The Isolator linear pen is a sterile, single use electro surgery 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.

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

This document is a 510(k) premarket notification for a medical device called the "Isolator Multifunctional Linear Pen." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the acceptance criteria or a study demonstrating the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to an existing predicate device (K130521) for regulatory clearance. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, not necessarily that it meets novel, quantifiable performance metrics against a specific clinical condition using AI/ML.

Here's what can be extracted from the document, and what is missing based on your request:

What can be found in the document:

Device Name: Isolator Multifunctional Linear Pen
Intended Use:
- To ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
- 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.
Regulatory Status: Class II medical device, Product Code OCL (Electrosurgical Cutting and Coagulation Device and Accessories).
Predicate Device: Isolator Multifunctional Linear Pen (cleared via 510(k) K130521 on April 05, 2013).
Comparison to Predicate Device:
- Same intended use
- Same operating principle
- No changes in operating principle or performance specifications
- Same sterilization parameters
Performance Data (Non-clinical Bench Testing and Biocompatibility):
- Reliability Testing (details not provided)
- Biocompatibility Testing (in accordance with ISO 10993-1, included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogen). This testing was done to assess risks of a modification to the PET material.

What is MISSING based on your request (and why):

This document is a 510(k) summary for a hardware electrosurgical device, not an AI/ML algorithm. Therefore, many of the requested elements for AI/ML device evaluation are not applicable or detailed:

A table of acceptance criteria and the reported device performance: Not provided in the context of specific, quantifiable clinical or AI performance metrics. The "performance data" section states "Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications," which is a general statement of compliance, not specific performance metrics.
Sample sized used for the test set and the data provenance: Not applicable as there's no "test set" in the context of an AI/ML algorithm evaluating data. The performance claims rely on the substantial equivalence to the predicate device and general non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this document demonstrates regulatory clearance for a traditional medical device based on substantial equivalence and general safety/performance testing, not the type of detailed AI/ML performance evaluation you've described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 3, 2017

AtriCure Inc. Melissa Smallwood Associate Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K163408

Trade/Device Name: Isolator Multifunctional 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: December 2, 2016 Received: December 5, 2016

Dear Melissa Smallwood:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Sincerely,

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) K163408

Device Name Isolator Multifunctional Linear Pen

Indications for Use (Describe)

The Isolator linear pen is a sterile, single use electro surgery device intended to ablate 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, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac or recording device.

Type of Use (Select one or both, as applicable)
☑ 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/1 description: The image shows the logo for AtriCure. The logo is in two colors, blue and orange. The first three letters, "Atri", are in blue, while the rest of the word, "Cure", is in orange. There is a blue dot in the middle of the "C" in "Cure", and a registered trademark symbol to the right of the word.

510(k) Summary

I. Submitter

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason, OH 45040P: 513-755-4100
Contact Person:	Melissa SmallwoodAssociate Regulatory Affairs Specialist
Alternate Contact:	Jonathan McElweeRegulatory Affairs Manager
Date Prepared:	12/02/2016
II.Device
Name of Device:	Isolator® Multifunctional Linear Pen
Common Name:	Surgical device, for ablation of cardiac tissue
Classification Name:	21 CFR 878 4400
Regulatory Class:	Class II
Product Code:	OCL

Predicate Device III.

The predicate device, Isolator Multifunctional Linear Pen, was cleared via 510(k) K130521 on April 05, 2013 under the Product Code OCL.

The predicate device has not been subject to a design-related recall.

The following reference devices were also used in this submission:

. K100501 Isolator linear pen original 510(k) cleared on June 18, 2010

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IV. Device Description

V. Indications for Use

VI. Comparison of Technological Characteristics with the Predicate Device

. Same intended use
. Same operating principle
. No changes were made in operating principle, or specifications of performance
. The same sterilization parameters

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VII. Performance Data

Testing was completed per 21 CFR 820.30 and AtriCure's Quality System to verify the device's conformance to design controls and specification. Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications.

Non-clinical Bench Testing

Reliability Testing

Biocompatibility Testing

The biocompatibility evaluation for the Isolator Multifunctional Linear Pen was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
. Sensitization
Irritation
. Systemic Toxicity
. Material Mediated Pyrogen

The Isolator Multifunctional Linear Pen is categorized as a class II, "Surgical device, for ablation of cardiac tissue", for contact with "Tissue/Bone" and permanent contact for a duration of "less than 24hrs".

Per the FDA final guidance issued in 1997, 'Deciding When to Submit a 510(k) for a Change to an Existing Device', PET is listed as a material in the Biomaterials Compendium, and would not necessitate additional biocompatibility testing. AtriCure conducted confirmatory biocompatibility testing to affectively assess additional risks associated with the modification to the PET material. The results indicated no additional risk has been introduced by the modified device.

VIII. Conclusions

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed AtriCure Isolator Multifunctional Linear Pen has been shown to be appropriate for its intended use and is considered substantially equivalent to the AtriCure Isolator linear pen previously cleared via 510(k) K130521 on April 05, 2013.

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.