The AtriCure Bipolar System includes hand held, single use, dual electrode, bipolar radiofrequency (RF) surgical instruments (Isolator Synergy™ Clamps) intended for the ablation of cardiac tissue. The clamp handpieces are connected via an integral cable to the AtriCure reuseable Ablation and Sensing Unit (ASU2) and the accessory Isolator Switch Matrix (ASB3).

AI/ML Overview

Here's an analysis of the provided text regarding the AtriCure Bipolar System, structured to address your specific questions.

Based on the provided text, the device is an electrosurgical cutting and coagulation device accessory intended for the ablation of cardiac tissue during surgery. The submission is a 510(k) Pre-Market Notification, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with detailed acceptance criteria and performance statistics like a PMA (Pre-Market Approval) submission would.

Therefore, much of the requested information, particularly quantitative details on acceptance criteria and specific study designs as you might find for novel AI-powered diagnostic devices, is not explicitly present or relevant in this type of submission. The text emphasizes demonstrating equivalency to a predicate device.

Acceptance Criteria and Device Performance

There are no explicit, quantitative acceptance criteria defined in the provided text in the way one might expect for a new diagnostic or AI-powered device. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device, especially regarding lesion transmurality and safe/effective operation.

The text states: "Clinical study data has proven lesson transmurality using the AtriCure Bipolar System including Isolator Synergy Dual Electrode clamps via assessment of pulmonary vein isolation."

Since this is a 510(k) for a surgical ablation device, the "performance" is largely about its ability to safely and effectively create cardiac tissue lesions, specifically achieving transmurality (meaning the lesion extends fully through the heart wall). The "acceptance" is the FDA's determination of substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Substantial Equivalence to Predicate Device	Demonstrated through testing, materials, intended use, and method of operation.
Lesion Transmurality	"Proven" via clinical study data and assessment of pulmonary vein isolation.
Safety and Efficacy (General)	All appropriate testing performed; components met required specifications.

Detailed Study Information (Based on Available Text)

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The text only mentions "Clinical study data."
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified. It's safe to assume a clinical study for a surgical device would likely be prospective, but this is not explicitly stated.
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)
- This information is not provided. For a surgical ablation device, "ground truth" might be assessed by surgeons, electrophysiologists, or pathologists examining ablated tissue.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not 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
- No, this is not applicable. The device is a surgical instrument (bipolar RF ablation clamps), not an AI-powered diagnostic or assistive tool for "human readers." Therefore, an MRMC study with "human readers" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is a physical surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text mentions "assessment of pulmonary vein isolation" to prove lesion transmurality. This assessment method could involve:
  - Electrophysiological testing (e.g., demonstrating no conduction across the ablation line post-procedure).
  - Pathological examination of tissue samples (if an animal study) or resected human tissue (less common in this context).
  - Imaging modalities to assess scar formation.
- The exact "type of ground truth" is not detailed beyond "assessment of pulmonary vein isolation."
The sample size for the training set
- Not applicable / Not specified. This device is hardware. There is no "training set" in the context of machine learning or AI algorithms. The term "training set" is not relevant here. The 'training' for this device would refer to non-clinical testing (e.g., engineering, bench, and animal studies) and then clinical study data.
How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the AI sense for this device. The "ground truth" for demonstrating safety and effectiveness relied on preclinical (chronic and acute animal studies) and clinical data demonstrating lesion transmurality and substantial equivalence to the predicate.

Summary

{0}------------------------------------------------

AtriCure Inc.

74 -- Request for Additional Information

Pg 1 of 2

510(k) Summary

NOV 1 2 2010 General Information Date Compiled April 26, 2010 Classification Class II, 21 CFR § 878.4400 Product code OCL Trade Name AtriCure Bipolar System including Isolator Synergy Dual Electrode clamps AtriCure, Inc. Submitter 6217 Centre Park Drive West Chester, Ohio 45069 Tel: 513-755-4100 Fax: 513-644-1354 James L. Lucky Contact VP of Quality Assurance and Regulatory Affairs Tel: 513-755-5754 Fax: 513-644-1354 Intended Use The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery. Predicate Devices AtriCure Bipolar System (including Isolator Single Electrode clamps) K043579 Manufactured by AtriCure, Inc.

K063630 AtriCure Bipolar System (including Isolator Synergy Dual Electrode clamps)

Manufactured by AtriCure, Inc.

Device Description

Materials

All materials used in the manufacture of the AtriCure Bipolar System including Isolator Synergy Dual Electrode clamps are suitable for this use and are identical to the predicate product.

Testina

All appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

Pre-Clinical: Chronic and acute animal studies were performed to show equivalency to the predicate device and for verification and validation of design.

Clinical: Clinical study data has proven lesion transmurality using the AtriCure Bipolar System including Isolator Synergy Dual Electrode clamps via assessment of pulmonary vein isolation,

AtriCure, Inc.

08/25/2010

{1}------------------------------------------------

K101174 – Request for Additional Information of 2

Summary of Substantial Equivalence

AtriCure, Inc. believes the AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

AtriCure, Inc.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

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

NOV 1 2 2010

Re: K101174

Trade/Device Name: AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps, Models OSL2, OLL2, EMR2, EMR2, EML2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: November 3, 2010 Received: November 4, 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 (Act (Act to 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 requirements tor almount institutions 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 of class in (rWA).
found in the Godon of First and 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

{3}------------------------------------------------

Page 2 - Mr. James Lucky

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.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/Industry/default.htm.

Sincerely yours,

Antilly B. Boar

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

Enclosure

{4}------------------------------------------------

K101174
Page 1 of 1

4. Indications for Use Statement

NOW 1. 2. 2010

510(k) Number (if known):	This application
Device Name:	AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps
Indications for Use:	The AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps is intended for the ablation of cardiac tissue during surgery.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anuley Bousem for BDZ

Cardiovascular Devices

510(k) Number L101174

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.