(79 days)
Not Found
No
The description focuses on standard electrosurgical and suction functionalities, with no mention of AI or ML.
Yes
The device is used to provide "coagulation therapeutic energy to tissue" and to achieve a "therapeutic affect" by passing high-frequency current through the tissue.
No
The device is described as an electrosurgical accessory used to provide coagulation therapeutic energy and suction. Its function is therapeutic (to coagulate tissue and aspirate), not to diagnose a condition.
No
The device description clearly outlines a physical medical device with hardware components (cable, handpiece, cannula tube, switching elements, non-stick coating) used for electrosurgical coagulation and suction. It connects to an electrosurgical generator unit, which is also a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a surgical tool used directly on tissue during a surgical procedure. It provides therapeutic energy (coagulation) and removes material (suction) from the surgical site. It does not analyze specimens in vitro (outside the body).
The description clearly indicates its use in "general surgical procedures" to "provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site." This is a direct surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
Product codes
GEI
Device Description
This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.
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
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Summary of Performance Studies
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Key Metrics
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.
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OCT 2 1 2005 Traditional 510(k) CONMED UltraClean™ Suction Coaguiator
52104
Summary of Safety and Effectiveness
| Submitted by: | CONMED Electrosurgery Division
14603 East Fremont Avenue
Centennial, CO 80112 USA
Telephone: 303-699-7600
Facsimile: 303-699-9854 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | August 1, 2005 |
| Proprietary Name: | UltraClean™ Hand Controlled Suction Coagulator and Foot Controlled
Suction Coagulator or other trade names as established |
| Common Name: | Suction Coagulator |
| Classification Name: | Electrode, Flexible Suction Coagulator
(21 CFR 878.4400)
79 GEI |
| Predicate Device: | Suction Coagulator
510(k) # K033003 |
Device Description: This suction coagulator has applications in general surgical procedures to provide a means of coagulation using electrosurgical current and also provide a means of suction using the vent on the handle. Suction and coagulation can be performed independently or simultaneously. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to the distal end of the handpiece. gonerater and as either a hand-switching or foot-switching conduit in delivering the HF energy from the electrosurgical generator unit through the cannula tube to produce the therapeutic affect. Current is activated by the coagulation switching element buttons on the handpiece or by using the footswitch. The devices contain a non-stick (UltraClean™) coating on the cannula tip. The devices will be distributed sterile and non-sterile for single-use applications.
Intended Use of Device: Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
Technological Characteristics: The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2, Sterilization of health care products - Requirements for validation and routine control -Radiation Sterilization, ISO 11137, Medical Devices Risk Management, ISO 14971 and Biocompatibility, ISO 10993.
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