(13 days)
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.
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.
This document is a 510(k) Premarket Notification for a medical device called the Trabectome™ High Frequency Generator/LP. It is not a study that proves the device meets acceptance criteria derived from performance metrics. Instead, it is documentation submitted to the FDA to demonstrate substantial equivalence to a predicate device already on the market.
Therefore, most of the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document establishes substantial equivalence to a predicate device, not performance against specific acceptance criteria. The primary "performance" characteristic discussed is the maximum power output, which is compared to the predicate device.
| Performance Characteristic | Predicate Device (Aaron Medical Model 800) | Trabectome™ High Frequency Generator/LP | Acceptance Criteria |
|---|---|---|---|
| Maximum Power Output | 30 watts | 6 watts | Not explicitly stated as an "acceptance criterion" in a performance study context. The lower power output of the Trabectome™ is noted as a difference from the predicate but doesn't appear to be a failure of an acceptance criterion for substantial equivalence, as it's intended for "low power microsurgical applications." |
| Operating Frequency | ~ 500 kHz | ~ 500 kHz | Match/Equivalence to predicate device. |
| Modes of Operation | Monopolar or Bipolar | Monopolar or Bipolar | Match/Equivalence to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or performance study is described. The submission is based on comparison to a predicate device and engineering documentation, not clinical or performance data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth determination by experts is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set performance or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is an electrosurgical generator, not an AI or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an electrosurgical generator, not an algorithm. Standalone performance as described is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth determination is mentioned in this substantial equivalence submission.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is mentioned.
Summary of the Document's Purpose:
The provided document is a 510(k) Premarket Notification for the NeoMedix Corporation Trabectome™ High Frequency Generator/LP. Its core purpose is to demonstrate substantial equivalence to a previously cleared predicate device, the Aaron Medical Model 800 High Frequency Desiccator (K955681). The key arguments for equivalence are:
- Similar Indications for Use: Both are for electrosurgical applications.
- Similar Technology: Both operate in monopolar or bipolar mode at ~500 kHz.
- Design and Construction: Described as substantially equivalent.
- Difference Noted: The Trabectome™ has a lower maximum power output (6 watts) compared to the predicate device (30 watts), which is considered acceptable as it's intended for "low power microsurgical applications."
The FDA's letter confirms that based on the provided information, the device is considered substantially equivalent to a legally marketed predicate device. This is a regulatory clearance process, not a clinical study proving performance against specific acceptance criteria.
§ 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.