software, not on any learning or adaptive capabilities.
Yes
The device is described as being used for the "cryosurgical treatment of cardiac arrhythmias" and "to block pain by temporarily ablating peripheral nerves," which are therapeutic applications. It creates a "cryonecrosis that blocks the electrical conduction pathway," indicating direct treatment of a medical condition.
No
The device description and indications for use clearly state its purpose is for "cryosurgical treatment" and "ablating" tissues, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "electro-mechanical and pneumatic cryogenic surgical system" and includes hardware components like the "AtriCure Cryo Module (ACM) unit" and "AtriCure's cryo-ablation probe (CRYO2)". While software validation is mentioned, it is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use statements clearly describe a device used for surgical treatment (cryosurgical treatment of cardiac arrhythmias and temporary ablation of peripheral nerves) by directly interacting with and modifying tissue within the body.
- Mechanism of Action: The device works by delivering cryogenic energy (nitrous oxide) to freeze target tissues, creating a physical effect (cryonecrosis) to block electrical conduction or pain. This is a direct therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces the surgical nature of the device, highlighting its role in a "cryogenic surgical system" used to "freeze target tissue."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis. The device's function is purely therapeutic/interventional.
IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a nonsterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.
cryolCE™ Indication for Use Statement: 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 (comma separated list FDA assigned to the subject device)
GXH, GEH
Device Description
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to the AtriCure cryo-ablation probes. The AtriCure's cryo-ablation probe (CRYO2) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The cryolCE™ probe can also be used to temporarily ablate peripheral nerves.
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
Adults
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)
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Design verification and validation, software validation, and electrical safety testing were completed to show that the AtriCure Cryosurgical System is substantially equivalent and in conformance with international standards and device specifications.
Non-clinical Bench Testing:
CRYO2 Comparison testing to Predicate Device - Bench testing - Passed
CRYO2 Mechanical Reliability - Bench testing - Passed
CRYO2 Performance testing - Bench testing - Passed
CRYO2 Acute Animal Verification Lab - Bench testing - Passed
CRYO2 ASTM Testing - Bench testing - Passed
Evaluation Against Similar Product - Bench testing - Passed
ACM Software Validation - Software testing - Passed
ACM Display Board Verification - Bench testing - Passed
ACM Controller Board Verification - Bench testing - Passed
Handpiece Connector Board Verification - Bench testing - Passed
ACM Power Board Verification - Bench testing - Passed
ACM Reliability Testing - Bench testing - Passed
ACM Simulated Use - Bench testing - Passed
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.
K082074, K111042, K112072, K121507, K140058, K031482
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.
Not Found
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
§ 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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Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized human figure with three faces in profile, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AtriCure Inc., Jonathan McElwee Regulatory Engineer 6217 Centre Park Dr. West Chester, OH 45069
Re: K142203
Trade/Device Name: AtriCure Cryosurgical System - AtriCure Cryo Module (ACM) and AtriCure cryoICE cryo-ablation probes (CRY02) Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Regulatory Class: Class II Product Code: GXH, GEH Dated: October 30, 2014 Received: October 31, 2014
Dear Mr. Jonathan McElwee:
This letter corrects our substantially equivalent letter of November 25, 2014.
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
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Page 2 - Mr. Jonathan McElwee:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/1/Picture/7 description: The image shows the FDA logo. The logo is in light gray and consists of the letters "FDA" in a stylized font. The letters are connected and have a geometric design.
Bram D. Zuckerman -S
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) K142203
Device Name: AtriCure Cryosurqical System, comprising:
- a) AtriCure Crvo Module (ACM)
- b) AtriCure cryolCE™ cryo-ablation probes (CRYO2)
Indications for Use:
AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a nonsterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.
cryolCE™ Indication for Use Statement: 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.
× Prescription Use (Part 21 CRF 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CRF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for AtriCure. The logo is in two colors, 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."
510(k) Summary
| I. Submitter | |
|---|---|
| Manufacturer: | AtriCure, Inc. |
| 6217 Centre Park Dr. | |
| West Chester, OH 45069 | |
| P: 513-755-4100 | |
| F: 513-755-4108 | |
| Contact Person: | Jonathan McElwee, RAC |
| Regulatory Engineer | |
| Alternate Contact: | Dennis Hong, JD, RAC |
| Senior Director, Regulatory Affairs | |
| Date Prepared: | 08/8/2014 |
| II. Device | |
| Name of Device: | AtriCure Cryosurgical System, comprising: |
| a) AtriCure Cryo Module (ACM) | |
| b) AtriCure cryoICE™ cryo-ablation probes (CRYO2) | |
| Common Name: | Cryosurgical probe |
| Cryo Surgical Unit and Accessories | |
| Cryoanalgesia System | |
| Classification Name: | Surgical, General and Plastic Surgery, 21 CFR 878.4350 |
| Cryogenic Surgical Device, 21 CFR 882.4250 | |
| Regulatory Class: | Class II |
| Product Code: | GEH and GXH |
lll. Predicate Devices
AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482
The predicate devices have not been subject to a design-related recall.
No reference devices were used in this submission.
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IV. Device Description
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to the AtriCure cryo-ablation probes. The AtriCure's cryo-ablation probe (CRYO2) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The cryolCE™ probe can also be used to temporarily ablate peripheral nerves.
