(72 days)
Not Found
Not Found
No
The description focuses on the physical function of a grounding pad for electrosurgery and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device's sole purpose is to safely return electrosurgical current to the generator, preventing burns during surgery; it does not treat or cure a disease or condition.
No
The device is described as a grounding pad or dispersive electrode used during surgery to conduct radio frequency current and reduce the risk of burns. Its function is to facilitate a surgical procedure, not to diagnose a condition.
No
The device is described as a "grounding pad" or "dispersive electrode," which is a physical component applied to the patient's skin. The description focuses on its function in conducting electrical current and its physical properties (large area, use with gel), indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the device is a "grounding pad" or "dispersive electrode" applied to the patient's skin during surgery to manage electrical current flow and prevent burns.
- No Specimen Examination: There is no mention of examining any specimens (blood, tissue, etc.) from the patient.
- Direct Patient Contact: The device is applied directly to the patient's skin, which is a characteristic of devices used in vivo (within the living body), not in vitro (in glass/outside the body).
The device described is an accessory used in electrosurgery, which is a surgical procedure performed on the patient.
N/A
Intended Use / Indications for Use
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient's skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient.
This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen.
The electrosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient.
The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or an abstract human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. Roger Strube E & M Engineering, Inc. 1705 Dabney Road Richmond, Virginia 23230
K984276 Re: Trade Name: Disposable Electrosurgery Grounding Pad Regulatory Class: II Product Code: GEI Dated: November 24, 1998 Received: November 30, 1998
Dear Mr. Strube:
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.
1
Page 2 - Mr. Roger Strube
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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 2 of 2
510 ( k ) NUMBER (IF KNOWN) : _ _ K984276
DISPOSABLE ELECTROSURGERY GROUNDING PAD DEVICE NAME :
INDICATIONS FOR USE:
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient's skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient.
This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen.
The electrosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient.
The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.
Roger Strube
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(per 21 CFR 801.109) | X | or | Over - the - Counter- Use
(Optional Format 1-2-96) |
| ------------------------------------------ | --- | ---- | ------------------------------------------------------- |
|---|
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984276 |
|---|---|
| --------------- | --------- |