(87 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard signal acquisition and analysis.
No
The device is used for acquiring, analyzing, and reporting ECG and heart sound data for diagnostic purposes, and for monitoring patient changes during therapeutic treatment, but it does not directly administer therapy.
Yes
The device is intended for use in "acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data for consideration by physicians," indicating its role in diagnosis.
No
The device description explicitly states it is a "stand-alone device" that "can be used to capture 10-second evaluations of ECG and heart sounds," and it is used with "AUDICOR Sensors on the chest wall." This indicates the device includes hardware components for data acquisition (sensors and the stand-alone device itself), not just software.
Based on the provided information, the Audicor 200 System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Audicor 200 System's function: The Audicor 200 System acquires, analyzes, and reports ECG and heart sound data directly from the patient's chest wall using sensors. This is a non-invasive procedure that does not involve testing samples taken from the body.
Therefore, the Audicor 200 System falls under the category of a medical device used for physiological monitoring and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Audicor 200 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 report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.
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).
Product codes
DPS, DQD
Device Description
The Audicor 200 is a stand-alone device that can be used to capture 10-second evaluations of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. In addition the system can be connected to a compatible laptop computer and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
adults (> 18 years), patients over 40 years of age (for added interpretative statements)
Intended User / Care Setting
Physician, under the direct supervision of a physician.
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 200 System has been tested to the applicable requirements of the following standards, and shown to comply.
• 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 requirement for the safety of electrocardiographs
- AAMI EC 11 Diagnostic Electrocardiographic Devices .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Summary of Safety and Effectiveness
As required by 21 CFR, part 807.92
.....
:
111
| Submitted By: | Inovise Medical, Inc.
10565 SW Nimbus Ave, Suite 100
Portland, OR 97233-4311
Phone 503-431-3837
Fax 503-431-3801 | | APR 13 20 | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------|--|
| Contact: | Steve Hesler
Director, Quality and Regulatory | | | |
| Date Prepared: | January 15, 2007 | | | |
| Proprietary
Name: | SDI Modification to AUDICOR 200 System | | | |
| Common/ Usual
Name: | Electrocardiograph/Acoustic Cardiograph | | | |
| Classification: | 870.2340, DPS class II, Electrocardiograph | | | |
| | 870.1875, DQD, class II, Electronic Stethoscope | | | |
| Performance
Standards: | AAMI EC 11 | | | |
| Intended Use: | The Audicor 200 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 report for consideration by
physicians. In addition the Audicor 200 System can be used with an add-on laptop
computer that allows data to be presented in the format of real-time and trended
display of cardiac indices derived from simultaneous ECG data and heart sounds
data. | | | |
| | 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
Description: | The Audicor 200 is a stand-alone device that can be used to capture 10-second
evaluations of ECG and heart sounds in patients suspected of heart failure or
acute coronary syndrome. In addition the system can be connected to a
compatible laptop computer and 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. | | | |
| Test Summary &
Conclusion: | The Audicor 200 System has been tested to the applicable requirements of the
following standards, and shown to comply. | | | |
| | • 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 requirement
for the safety of electrocardiographs | | | |
APR 1 3 2007
:
1
- AAMI EC 11 Diagnostic Electrocardiographic Devices .
Substantial Equivalence: The Inovise Audicor 200 System with added interpretive statements is substantially equivalent to the AUDICOR® 200 system (K043074, cleared as Liberty) with the incorporation of Audicor Advanced Parameters (K051450, cleared as Extended Measurements)
Technological Characteristics:
The SDI modification to the Audicor 200 System and the AUDICOR 200 predicate device are technologically equivalent in that both acquire ECG and heart sounds data from adult patients then present the data in the AUDICOR report format which can include graphic display of MI and LVH conditions along with detection and display of S3 and S4 heart sounds. Both systems can analyze and display "Advanced Parameters" derived from ECG and heart sounds information to include:
- . Left Ventricular Systolic Time (LVST)
- Left Ventricular Diastolic Time (LVDT) ●
- Pre-atrial Diastolic Filling Time (PADT)
- Accelerated Atrial Filling Time (AAFT) ●
- QS1 (EMAT) .
- QS2 .
- . R-R Interval
- S3 Strength .
- S4 Strength .
- S1/S2 Intensity Ratio �
The SDI modification to the Audicor 200 System includes addition of a new parameter, the Systolic Dysfunction Index (SDI). The system will also display added interpretive statements when analysis of patient data warrants. The added statements, appropriate only for patients over 40 years of age, are:
- Prolonged EMAT, cconsider LV systolic dysfunction .
- Consider LV systolic dysfunction [reason block] .
- Consider severe LV systolic dysfunction with diastolic dysfunction freason . block]
- � Consider elevated LV filling pressure
- S3 detected -consider acute heart failure in presence of dyspnea
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2007
Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 10565 SW Nimbus Avenue, Suite 100 Portland, Oregon 97223-4311
Re: K070136
Trade Name: SDI Modification to AUDICOR® 200 System Regulation Number: 21 CFR 870.2340 and 870.1875 Regulation Name: Electrocardiograph and Stethoscope Regulatory Class: Class II Product Code: DPS and DQD Dated: January 15, 2007 Received: January 16, 2007
Dear Mr. Hessler:
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 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
3
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 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 (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.
Sincerely yours,
Bzemmema for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
SDI Modification to AUDICOR ® 200 System Device Name:
Indications For Use:
The Audicor 200 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 report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.
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)
B. Summa
ardiovi
Page 1 of 1