(106 days)
The Liberty 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.
The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; 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 Liberty System is a pocket PC-based device that that can be used to allow clinicians access to the COR (correlated audioelectric cardiography) report including graphical display of MI, Ischemia, and LVH conditions as well as display of heart sound waveforms and identification of S3 and S4 heart sounds.
Here is an analysis of the provided text regarding the Liberty System, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device's diagnostic performance and its reported performance against those criteria. Instead, the "Test Summary & Conclusion" section focuses on compliance with established safety and electrical standards.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| Safety and Electrical Standards Compliance | • ANSI/AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices | Shown to comply |
| • ANSI/AAMI EC 53 ECG Cables and Leadwires | Shown to comply | |
| • EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | Shown to comply | |
| • IEC 60601-2-25 Medical Electrical Equipment Part 2: Particular requirements for the safety of electrocardiographs | Shown to comply | |
| • UL 60601-1 Standard for Medical Electrical Equipment: General Requirements for Safety | Shown to comply | |
| Technological Equivalence to Predicate Device | • Acquire 12 lead ECG and heart sounds data from adult patients | Stated to be technologically equivalent to predicate device |
| • Present data in COR report format | Stated to be technologically equivalent to predicate device | |
| • Include graphic display of MI and LVH conditions | Stated to be technologically equivalent to predicate device | |
| • Detect and display S3 and S4 heart sounds | Stated to be technologically equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's diagnostic performance or its ability to identify MI, Ischemia, LVH, S3, or S4 heart sounds. The "Test Summary & Conclusion" refers to compliance with performance standards (like ANSI/AAMI EC-11), which typically involve electrical and functional testing, not clinical diagnostic accuracy studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As no specific test set for diagnostic performance is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. The focus is on the device's ability to acquire and interpret data for physician consideration, but not on a comparative study of physician performance.
6. Standalone (Algorithm Only) Performance Study
While the device's description mentions it "provides interpretation of the data," and "interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read," the document does not present any standalone performance study data (e.g., sensitivity, specificity, accuracy) of the algorithm's interpretation capabilities without human-in-the-loop performance. Its primary claim of equivalence is based on technological characteristics to a predicate device, not on independent diagnostic performance metrics.
7. Type of Ground Truth Used
Given the lack of a described diagnostic performance study, the document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The evaluation appears to be based on compliance with electrical and functional standards and technological equivalence, rather than clinical diagnostic outcome agreement.
8. Sample Size for the Training Set
The provided document does not mention any training set size for the device's algorithms or interpretation capabilities. This implies either that the device uses rule-based algorithms or that any training data used for its interpretation models was not deemed relevant for this 510(k) submission, which focuses on technological equivalence and compliance with established product standards.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is also not provided.
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Summary of Safety and Effectiveness
| 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: | November 4, 2004 |
| ProprietaryName: | Liberty System |
| Common/ UsualName: | Electrocardiograph |
| Classification: | 870.2340, 74 DPS |
| PerformanceStandards: | AANSI/AAMI EC 11 |
| Intended Use: | The Liberty System, when used with Audicor Sensors on the chest wall, isintended for use in acquiring, analyzing and reporting ECG and heart sound dataand to provide interpretation of the data in an integrated COR report forconsideration by physicians. |
| The Liberty System can be used as an add-on device to work in conjunction withselect cardiographs, defibrillators, and patient monitors; or as a stand-aloneelectrocardiograph. The interpretations of ECG and heart sound data offered bythe device are only significant when used in conjunction with physician over readas well as consideration 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 Liberty System is a pocket PC-based device that that can be used to allowclinicians access to the COR (correlated audioelectric cardiography) reportincluding graphical display of MI, Ischemia, and LVH conditions as well as displayof heart sound waveforms and identification of S3 and S4 heart sounds. |
| Test Summary &Conclusion: | The Liberty System was tested to the applicable requirements of the followingstandards, and shown to comply. |
| • ANSI/AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices | |
| • ANSI/AAMI EC 53 ECG Cables and Leadwires | |
| • 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 requirements forthe safety of electrocardiographs | |
| • UL 60601-1 Standard for Medical Electrical Equipment: General Requirementsfor Safety | |
| SubstantialEquivalence: | The Inovise Medical Liberty System is substantially equivalent to the AudicorCardiograph Expansion system (K032145) and the Mortara Instrument ELI 200+ |
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Liberty Modification to Audicor™ 510(k) Submission
with Audicor Electrocardiograph (K031182).
Technological Characteristics: The Liberty 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.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 10565 SW Nimbus Avenue, Suite 100 Portland, OR 97223-4311
Re: K043074
Trade Name: Liberty System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 17, 2005 Received: February 18, 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, IDrug, 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 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
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Page 2 -- Mr. Steve C. Hesler
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,
Brimima 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): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Liberty 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.
The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; 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)
Bimmana
Divisio
Sign-Off
Page 1 of 1
§ 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).