(199 days)
Not Found
No
The summary describes a radiofrequency ablation system with hand-held clamps and a control unit. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on lesion transmurality and equivalency to predicate devices, not on AI/ML performance metrics.
Yes
The device is intended for the "ablation of cardiac tissue during surgery," which is a therapeutic intervention.
No
The device is intended for the ablation (destruction) of cardiac tissue, which is a therapeutic intervention, not a diagnostic one. While it does "sense" (as mentioned in ASU2 and ASB3), this sensing is likely for guiding the ablation, not for independently diagnosing a condition.
No
The device description explicitly states it includes hand-held surgical instruments (clamps), a reusable Ablation and Sensing Unit, and an accessory Isolator Switch Matrix, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ablation of cardiac tissue during surgery." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical instrument (clamps) used to ablate tissue. It's a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery.
The AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps is intended for the ablation of cardiac tissue during surgery.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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).
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