(38 days)
No
The summary describes a passive electrode with no mention of computational processing, image analysis, or AI/ML terms.
No
The device is described as a "return path for electrical current to generator" and a "dispersive electrode," commonly known as a neutral electrode. It does not actively treat a condition but rather facilitates the function of electrosurgical generators.
No
Explanation: The device description states it is a "return electrode" or "patient plate" for electrosurgical generators, providing a "return path for electrical current." Its stated purpose is not to diagnose medical conditions but to facilitate the operation of other electrosurgical equipment.
No
The device description clearly states it is a "disposable, single use device" and a "split, dual conductive plate design," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR." This describes a device used during a surgical procedure on a patient, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description further clarifies it's a "disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode." These terms are all associated with electrosurgical procedures performed on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis in vitro.
Therefore, this device is a surgical accessory used in conjunction with an electrosurgical generator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.
Product codes
GEI
Device Description
DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
FEB 2 7 1998
APPENDIX V
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The DermaSense PLUS Dispersive Electrode has the same intended use as the currently marketed predicate devices. The Dispersive Electrode has technological characteristics that are substantially equivalent to the predicate devices. The device design, device materials, nominal specifications and performance standards are either identical or substantially equivalent. The Dispersive Electrode has the same mode of operation as the predicate devices.
COMPANY AND CONTACT PERSON
Horizon Medical, Inc. 1719 South Grand Avenue Santa Ana, CA 92705
Philip L. Ritger Technical Director (714) 259-5200
DEVICE NAME
DermaSense™ PLUS Dispersive Electrode
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
-
- Vallevlab. Inc. REM® PolvHesive® II Patient Return Electrode
-
- ConMed Corporation ThermoGard™ PLUS ABC® Dual Dispersive Electrode
DESCRIPTION OF DEVICE
DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.
STATEMENT OF INTENDED USE
DermaSense PLUS Dispersive Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator. No electrosurgical effect, e.g., cutting and removal of tissue or coagulation, is intended at this electrode.
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STATEMENT OF INTENDED USE OF PREDICATE/MARKETEDDEVICES
-
- The Valleylab REM PolyHesive II Patient Return Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator..
-
- The ConMed ThermoGard PLUS ABC Dual Dispersive Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator ..
STATEMENT OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
For the Horizon and predicate devices, the dispersive electrodes are single use, non-sterile devices for use in monopolar electrosurgical applications. The electrodes are split, dual plate designs which are Return Monitor compatible. All of the devices are comprised of an electrode body and cable assembly.
All of the electrodes are comprised of an acrylic adhesive coated thermoplastic film or closed cell polvethylene foam border with a hydrogel conductive adhesive layer covering an aluminum metallized or laminated plastic film on a closed cell polyethylene foam backing.
The Horizon and predicate devices meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Mr. Philip L. Ritger Technical Director Horizon Medical, Inc. 1719 South Grand Avenue Santa Ana, California 92705-4808
Re: K980171 DermaSense Plus Dispersive Electrode Trade Name: Requlatory Class: II Product Code: GEI Dated: January 15, 1998 Received: January 20, 1998
Dear Mr. Ritger:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (QS) 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. Ritger
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 requlation (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,
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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Paqe 1 01 1
510(k) Number (if known): K980171
Oevice Name: DERMASENSE PLUS DISPERSIVE ELECTRODE
Indications For Use:
A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.
(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 General Restorative Devices | |
| 510(k) Number | K980171 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |