The Isolator® linear pen is intended to ablate cardiac tissue during cardiac surgery using . radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch (ASB) in Ablation mode.
The Isolator® 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 Isolator™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device, the Pen is designed to provide temporary pacing or monitoring.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Isolator® Linear Pen:

Disclaimer: The provided document is a 510(k) summary for a medical device. These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial report might. As such, direct "acceptance criteria" for performance metrics and a "study that proves the device meets the acceptance criteria" in the format typically seen for a new drug or novel medical device effectiveness claim are not explicitly detailed. Instead, the document discusses conformity to design controls and specifications.

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Isolator® Linear Pen does not provide a table of quantitative acceptance criteria and reported device performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it states that the device was tested to conform to "design controls and specification."

Criteria	Acceptance	Reported Performance
Biocompatibility	Suitable for intended use according to ISO 10993-1.	Testing conducted on all patient contacting materials in accordance with ISO 10993-1 ensured appropriate biocompatibility of all appropriate materials.
Design Controls & Product Specifications	Conformance to 21 CFR 820.30 and AtriCure's Quality System.	Testing determined that the modified Isolator® linear pen conformed to design controls and product specifications.
Substantial Equivalence	To the Isolator® linear pen cleared via K100501.	The modified Isolator® linear pen is considered substantially equivalent in indications for use, basic overall function, and materials used.

Study Information (Based on Available Text)

The document describes pre-market testing to ensure conformity, rather than a clinical study comparing performance against a specific metric.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Testing was conducted on all patient contacting materials" and "Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification." This implies engineering and laboratory testing rather than human subject clinical trials with a defined sample size for performance evaluation.
- Data Provenance: Not specified. Likely internal laboratory and engineering test data, given the nature of a 510(k) for a modification to a previously cleared device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. The testing described is verification of design controls and biocompatibility, not expert-adjudicated performance relative to a clinical ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified.
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:
- Not applicable. This device is an electrosurgical device, not an AI-driven diagnostic tool necessitating MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Adherence to ISO 10993-1 standards (a regulatory/scientific standard).
- For design conformance: Adherence to internal product specifications and quality system regulations (21 CFR 820.30).
- For substantial equivalence: Comparison to the predicate device (K100501) based on intended use, function, and materials.
The sample size for the training set:
- Not applicable. This is a medical device subject to design verification and validation, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K130521

510(k) Summary

APR 0 5 2013

General Information

Classification	Class 2
Trade name	Isolator® 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 45069P: 513-755-4100F: 513-755-4108
Contact	Rebecca Walters, RACRegulatory Affairs Manager

Date of Submission February 27, 2013

Intended Use

The Isolator® 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 ASU or ASB in Ablation mode. The Isolator® 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.

Cleared Device

The device proposed for modification in this submission is the Isolator® linear pen cleared via 510(k) K100501 on June 18, 2010.

Device Description

Materials

All materials in the modified Isolator® linear pen are suitable for their intended use. Testing was conducted on all patient contacting materials in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all appropriate materials.

Isolator® linear pen

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Image /page/1/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The "C" in "AtriCure" is designed with a circle around it, and there is a registered trademark symbol after the word. The font is bold and black, and the background is white.

Testing

Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification. Testing determined that the modified Isolator® linear pen conformed to design controls and product specifications.

Summary of Equivalence

The modified Isolator® linear pen proposed in this submission is considered substantially equivalent to the Isolator® linear pen cleared via K100501. 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 logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 5, 2013

Atricure, Inc. Rebecca Walters 6217 Centre Park Drive West Chester, OH 45069 US

Re: K130521

Trade/Device Name: Isolator linear pen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: March 5, 2013 Received: March 7, 2013

Dear Ms. Walters:

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.

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

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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/ReportaProblem/default.htmfor 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/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)_K130521

Device Name: Isolator® linear pen

Indications for Use:

The Isolator® linear pen is intended to ablate cardiac tissue during cardiac surgery using . radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch (ASB) in Ablation mode.
The Isolator® 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 × (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)

Owen P. Faris -S
2013.04.05
13:35:26 -04'00'

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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.