AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 by INOVISE MEDICAL, INC.

The Audicor ™ Sensors with Adapters are a family of dual-function transducers for use on patients where combined ECG/heart sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System.

There are disposable and reusable versions of the Audicor Sensor component. Both can be used in the recording of resting ECG / heart sound reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.

Device Description

The Audicor sensors/adapters included in this submission are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data. The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds. The sensor and adapter devices are intended for use on the chest wall in the V3 and V4 positions. Audicor sensors are available in two versions: 1) Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 4.0) 2) Reusable sensors (Sensor 3.0)

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the AUDICOR™ Sensor 4.0 with Adapter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies for a specific study is not available within the provided text.

Here's what can be extracted based on your requested format, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document as performance criteria against a clinical outcome or diagnostic accuracy.	The device is stated to "comply" with specific standards. However, actual performance metrics (e.g., sensitivity, specificity, accuracy) are not presented.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. The document describes testing against engineering standards (ANSI/AAMI EC12:2000, ISO 10993-1:2009), not a clinical test set with patient data for diagnostic evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The "testing" referred to in the document is against engineering standards, not against a clinical ground truth established by experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The document does not mention any MRMC study.
Effect Size with AI vs. Without AI: Not applicable. This device is a sensor, not an AI diagnostic tool that assists human readers in interpretive tasks.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study Done: No. The document focuses on the device's technical specifications and equivalence to a predicate device.

7. Type of Ground Truth Used

Type of Ground Truth: The document refers to compliance with engineering and biocompatibility standards (ANSI/AAMI EC12:2000 for disposable ECG electrodes and ISO 10993-1:2009 for biological evaluation). There is no mention of a "ground truth" in the diagnostic or clinical sense.

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This document does not describe an AI/machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable.

Summary of what the document does provide:

Performance Standards: The device was tested to and shown to comply with:
- ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
- ISO 10993-1:2009 – Biological Evaluation of Medical Devices - Evaluation and testing.
Substantial Equivalence: The primary basis for this 510(k) submission is to demonstrate substantial equivalence to the AUDICOR™ Sensor 2.0 (K080602), based on modifications such as replacing the microphone transducer with an accelerometer and moving the heart sound transducer function to the adapter.
Intended Use: Dual-function transducers for combined ECG/heart sounds data for evaluation of patient status, diagnosis aid, and determining treatment effects on ECG and hemodynamics.
Device Description: Sensors designed with conductive patient-contact surfaces for ECG data and an accelerometer in the mating cable adapter for heart sounds. Used on the chest wall in V3 and V4 positions. Available in disposable and reusable versions.

Summary

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K1035/6

Inovise Medical, Inc. Sensors 13 of 199

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510(k) Notification, Modification to AUDICOR

FEB - 4 2011

5 510(k) Summary

Summary of Safety and Effectiveness

As required by 21 CFR, part 807.92 Inovise Medical, Inc. Submitted By: 8770 SW Nimbus Avenue Suite D Beaverton, OR 97008-7196 Phone: (503) 431-3800 Toll Free: (877) 466-8473 Fax: (503) 431-3801 Contact: Earl Anderson Director, Quality and Regulatory Date Prepared: November 19, 2010 AUDICOR™ Sensor 4.0 with Adapter (Modification to AUDICOR™ Sensor 2.0 with Proprietary Name: Adapter) Common/ Usual ECG/ Heart Sound Sensor Name: Classification: 870.2360, DRX, class II, Electrocardiograph electrode 870.1875, DQD, class II, Stethoscope, electronic Performance ANSI/AAMI EC12:2000 Standards: The Audicor® Sensors with Adapters are a family of dual-function transducers for Intended Use: use on patients where combined ECG/heart sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System. There are disposable and reusable versions of the Audicor Sensor. Both can be used in the recording of resting ECG / heart sound reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours. The Audicor Sensors with Adapters are a group of devices that are intended for Device use with Audicor-enabled ECG/heart sounds detections systems. Sensors are Description: designed with conductive patient-contact surfaces to enable capture of ECG data. The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds. The sensor and adapter devices are intended for use on the chest wall in the V3 and V4 positions. Audicor sensors are available in two versions: Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 1) 4.0) 2) Reusable sensors (Sensor 3.0) Predicate Device: AUDICOR™ 2.0 Sensor -510(k) K080602

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510(k) Notification, Modification to AUDICOR Inovise Medical, Inc. Sensors 14 of 199 Test Summary The Audicor sensors have been tested to the applicable requirements of the & Conclusion: following standards, and shown to comply. ANSI/AAMI EC12:2000 – Disposable ECG Electrodes . . ISO 10993-1:2009, Biological Evaluation of Medical Devices - Evaluation and testing. The Audicor Sensors are substantially equivalent to the Audicor™ Sensor 2.0 Substantial (K080602). Modifications include: Equivalence: Replacement of the sensor microphone transducer with an accelerometer . transducer Heart sound transducer function moved from the disposable sensor to the . mating cable adapter head. The Audicor sensors/adapters included in this submission are technologically . Technological equivalent to the predicate in that both are dual function sensors (ECG/heart Characteristics: sounds detection) and are designed for use with Audicor-enabled ECG/heart sounds systems.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Inovise Medical, Inc. c/o Mr. Earl Anderson Quality and Regulatory Director 8770 SW Nimbus Avenue, Suite D Beaverton, OR 97008-7196

FEB - 4 201

Re: K103516

Trade/Device Name: AUDICOR™ Sensor 4.0 with Adapter Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD, DRX Dated: November 19, 2010 Received: November 30, 2010

Dear Mr. Anderson:

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 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. Earl Anderson

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 aft 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm far. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W. MacP.

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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Inovise Medical, Inc. Sensors 12 of 199

4 Indications for Use Statement

510(k) Number (if known): K103516

Device Name:____AUDICOR™ Sensor 4.0 with Adapter

Indications For Use:

Prescription Use X (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)

W. Wood.

(Division Sian-Off) ardiovascular Dev

510(k) Number K103516

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general 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.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.