ORI F6T DRY ECG MONITORING ELECTRODE

K062760 · Orbital Research, Inc. · DRX · Dec 11, 2006 · Cardiovascular

Device Facts

• Record ID: K062760
• Device Name: ORI F6T DRY ECG MONITORING ELECTRODE
• Applicant: Orbital Research, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Indications for Use

The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.

Device Story

ORI F6T Dry ECG Monitoring Electrode is a non-sterile, single-use, disposable electrode for ECG signal acquisition. Device utilizes solid, Ag/AgCl-coated conductive polymer element to interface with patient skin; eliminates need for electrolytic gel. Conductive element secured via adhesive tape patch. Used in clinical settings for short-term or long-term (up to 2 days) monitoring. Healthcare providers apply electrodes to patient; device captures electrical cardiac signals for transmission to standard ECG monitoring equipment. Output allows clinicians to visualize cardiac activity for diagnostic or monitoring purposes, facilitating clinical decision-making regarding patient heart health.

Clinical Evidence

Clinical testing conducted in accordance with ANSI/AAMI EC 12:2000 and FDA's ECG Electrode 510(k) guidance. Performance demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Ag/AgCl-coated conductive polymer element; adhesive tape patch; dry interface (no electrolytic gel). Dimensions/form factor: disposable electrode. Standards: ANSI/AAMI EC 12:2000 (disposable ECG electrodes), ISO 10993-1 (biological evaluation). Non-sterile.

Indications for Use

Indicated for adults (18+ years) requiring short-term or long-term (up to 2 days) ECG monitoring in any application where standard ECG electrodes are used.

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

• 3M Red Dot™ 2570 Monitoring Electrode (K970796)
• AccuHeart™ Electrode Belt (K043361)

Submission Summary (Full Text)

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## DEC 1 1 2006

## 510(k) Summary

## 510(k) Summary of Safety and Effectiveness (as required by 21 CFR § 807.92)

| 510(k) Submitter | Orbital Research Inc.<br>4415 Euclid Ave, Suite 500<br>Cleveland, Ohio 44103 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Aaron Rood<br>Senior Research Scientist & Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | 9/14/06 |
| Device Name | Proprietary Name: ORI F6T Dry ECG Monitoring Electrode |
| | Common Name: electrocardiograph (ECG) electrode |
| | Classification Name: "electrode, electrocardiograph," a class II device<br>per 21 CFR § 870.2360 (product code DRX). |
| Device Description | The ORI F6T Dry ECG Monitoring Electrode is a non-sterile,<br>single-use, disposable electrode system consisting of a solid,<br>Ag/AgCl-coated conductive polymer element with a mechanical<br>skin interface surface designed to ensure adequate skin interface<br>without the use of a component electrolytic gel. The conductive<br>polymer clement is held in place using a novel adhesive tape patch. |
| Intended Use | The ORI F6T Dry ECG Electrode is intended for use in all ECG<br>monitoring applications where standard ECG monitoring electrodes<br>are used. The F6T Electrode can be used in short term and long<br>term (up to 2 days) ECG monitoring. |
| Predicate Devices | The F6T Electrode is substantially equivalent to the following<br>legally marketed ECG electrodes:<br>-3M Red Dot™ 2570 Monitoring Electrode (K970796) 3M |
| | Health Care<br>-AccuHeart™ Electrode Belt (K043361) Advanced Bioelectric<br>Corporation |
| Substantial Equivalence | The F6T Electrode is substantially equivalent in terms of safety and<br>effectiveness to a combination of the predicate devices cited above<br>and is designed to ensure stable ECG monitoring performance over<br>the life of the device. |

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The biological safety of the F6T Electrodes has been assessed Non-clinical Testing through the tests specified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices.

> The electrical performance of the F6T Electrode was assessed and determined to meet the applicable requirements of ANSI/AAMI EC 12:2000, Disposable ECG Electrodes.

The safety and effectiveness of the F6T Electrode was assessed in Clinical Testing clinical testing conducted in accordance with the requirements of the ANSI/AAMI EC 12:2000, Disposable ECG Electrodes and FDA's ECG Electrode 510(k) guidance document. The performance of the device was substantially equivalent to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2006

Orbital Research Inc. Aaron Rood ·Regulatory Affairs Associate 4415 Euclid Ave. Suite 500 Cleveland, OH 44103

Re: K062760

Trade/Device Name: Ori F6T Dry ECG Monitoring Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II Product Code: DRX Dated: November 10, 2006 Received: November 1, 2006

Dear Mr. Rood:

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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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,

Q.S.U

CoR 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 Statement |
|-------------------------------|
|-------------------------------|

| 510(k) Number: | K062760 |
|----------------|---------------------------|
| Device Name: | ORI F6T Dry ECG Electrode |

**Indications for Use:** The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.

| Prescription Use (Part 21 CFR 801 Subpart D) | X | 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)

Figure 3 Revised

Version 1.1 created 10 November 2006

elsam 12/10/06

(Division Sign-Off) Division of Čardiovascular Devices

KO62760 510(k) Number_