(179 days)
The Cardiovascular Sonospectrographic Analyzer (CSA) is intended for use in health care environments and setting where conventional stethoscopes (both electronically augmented and non-augmented) and phonocardiographs are used by health care professionals for the auscultation, graphical representation, measurement and archiving of cardiovascular, pulmonary, and other such sounds, both normal and abnormal, as produced by the human body. The CSA is a medical instrument intended for use by, or at the direction of, a qualified health care professional as a diagnostic aid for the clinical assessment and discrimination of acoustic patterns relating to or caused by clinically significant pathologies and medical conditions as known, defined, or specified in standard medical auscultation/phonocardiographic reference textbooks, peer review journals, and medically approved auscultation training materials. The CSA is further intended for the monitoring of interventional or prophylactic therapies that are susceptible to the level of medical efficacy provided by CSA and as is clinically indicated at the discretion of the physician. The CSA is also intended for use in telemedical applications where medical acoustic experts are indicated or desired.
Limitations on Intended Use: The CSA is not intended for use on a singular basis for delivery of health care, not as a standalone diagnostic aid for evaluation of cardiovascular conditions and pathologies for which other more suitable diagnostic tools or medical procedures are available or indicated.
The Cardiovascular Sonospectrographic Analyzer (CSA) is a cardiovascular acoustic detection system. The CSA is a passive, non-invasive means of detecting, processing and displaying human physiologic acoustic data as an aide/adjunct to the clinician in diagnosing conditions. It is useable in all applications where clinicians have traditionally used the stethoscope. However, through the use of ultra-sensitive acoustic detection technology, digital signal processing and a Fast Fourier Transform (FFT), the CSA is able to detect, process and display physiologic acoustic signals from the human body that are as little as 1,000,000 times less than the peak acoustic energy level of a heart sound.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiovascular Sonospectrographic Analyzer (CSA):
Based on the provided document, the Cardiovascular Sonospectrographic Analyzer (CSA) is presented as substantially equivalent to its predicate device, the Transmedica Digital Electronic Stethoscope (DES) (510(k) 963418). The core argument for acceptance is this substantial equivalence rather than a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
The document heavily emphasizes that the CSA's primary advancements are in automating the analysis process and improving the efficiency of software for displaying derived data, while the underlying hardware and signal processing techniques (Fast Fourier Transform) remain essentially the same as the predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (DES) | Claimed Substantial Equivalence: The CSA hardware is "essentially the same as the DES predicate device." The basic digital signal processing algorithms and displays are "equivalent." Both devices are based on the "same processing standards." There is "full backwards and forward compatibility of the recorded cardiovascular physio-acoustic data." |
| Electromagnetic Compatibility (EMC) | Compliance with Standards: The device performs according to the following standards: - RF Emissions: CISPR-11/IEC-601-1-2 (modified) UL 2601 - Magnetic Fields: RE101(mod) MIL-STD-461D - Electrostatic Discharges (Immunity): IEC 801-2 - Radiated EM Fields (Immunity): IEC 601-1-2 (modified) - AC Voltage Fluctuations Transients and Surges: Guidelines per Para. (M) (7) and sub-para.C (2) |
| Mechanical and Environmental Safety | Compliance with Standards/Specifications: The device performs according to: - Controls Protection: Company design specifications - Connector Protective: Company design specifications - Mechanical Safety: Company design specifications - Vibration and Shock Resistance: Company design specifications - Fluid Spill Resistance: IEC-601 (44.6) IEC 529 - Temperature and Humidity: Company design specifications - Surface Temperature: Company design specifications - Toxic Materials: No toxic materials from the device come into contact with the patient or operator during use |
| Intended Use Safety & Effectiveness (implied) | Claimed Safety and Effectiveness: "Does not use any form of radiation, contains no physical properties or features that present a risk, use no chemicals and has no design elements that also manifest a risk, it is further concluded that it is safe and effective for its intended use." This is based on substantial equivalence and lack of new risks compared to the predicate. |
Study Information
The document does not describe a new clinical study to prove the device meets performance acceptance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it relies on the concept of substantial equivalence to a previously cleared predicate device.
Here's why no specific information is provided for points 2-9:
- Sample size used for the test set and the data provenance: Not applicable, as no new clinical performance study is described. The document states that "the clinical data acquired by the DES is 100% compatible with the CSA and data acquired by the CSA is fully backwards compatible and can be processed and analyzed using the DES software," suggesting data from the predicate could be used, but no new test set performance data is reported.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical performance study is described.
- Adjudication method for the test set: Not applicable, as no new clinical performance study is described.
- 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: Not applicable. The device is not presented as an AI-assisted diagnostic tool that improves human reader performance in a controlled MRMC study. Its primary advancement is automating the visualization of data derived from an existing, cleared technology. The document describes it as a "diagnostic aid" for "clinical assessment and discrimination of acoustic patterns" rather than an AI with a specific "effect size" on human performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is explicitly described as an adjunct: "as an aide/adjunct to the clinician in diagnosing conditions" and "not intended for use on a singular basis for delivery of health care, not as a standalone diagnostic aid."
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new clinical performance study is described.
- The sample size for the training set: Not applicable. The device is a signal processing and display system, not a machine learning model that requires a distinct training set in the modern sense. Its "training" (development) was based on established scientific medical literature and techniques used in the predicate device.
