(161 days)
The Extended Measurements 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 COR report for consideration by physicians. In addition the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data.
The Extended Measurements System can be used as an add-on device to work in conjunction with an AUDICOR-enabled device, or as a stand-alone electrocardiograph.
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).
The Extended Measurements System is a software-based device that that can be installed into a compatible computer to communicate with an AUDICOR-capable device via a Blue tooth interface. The Extended Measurements system will also be offered as a stand-alone electrocardiograph/ monitoring device.
The provided text does not contain acceptance criteria or a
description of a study that proves the device meets acceptance criteria.
Instead, it is a 510(k) premarket notification summary for the AUDICOR® Extended Measurements System.
This document focuses on establishing substantial equivalence to a
predicate device (AUDICOR® 200 system, K043074) based on technological
characteristics and intended use, rather than presenting a performance
study against predefined acceptance criteria.
The "Test Summary & Conclusion" section mentions that the device was
tested to applicable requirements of certain standards (like ANSI/AAMI EC-11) and shown to comply. However, it does not
provide details of specific acceptance criteria for performance
metrics, nor the results of such tests in the context of what you're
asking for.
Therefore, I cannot provide the requested table or detailed study
information as it is not present in the given text.
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Inovise Medical, Inc.
Extended Measurements Modification to AUDICOR® 200 System
NOV 1 0 2005
Summary of Safety and Effectiveness
| As required by 21 CFR, part 807.92 | |
|---|---|
| Submitted By: | Inovise Medical, Inc.10565 SW Nimbus Ave, Suite 100Portland, OR 97233-4311Phone 503-431-3837Fax 503-431-3801 |
| Contact: | Steve HeslerDirector, Quality and Regulatory |
| Date Prepared: | May 30, 2005 |
| ProprietaryName: | Extended Measurements AUDICOR System |
| Common/ UsualName: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| PerformanceStandards: | AANSI/AAMI EC 11 |
| Intended Use: | The Extended Measurements System, when used with AUDICOR Sensors on thechest wall, is intended for use in acquiring, analyzing and reporting ECG and heartsound data and to provide interpretation of the data in an integrated COR report forconsideration by physicians. In addition the data can be presented in the format ofreal-time and trended display of cardiac indices derived from simultaneous ECGdata and heart sounds data.The Extended Measurements System can be used as an add-on device to work inconjunction with an AUDICOR-enabled device, or as a stand-aloneelectrocardiograph.The interpretations of ECG and heart sound data offered by the device are onlysignificant when used in conjunction with physician over read as well asconsideration of other relevant patient data.The device is intended for use only under the direct supervision of a physician, andis for use on adults (≥ 18 years). |
| DeviceDescription: | The Extended Measurements System is a software-based device that that can beinstalled into a compatible computer to communicate with an AUDICOR-capabledevice via a Blue tooth interface. The Extended Measurements system will alsobe offered as a stand-alone electrocardiograph/ monitoring device. |
| Test Summary &Conclusion: | The Extended Measurements System was tested to the applicable requirements ofthe 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: GeneralRequirements for Safety EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: GeneralRequirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests IEC 60601-2-25 Medical Electrical Equipment Part 2: Particular requirementsfor the safety of electrocardiographs |
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Substantial Equivalence:
The Inovise Medical Extended Measurements System is substantially equivalent to the AUDICOR® 200 system (K043074, cleared as Liberty).
Technological Characteristics:
The Extended Measurements System and the AUDICOR 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.
The Extended Measurements System adds the capability of displaying and monitoring cardiac indices derived form the ECG and hearts sounds information. These indices 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 Evidence
- S4 Evidence .
- S1 Intensity .
- S2 Intensity t
- S1/S2 Intensity Ratio ↓
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Public Health Service
NOV 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Hesler Director, Quality and Regulatory Inovise Medical Inc. 10565 SW Nimbus Ave, Suite 100 Portland, OR 97223-4311
Re: K051450
Trade Name: AUDICOR® Extended Measurements System Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: May 31, 2005 Received: June 2, 2005
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 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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmar for
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
510(k) Number (if known): K051450
Extended Measurements AUDICOR System Device Name:
Indications For Use:
The Extended Measurements 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 COR report for consideration by physicians. In addition, the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data.
The Extended Measurements System can be used as an add-on device to work in conjunction with an Audicor-enabled device, or as a stand-alone electrocardiograph.
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)
Bhumimmar
Division of Cardlovascular Devices
Page 1 of 1
§ 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.