The Isolator™ Transpolar™ Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or 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™ Transpolar™ pen System (Pen) is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator " Transpolar™ pen, a footswitch, and the ASB1 Source Switch accessor. The 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 ASU, either directly or via the ASB1 Source Switch set to the ASU port, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the ASB1 is set to the auxiliary port the pen may be used with a commercially available temporary pacemaker or recorder for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery, based on the function of the device to which it is connected. The two modes of operation, ablation and pacing/sensing cannot be active at the same time.

AI/ML Overview

The provided text is a 510(k) summary for the AtriCure Isolator Transpolar Pen System, which is an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This type of document, particularly for electrosurgical devices, typically does not include detailed clinical study data with acceptance criteria, sample sizes for test sets, expert ground truth adjudication, or standalone algorithm performance as would be found in a submission for an AI/ML-based diagnostic device.

Therefore, many of the requested details are not present in the provided text. I will extract the information that is available and explicitly state when information is not provided.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as performance metrics in the provided text for this 510(k) summary. For medical devices like this, acceptance criteria often revolve around engineering specifications, safety testing (e.g., electrical safety, biocompatibility), and functional equivalence to predicate devices rather than clinical performance metrics (like sensitivity/specificity for diagnostic tools).
Reported Device Performance: The document states, "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." No specific performance values (e.g., power output ranges, ablation lesion size, pacing accuracy) are reported in this summary.

Criterion	Acceptance Value	Reported Performance
Clinical Performance Metrics	Not specified (N/A)	Not reported (N/A)
Substantial Equivalence	To predicate devices	Device is deemed substantially equivalent to predicate products for indications, function, and materials.
Material Biocompatibility	Conformance to ISO 10993-1	Testing conducted in accordance with ISO 10993-1.
Product Specification Conformance	Conformance to internal product specifications	Appropriate product testing conducted.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided 510(k) summary. The testing mentioned appears to be primarily bench or engineering testing rather than a clinical trial with a defined "test set" of patients or cases in the context of diagnostic AI.
Data Provenance: Not specified. Given the nature of the device (electrosurgical pen), provenance wouldn't be in terms of countries of origin for patient data but rather the location of engineering labs or test facilities. The document does not provide such details.
Retrospective/Prospective: Not applicable in the context of this device's evaluation as described.

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

Number of Experts: Not applicable. The evaluation described is not based on expert-established ground truth for a diagnostic task.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no expert ground truth establishment or clinical test set adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is typically performed for imaging or diagnostic devices where human readers interpret data, often comparing AI-assisted vs. unassisted performance. This is an electrosurgical device, not a diagnostic one.
Effect Size of Human Readers Improvement with AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Not applicable. This device is a physical electrosurgical tool, not a software algorithm or AI model with standalone performance metrics.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the sense of expert consensus, pathology, or outcomes data for a diagnostic algorithm. The "ground truth" for this device's evaluation would be its adherence to engineering specifications, safety standards, and functional requirements, benchmarked against predicate devices and internal testing.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not developed using machine learning or AI models that require a "training set."

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary of Study:

The "study" described in the 510(k) summary is not a clinical performance study with defined acceptance criteria and human reader evaluations as would be expected for AI/ML diagnostic devices. Instead, it's a regulatory submission demonstrating substantial equivalence to already legally marketed predicate devices.

The key points of the "testing" mentioned are:

Evaluation of conformance to product specification.
Evaluation of substantial equivalence to predicate devices.
Biocompatibility testing in accordance with ISO 10993-1.

The conclusion is that the Isolator Transpolar Pen System is "substantially equivalent" to predicate products regarding its indications for use, basic overall function, and materials used. This means the device is considered as safe and effective as the predicate devices without requiring new clinical performance data to prove its efficacy, as its fundamental technology and application are already established.

Summary

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510(k) Summary

JUL 1 2 2005

000223

General Information

Classification Class II, Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)

Product Cod

Trade Name Isolator™ Transpolar™ Pen System

Elsa Abruzzo

GEI

Manufacturer

AtriCure, Inc. 6033 Schumacher Park Drive West Chester, OH 45069

Contact

Vice President, Clinical and Regulatory Affairs

Intended Use

The Isolator™ Transpolar™ Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Predicate Devices

AtriCure Isolator Transpolar Pen (K050459) ಂ
Medtronic Detect Mapping and Sensing Tool (K040812) 0
0 Viking Diagnostic Electrode Catheter (K971265)
0 Estech Cobra System (K051749)

Device Description

Materials

All materials used in the manufacture of the Isolator Transpolar Pen System are suitable for this 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.

Summary of Substantial Equivalence

The Isolator Transpolar Pen System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atricure, Inc. c/o Ms. Elsa C. Abruzzo, RAC Vice President, Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069

Re: K061593

Trade Name: Atricure Isolator Transpolar Pen System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II (two) Product Code: OCL Dated: June 7, 2006 Received: June 8, 2006

Dear Ms. Abruzzo:

This letter corrects our substantially equivalent letter of July 12, 2006.

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 (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.

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Page 2 - Ms. Elsa C. Abruzzo. RAC

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours

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): K061593

Device Name: Atricure Isolator Transpolar Pen™

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Aymuma

ular Devices 510(k) Number

Page 1 of 1

000225

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.