(25 days)
Not Found
No
The summary describes a basic electrosurgical electrode and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as an electrosurgical electrode used to deliver current for procedures like cutting and coagulation, which are therapeutic interventions. However, the device itself is an accessory that delivers the therapeutic current, not a device that performs a therapeutic function independently. It's a tool used in a therapeutic procedure, rather than being the therapeutic device itself.
No
The device description states its use for "basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation," and delivering "electrosurgical current." These are therapeutic or procedural functions, not diagnostic ones which involve identifying or characterizing a condition.
No
The device description clearly states it is a "disposable, electrosurgical electrode," which is a physical hardware component used to deliver electrical current.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation." These are surgical procedures performed directly on a patient's tissue, not tests performed on samples taken from the body (which is the definition of in vitro diagnostics).
- Device Description: The device is described as an "electrosurgical electrode" used to "deliver electrosurgical current." This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Geiger Disposable Electrosurgical Electrode is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Utilized for basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation.
Product codes
GEI
Device Description
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 a non-sterile, disposable, electrosurgical electrode designed to be used in conjunction with a standard electrosurgical generator and handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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.
1087 Page 27 of 27
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.
2
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.
3
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
4
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 _______________________________________________________________________________________________________________________________________________________________