(919 days)
Not Found
No
The summary describes a bipolar ablation system for cardiac tissue and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "ablation of cardiac tissue during surgery," which is a therapeutic intervention.
No
The device is described as being for "ablation of cardiac tissue during surgery," which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is comprised of a bipolar clamping hand-piece and a re-useable generator, 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 "bipolar clamping hand-piece" and a "re-useable generator." These are tools used for a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The AtriCure Bipolar (Transpolar) System 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 is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).
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)
Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission. The AtriCure Bipolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
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.
K020919, K013392, K013873, K040690, K003978, K040641
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
510(k) Summary
K043579
page 1/2
General Information
| Classification | Device, Electrosurgical, Cutting and
Coagulation and Accessories (21CFR878.440) |
|----------------|------------------------------------------------------------------------------------|
| Trade Name | AtriCure Bipolar System |
| Manufacturer | AtriCure, Inc.
6033 Schumacher Park Drive
West Chester, OH 45069 |
| Contact | Elsa Abruzzo
Vice President, Clinical and Regulatory Affairs |
Intended Use
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
Predicate Devices
The predicate devices for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641).
Device Description
The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).
Materials
All materials used in the manufacture of the AtriCure Bipolar 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.
1
Testing
K043579
page 2/2
Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission.
Summary of Substantial Equivalence
The AtriCure Bipolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
AtriCure, Inc. CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atricure, Inc. c/o Ms. Elsa C. Abruzzo Vice President of Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069
Re: K043579
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 (two) Product Code: OCL Dated: March 30, 2007 Received: April 6, 2007
Dear Ms. Abruzzo:
This letter corrects our substantially equivalent letter of July 5, 2007.
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.
3
Page 2 - Ms. Elsa C. Abruzzo
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 yours,
el. Mdl.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
page i/1
510(k) Number (if known) K043579
Device Name: AtriCure Bipolar (Transpolar) System
Indications for Use:
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
Prescription Use . X (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)
M.S. Wilhelme for Biam Zuckerman
diovascular Devices
510(k) I
AtriCure, Inc. CONFIDENTIAL