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.

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.

AI/ML Overview

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.

Summary

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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 CFR878.4400, 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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<061258

NeoMedix Corporation 510(k) Premarket Notification April 12, 2006

Indications for Use

Page 2 of (2)

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.

Device Description

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 2006

NeoMedix Corporation c/o Ms. Michelle S. Lee Underwriters Laboratories Inc. 2600 NW Lake Road Camas, Washington 98607

Re: K061258

Trade/Device Name: Trabectome™ High Frequency Generator/LP Regulation Name: Electrosurgical cutting and coagulation device Regulatory Class: II Product Code: GEI Dated: May 1, 2006 Received: May 5, 2006

Dear Ms. Lee:

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 - Ms. Michelle S. Lee

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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hulbert Leiner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NeoMedix Corporation 510(k) Premarket Notification April 12, 2006

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __

K061258

Trabectome™ High Frequency Generator/LP Device Name:

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.

Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hake Steiner as

(Division Sign-Off Division of General, Restorative. and Neurological Devices

510(k) Number K061258

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Regulation Number and Section

§ 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.