(51 days)
Not Found
No
The summary describes a standard RF ablation system and does not mention any AI or ML components or functionalities.
No
The device is described as a surgical instrument for ablating soft tissues, which falls under general surgery and involves removing or destroying tissue, rather than treating a disease or condition for therapeutic benefit.
No
The device is described as an ablation system intended to ablate soft tissues during general surgery using radiofrequency energy. Its purpose is therapeutic (tissue destruction), not diagnostic (identifying diseases or conditions).
No
The device description explicitly states it includes hardware components such as a hand held surgical instrument, an accessory instrument guide, and a re-useable Ablation and Sensing Unit (ASU2) or Isolator Switch Matrix (ASB3) console.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate soft tissues during general surgery using radiofrequency energy." This describes a surgical procedure performed directly on a patient's tissues, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical instrument (clamps) and a console used for delivering radiofrequency energy. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the AtriCure Ablation System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AtriCure Ablation System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (Isolator® Transpolar Clamps or Isolator Synergy™ Clamps) intended for the ablation of soft tissues and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU2) or an Isolator Switch Matrix (ASB3) console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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
Ka63630.
ATTACHMENT 7 510(k) SUMMARY
510(k) Summary
General Information
| Classification | Class II | |
|---|---|---|
| Trade Name | AtriCure Ablation System | JAN 26 2007 |
| Manufacturer | AtriCure, Inc. | |
| 6033 Schumacher Park Drive | ||
| West Chester, OH 45069 | ||
| Contact | Elsa Abruzzo | |
| Vice President, Clinical and Regulatory Affairs |
Intended Use
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.
Predicate Devices
The predicate devices for the AtriCure Ablation System are the AtriCure Bipolar System (K020919), the AtriCure Transpolar™ System (K052893), and the Medtronic Cardioablate Surgical Ablation System (K060400)
Device Description
The AtriCure Ablation System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (Isolator® Transpolar Clamps or Isolator Synergy™ Clamps) intended for the ablation of soft tissues and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU2) or an Isolator Switch Matrix (ASB3) console.
Materials
All materials in the AtriCure Ablation 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.
Summary of Substantial Equivalence
The AtriCure Ablation System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regulatory Technology Services, LLC % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K063630
Trade/Device Name: Atricure Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2006 Received: December 6, 2006
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Mark Job
This letter will allow you to begin 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) 276-0115 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): __
1061630
Device Name: AtriCure Ablation System
Indications For Use:
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph. Rood
ision Sign-Off) "sion of General, Restorative and Neurological Devices
Number K063630
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