(14 days)
No
The description focuses on electro-mechanical and pneumatic systems for delivering cryogenic energy, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for the cryosurgical treatment of cardiac arrhythmias, directly treating a medical condition.
No
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." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly states that the AtriCure Cryo Module (ACM) unit is a "non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system" and is used in conjunction with "sterile, single use, cryosurgical device[s]" (probes). This indicates the device includes significant hardware components beyond just software.
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 describes a surgical procedure performed directly on the patient's cardiac tissue.
- Device Description: The device description details a system that delivers cryogenic energy to freeze target tissue in vivo (within the living body) to block electrical conduction pathways.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used for treatment directly on the patient.
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 nonsterile, 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 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 cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or AtriCure ACC2 (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. Design verification and validation, software validation, and electrical safety testing 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 60601-1 186 Ed.: Medical Electrical Equipment, Part 1: General Requirements . for Safety. (2003)
- EN
- IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility Reg. & Tests . (2007)
- 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): 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 System 510(k) SUMMARY
JAN 2 4 2014
| General Information | |
|---|---|
| --------------------- | -- |
ت
| Date Compiled | December 6, 2013 |
|---|---|
| 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 | Karl Dahlquist |
| VP of Quality Systems, Regulatory Affairs, and Legal |
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 Cryo1 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) (K111042, K112072, and K121507).
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 cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or AtriCure ACC2 (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 Crvo 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 cryo-ablation probes (Cryo1 and cryoICE).
1
Testing
ﺔ ﺍﻟﺘﻲ
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 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 60601-1 186 Ed.: Medical Electrical Equipment, Part 1: General Requirements . for Safety. (2003)
- . EN
- IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility Reg. & Tests . (2007)
- FDA Guidance for the Content of Premarket Submissions for Software Contained . in Medical Devices (Issued May 11, 2005)
Summary of Technological Characteristics
The modified AtriCure Cryo Module System has the following similarities to the technological characteristics of the previously cleared predicate AtriCure Cryo Module System (K111042, K112072, and K121507):
- Same intended use .
- Same operating principle .
- Same fundamental scientific technology .
- Same cryo-ablation probes .
- . Same materials used
- Same module design .
- Same electronic solenoid valves
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 K111042. K112072. and K121507. The indications for use, basic overall function, and materials used are substantially equivalent.
2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2014
Atricure Inc. % Mr. Mark Job Third Party Reviewer Regulatory Technology Service LLC 1394 25th Street NW Buffalo, MN 55313
Re: K140058
Trade/Device Name: Atricure Cryo Module System Regulation Number: 21 CFR 879.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: January 8, 2014 Received: January 10, 2014
Dear Mr. Mark 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. 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.
3
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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
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,
Owe
Paris-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on lest page.
510(k) Number (if known)
Device Name
AtriCure Cryo Module System (ACM, Cryol, and cryolCE)
Indications for Use (Describe)
The AttiCure Cryo Module System is in the cryosurgical treatment of cardias arthythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryol cryo-ablation probe-a sterile, single use device -and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDAIUSE ONLY FE ﺃﻧﺎ ﻳﻮﻧﻴﻮ ﺑﺎﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺍﺻﻞ ﺍﻟﻤ ない
ダ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
差
Digitally signed by Owen
P. Faris-S
Date: 2014.01.24
14:34:14-05'00'
FORM FDA 3881 (9/13)
PSC Publishing Secrives (34 ) 24 J-4 748
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