(25 days)
The Geiger Disposable Electrosurgical Electrode is intended to be utilized for basic non-sterile electrosurgical procedures. Examples of non-sterile procedures include the removal of moles, warts and skin tags. The electrodes are a standard 3/32" in diameter and will fit the majority of electrosurgical generators and handpieces in the marketplace.
Utilized for basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation.
The Geiger Disposable Electrosurgical Electrode is a non-sterile, disposable, electrosurgical electrode, designed to be used to deliver electrosurgical current generated by an electrosurgical generator.
The provided text describes a 510(k) premarket notification for the "Geiger Disposable Electrosurgical Electrode." This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated study. As such, the document does not contain the detailed information typically found in a study designed to establish device performance metrics and acceptance criteria.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.
However, I can extract the relevant information from the document regarding the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria and reported device performance values in the way a clinical or technical performance study would. Instead, the "acceptance criteria" for a 510(k) submission is met by demonstrating substantial equivalence to a predicate device.
The reported "performance" in this context is the assertion that the device is substantially equivalent to the predicate.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Assertion from Submission) |
|---|---|
| Substantial equivalence to predicate device in: | The Geiger Disposable Electrosurgical Electrode is substantially equivalent to the E & M Engineering Blade Electrode (K945531) in design, operation, intended use, materials, method of preparation, and performance claims. |
| - Design | Equivalent |
| - Operation | Equivalent |
| - Intended Use | Equivalent |
| - Materials | Equivalent (Stainless steel electrode, Polystyrene insulation) |
| - Method of Preparation | Equivalent (Manufactured by Modern Medical Equipment Mfg., Ltd. in Hong Kong to Geiger's specifications) |
| - Performance Claims | Equivalent (Utilizes radio frequency current for cutting and coagulation of tissue) |
| - Safety and Effectiveness | Considered a safe and effective product based on provided information and equivalence to predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on demonstrating similarity to a predicate device, not on testing a sample set against specific performance metrics.
- Data Provenance: Not applicable. No new performance data from a test set is provided. The submission references engineering specifications and material information (chemical makeup of stainless steel and polystyrene insulation), but these are not "test set" data in the context of a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "ground truth" for a test set was established as part of this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was performed.
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 electrode and does not involve AI or human "readers" in the context of medical imaging or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical electrosurgical electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission focuses on substantial equivalence to an existing legally marketed predicate device (E & M Engineering Blade Electrode, K945531). The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. As this is not an AI/algorithm-driven device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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DEC 27 1999
Image /page/0/Picture/2 description: The image shows the logo for "GEIGER medical technologies". The word "GEIGER" is in large, bold, sans-serif font. Below it, "medical technologies" is in a smaller, sans-serif font, set against a black background.
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: COMMON NAME: CLASSIFICATION NAME: (878.4400)
Geiger Disposable Electrosurgical Electrode Electrosurgical Electrode Device, Electrosurgical, Cutting & Coagulation & Accessories,
The Geiger Disposable Electrosurgical Electrode is a non-sterile, disposable, electrosurgical electrode, designed to be used to deliver electrosurgical current generated by an electrosurgical generator.
The Geiger Disposable Electrosurgical Electrode is substantially equivalent to the E & M Engineering Blade Electrode, cleared under 510(k) K945531. The Geiger Disposable Electrosurgical Electrode is substantially equivalent to the listed device in design, operation, intended use, materials, method of preparation, and performance claims.
In conclusion, the Geiger Disposable Electrosurgical Electrode is substantially equivalent to the predicate device 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 November 30, 1999 Date:
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K994075
Page of 27
2022
PRODUCT DESCRIPTION:
The Geiger Disposable Electrosurgical Electrode is a non-sterile, disposable, electrosurgical electrode designed to be used in conjunction with a standard electrosurgical generator and handpiece.
INTENDED USE:
The Geiger Disposable Electrosurgical Electrode is intended to be utilized for basic non-sterile electrosurgical procedures. Examples of non-sterile procedures include the removal of moles, warts and skin tags. The electrodes are a standard 3/32" in diameter and will fit the majority of electrosurgical generators and handpieces in the marketplace.
METHOD OF OPERATION:
Electrosurgical generators produce a radio frequency current, which is delivered to the patient via an electrosurgical generator, handpiece and electrode. The radio frequency current produces a physiologic effect allowing the physician to cut and coagulate tissue. The type of electrode used is a function of the procedure being performed and the personal preference of the physician.
ENGINERING SPECIFICATIONS:
The Geiger Disposable Electrosurgical Electrodes are manufactured by Modern Medical Equipment Mfg., Ltd. in Hong Kong to Geiger's specifications. An engineering drawing providing specifications is provided in Appendix A-1.
BIOCOMPATIBILITY:
During an electrosurgical procedure, the Polystyrene insulation material will not normally come in contact with the patient (momentary patient contact is made only by approximately 1/16" of the tip of the electrosurgical electrode delivering the electrosurgical current). Information regarding the chemical makeup of the stainless steel electrode and Polystyrene insulation is contained in Appendix A-2
Based on the information supplied, Geiger Medical Technologies, Inc. considers the Geiger Disposable Electrosurgical Electrode to be a safe and effective product.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three stripes representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 1999
Mr. John Bottjer President Geiger Medical Technologies 24040 Camino Del Avion, Suite A-195 Monarch Beach, California 92629
K994075 Re: Trade Name: Disposable Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: November 30, 1999 Received: December 2, 1999
Dear Mr. Bottjer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 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 device 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 device as described in your 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 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 device, 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.
Hennell J. Osgood
James E. Dillard III Acting 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) : K994075
DEVICE NAME : -Geiger-Disposable_Electrosurgical Electrode INDICATIONS FOR USE :
Utilized for basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter - Use (Optional Format 1-2-96)
Thos. H. Taylor for 57/
(Division Sign-Off) Devices of General Restorative Devices 5 IO(k) Number _______________________________________________________________________________________________________________________________________________________________
§ 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.