(109 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on proprietary software for data analysis and display, not learning algorithms.
No.
The device is intended for acquiring, analyzing, and reporting ECG and heart sound data for physician consideration, not for direct treatment or therapy.
Yes
The device acquires, analyzes, and reports ECG and heart sound data to provide an interpretation for consideration by physicians, which is a diagnostic function.
No
The device description explicitly states it is a "pocket PC with proprietary software," indicating it includes hardware (the pocket PC) in addition to the software.
Based on the provided information, the Audicor™ Upgrade System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Audicor Upgrade System acquires and analyzes ECG and heart sound data directly from the patient's chest wall (V3 and V4 positions). It does not process biological samples like blood, urine, or tissue.
- The intended use describes direct patient interaction. The system is used with sensors placed on the chest wall to acquire physiological signals.
- The device description focuses on analyzing electrical and acoustic signals. It processes ECG and heart sound waveforms, not biological markers or substances.
Therefore, the Audicor Upgrade System falls under the category of a medical device that acquires and analyzes physiological data from the patient, rather than an IVD which analyzes specimens taken from the patient.
N/A
Intended Use / Indications for Use
The Audicor Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians. The Audicor Upgrade System is an add-on device designed to work with the following electrocardiographs: GE Mac 8, GE Mac Vu, GE Mac 5000, Philips Pagewriter XL. The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician overread as well as consideration of all 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
Device Description
The Audicor Upgrade System is a pocket PC with proprietary software that can be used with several models of existing electrocardiographs to allow clinicians access to the COR (correlated audioelectric cardiography) report including graphical display of MI and LVH conditions as well as display of heart sound waveforms and identification of S3 and S4 heart sounds.
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
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 Upgrade System was tested to the applicable requirements of the performance standards, and shown to comply. Laboratory and bench testing indicates compliance to the standard. Based on the results of the engineering/design level tests, it is concluded that the Audicor Upgrade System performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy.
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
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
OCT 3 1 2003
Audicor™ Upgrade System
Summary of Safety and Effectiveness
As required by 21 CFR, part 807.92
| Submitted By: | Inovise Medical, Inc.
1025 Industrial Parkway, Suite C
Newberg, OR 97132
Phone 503-554-4291
Fax 503-538-8868 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Steve Hesler
Director, Quality and Regulatory |
| Date Summary
Prepared: | July 10, 2003 |
| Proprietary Name: | Audicor™ Upgrade System |
| Common/Usual
Name: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| Performance
Standards: | UL 2601-1
IEC 60601-2-25
EN 60601-1-2
ANSI/AAMI EC 11 |
| Intended Use: | The Audicor Upgrade System, when used with Audicor Sensors in the V3
and V4 positions on the chest wall, is intended for use in acquiring,
analyzing and reporting ECG and heart sounds (phonocardiograph) data
and to provide interpretation of the data for consideration by physicians. |
| | The Audicor Upgrade System is an add-on device designed to work with
the following electrocardiographs:
GE Mac 8
GE Mac Vu
GE Mac 5000
Philips Pagewriter XL
The interpretations of ECG and heart sound data offered by the device are
only significant when used in conjunction with physician overread as well
as consideration of all 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 Upgrade System is a pocket PC with proprietary software that
can be used with several models of existing electrocardiographs to allow
clinicians access to the COR (correlated audioelectric cardiography) report
including graphical display of MI and LVH conditions as well as display of
heart sound waveforms and identification of S3 and S4 heart sounds. |
| Test Summary &
Conclusion: | The Audicor Upgrade System was tested to the applicable requirements of
the performance standards, and shown to comply. Laboratory and bench
testing indicates compliance to the standard.
Based on the results of the engineering/design level tests, it is concluded
that the Audicor Upgrade System performs as expected and compares
well, in terms of overall performance to the selected predicate devices and |
1
Image /page/1/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the number '0', then '3', '2', '1', '4', and finally '5'. The digits are written in a simple, slightly irregular style, typical of handwriting.
:
Audicor™ Upgrade System
| raises no new questions with regard to safety and efficacy. | |
|---|---|
| Substantial | |
| Equivalence: | The Inovise Medical Audicor Upgrade System is substantially equivalent to |
| the Mortara Instrument ELI 200+ with Audicor Electrocardiograph | |
| (K031182). | |
| Technological | |
| Characteristics: | The Audicor Upgrade System and the predicate device are technologically |
| equivalent in that both acquire 12 lead ECG and heart sounds data from | |
| adult patients then present the data in the COR report format which | |
| includes graphic display of MI and LVH conditions along with detection | |
| and display of S3 and S4 heart sounds. |
Predicate Device Comparison Table
| Feature | ELI 200+ Electrocardiograph
with Audicor COR | Audicor Digital Upgrade
Box System |
|------------------------------------------------------------------|-------------------------------------------------|----------------------------------------|
| Manufacturer | Mortara Instrument, Inc. | Inovise Medical, Inc. |
| 510(k) Identifier | K031182 | |
| ECG Waveform Acquisition | Yes | Yes (through host lead set) |
| Interprets ECG Waveform
Data | Yes | Yes |
| ECG Waveform Report
Output | Yes | Yes |
| LVH Detection Algorithm | Yes | Yes |
| MI (prior) Detection
Algorithm | Yes | Yes |
| MI (acute) Detection
Algorithm | Yes | Yes |
| Heart Sounds Waveform
Acquisition | Yes | Yes |
| Displays S1 - S4 Heart
Sounds | Yes | Yes (with informational
statements) |
| Analysis Test Report Output | Yes, multiple formats | Yes, single format |
| Printer | Built into unit | Separate printer |
| Graphical Representation of
MI and LVH Analysis
Statements | Yes | Yes |
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo is circular and contains text around the perimeter. Inside the circle is a symbol that resembles three curved lines stacked on top of each other. The logo appears to be a seal or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 1025 Industrial Parkway, Suite C Newberg, OR 97132
Re: K032145
Trade Name: Audicor™ Upgrade System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 9, 2003 Received: October 14, 2003
Dear Mr. Hesler:
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.
3
Page 2 -- Mr. Steve C. Hesler
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 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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dra Husher for
Dr. D. Zusher, MD
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 Statement
Applicant: Inovise Medical, Inc. 510(k) Number (if known): Device Name: Audicor™ Upgrade System
Indications for use:
The Audicor™ Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians.
The Audicor System is an add-on device designed to work with the following electrocardiographs:
GE Mac 8 GE Mac Vu GE Mac 5000 Philips Pagewriter XL
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 all 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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Dra Stexhu
510(k) Number K037 K032145