AUDICOR, HEMO AMBULATORY MONITOR

K073545 · Inovise Medical, Inc. · MWJ · Sep 9, 2008 · Cardiovascular

Device Facts

• Record ID: K073545
• Device Name: AUDICOR, HEMO AMBULATORY MONITOR
• Applicant: Inovise Medical, Inc.
• Product Code: MWJ · Cardiovascular
• Decision Date: Sep 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI. Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device. 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 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 system captures ECG and heart sound data via chest-wall sensors; processes inputs to calculate advanced cardiac parameters including EMAT, LVST, S3/S4 strength, and Systolic Dysfunction Index (SDI). System operates as a standalone unit for 10-second snapshots or with an optional ambulatory harness for up to 48-hour data collection. Data is analyzed and presented in snapshot or trended reports. Used in clinical settings under physician supervision to monitor patient changes during therapeutic treatment or CRT studies. Output assists physicians in evaluating systolic dysfunction and cardiac performance; provides objective data to support clinical decision-making regarding heart failure or acute coronary syndrome management.

Clinical Evidence

Bench testing only. The device was tested for compliance with ANSI/AAMI EC-11, EN 60601-1, EN 60601-1-2, IEC 60601-2-25, and IEC 60601-2-51. The ambulatory harness was tested for compliance with ANSI/AAMI EC38:1998.

Technological Characteristics

Wearable, battery-powered ambulatory monitor. Uses proprietary chest-wall sensors for simultaneous ECG and heart sound acquisition. Data stored on non-volatile memory for download to analysis module. Complies with AAMI EC-11, IEC 60601-2-25, and IEC 60601-2-51 standards.

Indications for Use

Indicated for adults (≥ 18 years) suspected of heart failure or acute coronary syndrome. Used for acquisition, analysis, and reporting of ECG and heart sound data to assist physicians in clinical assessment.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• GE Medical Systems SEER Light Holter Recorder (K021470)

Submission Summary (Full Text)

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SEP 0 9 2008

| Summary of Safety and Effectiveness | | SEP 09 2008 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| As required by 21 CFR, part 807.92 | | |
| Submitted By: | Inovise Medical, Inc.<br>10565 SW Nimbus Ave, Suite 100<br>Portland, OR 97233-4311<br>Phone [phone]<br>Fax [phone] | |
| Contact: | Kendra Rathkey<br>Manager, Quality and Regulatory | |
| Date Prepared: | July 2, 2008 | |
| Proprietary<br>Name: | Modification to AUDICOR 200 | |
| Common/ Usual<br>Name: | Electrocardiograph/Acoustic Cardiograph | |
| Classification: | 870.2340, DPS class II, Electrocardiograph<br>870.1875, DQD, class II, Electronic Stethoscope<br>870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program) | |
| Performance<br>Standards: | AAMI EC 11 | |
| Intended Use: | The Audicor® System, when used with AUDICOR Sensors on the chest wall, is<br>intended for use in acquiring, analyzing and reporting ECG and heart sound data<br>and to provide interpretation of the data in an integrated ACG (acoustic<br>cardiograph) report for consideration by physicians. Audicor systems allow<br>detection, reporting and interpretation of standard ECG data as well as advanced<br>parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI. | |
| | Data may be reported in a single snapshot report and in a trended report format<br>where multiple data points are trended over time. The Audicor system also accepts<br>and analyzes downloads of up to 48 hours of patient data from an optional<br>ambulatory ECG/heart sounds collection device. | |
| | ECG and heart sound data offered by the device are only significant when used in<br>conjunction with physician over read as well as consideration of other relevant<br>patient data. | |
| | The device is intended for use only under the direct supervision of a physician and<br>is for use on adults (≥ 18 years). | |
| Device<br>Description: | The Audicor 200 is a stand-alone device that can be used to capture 10-second<br>snapshots of ECG and heart sounds in patients suspected of heart failure or acute<br>coronary syndrome. | |
| | The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabled<br>laptop computer, is used to display and analyze patient data over time in a trended<br>format. The trending system can be used in monitoring patient changes during<br>therapeutic treatment or during CRT studies. | |
| | The Audicor system, when used with either a 10 wire or 4 wire patient cable<br>analyzes and reports the following advanced parameters and a systolic<br>dysfunction index (SDI) calculated from advanced parameters: | |
| | LVST ( Left Ventricular Systolic Time )<br>LVDT (Left Ventricular Diastolic Time) | |

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- PADT (Pre-atrial Diastolic Filling Time) �
- AAFT (Accelerated Atrial Filling Time ) .
- EMAT (QS1, Electromechanical Activation Time) .
- QS2 .
- R-R Interval .
- S3 Strength .
- S4 Strenth �
- SDI (Systolic Dysfunction Index)

The Audicor-enabled laptop computer also accepts, analyzes and displays trended data from an optional ambulatory data collection harness for trend and event analysis.

Test Summary & The Audicor System has been tested to the applicable requirements of the Conclusion: following standards, and shown to comply.

- . ANSI/AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices
- EN 60601-1 (UL 60601-1) Standard for Medical Electrical Equipment: General . Requirements for Safety
- . EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-2-25 Medical Electrical Equipment Part 2-25: Particular . Requirements for the Safety of Electrocardiographs
- IEC 606601-2-51 Medical Electrical Equipment Part 2. Particular . Requirements for Safety, Including Essential Performance, of Recording and Analyzing Single Channel and Multi-channel Electrocardiographs

The optional ambulatory ECG/heart sounds data collection harness (Hemo) is designed to comply with

ANSI/AAMI EC38:1998 Ambulatory Electrocardiographs .

Substantial Equivalence:

.

The added Hemo accessory wireless ambulatory ECG/heart sounds data collection harness is found to be substantially equivalent to the following cleared devices:

- GE Medical Systems SEER Light Holter Recorder (K021470)
The Audicor System Hemo wireless ECG/heart sounds data collection harness Technological and the predicate GE SEER Light Holter Recorder are technologically equivalent in Characteristics: that both devices:

- Are small, wearable, battery-powered devices .
- Acquire ECG data from patients using limited ECG leads .
- Use non-volatile memory to store patient data for download to the analysis . module of the system

The Audicor Ambulatory system is different from the predicate in the following ways:

- It requires use of proprietary Audicor sensors to capture ECG and heart . sounds data
- The GE SEER Light does not perform the analysis on recorded data while the . Audicor system does.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 0 9 2008

Inovise Medical, Inc. c/o Ms. Kendra Rathkey Manager, Quality and Regulatory 10565 SW Nimbus Avenue Suite 100 Portland, OR 97223-4311

Re: K073545

Trade Name: AUDICOR Hemo Ambulatory Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: August 6, 2008 Received: August 11, 2008

Dear Ms. Rathkey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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. Kendra Rathkey

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 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 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

If you have any questions regarding the content of this letter, please contact Frank Lacy at [phone].

Sincerely yours,

er R. V. Annes

A 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): K073545

Device Name: Audicor Hemo Amonalastory,

Indications For Use:

The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI.

Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device,

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 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).

Prescription Use XXX (Part 21 CFR 801 Subpart D) 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)

Page 1 of 1

Duna D. Schunes

(Division Sian-Off Division of Cardiovascular Devices

510(k) Number_K0+5545