(94 days)
Not Found
Not Found
No
The provided text describes a surgical electrode device and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML medical devices.
Yes
The device is described as being used for "resection/coagulation of the soft tissue," which are therapeutic actions to treat or modify a physiological function.
No
The device is described as an electrode for the resection/coagulation of soft tissue, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device is described as an "Omnitech Fulgurating Electrode Device" and is indicated for "resection/coagulation of the soft tissue." This description strongly suggests a physical electrode, which is a hardware component, used for surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, the Omnitech Fulgurating Electrode Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "resection/coagulation of the soft tissue" during surgical procedures (specifically with cystoscopes and ureteroscopes in the urological field). This is a direct surgical intervention on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
The Omnitech Fulgurating Electrode Device is a surgical tool used within the body for treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.
Product codes
FAS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, Urological field
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national bird. The bird is depicted in a stylized manner with flowing lines, giving it a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Mr. Jon D. Barrett General Manager Omnitech Systems, Inc. 456 S. Campbell (Building C) VALPARAISO IN 46385
Re: K050454
Trade/Device Name: Omnitech Fulgurating Electrode Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: April 22, 2005 Received: May 2, 2005
Dear Mr. Barrett:
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 (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 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 nanufacturing 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.
1
This letter will allow you to begin marketing your device as described in your Scelion 5 I 0(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA Inding of saosantial vice 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 If you desire specific advice for your device of our labering organisation.
contact the Office of Compliance at one of the following numbers, based on the regulation number a the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Whisonalians of your responsibilities under the Act from the 180 807.97). You may obtain other general mixthance at its toll-free number (800)
Division of Small Manufacturers, International and Consumers of Acresperain http:// Division of Small Manufacturers, International and Contraction of the South Asmaman. http://www.fdsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE:
K050454 510(k) Number (if Known): _
Omnitech Fulgurating Electrode
Indications For Use:
Device Name:
The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.
(Please do not write below this line, continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off:
Division of Reproductive, Abdominal, ENT, and Radiological Devices.
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Prescription Use V Per 21 CFR 801.109
Or
Over The Counter Use Optional Format (1-2-96)
David R. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices (050454 510(k) Number_
Page 5.