AUDICOR UPGRADE SYSTEM

K032145 · Inovise Medical, Inc. · DPS · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K032145
• Device Name: AUDICOR UPGRADE SYSTEM
• Applicant: Inovise Medical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Audicor Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians. The Audicor Upgrade System is an add-on device designed to work with the following electrocardiographs: GE Mac 8 GE Mac Vu GE Mac 5000 Philips Pagewriter XL The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data. The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

Device Story

Audicor Upgrade System is a pocket PC-based add-on device; interfaces with existing electrocardiographs (GE Mac 8, Mac Vu, Mac 5000; Philips Pagewriter XL) to provide Correlated Audioelectric Cardiography (COR) reports. Inputs: 12-lead ECG signals and heart sounds via Audicor sensors placed at V3/V4 chest positions. Processing: proprietary software analyzes inputs to identify S3/S4 heart sounds and detect MI and LVH conditions. Output: graphical display of MI/LVH conditions, heart sound waveforms, and COR reports. Used in clinical settings by clinicians under physician supervision. Output serves as decision-support tool; requires physician overread and integration with other patient data for clinical diagnosis.

Clinical Evidence

Bench testing only. Engineering and design-level tests confirmed compliance with UL 2601-1, IEC 60601-2-25, EN 60601-1-2, and ANSI/AAMI EC 11 standards. No clinical trial data presented.

Technological Characteristics

Pocket PC-based system; interfaces with host electrocardiographs for signal acquisition. Sensing: Audicor sensors (V3/V4 positions). Connectivity: wired interface to host ECG. Software: proprietary algorithm for COR report generation, MI/LVH detection, and heart sound analysis. Standards: UL 2601-1, IEC 60601-2-25, EN 60601-1-2, ANSI/AAMI EC 11.

Indications for Use

Indicated for adults (≥ 18 years) requiring ECG and heart sound (phonocardiograph) acquisition and analysis. Used under direct physician supervision for clinical assessment of cardiac conditions.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Mortara Instrument ELI 200+ with Audicor Electrocardiograph (K031182)

Submission Summary (Full Text)

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## OCT 3 1 2003

Audicor™ Upgrade System

## 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>Phone [phone]<br>Fax [phone] |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Steve Hesler<br>Director, Quality and Regulatory |
| Date Summary<br>Prepared: | July 10, 2003 |
| Proprietary Name: | Audicor™ Upgrade System |
| Common/Usual<br>Name: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| Performance<br>Standards: | UL 2601-1<br>IEC 60601-2-25<br>EN 60601-1-2<br>ANSI/AAMI EC 11 |
| Intended Use: | The Audicor Upgrade System, when used with Audicor Sensors in the V3<br>and V4 positions on the chest wall, is intended for use in acquiring,<br>analyzing and reporting ECG and heart sounds (phonocardiograph) data<br>and to provide interpretation of the data for consideration by physicians. |
| | The Audicor Upgrade System is an add-on device designed to work with<br>the following electrocardiographs:<br>GE Mac 8<br>GE Mac Vu<br>GE Mac 5000<br>Philips Pagewriter XL<br>The interpretations of ECG and heart sound data offered by the device are<br>only significant when used in conjunction with physician overread as well<br>as consideration of all other relevant patient data.<br>The device is intended for use only under the direct supervision of a<br>physician, and is for use on adults (≥ 18 years). |
| Device Description: | The Audicor Upgrade System is a pocket PC with proprietary software that<br>can be used with several models of existing electrocardiographs to allow<br>clinicians access to the COR (correlated audioelectric cardiography) report<br>including graphical display of MI and LVH conditions as well as display of<br>heart sound waveforms and identification of S3 and S4 heart sounds. |
| Test Summary &<br>Conclusion: | The Audicor Upgrade System was tested to the applicable requirements of<br>the performance standards, and shown to comply. Laboratory and bench<br>testing indicates compliance to the standard.<br>Based on the results of the engineering/design level tests, it is concluded<br>that the Audicor Upgrade System performs as expected and compares<br>well, in terms of overall performance to the selected predicate devices and |

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:

Audicor™ Upgrade System

| | raises no new questions with regard to safety and efficacy. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | The Inovise Medical Audicor Upgrade System is substantially equivalent to<br>the Mortara Instrument ELI 200+ with Audicor Electrocardiograph<br>(K031182). |
| Technological<br>Characteristics: | The Audicor Upgrade System and the predicate device are technologically<br>equivalent in that both acquire 12 lead ECG and heart sounds data from<br>adult patients then present the data in the COR report format which<br>includes graphic display of MI and LVH conditions along with detection<br>and display of S3 and S4 heart sounds. |

Predicate Device Comparison Table

| Feature | ELI 200+ Electrocardiograph<br>with Audicor COR | Audicor Digital Upgrade<br>Box System |
|------------------------------------------------------------------|-------------------------------------------------|----------------------------------------|
| Manufacturer | Mortara Instrument, Inc. | Inovise Medical, Inc. |
| 510(k) Identifier | K031182 | |
| ECG Waveform Acquisition | Yes | Yes (through host lead set) |
| Interprets ECG Waveform<br>Data | Yes | Yes |
| ECG Waveform Report<br>Output | Yes | Yes |
| LVH Detection Algorithm | Yes | Yes |
| MI (prior) Detection<br>Algorithm | Yes | Yes |
| MI (acute) Detection<br>Algorithm | Yes | Yes |
| Heart Sounds Waveform<br>Acquisition | Yes | Yes |
| Displays S1 - S4 Heart<br>Sounds | Yes | Yes (with informational<br>statements) |
| Analysis Test Report Output | Yes, multiple formats | Yes, single format |
| Printer | Built into unit | Separate printer |
| Graphical Representation of<br>MI and LVH Analysis<br>Statements | Yes | Yes |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2003

Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 1025 Industrial Parkway, Suite C Newberg, OR 97132

Re: K032145

Trade Name: Audicor™ Upgrade System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 9, 2003 Received: October 14, 2003

Dear Mr. Hesler:

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 -- Mr. Steve C. Hesler

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 may be obtained 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,

Dra Husher for
Dr. D. Zusher, MD

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

Applicant: Inovise Medical, Inc. 510(k) Number (if known): Device Name: Audicor™ Upgrade System

Indications for use:

The Audicor™ Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians.

The Audicor System is an add-on device designed to work with the following electrocardiographs:

GE Mac 8 GE Mac Vu GE Mac 5000 Philips Pagewriter XL

The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of all other relevant patient data.

The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

(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)

Dra Stexhu

510(k) Number K037 K032145