(30 days)
Not Found
No
The summary describes a standard electrosurgery device for ablating cardiac tissue using radiofrequency energy. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes.
The device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy, which is a therapeutic function.
No
The device is described as an electrosurgery device intended to ablate cardiac tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use electrosurgery device" and a "sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during cardiac surgery using radiofrequency energy." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an "electrosurgery device" used for delivering "radiofrequency current." This is a surgical tool.
- Anatomical Site: The device is used on "cardiac tissue," which is part of the patient's body.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used on the human body for treatment.
N/A
Intended Use / Indications for Use
The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes
OCL
Device Description
The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
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
Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Coolrail Linear Pen conformance to design controls and specification. Testing determined that the modified Coolrail Linear Pen conformed to design controls and product specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) Summary
General Information
| Classification | Class 2 |
|---|---|
| Trade name | Coolrail Linear Pen |
| Classification Name | Surgical Device, For Ablation Of Cardiac Tissue |
| (21 CFR 878.4400, Product Code OCL) | |
| Manufacturer | AtriCure, Inc. |
| 6217 Centre Park Dr. | |
| West Chester, OH 45069 | |
| P: 513-755-4100 | |
| F: 513-755-4108 | |
| Contact | James Lucky, RAC |
| Vice President Quality Systems and Regulatory Affairs | |
| Date of Submission | August 24, 2012 |
Intended Use
The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cleared Device
The device proposed for modification in this submission is the Coolrail Linear Pen cleared via 510(k) K073605 on March 11, 2008.
Device Description
The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
Materials
All materials in the modified Coolrail Linear Pen are suitable for their intended use. Testing was previously conducted on all patient contacting materials in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all appropriate materials.
Testinq
Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Coolrail Linear Pen conformance to design controls and specification. Testing determined that the modified Coolrail Linear Pen conformed to design controls and product specifications.
Summary of Equivalence
The modified Coolrail Linear Pen proposed in this submission is considered substantially equivalent to the Coolrail Linear Pen cleared via K073605. The indications for use, basic overall function, and materials used are substantially equivalent.
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Coolrail Linear Pen Page 64 of 90
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AtriCure Inc. c/o Mr. James Lucky VP of quality Systems and Regulatory Affairs 6217 Center Park Dr. West Chester, OH 45069
SEP 26 2012
Re: K122611
- Trade/Device Name: Coolrail Linear Pen
Regulation Number: 21 CFR 870.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories. . · Regulatory Class: Class II (two) Product Code: OCL Dated: August 24, 2012 Received: August 27, 2012
Dear Mr. Lucky:
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.
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Page 2 - Mr. James Lucky
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.html 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,
D. Zuckerman, M.D.
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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