BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 by GEIGER MEDICAL TECHNOLOGIES, INC.

The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.

Utilized for basic electrosurgical procedures such as cutting, Utilized for basic electrosurgicul problement of desiccation.
blended cutting, coagulation, fulguration, or desiccation.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for the "Blue Value Line of Electrosurgical Electrodes." This type of document is for medical device clearance, not for AI/ML-based medical devices, so many of the requested details about acceptance criteria, study design, and ground truth for AI models are not applicable.

However, I can extract the information that is present concerning the device's performance justification.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Compliance with ANSI/AAMI HF-18-1993, Sec. 5.2.5.4 requirements	The Blue Value Line of Electrosurgical Electrodes meets ANSI/AAMI HF-18-1993, Sec. 5.2.5.4 requirements.
Substantial Equivalence to Predicate Devices	The Blue Value Line of Electrosurgical Electrodes is substantially equivalent to listed predicate devices in design, operation, intended use, materials, method of preparation, and performance claims.

Study Details (as relevant to a traditional medical device 510(k)):

Sample size used for the test set and the data provenance: Not applicable. This is a traditional device clearance based on substantial equivalence and compliance with a standard, not a data-driven AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device is its physical performance characteristics and adherence to a recognized standard.
Adjudication method for the test set: Not applicable.
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 is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For compliance with the ANSI/AAMI standard, the "ground truth" would be the results of objective engineering and performance tests as defined by the standard. For substantial equivalence, the "ground truth" is the established performance and safety of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of the Device's Claimed Performance Basis:

The "Blue Value Line of Electrosurgical Electrodes" meets its acceptance criteria by demonstrating conformance to a specific industry standard (ANSI/AAMI HF-18-1993, Sec. 5.2.5.4) and by proving substantial equivalence to several previously cleared predicate electrosurgical electrodes. The supporting "study" is the testing performed to demonstrate compliance with this standard and the comparison of the device's characteristics to those of the predicate devices. This is a standard approach for 510(k) clearance of non-AI medical devices.

Summary

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510(k) SAFETY AND EFFECTIVENESS SUMMARY

Blue Value Line of Electrosurgical Electrodes TRADE NAME: COMMON NAME: Electrosurgical Electrodes Electrosurgical Cutting and Coagulation Devices (878.4400) CLASSIFICATION NAME:

The Blue Value Line of Electrosurgical Electrodes is substantially equivalent to those electrodes previously FDA-cleared for Geiger ( K955681 - since sold by Geiger to another manufacturer), to electrodes sold by Geiger under the Electricator product line (preamendment device), to a blade electrode FDA-cleared under K861495, and to a loop electrode FDA-cleared under K944265. The electrodes are also substantially equivalent to electrodes FDA-cleared under K800617. The Blue Value Line of Electrodes is substantially equivalent to the listed FDA-cleared devices in design, operation, intended use, materials, method of preparation, and performance claims.

Furthermore, testing performed on the Blue Value Line of Electrosurgical Electrodes indicates that the devices meet ANSI/AAMI HF-18-1993, Sec. 5.2.5.4 requirements.

In conclusion, the Blue Value Line of Electrosurgical Electrodes is substantially equivalent to the predicate devices in methods of operation, intended use, and results derived from operation.

Submitted By: John Bottjer President Geiger Medical Technologies, Inc. 24040 Camino del Avion, A-195 Monarch Beach, CA 92629 (949) 240-7584

Contact Person: John Bottjer October 28, 1998 Date:

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Mr. John Bottjer President Geiger Medical Technologies, Inc. 24040 Camino Del Avion, Suite A-195 Monarch Beach, California 92629

Re: K983852

Trade Name: Blue Value Line of Electrosurgical Electrodes Regulatory Class: II Product Code: GEI Dated: October 28, 1998 Received: October 30, 1998

Dear Mr. Bottjer:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. John Bottjer

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K983852 DEVICE NAME: _ Blue Value Line of Electrosurgical Electrodes INDICATIONS FOR USE:

Utilized for basic electrosurgical procedures such as cutting, Utilized for basic electrosurgicul problement of desiccation.
blended cutting, coagulation, fulguration, or desiccation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Pcolle

(Division Bign-Off)
Division of General Restorative Devices
510(k) Number K983852.

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.