(109 days)
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).
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.
The provided document is a 510(k) summary for the Audicor™ Upgrade System. It describes the device's intended use and substantial equivalence to a predicate device, but does not contain information about specific acceptance criteria or a detailed study proving the device meets said criteria beyond compliance with performance standards.
Instead, the document states: "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."
Therefore, I cannot populate most of the requested fields as the detailed study information is not present in the provided text.
Here is what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance:
| Feature/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Standards | Compliance with: UL 2601-1, IEC 60601-2-25, EN 60601-1-2, ANSI/AAMI EC 11 | Device shown to comply with these applicable requirements. Laboratory and bench testing indicates compliance. |
| Functional Equivalence to Predicate Device | The device should acquire 12-lead ECG and heart sounds data, present data in COR report format, include graphic display of MI and LVH conditions, and detect/display S3 and S4 heart sounds, similar to the Mortara Instrument ELI 200+ with Audicor Electrocardiograph (K031182). | The Audicor Upgrade System performs all these functions, technologically equivalent to the predicate device. |
| Safety and Effectiveness | The device should raise no new questions with regard to safety and efficacy compared to the predicate device. | The device "raises no new questions with regard to safety and efficacy" compared to the predicate device. |
| ECG Waveform Acquisition | Yes (implied: accurate acquisition via host lead set) | Yes (through host lead set) |
| Interprets ECG Waveform Data | Yes (implied: accurate interpretation) | Yes |
| ECG Waveform Report Output | Yes (implied: clear and accurate output) | Yes |
| LVH Detection Algorithm | Yes (implied: effective detection) | Yes |
| MI (prior) Detection Algorithm | Yes (implied: effective detection) | Yes |
| MI (acute) Detection Algorithm | Yes (implied: effective detection) | Yes |
| Heart Sounds Waveform Acquisition | Yes (implied: accurate acquisition) | Yes |
| Displays S1 - S4 Heart Sounds | Yes (implied: accurate display) | Yes (with informational statements) |
| Analysis Test Report Output | Yes (implied: clear and accurate output) | Yes, single format (Predicate had multiple formats, but single format is acceptable for substantial equivalence) |
| Graphical Representation of MI and LVH Analysis | Yes (implied: accurate and clear graphical representation) | Yes |
Study Information (Based on the provided text):
-
2. Sample size Used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document only mentions "Laboratory and bench testing" and "engineering/design level tests."
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A formal MRMC study is not described. The device's interpretation features are intended "for consideration by physicians" and are "only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data." This implies a human-in-the-loop scenario, but no specific study quantifying human improvement with AI assistance is detailed.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device's interpretations are not standalone, as they require "physician overread." No standalone performance metrics are provided.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified.
-
8. The sample size for the training set:
- Not specified. The document does not describe the development or training of any algorithms, only testing for compliance and equivalence.
-
9. How the ground truth for the training set was established:
- Not specified.
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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 CNewberg, OR 97132Phone 503-554-4291Fax 503-538-8868 |
|---|---|
| Contact: | Steve HeslerDirector, Quality and Regulatory |
| Date SummaryPrepared: | July 10, 2003 |
| Proprietary Name: | Audicor™ Upgrade System |
| Common/UsualName: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| PerformanceStandards: | UL 2601-1IEC 60601-2-25EN 60601-1-2ANSI/AAMI EC 11 |
| Intended Use: | The Audicor Upgrade System, when used with Audicor Sensors in the V3and V4 positions on the chest wall, is intended for use in acquiring,analyzing and reporting ECG and heart sounds (phonocardiograph) dataand to provide interpretation of the data for consideration by physicians. |
| The Audicor Upgrade System is an add-on device designed to work withthe following electrocardiographs:GE Mac 8GE Mac VuGE Mac 5000Philips Pagewriter XLThe interpretations of ECG and heart sound data offered by the device areonly significant when used in conjunction with physician overread as wellas consideration of all other relevant patient data.The device is intended for use only under the direct supervision of aphysician, and is for use on adults (≥ 18 years). | |
| Device Description: | The Audicor Upgrade System is a pocket PC with proprietary software thatcan be used with several models of existing electrocardiographs to allowclinicians access to the COR (correlated audioelectric cardiography) reportincluding graphical display of MI and LVH conditions as well as display ofheart sound waveforms and identification of S3 and S4 heart sounds. |
| Test Summary &Conclusion: | The Audicor Upgrade System was tested to the applicable requirements ofthe performance standards, and shown to comply. Laboratory and benchtesting indicates compliance to the standard.Based on the results of the engineering/design level tests, it is concludedthat the Audicor Upgrade System performs as expected and compareswell, in terms of overall performance to the selected predicate devices and |
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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. | |
|---|---|
| SubstantialEquivalence: | The Inovise Medical Audicor Upgrade System is substantially equivalent tothe Mortara Instrument ELI 200+ with Audicor Electrocardiograph(K031182). |
| TechnologicalCharacteristics: | The Audicor Upgrade System and the predicate device are technologicallyequivalent in that both acquire 12 lead ECG and heart sounds data fromadult patients then present the data in the COR report format whichincludes graphic display of MI and LVH conditions along with detectionand display of S3 and S4 heart sounds. |
Predicate Device Comparison Table
| Feature | ELI 200+ Electrocardiographwith Audicor COR | Audicor Digital UpgradeBox System |
|---|---|---|
| Manufacturer | Mortara Instrument, Inc. | Inovise Medical, Inc. |
| 510(k) Identifier | K031182 | |
| ECG Waveform Acquisition | Yes | Yes (through host lead set) |
| Interprets ECG WaveformData | Yes | Yes |
| ECG Waveform ReportOutput | Yes | Yes |
| LVH Detection Algorithm | Yes | Yes |
| MI (prior) DetectionAlgorithm | Yes | Yes |
| MI (acute) DetectionAlgorithm | Yes | Yes |
| Heart Sounds WaveformAcquisition | Yes | Yes |
| Displays S1 - S4 HeartSounds | Yes | Yes (with informationalstatements) |
| Analysis Test Report Output | Yes, multiple formats | Yes, single format |
| Printer | Built into unit | Separate printer |
| Graphical Representation ofMI and LVH AnalysisStatements | Yes | Yes |
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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.
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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
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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
§ 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).