SKINTACT AND VARIOUS OTHER TRADENAMES

K073104 · Leonhard Lang GmbH · DRX · Nov 16, 2007 · Cardiovascular

Device Facts

• Record ID: K073104
• Device Name: SKINTACT AND VARIOUS OTHER TRADENAMES
• Applicant: Leonhard Lang GmbH
• Product Code: DRX · Cardiovascular
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

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 ECG Electrodes are self-adhesive, single-use, non-sterile disposable devices; used for patient ECG surveillance and diagnostic recording. Electrodes interface with patient skin via conductive adhesive gel; capture electrical signals for transmission to external ECG monitoring equipment. Used in clinical settings under physician order. Benefit: provides reliable skin-to-electrode interface for cardiac monitoring. Device is a modification of existing Skintact line, specifically incorporating a new conductive gel.

Clinical Evidence

Bench testing only. Biocompatibility testing passed ISO 10993 requirements for intact skin. Performance testing conducted per ANSI/AAMI EC12:2000 standards. Accelerated aging studies performed to validate shelf life.

Technological Characteristics

Self-adhesive, single-use, non-sterile disposable ECG electrodes. Features conductive adhesive gel (AmGel Technologies). Materials consistent with predicate devices. Complies with ANSI/AAMI EC12:2000 performance standards. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording during general electrocardiographic procedures. 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 (K023503)
• Leonhard Lang Skintact radiolucent and MRI-compatible ECG Electrodes (K040249)
• 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive (K000690)
• Pals Neonatal Pediatric ECG Electrodes, Models PN100 PN200 (K000206)

Submission Summary (Full Text)

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## 510(k) Summary K073104

| SUBMITTER | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted on behalf of: | Company Name:<br>Address: | Leonhard Lang GmbH<br>Archenweg 56<br>6020 Innsbruck<br>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<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082<br>Telephone: [phone]<br>Fax: [phone] |
| Contact Person: | Elaine Duncan | |
| Date prepared: | October 31, 2007 | |
| Trade Name: | Skintact® ECG Electrodes with Conductive Adhesive<br>(and as also to be offered for sale under various private label tradenames) | |
| Common Name: | Disposable ECG Electrodes | |
| Classification Name: | Electrocardiograph (ECG) Electrode | |
| Regulation | 21 CFR 870.2360 | |
| Regulatory Class | This device is Class II | |
| Device Panel and Product Code: | Cardiovascular: 74 DRX | |
| Reason for 510(k) Submission: | change in material: gel | |

Substantial Equivalence: Skintact® ECG Electrodes with Conductive Adhesive are substantially equivalent to the stated predicate devices. The only change between the original Skintact® ECG Electrodes and the Skintact® ECG Electrodes with Conductive Adhesive is the change in the conducting media gel, Conductive gel electrodes were previously cleared by FDA (3M Red Dot) and the gel has been previously, cleared in a submission by the manufacturer.

K023503 Leonhard Lang Skintact® ECG Electrodes with solid adhesive gel

- K040249 Leonhard Lang Skintact® radiolucent and MRI-compatible ECG Electrodes
- K000690 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive

K000206 Pals Neonatal Pediatric ECG Electrodes, Models PN100 PN200

Description of device: All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Electrodes with Conductive Adhesive are composed of the same naterials as the predicate devices by Leonhard Lang except the gel, which is made by AmGel Technologies.

Skintact® ECG Electrodes with Conductive Adhesive have the same indications for Indications for use: use as approved in predicate 510(k)s: Skintact® ECG Electrodes are designed for use in general electrocurdiographic 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. Skintacle ECG Electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.

Basis for Equivalence: performance testing: Biocompatibility testing was the same as predicate devices and passed ISO 10993 for intact skin. The performance data of Skintact® ECG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMU EC12:2000. The shelf life of Skintact® ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate devices. The introduction of the Skintact® 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 and the Skintact® ECG Electrodes with Conductive Adhesive are substantially equivalent to the predicate devices.

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గ్రా

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is composed of three parallel lines that curve and converge, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Leonhard Lang GmbH c/o Ms. Elaine Duncan, MSME, RAC President Paladin Medical Inc., P.O. Box 560 Stillwater, MN 55082

Re: K073104

Skintact® ECG Electrodes with Conductive Adhesive (and various private label tradenames) Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: October 31, 2007 Received: November 2, 2007

## 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

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) I mis lotter will and w yourse of substantial equivalence of your device to a legally promation in the 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,

B.Bummimo for

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):

K073104

Device Name: Skintact®ECG Electrodes with Conductive Adhesive

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.

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

| Prescription Use | <b>X</b> | 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)

Bhumma