NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)

K993306 · Paladin Medical, Inc. · HAM · Nov 3, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993306
• Device Name: NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
• Applicant: Paladin Medical, Inc.
• Product Code: HAM · General, Plastic Surgery
• Decision Date: Nov 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive pad used as a return electrode during electrosurgical procedures. It features a 143 sq cm conductive area and 242 sq cm adhesive area, integrated with a 3-meter cable and standard US 2-female connector. The device is applied to the patient's skin to provide a safe return path for high-frequency electrical current generated by electrosurgical units during cutting and coagulation. It is intended for clinical use in surgical settings. The device functions as a passive electrical component; it does not involve active processing, software, or algorithms.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed in accordance with ISO 10993-1 for acute (less than 24-hour) intact skin contacting devices. All materials passed the required screens.

Technological Characteristics

Flexible, conductive adhesive grounding pad. Conductive area: 143 sq cm; adhesive area: 242 sq cm. Includes 3-meter cable with 2-female connector. Passive electrical device. Biocompatibility compliant with ISO 10993-1.

Indications for Use

Indicated for use with electrosurgical generators for cutting and coagulation in patients requiring electrosurgery.

Regulatory Classification

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.

Predicate Devices

• GP-100 Adult Electrosurgical Ground Pad (K853291)

Submission Summary (Full Text)

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# 510(k) Summary

## SUBMITTED ON BEHALF OF:

| Company Name: | Nikomed U.S.A., Inc. |
|---------------|-------------------------------------------|
| Address: | 206 Airport Blvd.<br>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.

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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.

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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ | OR | Over -The-Counter Use ___________ |
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| | | | (Optional Format 1-2-96) |

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(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K993306 |
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