Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).

Device Description

Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Skintact® Neutral Electrodes for Neonates consist of a backing material, conductive layer and conductive adhesive gel. The Neutral Electrodes for Neonates are applied on a release liner. The only change in construction materials is a slight modification of the conductive hydrogel. This modification was carried out to adapt the gel to the skin of neonates. Skintact® Neutral Electrodes for Neonates are accessories to surgery devices.

Skintact® Neutral Electrodes for Neonates are passive devices and do not contain active electronics, software or firmware Skintact® Neutral Electrodes for Neonates are packaged in water-vapour-proofed, heat-sealed, non-transparent, aluminized pouches.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Skintact® Neutral Electrodes for Neonates, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance (per EN60601-2-2:2009)
NE Thermal Performance	(Implied: Meet thermal performance requirements)	"Results are within limits," including comparative testing against predicate product.
NE Contact Impedance	(Implied: Meet contact impedance requirements)	"Results are within limits."
NE Adhesion	(Implied: Meet adhesion requirements)	"Results are within limits."
Material Properties (durability)	Release test after 43 days at +23°C	"Results are within limits."
Material Properties (shelf-life)	Accelerated aging test after 43 days at +75°C	"Results are within limits."
Biocompatibility	No new risks or adverse reactions from direct skin contact	"Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks."
Substantial Equivalence	Same indications for use as predicate devices, with expanded target population (neonates). Physical and technical characteristics similar to predicate devices.	Device has the same indications for use as K030362 and K063161, expanded with neonates (like K994428). Technical characteristics are listed as "single patient use, disposable, self-adhesive, non-sterile, sealed foil pouch, backing material, conductive layer, conductive adhesive hydrogel, cover material."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted according standard EN60601-2-2:2009" and "Biocompatibility testing has been performed."

3. Number of Experts Used and Qualifications

Not applicable. This device is a passive, non-diagnostic accessory (neutral electrodes) and its performance evaluation does not involve expert interpretation or ground truth establishment in the manner of an AI diagnostic device. The evaluation is based on objective physical, electrical, and biological safety standards.

4. Adjudication Method

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers or comparative effectiveness in that context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a passive medical device, not an algorithm or software. Its performance is inherent to its physical properties and material composition.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by adhering to recognized international standards and specifications for medical electrodes:

Engineering Standards: EN60601-2-2:2009 for thermal performance, contact impedance, and adhesion.
Material Science Standards: Tests for material durability (release and shelf-life) and biocompatibility.

These standards define the acceptable range of physical, electrical, and biological properties for safe and effective use.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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510(K) SUMMARY

JUL 2 9 2014

This 510(k) summary has been prepared in accordance with the requirements of 21CFR 807.92:

Submitted on behalf of:

Company Name:Address:	Leonhard Lang GmbHArchenweg 566020 InnsbruckAustria
Telephone:Fax:	+43 512 334257+43 512 392210
Contact Person:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
Date prepared:	July 25, 2014
Device Identification:
TRADE NAME:	Skintact® Neutral Electrodes for Neonates(and also to be offered for sale under various private labeltradenames)
COMMON NAME:	Neutral Electrodes
CLASSIFICATION NAME:	Electrosurgical cutting and coagulation device andaccessories
PRO CODE:	GEI
Regulation No.:	21CFR 878.4400
Classification:	Class II
SUBSTANTIALLY EQUIVALENT TO:
K063161	Leonhard Lang Skintact® Cool Contact ElectrosurgicalGrounding Plates, Leonhard Lang GmbH with NH04 Gel,decision date: 11/21/2006
K030362	Leonhard Lang Skintact® Cool Contact ElectrosurgicalGrounding Plates, Leonhard Lang GmbH, decision date:04/14/2003
K994428	E7512 Premie REM PolyHesive II Patient Return Electrode

INDICATIONS FOR USE:

Valleylab Inc., decision date: 03/07/2000

Traditional 510(k): Skintact® Neutral Electrodes for Neonates

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510(k) Summary-Continued

DESCRIPTION of the DEVICE:

Skintact® Neutral Electrodes for Neonates are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

SUMMARY of TESTING:

Performance and Standards:

Performance testing was conducted according standard EN60601-2-2:2009 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009), relevant clauses.

EN60601-2-2:2009, 201.15.101.5 - NE thermal performance- including comparative thermal performance testing against predicate product.

EN60601-2-2:2009, 201.15.101.6 - NE contact impedance

EN60601-2-2:2009, 201.15.101.7 - NE adhesion

Release test with electrodes aged at +23°C for 43 days and Shelf life test with accelerated aged electrodes at increased temperature of +75°C for 43 days.

According EN60601-2-2:2009, 201.15.101.8. Results are within limits.

Biocompatibility and Sterility:

Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.Skintact® Neutral Electrodes for Neonates are NON-STERILE so there was no sterility testing required.

Substantial Equivalence Summary [21CFR 807.92(a) (6)]

Skintact® Neutral Electrodes for Neonates have the same indications for use as Skintact® Cool Contact Electrosurgical Grounding Plates approved in existing 510(k)s K030362 and K063161, expanded with the addition of target group "neonates" like approved in existing 510(k) K994428.

	Comparison of Indications for Use
	K030362, K063161	This submission	K994428
similar	Skintact® Cool ContactElectrosurgicalGrounding Plates	Skintact® NeutralElectrodes forNeonates	The E7512 NeonatalREM PolyHesive™ IINeonatal PatientReturn Electrode	similar
SAME	are designed for usewith electrosurgicalgenerators for cuttingand coagulation ofhuman tissue.	are designed for usewith electrosurgicalgenerators for cuttingand coagulation ofhuman tissue	is single use, non-sterile dispersive witha preattached cord.The electrode adheresto the patient over itsentire surface. Itspurpose is to completethe electrosurgicalcircuit between thegenerator, the activeelectrode, and the	similar

Traditional 510(k): Skintact® Neutral Electrodes for Neonates

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510(k) Summary-Continued

		patient.Indications for use aregeneral monopolarelectrosurgery on
--	--	of newborn orprematurely bornpatients of betweenapproximately 1	newborn orprematurely bornpatients of betweenapproximately 1	SAME
--	--	and 11 lbs.	and 6 lbs.	similar

The patient weight range of Skintact® Neutral Electrodes for Neonates is indicated according standard EN60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)

Skintact® Neutral Electrodes for Neonates are substantially equivalent to predicate devices

Comparison	K030362 K063161	Skintact® NeutralElectrodes forNeonates	K994428
TechnicalCharacteristics /Features	single patient use
	disposable
	self-adhesive
	non-sterile
	for use onadults and children	for use onneonates (newborn or prematurely born)
Packaging	sealed foil pouch		unknown
Testing	Based on biocompatibility testing and electrical and adhesiveperformance testing of the electrodes the devices are safe and effectivewhen used according instructions for use.
Construction	> Backing material> Conductive layer> Conductive adhesive hydrogel> Cover material

CONCLUSION:

The introduction of the Skintact® Neutral Electrodes for Neonates (and also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and the Skintact® Neutral Electrodes for Neonates are substantially equivalent to the predicate device. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.

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Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular and features a stylized caduceus symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2014

Leonhard Lang GmbH Ms. Elaine Duncan, M.S.M.E, RAC President, Paladian Medical Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K140500

Trade/Device Name: SkinTact® Neutral Electrodes for Neonates Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI Dated: June 26, 2014 Received: June 30, 2014

Dear Ms. Duncan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Elaine Duncan, M.S.M.E, RAC

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known): K140500

Skintact® Neutral Electrodes for Neonates Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

Regulation Number and Section

§ 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.