(66 days)
Not Found
No
The summary describes sensors and adapters for capturing ECG and heart sound data, but there is no mention of AI or ML being used for data processing, analysis, or interpretation. The performance studies focus on compliance with standards for electrodes and biological evaluation.
No
The device is described as a diagnostic tool for evaluating patient status, aiding in diagnosis, and determining the effects of treatment, rather than providing therapy itself.
Yes
The "Intended Use / Indications for Use" states that the device is used "to aid in diagnosis and determine effects of treatment on ECG and hemodynamics."
No
The device description explicitly mentions "Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data" and "The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds," indicating the presence of hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Audicor Sensors with Adapters are described as transducers that capture ECG (electrocardiogram) and heart sounds directly from the patient's chest wall. This is a non-invasive method of collecting physiological data from within the body, not from a specimen taken from the body.
- Intended Use: The intended use is for evaluating patient status, aiding in diagnosis, and determining treatment effects based on this directly captured physiological data.
Therefore, the Audicor Sensors with Adapters fall under the category of devices that collect physiological signals directly from the patient, not devices that analyze specimens in vitro.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRX, DQD
Device Description
The Audicor Sensors with Adapters 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: Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 4.0). Reusable sensors (Sensor 3.0).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall in the V3 and V4 positions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Audicor sensors have been tested to the applicable requirements of the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
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.
3
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
4
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