SKINTACT AND VARIOUS OTHER TRADENAMES

K092291 · Leonhard Lang GmbH · DRX · Aug 21, 2009 · Cardiovascular

Device Facts

• Record ID: K092291
• Device Name: SKINTACT AND VARIOUS OTHER TRADENAMES
• Applicant: Leonhard Lang GmbH
• Product Code: DRX · Cardiovascular
• Decision Date: Aug 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

ECG Skintact Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact® ECG Electrodes are single-use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Device Story

Skintact ECG Tab Electrodes are disposable, self-adhesive, non-sterile electrodes; used for patient ECG surveillance and diagnostic recording. Device functions as interface between patient skin and ECG monitoring equipment; captures electrical signals from heart. Electrodes applied to intact skin by healthcare professionals in clinical settings. Output is electrical signal transmitted to ECG monitor for physician interpretation; aids in cardiac rhythm assessment and diagnosis. Benefit is reliable, non-invasive signal acquisition for cardiac monitoring.

Clinical Evidence

Bench testing only. Device met specifications established in ANSI/AAMI EC12:2000/(R)2005. Biocompatibility testing passed ISO 10993 requirements for intact skin. Shelf life validated via accelerated aging.

Technological Characteristics

Self-adhesive, non-sterile, single-use disposable ECG electrodes. Conductive KH06D gel. Compliant with ANSI/AAMI EC12:2000/(R)2005 standards. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording. For use on intact, uninjured skin only. Prescription use.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Predicate Devices

• Leonhard Lang Skintact ECG Electrodes with KH06 Gel (K030509)

Submission Summary (Full Text)

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# 510(k) Summary

#### AUG 21 2009

| Company Name: | Leonhard Lang GmbH |
|------------------------|----------------------------------|
| Address: | Archenweg 56 |
| | 6020 Innsbruck |
| | Austria |
| Telephone: | ++ 43 / 512 / 33 4 25 7 |
| Fax: | ++ 43 / 512 / 39 22 10 |
| Registration Number: | 8020045 |
| Owner/Operator Number: | 8020045 |
| by: | Elaine Duncan, MS.M.E., RAC |
| | President, Paladin Medical, Inc. |
| | PO Box 560 |
| | Stillwater, MN 55082 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Elaine Duncan |
| | 28, July 2009 |

Contact Person: Date prepared: Trade Name:

:

SUBMITTER

Submitted on behalf of:

Common Name: Classification Name: Regulation: Regulatory Class Device Panel and Product Code: Cardiovascular: 74 DRX Reason for 510(k) Submission:

-6032 -5380 Skintact® ECG Tab Electrodes with KH06D Gel (and as also to be offered for sale under various private label tradenames)

Disposable ECG Electrodes Electrocardiograph (ECG) Electrode Electrocardiographic electrode, 21 CFR 870.2360 This device is Class II change of material

Substantial Equivalence: Skintact® ECG Tab Electrodes with KH06D Gel are substantially equivalent to K030509 "Leonhard Lang Skintact" ECG Electrodes with KH06 Gel" and have same individual for use. The only change between the original Skintact® ECG Tab Electrodes with KH06 Gel and the Skintact® ECG Tab Electrodes with KH06D Gel is the modification of gel. No new technology is required for this change.

Description of device: All Skintact® ECG Tab Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Tab Electrodes with KH06D Gel are composed of the same materials as the predicate devices by Leonhard Lang except the modified gel.

Indications for use: Skintact ECG Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physiciati. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact® ECG Electrodes are single-use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Basis for Equivalence - performance testing: Biocompatibility testing was cleared and passed ISO 10993 for intact skin. Biocompatibility testing confirms the materials are biocompatible and the change does not introduce new risks. According to the performance data, Leonhard Lang Skintact® ECG Tab Electrodes with KH06D Gel met specifications as established in the standard, ANSI/AAMI EC12:2000/(R)2005, as did the predicate device). The shelf life of Skintact® ECG Tab Electrodes with KH06D Gel was tested in accelerated aging in the same manner as the predicate device K030509. The introduction of the Skintacte ECG Tab Electrodes with KH06D Gel does not introduce new issues of safety or effectiveness and the Skintact® ECG Tab Electrodes with KH06D Gel are substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right of the image. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

#### AUG 21 2009

Leonhard Lang, GmbH c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082-0560

Re: K092291

> Trade/Device Name: Leonhard Lang Skintact ECG Tab Electrode with KH06D Gel Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (Two) Product Code: DRX Dated: July 28, 2009 Received: July 29, 2009

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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

M. A. Villebrun

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Skintact® ECG Tab Electrodes with KH06D Gel

Indications For Use:

ECG Skintact Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.

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

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)

M. A. Hilleheusen

(Division Sign-Off)
Division of Cardiovascular Devices

1092291 510(k) Number