The Multifunctional linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the AtriCure Ablation and Sensing Unit or to the ASU Source Switch in Ablation mode and the Multifunctional linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Device Description

The Multifunctional linear pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the pen is connected to the AtriCure Ablation and Sensing Unit (ASU) directly or via the AtriCure ASU Source Switch in ablation mode, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the pen is connected to a commercially available temporary pacemaker or recorder the pen is used for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery.

AI/ML Overview

The information provided describes a 510(k) submission for the AtriCure Multifunctional Linear Pen. A 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria in the way a clinical trial would for a novel device.

The document states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen."

This indicates that the acceptance criteria are implicitly defined by the performance of the predicate devices: the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). The study's goal was to show similar performance. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in this 510(k) summary.

Based on the provided text, a table of explicit acceptance criteria and reported performance cannot be fully constructed as it would be for a direct performance study against pre-defined thresholds. The submission focuses on substantial equivalence, meaning the new device's safety and effectiveness are similar to legally marketed predicate devices.

Here's an attempt to extract and present the information as requested, acknowledging the limitations of data from a 510(k) summary:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) premarket notification, the "acceptance criteria" are implicitly set by the performance and safety profiles of the legally marketed predicate devices. The study's objective was to demonstrate substantial equivalence rather than meeting specific numerical performance targets.

Acceptance Criterion (Implicitly based on Predicate Devices)	Reported Device Performance (Summary in 510(k))
Cardiac Ablation: Ability to ablate cardiac tissue using RF energy safely and effectively.	Demonstrated ability to ablate cardiac tissue "as safely and effectively as" the AtriCure Isolator Transpolar pen and AtriCure Coolrail linear pen (predicate devices).
Cardiac Pacing: Ability for temporary pacing during surgery.	Demonstrated ability to pace cardiac tissue "as safely and effectively as" the predicate devices.
Cardiac Sensing: Ability for temporary sensing during surgery.	Demonstrated ability to sense cardiac activity "as safely and effectively as" the predicate devices.
Cardiac Stimulation: Ability for temporary stimulation during surgery.	Demonstrated ability to stimulate cardiac tissue "as safely and effectively as" the predicate devices.
Biocompatibility: Materials suitable for intended use, no adverse biological reactions.	Materials suitable for intended use, testing conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility.
Conformance to Product Specification: Meeting engineering and design requirements.	"Appropriate product testing was conducted to evaluate conformance to product specification."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "in-vitro and in-vivo testing," but does not provide details on the number of samples, animals, or human subjects used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this 510(k) summary. The testing described is technical or preclinical (in-vitro/in-vivo) to demonstrate functional equivalence, not a clinical study requiring expert ground truth or consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for clinical studies involving human subject data and interpretive assessments, which are not detailed in this submission.
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:
- No. An MRMC study is not mentioned. This device is a surgical tool, not an AI diagnostic or interpretive device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a medical device, not an algorithm. The testing described involves the device's physical functions (ablation, pacing, sensing, stimulation).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "in-vitro" and "in-vivo" testing, the ground truth would likely be based on established physiological measurements, histological analysis (for ablation efficacy), and direct observation of electrical signals (for pacing/sensing/stimulation).
- However, specific details on how this "ground truth" was established are not provided in the 510(k) summary. The primary "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.
The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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K10 0561 1/2

ATRICURE MULTIFUNCTIONAL LINEAR PEN 510(k) SUMMARY

General Information

JUN 1 8 2010

Date Compiled	February 16, 2010
Classification	Class II (Surgical device, for ablation of cardiac tissue)
Product Code	OCL
Trade Name	AtriCure Multifunctional linear pen
Manufacturer	AtriCure, Inc6217 Centre Park DriveWest Chester, OH 45069
Contact	James L. LuckyVP of Quality Assurance and Regulatory Affairs(513) 755-5754

Indications for Use

Predicate Devices

The predicate devices for the AtriCure Multifunctional linear pen are the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605).

Device Description

Materials

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All materials used in the manufacture of the AtriCure Multifunctional linear pen are suitable for their intended use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen.

Summary of Substantial Equivalence

The Multifunctional linear pen is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 8 2010

AtriCure, Inc. c/o Mr. James Lucky, RAC Vice President of Quality Assurance and Regulatory Affairs 6217 Centre Park Dr. West Chester, OH 45069

Re: K100501

Trade/Device Name: AtriCure Multifunctional Linear Pen Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: May 20, 2010 Received: May 21, 2010

· 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.

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

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Page 2 - Mr. James Lucky

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 (OS) 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/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

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

K100501 510(k) Number (if known) _

Device Name: AtriCure Multifunctional linear pen

Indications for Use:

The Multifunctional Linear Pen is a sterile, single use electrosurgery device intended to ablate cardiac . tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the AtriCure Ablation and Sensing unit (ASU) or to the ASU Source Switch in Ablation mode.
The Multifunctional Linear Pen may be used for temporary cardiac pacing, sensing, recording, and . stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Prescription Use X (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)

WMP

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numb

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.