AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)

K030316 · Inovise Medical, Inc. · DRX · Aug 7, 2003 · Cardiovascular

Device Facts

• Record ID: K030316
• Device Name: AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
• Applicant: Inovise Medical, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.

Device Story

Audicor Sensor is a single-use, disposable, non-sterile device for V4 chest position. It functions as both an ECG electrode and an electronic stethoscope microphone. Input: electrical ECG signals and acoustic heart sounds from patient skin surface. Operation: requires Audicor Adaptor to transmit signals to compatible electrocardiographs and physiological monitors. Used in hospitals, clinics, and emergency vehicles by healthcare professionals. Output: raw ECG and heart sound signals for display/analysis by external equipment. Benefits: enables simultaneous acquisition of electrical and acoustic cardiac data using a single sensor site, simplifying clinical workflow for cardiac monitoring.

Clinical Evidence

Bench testing only. Compliance with AAMI EC12:2000 (disposable ECG electrodes) and AAMI EC53:1995 (ECG cables/lead wires) confirmed. Biocompatibility testing (cytotoxicity, primary skin irritation, delayed dermal contact sensitization) for the conductive hydrogel material showed acceptable results.

Technological Characteristics

Single-use, disposable sensor. Materials: conductive hydrogel. Sensing: ECG electrode and integrated microphone. Frequency range: 20–660 Hz. Connectivity: wired transmission to compatible monitors via Audicor Adaptor. Standards: AAMI EC12:2000, AAMI EC53:1995, ISO 10993. Operating temperature: 10°C to 35°C.

Indications for Use

Indicated for resting adult patients (18+ years) requiring short-duration (up to 1 hour) acquisition of heart sounds and ECG signals at the V4 chest position.

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

• Kendall-LTP Disposable ECG electrode (K953649)
• E-Scope Electronic Stethoscope (K961301)

Submission Summary (Full Text)

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Inovise Inc.

K030316

## Attachment 3

AUG - 7 2003

Summary of Safety and Effectiveness As required by 21 CFR, part 807.92

| Submitted By: | Inovise Medical, Inc.<br>1025 Industrial Parkway, Suite C<br>Newberg, OR 97132<br>Fax [phone] |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kendra Rathkey<br>Tel [phone] |
| Date Summary<br>Prepared: | February 14, 2003 (revised June 24, 2003) |
| Proprietary<br>Name: | Audicor™ Sensor |
| Common/Usual<br>Name: | ECG Electrode & Heart Sound Transducer. |
| Classification: | 21 CFR 870.2360 ECG Electrode, Class II, Product Code:<br>DRX<br>21 CFR 870.2860 Heart Sound Transducer, Class II, Product<br>Code: JOO |
| Performance<br>Standards: | AAMI EC12:2000 (Disposable ECG Electrodes)<br>AAMI EC53:1995 (ECG Cables and Lead Wires) |
| Intended Use: | The Audicor™ Sensor is a single-use, disposable medical<br>device designed for short duration contact (up to 1 hour) for<br>use at the V4 ECG electrode position to acquire both heart<br>sounds and ECG electrical signals when attached to the body<br>surface of a resting, adult (18+ years of age) patient, and to<br>transmit these signals to compatible electrocardiographs and<br>physiological recorders/monitors. Such equipment is<br>commonly located in hospitals, doctor's offices and<br>emergency vehicles. |
| Device<br>Description: | The sensor is a single use, non-sterile, disposable medical<br>device. When used with the Audicor Adaptor the device is<br>designed to perform the functions of both a standard resting<br>ECG Electrode by acquiring ECG signals and an Electronic<br>Stethoscope by acquiring heart sounds from the surface of a<br>patients skin. The device is intended for use on the surface of<br>an adult patient's skin in the V4 electrode position on the<br>chest. |
| Test Summary<br>& Conclusion: | The sensor was tested to the applicable requirements of the<br>performance standards, identified above, and shown to<br>comply. Laboratory and bench testing indicates compliance |

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to the standard.

Biocompatibility for the hydrogel, the primary patient contact material of the sensor, was evaluated. Test results demonstrate that the material was found acceptable for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization.

Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy.

The Inovise Medical Audicor Sensor is substantially Substantial Equivalence: equivalent to the Kendall-LTP Disposable ECG electrode (K953649) and the E-Scope Electronic Stethoscope.

The table below contains the comparison of features and Technological principles of operation between the Audicor Sensor and other Characteristics: selected predicate devices.

| Feature | Inovise Medical, Inc<br>Audicor Sensor | Kendall<br>Disposable ECG<br>Electrode | E-Scope Electronic<br>Stethoscope |
|------------------------------|----------------------------------------|----------------------------------------|-----------------------------------|
| 510(k) Identifier | K030316 | K953649 | K961301 |
| Meets EC12-2000 Standard | Yes | Yes | No |
| Meets ISO 10993 Standard | Yes | Yes | Unknown |
| Disposable Device | Yes | Yes | No |
| Used on Patient Skin Surface | Yes | Yes | Yes |
| ECG Electrode Functionality | Yes | Yes | No |
| Used in V4 position | Yes | Yes | Yes and other<br>locations |
| Uses Conductive Hydrogel | Yes | Yes | No |
| Primary Packaging | Paper/Poly/Foil<br>Pouch | Paper/Poly/Foil<br>Pouch | Durable device |
| Acquires Heart Sounds | Yes | No | Yes |
| Uses Microphone | Yes | No | Yes |
| Frequency Range | 20 – 660 Hz<br>(nominal) | N/A | 10 - 2000 Hz |
| Operating Temperature | 10°C to 35 °C | Unknown | Unknown |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three stripes coming off of its head.

AUG - 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inovise Medical, Inc. c/o Mr. John C. So Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607

Re: K030316

Trade Name: Audicor™ COR Sensor Model M200 Regulation Number: 21 CFR 870.2360 and 21 CFR 870.1875 Regulation Name: Electrocardiograph Electrode and Stethoscope Regulatory Class: Class II (two) Product Code: DRX and DQD Dated: July 29, 2003 Received: July 30, 2003

Dear Mr. So:

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.

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

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Page 2 - Mr. John C. So

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 (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. 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

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Inovise Inc.

## Attachment 2

## Indications for Use Statement

Applicant: Inovise Medical, Inc. K030316 510(k) Number (if known): Device Name: Audicor Sensor

Indications for use:

The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109) ✓

Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030316