(30 days)
Not Found
No
The description details a passive electrosurgical grounding pad and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is an electrosurgical grounding pad used with electrosurgical generators for cutting and coagulation, not for directly treating a disease or condition.
No
Explanation: The device description states it is an "electrosurgical grounding pad...indicated for use with electrosurgical generators for cutting and coagulation." This describes a therapeutic, not a diagnostic, function. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it is a "flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with electrosurgical generators for cutting and coagulation." This describes a device used during a surgical procedure on a patient to manage electrical current.
- Device Description: The description details a "flexible, conductive adhesive electrosurgical grounding pad." This is a physical device applied to the patient's skin.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical accessory used on the body during a procedure.
N/A
Intended Use / Indications for Use
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
Product codes
HAM, GEI
Device Description
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
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
Biocompatibility testing consistent with the ISO 10993-1, recommended material evaluations for acute (less than 24-hour) intact skin contacting devices. The materials passed all screens.
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
510(k) Summary
SUBMITTED ON BEHALF OF:
| Company Name: | Nikomed U.S.A., Inc. |
|---|---|
| Address: | 206 Airport Blvd. |
| Doylestown, PA 18901 | |
| Telephone: | 215-230-8455 |
| Fax: | 215-230-8446 |
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical®, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
CONTACT PERSON:
Telephone: Fax:
Elaine Duncan
DATE PREPARED:
October 1, 1999
Nikopad* Electrosurgical Grounding Pad (*or sold under TRADE NAME: various commercial names) COMMON NAME: Electrosurgical Grounding Pad
SUBSTANTIALLY EQUIVALENT TO:
K853291: GP-100 Adult Electrosurgical Ground Pad
DESCRIPTION of the DEVICE:
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
INDICATIONS FOR USE:
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
SUMMARY of TESTING:
Biocompatibility testing consistent with the ISO 10993-1, recommended material evaluations for acute (less than 24-hour) intact skin contacting devices. The materials passed all screens.
Nikomed U.S.A., Inc.
1
Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 3 1999
Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082-0560
Re: K993306 Trade Name: Nikomed Electrosurgical Grounding Pad Regulatory Class: II Product Code: HAM, GEI Dated: October 1, 1999 Received: October 4, 1999
Dear Ms. Duncan:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
2
Page 2 -- Ms. Elaine Duncan, M.S.M.E., RAC
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 Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K993306 510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Device Name: Nikomed Electrosurgical Grounding Pad
Indications for Use:
The Nikomed USA electrosurgical grounding pad (sold under various commercial names I he Ankomed CBA electronical is indicated for use with electrosurgical generators for cutting and coagulation.
(Please Do Not Write Below This Line-Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over -The-Counter Use ___________ |
|---|---|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K993306 |
|---|---|
| --------------- | --------- |
(