SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE

K080106 · Leonhard Lang GmbH · DRX · Feb 1, 2008 · Cardiovascular

Device Facts

• Record ID: K080106
• Device Name: SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
• Applicant: Leonhard Lang GmbH
• Product Code: DRX · Cardiovascular
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Skintact ECG 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 Pre-wired ECG Electrodes are single-use, non-sterile, disposable electrodes; designed for general electrocardiographic procedures, including patient surveillance and diagnostic recording. Device consists of conductive adhesive electrode with pre-attached lead wire. Used in clinical settings where ECG monitoring is ordered by physician. Electrodes applied to patient's intact skin to capture electrical signals for transmission to ECG monitoring equipment. Output allows healthcare providers to visualize cardiac activity, facilitating clinical decision-making regarding patient heart health.

Clinical Evidence

Bench testing only. Device met ANSI/AAMI EC12:2000 performance specifications. Biocompatibility testing passed ISO 10993 requirements for intact skin. Shelf life validated via accelerated aging testing.

Technological Characteristics

Self-adhesive, non-sterile, single-use disposable ECG electrodes. Features conductive adhesive and pre-attached lead wire. Materials consistent with predicate devices. Complies with ANSI/AAMI EC12:2000 performance standards and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording as ordered by a physician. For use on intact, uninjured skin.

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 Conductive Adhesive (K073104)
• Pals Neonatal Pediatric ECG Electrode (K000206)
• Pro-Neo Neonatal ECG Electrode (K053011)
• Ambu Blue sensor Neo and Neo X (K053550)

Submission Summary (Full Text)

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## 510(k) Summary

K080/06
P/1

## SUBMITTER

Submitted on behalf of:

Classification Name:

Regulatory Class

Regulation:

Company Name: Address: Telephone: Fax:

Registration Number:

Leonhard Lang GmbH Archenweg 56 6020 Innsbruck Austria ++ 43 / 512 / 33 4 25 7 ++ 43 / 512 / 39 22 10 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]

Contact Person: Elaine Duncan Date prepared: Trade Name: Common Name:

January 11, 2007 Skintact® Pre-wired ECG Electrodes with Conductive Adhesive (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 Device Panel and Product Code: Cardiovascular: 74 DRX Reason for 510(k) Submission: addition of pre-attached lead wire

Substantial Equivalence: Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are substantially equivalent to K073104 Leonhard Lang Skintact® ECG Electrodes with Conductive Adhesive and have the same indications for use. The only change between the original Skintact® ECG Electrodes with Conductive Adhesive and the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive is the addition of preattached lead wire. No new technology is required for this change since ECG Electrodes with pre-attached lead wires have been previously cleared in predicate devices using similar materials:

| K000206 | Pals Neonatal Pediatric ECG Electrode |
|---------|---------------------------------------|
| K053011 | Pro-Neo Neonatal ECG Electrode |
| K053550 | Ambu Blue sensor Neo and Neo X |

Description of device: All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are composed of the same materials as the predicate devices by Leonhard Lang except the pre-attached lead wire. The lead wires are similar to those in predicate devices.

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 physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintace 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 in predicate devices and passed ISO 10993 for intact skin. According to the performance data, Leonhard Lang Skintact® Pre-wired ECG Electrodes with Conductive Adhesive met specifications as established in ANSI/AAMI EC12:2000, as did the predicate devices (K073104, K000206, K053011, K053550). The shelf life of Skintact® Pre-wired ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate device K073104. The introduction of the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive (and as also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K080106

Skintact® Pre-wired ECG Electrodes with Conductive Adhesive Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II (two) Product Code: DRX Dated: January 11, 2008 Received: January 15, 2008

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.

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, MS.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.

Bhimima fo

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® Pre-wired ECG Electrodes with Conductive Adhesive

Indications For Use:

Skintact ECG Electrodes are designed for use in general electrocardioaraphic 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 AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

B. Ramirez

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