(80 days)
Not Found
No
The description focuses on mechanical modifications to a surgical clamp and mentions no software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "ablation of cardiac tissue," which is a medical intervention aimed at treating a pathological condition of cardiac tissue.
No
The device is described as a surgical instrument intended for the ablation of cardiac tissue during surgery, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines hardware components including a hand-held surgical instrument, an accessory instrument guide, and connections to reusable consoles (Ablation and Sensing Unit and Isolator Switch Matrix). The modification described is also a mechanical feature (hinged jaw assembly).
Based on the provided text, 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 is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument (clamp) used to perform this ablation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to test samples from the body to provide diagnostic information. This device is used to treat tissue within the body.
N/A
Intended Use / Indications for Use
The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery.
Product codes
OCL
Device Description
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).
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020919, K052893, K063630, K043579, K101174
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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, Inc |
| 6217 Centre Park Drive | |
| West Chester, OH 45069 | |
| Contact | James L. Lucky |
| VP 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
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).
1
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.
2
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
3
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
4
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