(16 days)
No
The description focuses on the electro-mechanical and pneumatic aspects of the device and the delivery of a cryogenic energy source. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for the "cryosurgical treatment of cardiac arrhythmias" and "delivers a cryogenic energy source...to create lines of ablation through cardiac tissue," clearly indicating a therapeutic purpose.
No
This device is described as a surgical system for cryosurgical treatment of cardiac arrhythmias, not for diagnosing them. It delivers cryogenic energy to create ablation lines, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it is an "electro-mechanical and pneumatic cryogenic surgical system" and includes reusable and single-use hardware components (Cryo Module and cryo-ablation probes).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cryosurgical treatment of cardiac arrhythmias." This is a therapeutic procedure performed directly on the patient's cardiac tissue.
- Device Description: The device delivers a cryogenic energy source to a probe to freeze target tissue and create ablation lines. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to treat, not to diagnose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Crvo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Product codes
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 an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or crvolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
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)
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Transit testing, design verification and validation, software validation, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications. The standards and FDA Guidance used to determine substantial equivalence include, but are not limited to:
- . UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety. (2006)
- EN 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety (1998) +A1 +A2, 2nd Edition
- IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility - Req. & Tests (2007)
- . EN 55011: Industrial, scientific and medical (ISM) radio-frequency Equipment. Electromagnetic disturbance characteristics. Limits and methods of measurement. (2007)
- 1STA Procedure 3A: Packaged Product for Parcel Delivery System Shipment . 70kg (150 lb) or Less; (2008)
- ASTM F882-84: Standard Performance and Safety Specification for Cryosurgical . Medical Instrument's (2002)
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued May 11, 2005)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K121507 P1/2
ATRICURE Cryo Module System 510(k) SUMMARY
General Information
| Date Compiled | May 8, 2012 |
|---|---|
| Classification | Class II |
| Product Code | GEH, 21 CFR 878.4350 |
| Trade Name | AtriCure Cryo Module System (ACM, Cryo1, and cryolCE) |
| Manufacturer | AtriCure, Inc |
| 6217 Centre Park Drive | |
| West Chester, OH 45069 | |
| (513) 755-4100 | |
| (513) 644-1354 (fax) | |
| Contact | James L. Lucky |
| VP of Quality Systems and Regulatory Affairs |
Indications for Use
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a nonsterile, reusable device-used with the Crvo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Cleared Device
The device proposed for modification in this submission is the AtriCure Cryo Module System (ACM, Cryo1, and cryolCE) (K112072).
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 an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or crvolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Materials
All materials used in the manufacture of the AtriCure Cryo Module 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 crvo-ablation probes (Cryo1 and cryolCE).
Testing
1
K121507 P2/2
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Transit testing, design verification and validation, software validation, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications. The standards and FDA Guidance used to determine substantial equivalence include, but are not limited to:
- . UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety. (2006)
- EN 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety (1998) +A1 +A2, 2nd Edition
- ◆ IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility - Req. & Tests (2007)
- . EN 55011: Industrial, scientific and medical (ISM) radio-frequency Equipment. Electromagnetic disturbance characteristics. Limits and methods of measurement. (2007)
- 1STA Procedure 3A: Packaged Product for Parcel Delivery System Shipment . 70kg (150 lb) or Less; (2008)
- ASTM F882-84: Standard Performance and Safety Specification for Cryosurgical . Medical Instrument's (2002)
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued May 11, 2005)
Summary of Substantial Equivalence
The modified AtriCure Cryo Module System proposed in this submission is considered substantially equivalent to the AtriCure Cryo Module System cleared via K112072. The indications for use, basic overall function, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a bird-like figure with three upward-pointing lines and a curved base.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atricure, Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313
JUN - 6 2012
Re: K121507
Trade Name: Atricure Cryo Module System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Codes: GEH Dated: May 18, 2012 Received: May 21, 2012
Dear Mr. Job:
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.
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
3
Page 2 - Atricure, Inc., c/o Mr. Mark Job
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: AtriCure Cryo Module System (ACM, Cryo1, and cryolCE)
Indications For Use:
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable deviceused with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe a sterile, single use device.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concyrence of CDRH, Office of Device Evaluation (ODE)
signature
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K121507