(11 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the RF ablation technology and its components.
No
The device uses ablation to cut or remove soft tissues during surgical procedures, which is a surgical tool function, not a therapeutic treatment for disease.
No
Explanation: The device is intended for ablation (removal) of soft tissues during surgical procedures, not for identifying the presence or nature of a disease or condition.
No
The device description explicitly states that the system includes a hand-held, single-use, bipolar radiofrequency (RF) surgical instrument (hardware) and an accessory guide (hardware). It also mentions an integral cable connecting to a re-usable Ablation and Sensing Unit (ASU), which is also hardware. Therefore, it is not a software-only medical device.
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 i General, ENT, Thoracic, Gynecology, and Urology surgical procedures." This describes a surgical tool used during a procedure on a patient, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description details a surgical instrument (clamp) and related components used for ablation, which is a surgical technique.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The AtriCure Transpolar System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Product codes
GEI
Device Description
The AtriCure Transpolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (AtriCure Transpolar Clamp) intended for the ablation of soft tissues (for use by trained surgeons only) innonou for the and the and guide (Glidepath™ Tape). The Transpolar and an accessory of an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained surgeons only
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 Approphate product and substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
131 2 5 2005
K 052893
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | AtriCure Transpolar™ 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 Transpolar System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Predicate Devices
The predicate device for the AtriCure Transpolar System is the AtriCure Bipolar System (K020919).
Device Description
The AtriCure Transpolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (AtriCure Transpolar Clamp) intended for the ablation of soft tissues (for use by trained surgeons only) innonou for the and the and guide (Glidepath™ Tape). The Transpolar and an accessory of an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU).
Materials
all materials used in the manufacture of the AtriCure Transpolar Clamp and / Ill matchale are suitable for this use and have been use and have been used Ondepath Tapo inously cleared products. Testing was conducted in in numbrous provise in to ensure appropriate biocompatibility of all materials.
Testing
Appropriate product testing was conducted to evaluate conformance to Approphate product and substantial equivalence to predicate devices.
Summary of Substantial Equivalence
The Atricure Transpolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures connected at the shoulders, with flowing lines representing movement or connection.
Public Health Service
OCT 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AtriCure, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K052893
Trade/Device Name: Atricure Transpolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 11, 2005 Received: October 14, 2005
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.