(266 days)
Not Found
No
The summary describes analysis and interpretation of ECG and heart sound data, but does not mention AI or ML algorithms being used for this analysis or interpretation. The performance studies listed are related to electrical safety and ECG standards, not AI/ML performance metrics.
No
The device is described as acquiring, analyzing, and reporting ECG and heart sound data for diagnostic purposes, and for monitoring during therapeutic treatment, but it does not directly treat or alleviate a medical condition itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device 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." This process of acquiring, analyzing, and interpreting data to aid physicians in understanding a patient's condition falls under the definition of a diagnostic device. Furthermore, the "Device Description" mentions its use in patients "suspected of heart failure or acute coronary syndrome," indicating its role in identifying or characterizing these conditions. The listed parameters like LVST, EMAT, and SDI are all diagnostic in nature.
No
The device description explicitly mentions "AUDICOR Sensors on the chest wall" and "Audicor 200 is a stand-alone device that can be used to capture 10-second snapshots of ECG and heart sounds". It also refers to "a combination of the Audicor 200 with an Audicor-enabled laptop computer" and "a 10 wire or 4 wire patient cable". These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Audicor® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Audicor System Function: The Audicor System acquires, analyzes, and reports ECG and heart sound data directly from the patient's chest wall using sensors. This is a non-invasive method of collecting physiological data from the body itself, not from a specimen taken from the body.
- Intended Use: The intended use describes the device as acquiring and analyzing ECG and heart sound data from the chest wall for consideration by physicians. This aligns with in vivo (within the living body) diagnostic methods, not in vitro.
Therefore, the Audicor System falls under the category of a medical device used for physiological monitoring and analysis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
MWJ
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.
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)
Intended User / Care Setting
only 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)
Test Summary & Conclusion: The Audicor System has been tested to the applicable requirements of the 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 .
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
§ 870.2800 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).
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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 100 | ||
| Portland, OR 97233-4311 | ||
| Phone 503-431-3849 | ||
| Fax 503-431-3801 | ||
| Contact: | Kendra Rathkey | |
| Manager, Quality and Regulatory | ||
| Date Prepared: | July 2, 2008 | |
| Proprietary | ||
| Name: | Modification to AUDICOR 200 | |
| Common/ Usual | ||
| Name: | Electrocardiograph/Acoustic Cardiograph | |
| Classification: | 870.2340, DPS class II, Electrocardiograph | |
| 870.1875, DQD, class II, Electronic Stethoscope | ||
| 870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program) | ||
| Performance | ||
| Standards: | AAMI EC 11 | |
| Intended Use: | 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) |
1
- 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol.
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.
3
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
4
Indications for Use
510(k) Number (if known): K073545
Device Name: Audicor Hemo Amonalastory,
Indications For Use:
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).
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