Model numbers:
AtriCure Cryo Module - ACM1 AtriCure cryoICE™ cryo-ablation probe - CRYO2
Materials:
All materials used in the manufacture of the AtriCure Cryosurgical System are safe and suitable for their intended use and suitable for their use with pressurized nitrous oxide. The ACM is not intended for patient contact. Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure cryolCE™ cryoablation probe (CRYO2).
V. Indications For Use
AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to the AtriCure cryoablation probes.
cryolCE™ Indication for Use Statement: 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 Devices
When used for the intended use of "cryosurgical treatment of cardiac arrhythmias", the AtriCure Cryosurgical System has the following similarities to the technological characteristics of the previously cleared predicate AtriCure Cryo Module System (K082074, K111042, K112072, K121507, and K140058):
- Same intended use ●
- . Same operating principle
- Same fundamental scientific technology ●
- Same crvo-ablation probes ●
- Same materials used ●
- . Same module design
- Same electronic solenoid valves ●
- Same 3 year age shelf life of the cryo-ablation probes ●
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AtriCure®
When used for the intended use of "blocking pain by temporarily ablating the peripheral nerve", the AtriCure Cryosurgical System has the following similarities to the technological characteristics of the previously cleared predicate CryoStar™ System K031482:
| CryoStar™ Predicate | AtriCure Device | |
|---|---|---|
| Manufacturer | Cryomedical Instruments LTD. | |
| (now Kryo Science LTD) | AtriCure | |
| Market Product | ||
| Name | CryoStar™ System | |
| (Cryostar™ console, 1 & 2mm | ||
| cryoprobe, convenience procedure kit | ||
| for the probe placement) | AtriCure Cryosurgical System | |
| (ACM and cryolCE™ (CRYO2) cryo- | ||
| ablation probe) | ||
| 510(k) Number | K031482 | Subject of this Submission |
| Intended Use | Cryoanalgesia device intended for use | |
| in blocking pain by temporarily ablating | ||
| the peripheral nerves. | The AtriCure Cryosurgical System is | |
| intended for use in blocking pain by | ||
| temporarily ablating the peripheral | ||
| nerves. | ||
| Target Population | Adults | Adults |
| Operating Principle | Joule-Thompson Effect | Joule-Thompson Effect |
| Technology | The system consists of a range of | |
| cryoprobes that are used for freezing | ||
| nerves to block pain by temporary | ||
| ablation. A console is used to house | ||
| and control the supply of gas to the | ||
| cryoprobe and to provide an electrical | ||
| nerve location device. | The system consists of cryoprobes | |
| that are used for freezing target tissue | ||
| to treat cardiac arrhythmias and for | ||
| freezing nerves to block pain by | ||
| temporary ablation. A console is used | ||
| to control the supply of gas to the | ||
| cryoprobe. | ||
| Energy Used | Nitrous Oxide | Nitrous Oxide |
| Operating | ||
| Temperature | -40C to -70C | -50°C to 70°C |
| Peripheral Nerve | ||
| Stimulation | Included as part of the system | Not included in the system. |
| Human Factors | Hand-held device containing cryogen | |
| with footswitch. | Hand-held device containing cryogen | |
| with activation button on console or | ||
| footswitch. | ||
| Gas Purge System | Automatic | Automatic |
| Freeze Timer | Manual or automatic | Manual or automatic |
| Patient Contacting | ||
| Materials | Hemispherical and trocar-tip stainless | |
| steel 1mm & 2mm diameter cryoprobe | Closed-tip aluminum 4mm cryoprobe | |
| Cryotip | Rigid | Malleable |
| Biocompatibility | Biocompatible patient contacting | |
| materials. | Biocompatible patient contacting | |
| materials. | ||
| Probe Packaging | Non-Sterile - Reusable device | Sterile - Single Use disposable device |
| Sterilization | Steam Autoclave; EtO; or Sterrad | Gamma Irradiation |
| Power Source | Mains Powered | Mains Powered |
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Image /page/6/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, while "Cure" is in orange. There is a blue dot in the middle of the "C".
VII. Performance Data
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Design verification and validation, software validation, and electrical safety testing were completed to show that the AtriCure Cryosurgical System is substantially equivalent and in conformance with international standards and device specifications.
Non-clinical Bench Testing
| Name | Description | Results |
|---|---|---|
| CRYO2 Comparison testing to Predicate Device | Bench testing | Passed |
| CRYO2 Mechanical Reliability | Bench testing | Passed |
| CRYO2 Performance testing | Bench testing | Passed |
| CRYO2 Acute Animal Verification Lab | Bench testing | Passed |
| CRYO2 ASTM Testing | Bench testing | Passed |
| Evaluation Against Similar Product | Bench testing | Passed |
| ACM Software Validation | Software testing | Passed |
| ACM Display Board Verification | Bench testing | Passed |
| ACM Controller Board Verification | Bench testing | Passed |
| Handpiece Connector Board Verification | Bench testing | Passed |
| ACM Power Board Verification | Bench testing | Passed |
| ACM Reliability Testing | Bench testing | Passed |
| ACM Simulated Use | Bench testing | Passed |
VIII. Conclusions
When used for the intended use of "cryosurgical treatment of cardiac arrhythmias", the proposed AtriCure Cryosurgical System is equivalent to the previously cleared AtriCure Cryo Module System, as the intended use, overall function, and materials used are the same.
When used for the intended use of "blocking pain by temporarily ablating the peripheral nerve", the proposed AtriCure Cryosurgical System is equivalent to the previously cleared CryoStar™ System, as the intended use, basic overall function, and materials used are substantially equivalent.