AUDICOR, HEMO AMBULATORY MONITOR by INOVISE MEDICAL, INC.

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 Description

The Audicor 200 is a stand-alone device that can be used to capture 10-second snapshots of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome.

The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabled laptop computer, is used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.

The Audicor system, when used with either a 10 wire or 4 wire patient cable analyzes and reports the following advanced parameters and a systolic dysfunction index (SDI) calculated from advanced parameters:

LVST ( Left Ventricular Systolic Time )
LVDT (Left Ventricular Diastolic Time)
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.

AI/ML Overview

The provided text describes modifications to the AUDICOR 200 system and the addition of an AUDICOR Hemo Ambulatory Monitor. However, it does not explicitly detail acceptance criteria or a study designed to prove the device meets specific performance criteria through statistical metrics (like sensitivity, specificity, or AUC) against a defined ground truth.

Instead, the document focuses on regulatory compliance and substantial equivalence to predicate devices, particularly regarding safety standards and technological characteristics.

Here’s a breakdown of what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document lists compliance with various safety and electrical standards (e.g., ANSI/AAMI EC-11, EN 60601-1, IEC 60601-2-25, IEC 60601-2-51, ANSI/AAMI EC38:1998 for the ambulatory component). While these are "performance standards" in the context of device safety and functionality, they are not framed as specific clinical acceptance criteria for diagnostic performance (e.g., a device must achieve X sensitivity for detecting Y condition).

2. Sample size used for the test set and the data provenance

This information is not provided. The document describes the device and its intended use but does not detail any specific clinical performance study with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided.

4. Adjudication method for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC comparative effectiveness study is not mentioned. The document describes the device's role in acquiring, analyzing, and reporting data for physicians' consideration, but it does not evaluate how the device "assists" human readers or the effect size of such assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study focused on algorithm-only performance with clinical metrics is not described. The device is intended "only when used in conjunction with physician over read as well as consideration of other relevant patient data." This strongly implies it is not a standalone diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided as no specific clinical performance study for diagnostic accuracy is detailed.

8. The sample size for the training set

This information is not provided as no machine learning algorithm training is explicitly described with specific data sets. The device "analyzes and reports" data, but the method of analysis for parameters like SDI is not detailed as a trained algorithm.

9. How the ground truth for the training set was established

This information is not provided.

Summary of Device and Regulatory Context (based on provided text):

The document is a "Summary of Safety and Effectiveness" for an update to the Inovise Medical AUDICOR 200 and the addition of the AUDICOR Hemo Ambulatory Monitor. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily the GE Medical Systems SEER Light Holter Recorder.

The substantial equivalence argument for the ambulatory component centers on:

Technological characteristics: Both are small, wearable, battery-powered devices that acquire ECG data using limited leads and store data in non-volatile memory for download.
Differences: The Audicor system requires proprietary sensors and performs analysis on recorded data, whereas the GE SEER Light does not.

The "study" referenced in the document is the set of tests performed to ensure compliance with recognized electrical and safety standards (e.g., AAMI, EN, IEC standards for electrocardiographs and ambulatory ECG devices). This means the device was demonstrated to operate safely and within electrical specifications, but not necessarily to achieve specific clinical diagnostic accuracy metrics in a patient population.

The device's intended use explicitly states that the ECG and heart sound data are "only significant when used in conjunction with physician over read as well as consideration of other relevant patient data," and it is for use "only under the direct supervision of a physician." This positions the system as a data acquisition and reporting tool that aids physicians, rather than a standalone diagnostic or interpretative device with its own diagnostic accuracy claims against a ground truth.

Summary

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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.10565 SW Nimbus Ave, Suite 100Portland, OR 97233-4311Phone 503-431-3849Fax 503-431-3801
Contact:	Kendra RathkeyManager, Quality and Regulatory
Date Prepared:	July 2, 2008
ProprietaryName:	Modification to AUDICOR 200
Common/ UsualName:	Electrocardiograph/Acoustic Cardiograph
Classification:	870.2340, DPS class II, Electrocardiograph870.1875, DQD, class II, Electronic Stethoscope870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program)
PerformanceStandards:	AAMI EC 11
Intended Use:	The Audicor® System, when used with AUDICOR Sensors on the chest wall, isintended for use in acquiring, analyzing and reporting ECG and heart sound dataand to provide interpretation of the data in an integrated ACG (acousticcardiograph) report for consideration by physicians. Audicor systems allowdetection, reporting and interpretation of standard ECG data as well as advancedparameters such as EMAT, LVST, S3 strength, S4 strength, and SDI.
	Data may be reported in a single snapshot report and in a trended report formatwhere multiple data points are trended over time. The Audicor system also acceptsand analyzes downloads of up to 48 hours of patient data from an optionalambulatory ECG/heart sounds collection device.
	ECG and heart sound data offered by the device are only significant when used inconjunction with physician over read as well as consideration of other relevantpatient data.
	The device is intended for use only under the direct supervision of a physician andis for use on adults (≥ 18 years).
DeviceDescription:	The Audicor 200 is a stand-alone device that can be used to capture 10-secondsnapshots of ECG and heart sounds in patients suspected of heart failure or acutecoronary syndrome.
	The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabledlaptop computer, is used to display and analyze patient data over time in a trendedformat. The trending system can be used in monitoring patient changes duringtherapeutic treatment or during CRT studies.
	The Audicor system, when used with either a 10 wire or 4 wire patient cableanalyzes and reports the following advanced parameters and a systolicdysfunction index (SDI) calculated from advanced parameters:
	LVST ( Left Ventricular Systolic Time )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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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 (240) 276-4095.

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:

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

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).