(13 days)
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No
The description focuses on the electrosurgical generator's function and modes, with no mention of AI or ML terms or capabilities.
Yes
The device is used for "removal, destruction and coagulation of tissue," which are direct interventions aimed at treating a medical condition or disease, fitting the definition of a therapeutic device.
No
The device description explicitly states its function is for "removal, destruction and coagulation of tissue," which are treatment/surgical applications, not diagnostic ones.
No
The device description clearly states it is a "non-sterile, reusable electrosurgical generator" and describes hardware components like voltage models, input jacks, and activation mechanisms.
Based on the provided information, the Trabectome™ High Frequency Generator/LP is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "removal, destruction and coagulation of tissue" using electrosurgical instruments. This is a surgical procedure performed on a living patient, 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 an electrosurgical generator that produces high-frequency current for surgical applications. This aligns with surgical equipment, not diagnostic equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Trabectome™ High Frequency Generator/LP is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.
Product codes
GEI
Device Description
The Trabectome™ High Frequency Generator/LP is a non-sterile, reusable electrosurgical generator. The device is designed to generate high frequency (radiofrequency "RF") high voltage and low amperage current. The device operates in either the monopolar or the bipolar mode. The device is available in two voltage models: 110 VAC or 220 VAC (for international use). The generator is activated through an input jack on the front panel. The activation can be via a footswitch or other single pole closure device with a compatible plug.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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
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NeoMedix Corporation 510(k) Premarket Notification April 12, 2006
Page 1 of 2
510 (k) SUMMARY
K 061258
Applicant
NeoMedix Corporation 15042 Parkway Loop, Ste. A Tustin, CA 92780
Contact Person
Thomas Schroeder VP, RAIQA Phone (714) 290-5720 FAX: (949) 646-8177 e-mail: tschroeder@neomedix.net
Common, Classification and Proprietary Names
| Common Names: | Electrosurgical Generator |
|---|---|
| Classification Name: | Electrosurgical cutting and coagulation device, 21 CFR |
| 878.4400, Product Code GEI. | |
| Proprietary name: | Trabectome™ High Frequency Generator/LP |
Predicate Device
The NeoMedix Corporation Trabectome™ High Frequency Generator/LP is substantially equivalent in design, construction and features to the Aaron Medical Model 800 High Frequency Desiccator cleared under K955681. Both devices operate in either the monopolar or bipolar mode at an operating frequency of ~ 500 kHz. There are no technological differences between the two devices other than the maximum power output. The Aaron 800 generator has a maximum power output of 30 watts while the Trabectome™ High Frequency Generator/LP has a maximum power output of 6 watts.
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