LIBERTY SYSTEM

K043074 · Inovise Medical, Inc. · DPS · Feb 22, 2005 · Cardiovascular

Device Facts

• Record ID: K043074
• Device Name: LIBERTY SYSTEM
• Applicant: Inovise Medical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Liberty 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 COR report for consideration by physicians. The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; or as a stand-alone electrocardiograph. 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 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

Liberty System is a pocket PC-based electrocardiograph; acquires 12-lead ECG and heart sound data via Audicor Sensors on chest wall. Transforms inputs into COR (correlated audioelectric cardiography) report; provides graphical display of MI, ischemia, and LVH conditions; identifies S3 and S4 heart sounds. Operates as standalone device or add-on to cardiographs, defibrillators, and patient monitors. Used in clinical settings by clinicians under direct physician supervision. Output assists physicians in diagnostic decision-making; requires physician over-read and integration with other patient data. Benefits include integrated diagnostic reporting for cardiac conditions.

Clinical Evidence

Bench testing only. Device demonstrated compliance with ANSI/AAMI EC-11 (diagnostic ECG), ANSI/AAMI EC-53 (cables/leadwires), EN 60601-1-2 (EMC), IEC 60601-2-25 (safety of electrocardiographs), and UL 60601-1 (general safety). No clinical trial data provided.

Technological Characteristics

Pocket PC-based electrocardiograph. Uses Audicor Sensors for data acquisition. Complies with ANSI/AAMI EC-11, EC-53, IEC 60601-2-25, and UL 60601-1 standards. Connectivity via integration with cardiographs, defibrillators, or patient monitors. Software-based analysis for COR report generation.

Indications for Use

Indicated for adult patients (> 18 years) requiring acquisition, analysis, and reporting of ECG and heart sound data. Used for clinical assessment of MI, ischemia, LVH, and identification of S3/S4 heart sounds. Must be used under direct physician supervision.

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

• Audicor Cardiograph Expansion system (K032145)
• Mortara Instrument ELI 200+ (K031182)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| <b>Summary of Safety and Effectiveness</b> | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Steve Hesler<br>Director, Quality and Regulatory |
| Date Prepared: | November 4, 2004 |
| Proprietary<br>Name: | Liberty System |
| Common/ Usual<br>Name: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| Performance<br>Standards: | AANSI/AAMI EC 11 |
| Intended Use: | The Liberty 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 COR report for<br>consideration by physicians. |
| | The Liberty System can be used as an add-on device to work in conjunction with<br>select cardiographs, defibrillators, and patient monitors; or as a stand-alone<br>electrocardiograph. The interpretations of ECG and heart sound data offered by<br>the device are only significant when used in conjunction with physician over read<br>as well as consideration of other relevant 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 Liberty System is a pocket PC-based device that that can be used to allow<br>clinicians access to the COR (correlated audioelectric cardiography) report<br>including graphical display of MI, Ischemia, and LVH conditions as well as display<br>of heart sound waveforms and identification of S3 and S4 heart sounds. |
| Test Summary &<br>Conclusion: | The Liberty System was tested to the applicable requirements of the following<br>standards, and shown to comply. |
| | • ANSI/AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices |
| | • ANSI/AAMI EC 53 ECG Cables and Leadwires |
| | • EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General<br>Requirements for Safety - Collateral Standard: Electromagnetic Compatibility –<br>Requirements and Tests |
| | • IEC 60601-2-25 Medical Electrical Equipment Part 2: Particular requirements for<br>the safety of electrocardiographs |
| | • UL 60601-1 Standard for Medical Electrical Equipment: General Requirements<br>for Safety |
| Substantial<br>Equivalence: | The Inovise Medical Liberty System is substantially equivalent to the Audicor<br>Cardiograph Expansion system (K032145) and the Mortara Instrument ELI 200+ |

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Liberty Modification to Audicor™ 510(k) Submission

with Audicor Electrocardiograph (K031182).

Technological Characteristics: The Liberty System and the predicate device are technologically equivalent in that both acquire 12 lead ECG and heart sounds data from adult patients then present the data in the COR report format which includes graphic display of MI and LVH conditions along with detection and display of S3 and S4 heart sounds.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 10565 SW Nimbus Avenue, Suite 100 Portland, OR 97223-4311

Re: K043074

Trade Name: Liberty System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 17, 2005 Received: February 18, 2005

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, IDrug, 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 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

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Page 2 -- Mr. Steve C. Hesler

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,

Brimima 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): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Liberty 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 COR report for consideration by physicians.

The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; or as a stand-alone electrocardiograph. 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 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
(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)

Bimmana
Divisio

Sign-Off

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