SKINTACT

K140500 · Leonhard Lang GmbH · GEI · Jul 29, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140500
• Device Name: SKINTACT
• Applicant: Leonhard Lang GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Skintact Neutral Electrodes for Neonates are single-use, non-sterile, disposable passive devices applied to intact skin. They function as dispersive return electrodes to complete the electrosurgical circuit between the generator, active electrode, and patient during monopolar electrosurgery. The device consists of a backing material, conductive layer, and a modified conductive hydrogel optimized for neonatal skin. Used in clinical settings by healthcare professionals, the electrode adheres to the patient to safely return high-frequency current, preventing thermal injury. The device contains no active electronics, software, or firmware.

Clinical Evidence

Bench testing only. Performance testing conducted per EN60601-2-2:2009, including thermal performance, contact impedance, and adhesion testing. Biocompatibility testing confirmed materials are safe for direct skin contact. No clinical data required.

Technological Characteristics

Passive dispersive electrode; backing material, conductive layer, and conductive adhesive hydrogel. Dimensions/form factor: neonatal-specific. Connectivity: none (passive). Sterilization: non-sterile. Standards: EN60601-2-2:2009 (thermal performance, impedance, adhesion).

Indications for Use

Indicated for use with electrosurgical generators for cutting and coagulation of human tissue in newborn or prematurely born patients weighing between approximately 1 and 11 lbs (0.45 kg and 4.99 kg).

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

• Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates (K063161)
• Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates (K030362)
• E7512 Premie REM PolyHesive II Patient Return Electrode (K994428)

Submission Summary (Full Text)

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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:<br>Address: | Leonhard Lang GmbH<br>Archenweg 56<br>6020 Innsbruck<br>Austria |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| Date prepared: | July 25, 2014 |
| Device Identification: | |
| TRADE NAME: | Skintact® Neutral Electrodes for Neonates<br>(and also to be offered for sale under various private label<br>tradenames) |
| COMMON NAME: | Neutral Electrodes |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and<br>accessories |
| PRO CODE: | GEI |
| Regulation No.: | 21CFR 878.4400 |
| Classification: | Class II |
| SUBSTANTIALLY EQUIVALENT TO: | |
| K063161 | Leonhard Lang Skintact® Cool Contact Electrosurgical<br>Grounding Plates, Leonhard Lang GmbH with NH04 Gel,<br>decision date: 11/21/2006 |
| K030362 | Leonhard Lang Skintact® Cool Contact Electrosurgical<br>Grounding Plates, Leonhard Lang GmbH, decision date:<br>04/14/2003 |
| K994428 | E7512 Premie REM PolyHesive II Patient Return Electrode |

#### INDICATIONS FOR USE:

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).

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.

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.

#### 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 Contact<br>Electrosurgical<br>Grounding Plates | Skintact® Neutral<br>Electrodes for<br>Neonates | The E7512 Neonatal<br>REM PolyHesive™ II<br>Neonatal Patient<br>Return Electrode | similar |
| SAME | are designed for use<br>with electrosurgical<br>generators for cutting<br>and coagulation of<br>human tissue. | are designed for use<br>with electrosurgical<br>generators for cutting<br>and coagulation of<br>human tissue | is single use, non-<br>sterile dispersive with<br>a preattached cord.<br>The electrode adheres<br>to the patient over its<br>entire surface. Its<br>purpose is to complete<br>the electrosurgical<br>circuit between the<br>generator, the active<br>electrode, and the | similar |

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

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### 510(k) Summary-Continued

| | | patient.<br>Indications for use are<br>general monopolar<br>electrosurgery on | | |
|----|----|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------|
| -- | -- | of newborn or<br>prematurely born<br>patients of between<br>approximately 1 | newborn or<br>prematurely born<br>patients of between<br>approximately 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<br>K063161 | Skintact® Neutral<br>Electrodes for<br>Neonates | K994428 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------|
| Technical<br>Characteristics /<br>Features | single patient use | | |
| | disposable | | |
| | self-adhesive | | |
| | non-sterile | | |
| | for use on<br>adults and children | for use on<br>neonates (newborn or prematurely born) | |
| Packaging | sealed foil pouch | | unknown |
| Testing | Based on biocompatibility testing and electrical and adhesive<br>performance testing of the electrodes the devices are safe and effective<br>when used according instructions for use. | | |
| Construction | > Backing material<br>> Conductive layer<br>> Conductive adhesive hydrogel<br>> 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 [phone] or [phone] 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 [phone] or [phone] 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:

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).

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