AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0

K103516 · Inovise Medical, Inc. · DQD · Feb 4, 2011 · Cardiovascular

Device Facts

• Record ID: K103516
• Device Name: AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
• Applicant: Inovise Medical, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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 Story

Dual-function transducer system; captures ECG and heart sounds via chest wall placement (V3/V4 positions). System consists of sensor and mating cable adapter. Sensor 4.0 modification moves heart sound transducer from disposable sensor to cable adapter head; replaces microphone with accelerometer. Used with compatible Audicor-enabled systems for resting reports or monitoring up to 48 hours. Data processed by Audicor system to aid clinicians in evaluating patient status and hemodynamic treatment effects.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI EC12:2000 (Disposable ECG Electrodes) and ISO 10993-1:2009 (Biological Evaluation of Medical Devices) confirmed.

Technological Characteristics

Dual-function transducer (ECG/heart sound). Sensor 4.0 uses accelerometer for heart sound detection. Designed for V3/V4 chest wall placement. Compatible with Audicor-enabled systems. Disposable and reusable versions available. Complies with ANSI/AAMI EC12:2000 and ISO 10993-1:2009.

Indications for Use

Indicated for patients requiring combined ECG and heart sound data for evaluation of patient status, diagnostic aid, and monitoring treatment effects on ECG and hemodynamics. Disposable sensors indicated for short-term and long-term monitoring up to 48 hours.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• AUDICOR™ 2.0 Sensor (K080602)

Submission Summary (Full Text)

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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: [phone] Toll Free: [phone] Fax: [phone] 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 [phone] or [phone] 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:

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.

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