The AtriCure Bipolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument {Isolator Transpolar Clamps or Isolator Synergy Clamps} intended for the ablation of cardiac tissue and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-usable Ablation and Sensing Unit (ASU2) and an Isolator Switch Matrix (ASB3) console. This 510(k) specifically seeks approval of a modification to AtriCure Bipolar System to include the Synergy Access Clamp. The only changes incorporated in the Synergy Access Clamp is the addition of mechanical features allowing for more surgical options due to surgeon preference and varying patient body habitus including a hinged jaw assembly allowing jaw position to be locked at the preferred angle and a passive proximal jaw allowing wider jaw aperture. There are no changes being made to the current Isolator Synergy Clamps, the Ablation and Sensing Unit or the Isolator Switch Matrix as part of this 510(k).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the AtriCure Bipolar System:

Summary of Device and Study Information:

The provided document is a 510(k) summary for the AtriCure Bipolar System, specifically seeking approval for a modification to include the Synergy Access Clamp. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through new clinical trials with defined acceptance criteria for disease detection/diagnosis. Therefore, the information provided focuses on engineering and biocompatibility testing, along with a statement of equivalence.

The document does not contain information related to a study that would typically establish acceptance criteria in the context of diagnostic or assistive AI devices (e.g., sensitivity, specificity, accuracy for a particular task). Instead, the "acceptance criteria" here would be implicitly conformance to product specifications and substantial equivalence to predicate devices. The study performed is a series of engineering verification and validation tests rather than a clinical trial measuring a device's performance in a diagnostic or treatment outcome context against a ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not define explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be expected for an AI/diagnostic device. Instead, the general acceptance criteria are conformance to product specifications and substantial equivalence to predicate devices. The reported performance is that the device met these criteria.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to product specification (mechanical, electrical, reliability, transit, aging)	"complete design verification testing was performed including but not limited to mechanical testing, electrical safety and compliance testing, reliability testing per the device design life, transit, and aging to ensure the design outputs meets the design input specifications."
Biocompatibility (ISO 10993-1)	"All materials used in the manufacture of the AtriCure Bipolar System 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."
Ability to ablate cardiac tissue safely and effectively	"In-vitro and in-vivo testing demonstrated that the proposed AtriCure Bipolar System is able to ablate cardiac tissue as safely and effectively as the previously approved AtriCure Bipolar System." (This implies the performance is at least equivalent to the predicate, even if specific numerical performance metrics are not given).
Substantial Equivalence to Predicate Devices	"The AtriCure Bipolar System is equivalent to the predicate products as shown through the device descriptions and provided performance data. The indications for use, basic overall function, and materials used are substantially equivalent to the predicate devices." (The FDA's 510(k) clearance confirms this finding: "We have reviewed... and have determined the device is substantially equivalent...").

Detailed Information on the "Study" (Verification and Validation Testing):

The document describes engineering verification and validation testing, not a clinical study in the typical sense of evaluating diagnostic or treatment efficacy with patient outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not explicitly stated in terms of number of devices or cardiac tissue samples. The text mentions "in-vitro and in-vivo testing," but details on the number of samples or subjects are not provided.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a 510(k) for a surgical tool, the "data" largely refers to engineering test results and potentially animal (in-vivo) studies.

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

Not applicable. The ground truth for this type of device (a surgical ablation tool undergoing 510(k) clearance) is typically objective measurements (e.g., temperature achieved, lesion size, electrical performance, material properties) and comparison to the performance of predicate devices, not expert consensus on diagnostic images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert opinions or interpretations.

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:

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is a surgical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for showing substantial equivalence for this device would be established through:
- Objective Engineering Measurements: Conformance to electrical, mechanical, and reliability specifications.
- Biocompatibility Testing: Results according to ISO 10993-1 standards.
- Pre-clinical Performance Characteristics: In-vitro and in-vivo data demonstrating the ability to ablate cardiac tissue, with performance comparable to predicate devices. This might involve measuring lesion characteristics in animal models or explanted tissue.

8. The Sample Size for the Training Set:

Not applicable for this type of device and submission. There is no "training set" in the context of an AI/machine learning model. The device design is based on engineering principles and prior validated devices.

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

Not applicable as there is no training set for an AI model.

Summary

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KII0117 pg. 1 of 2

APR - 8 2011

ATRICURE BIPOLAR SYSTEM 510(k) SUMMARY

General Information

Date Compiled	January 13, 2011
Classification	Class II (Surgical device, for ablation of cardiac tissue)
Product Code	OCL
Trade Name	AtriCure Bipolar System
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

The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery.

Predicate Devices

The predicate devices for the AtriCure Bipolar System include the AtriCure Bipolar System (K020919), the AtriCure Transpolar System (K052893), the AtriCure Ablation System (K063630), the AtriCure Bipolar System (K043579), and the AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps (K101174).

Device Description

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Materials

All materials used in the manufacture of the AtriCure Bipolar System 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 proposed AtriCure Bipolar System is able to ablate cardiac tissue as safely and effectively as the previously approved AtriCure Bipolar System. Additionally, complete design verification testing was performed including but not limited to mechanical testing, electrical safety and compliance testing, reliability testing per the device design life, transit, and aging to ensure the design outputs meets the design input specifications.

Summary of Substantial Equivalence

The AtriCure Bipolar System is equivalent to the predicate products as shown through the device descriptions and provided performance data. The indications for use, basic overall function, and materials used are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that resemble a person's head, torso, and legs.

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

AtriCure, Inc. C/O James Lucky, RAC 6217 Centre Park Drive West Chester, OH 45069

APR - 8 2011

Re: K110117

Trade/Device Name: AtriCure Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: January 13, 2011 Received: January 11, 2011

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. 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

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Page 2 - Mr. James Lucky

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.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Coram 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

KII0117 510(k) Number (if known) __

Device Name: AtriCure Bipolar System

Indications for Use:

The AtriCure Bipolar System is intended for the ablation of caridac tissue during surgery.

× 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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K110117

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.