(41 days)
Not Found
No
The summary describes a purely electro-mechanical and pneumatic system for delivering cryogenic energy. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on substantial equivalence through bench testing and compliance with standards, not on the performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as a "cryosurgical system that delivers a cryogenic energy source...to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias," which directly addresses a medical condition.
No
The device is described as a "cryosurgical system" intended for "treatment" of cardiac arrhythmias, and it "delivers a cryogenic energy source... to create lines of ablation through cardiac tissue." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly states it is an "electro-mechanical and pneumatic cryogenic surgical system" and includes hardware components like the 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 surgical procedure performed directly on the patient's cardiac tissue.
- Device Description: The device is described as an "electro-mechanical and pneumatic cryogenic surgical system" that delivers a cryogenic energy source to a handpiece for "ablation through cardiac tissue." This is a therapeutic device used for treatment, not for diagnosing conditions by examining samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for therapeutic purposes.
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 Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Product codes (comma separated list FDA assigned to the subject device)
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 a cryosurgical handpiece to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias.
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. Bench comparison testing, transit testing, electromagnetic compatibility, reliability, reliability testing, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications.
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.
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
§ 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
ATRICURE CRYO MODULE 510(k) SUMMARY
MAY 2 6 2011
General Information
| Date Compiled | January 31, 2011 |
|---|---|
| Classification | Class II |
| Product Code | GEH |
| Trade Name | AtriCure Cryo Module |
| Manufacturer | AtriCure, Inc |
| 6217 Centre Park Drive | |
| West Chester, OH 45069 | |
| Contact | Rebecca Walters, RAC |
| Regulatory Affairs Manager | |
| (513) 755-4576 |
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 Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Predicate Devices
The predicate devices for the AtriCure Cryo Module are the AtriCure frigitronics CCS-200 Cardiac Cryosurgical System (K811390) and the AtriCure Cryo1 cryo-ablation probe (K082074).
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 a cryosurgical handpiece to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias.
Materials
All materials used in the manufacture of the AtriCure Cryo Module are suitable for their intended use and suitable for use with pressurized nitrous oxide. The AtriCure Cryo Module is not intended for patient contact.
1
K111042²/₂
Testing
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Bench comparison testing, transit testing, electromagnetic compatibility, reliability, reliability testing, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications.
Summary of Substantial Equivalence
The AtriCure Cryo Module is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a stylized body.
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 Third Party Official Regulatory Technology Services LLC. 1394 25th Street NW Buffalo, MN 55313
MAY 2 6 2011
Re: K111042
Trade/Device Name: AtriCure Cryo Module System (ACM, CRYO1 and cryoICE) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II (two) Product Code: GEH Dated: April 14, 2011 Received: April 15, 2011
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.
3
Page 2 -- Mr. Mark Job
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 (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/CDRH/CDRHOffices/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/ReportalProblem/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,
D. Zadeh M.D.
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) K111042
Device Name: AtriCure Cryo Module
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 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 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)
r
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K111042