The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

AI/ML Overview

The provided text is a 510(k) summary for the AtriCure Coolrail Linear Pen (MCR1). It describes a submission for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance. Instead, it makes a general statement about meeting predetermined criteria.

Acceptance Criteria Category	Reported Device Performance
Mechanical Design Verification	The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K122611 MCR1 device. No new safety or performance issues were raised during testing.
Reliability Testing	Completed per AtriCure's Quality System, implying conformance.
Thermistor Testing	Completed per AtriCure's Quality System, implying conformance.
Mechanical Testing	Completed per AtriCure's Quality System, implying conformance.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It describes non-clinical bench testing. The data provenance is internal to AtriCure, Inc., as the testing was completed "per AtriCure's Quality System." The testing is described as "Non-clinical Bench Testing," which by nature would be prospective for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The study involves bench testing of a medical device, which typically relies on established engineering and performance specifications rather than expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves engineering and performance characteristics of a physical device, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The device described is an electrosurgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a physical electrosurgical pen; there is no "algorithm only" component.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on engineering specifications and established performance standards for electrosurgical devices. The testing (Reliability, Thermistor, Mechanical) verifies that the device performs according to these pre-defined, objective criteria. This is not clinical 'ground truth' like pathology or outcomes data, but rather a demonstration of physical device performance.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a hardware product, not a software algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided since there is no training set for this type of device.

Summary

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December 4, 2018

AtriCure, Inc. Caitlin Wunderlin Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K183065

Trade/Device Name: Coolrail Linear Pen (MCR1) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: October 24, 2018 Received: November 5, 2018

Dear Caitlin Wunderlin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Minde Jellman
for

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) K183065

Device Name Coolrail Linear Pen (MCR1)

Indications for Use (Describe)

The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot above the "i" in "AtriCure". There is a registered trademark symbol next to the "e" in "Cure".

510(k) Summary

l. Applicant Information

Manufacturer:	AtriCure®, Inc.7555 Innovation WayMason, Ohio 45040P: 513-755-4100
Contact Person:	Caitlin WunderlinRegulatory Affairs Specialist
Alternate Contact:	Jonathan McElweeManager, Regulatory Affairs
Date Prepared:	23 October 2018

. Device Information

Proprietary Name:	Coolrail® Linear Pen (MCR1)
Common Name:	Electrosurgical device
Classification:	Surgical device for cutting, coagulation, and/or ablation of tissue including cardiac tissueRegulatory Class: Class II; per 21 CFR 878.4400Product Code: OCLClassification Panel: Cardiovascular
Predicate Device:	Coolrail linear pen (MCR1)(K122611, 26 September 2012)

III. Device Description

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IV. Intended Use/ Indications for Use

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

Comparison of Technological Characteristics (MCR1 K122611) V.

The devices include the same intended use, and; ●
. No changes were made in operating principle, or specifications of performance, and;
The contraindications, warnings, and precautions remain the same for both the proposed . and predicate, and;
The devices are applied to the tissue in the same manner with the same method of ablation, and;
The results of the verification and validation testing:
- o Demonstrated equivalency in performance
- Did not raise any new issues of safety o

Modifications included in the Coolrail linear pen were to increase the rigidity of the rigid zone of the shaft.

	MCR1 (Predicate)	MCR1 (Subject)
Market Product Name	Coolrail Linear Pen	Coolrail Linear Pen
510(k) Number	K122611	Subject of this submission (K183065)
Intended Use	The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.	The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.
Contraindication	The device is not intended for contraceptive tubal coagulation (permanent female sterilization).	The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Method of Energy Activation	Footswitch	Footswitch
Energy Source	Bipolar radiofrequency energy is generated by the Ablation and Sensing Unit that is sold separately.	Bipolar radiofrequency energy is generated by the Ablation and Sensing Unit that is sold separately.
Ablating Element Length	30 mm	30 mm
Functional Shaft Length	10.0 inches minimum	10.0 inches minimum
Shaft - Outer Stiffener Length	7.5 inches minimum	Lengthened by 0.5 inches
Shaft - Outer Stiffener Material (Non-patient contacting)	Nylon	Aluminum Alloy

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Outer Stiffener to Shaft Bonding Agent (Non-patient contacting)	Cyanoacrylate	Epoxy
Packaging	Sterile – Single use disposable device	Sterile – Single use disposable device
Sterilization	EtO	EtO

VI. Performance Data

Mechanical design verification testing was completed per AtriCure's Quality System to verify the device's conformance to appropriate design controls and specifications to demonstrate equivalence to the previously cleared Coolrail linear pen device. The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K122611 MCR1 device. No new safety or performance issues were raising during testing.

Non-clinical Bench Testing:

Reliability Testing ●
. Thermistor Testing
Mechanical testing .

VII. Conclusions

AtriCure has demonstrated that the Coolrail linear pen is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use as the previously cleared Coolrail linear pen device via K122611 on 26 September 2012.

Regulation Number and Section

§ 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.