- How the ground truth for the training set was established: Not applicable for the reasons stated above. The system processes and displays signals, rather than being "trained" on a ground truth dataset in the way an AI model would be.
Summary of Approach:
The submission for the Cardiovascular Sonospectrographic Analyzer (CSA) relies entirely on a substantial equivalence (SE) argument. The acceptance criteria primarily revolve around demonstrating that the new device is as safe and effective as the predicate device by showing:
- Similar intended use.
- Similar technological characteristics (hardware is "essentially the same," core signal processing is identical).
- Differences (primarily software automation for display and analysis) do not raise new questions of safety or effectiveness.
No new clinical performance studies are described within this section of the 510(k) summary, as the submission aims to show "equivalence" rather than a novel claim requiring new clinical validation data.
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SE 5.6.02 510(k) submission Cardiovascular Sonospectrographic Analyzer
APPENDIX G
510(K) Summary
DATE: November, 2002
SonoMedica LLC Applicant: 8239 Leesburg Pike Vienna. Virginia 22182 703-448-4300 Fax: 703-734-0410
Sailor Mohler, Executive Vice President, Chief Technology Officer Contact: Phone: Fax:
Predicate Device:
Transmedica: Digital Electronic Stethoscope 510(k) 963418 910(k) 905410
CFR section: 米米米 CFR section: XXXX
Device Description
The Cardiovascular Sonospectrographic Analyzer (CSA) is a cardiovascular acoustic detection The CSA is a passive, non-invasive means of detecting, processing and displaying svstem. human physiologic acoustic data as an aide/adjunct to the clinician in diagnosing conditions. It is useable in all applications where clinicians have traditionally used the stethoscope. However, through the use of ultra-sensitive acoustic detection technology, digital signal processing and a Fast Fourier Transform (FFT), the CSA is able to detect, process and display physiologic acoustic signals from the human body that are as little as 1,000,000 times less than the peak acoustic energy level of a heart sound.
Intended Use
The Cardiovascular Sonospectrographic Analyzer (CSA) is intended for use in health care environments and setting where conventional stethoscopes (both electronically augmented and non-augmented) and phonocardiographs are used by health care professionals for the auscultation, graphical representation, measurement and archiving of cardiovascular, pulmonary, and other such sounds, both normal and abnormal, as produced by the human body. The CSA is a medical instrument intended for use by, or at the direction of, a qualified health care professional as a diagnostic aid for the clinical assessment and discrimination of acoustic patterns relating to or caused by clinically significant pathologies and medical conditions as known, defined, or specified in standard medical auscultation/phonocardiographic reference textbooks, peer review journals, and medically approved auscultation training materials. The CSA is further intended for the monitoring of interventional or prophylactic therapies that are
Appendix G-I
453
{1}------------------------------------------------
510(k) submission Cardiovascular Sonospectrographic Analyzer
susceptible to the level of medical efficacy provided by CSA and as is clinically indicated at the suscetion of the p physician. The CSA is also intended for use in telemedical applications where discreation of the p prysicial medical medical acoustic experts are indicated or desired.
Limitations on Intended Use: The CSA is not intended for use on a singular basis for delivery of health care, not as a standalone diagnostic aid for evaluation of cardiovascular conditions and nethologies for which other more suitable diagnostic tools or medical procedures are available or indicated.
Hardware Components
Medical cart with Uninterruptible Power Supply (UPS) See Figure 2.2. IBM Compatible Computer, monitor, mouse, keyboard (See Figure 2.2) Data Acquisition Module, I/O Tech DaqBoard 2000 series Conditioning Electronics amplifier(See Figures 2.3 and 2.4) Two physiological sensors (See Figure 2.5) One environmental noise cancellation sensor (See Figure 2.6) Audio reproduction Headphone (optional)
Software Components:
- Data Recording Application (the DRA) ●
- Data Analysis Application (the DAA) .
Performance Standards:
Electromagnetic Capability
| PERFORMANCE TEST | APPLICABLE STANDARD |
|---|---|
| RF Emissions | CISPR-11/IEC-601-1-2 (modified) UL 2601 |
| Magnetic Fields | RE101(mod)MIL-STD-461D |
| Electrostatic Discharges (Immunity) | IEC 801-2 |
| Radiated EM Fields (Immunity) | IEC 601-1-2 (modified) |
| AC Voltage Fluctuations Trasients and Surges | Guidelines per Para. (M) (7) and sub-para.C(2) |
Mechanical and Environmental
| Performance Tests | Applicable Standard |
|---|---|
| Controls Protection | Company design specifications |
| Connector Protective | Company design specifications |
| Mechanical Safety | Company design specifications |
| Vibration and ShockResistance | Company design specifications |
Appendix G-2
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510(k) submission Cardiovascular Sonospectrographic Analyzer
| Fluid Spill Resistance | IEC-601 (44.6)IEC 529 |
|---|---|
| Temperature and Humidity | Company design specifications |
| Surface Temperature | Company design specifications |
| Toxic Materials | No toxic material from the device come into contact with the patientor operator during use |
Similarities and Differences to Predicate Devices
The DES predicate device was developed in the 1990's based on basic technology and signal processing techniques well established in the scientific medical literature and in cleared auscultation and phonocardiography technology for the detection, processing, discrimination and display of the full range of cardiovascular sounds and murmurs. The DES development had required a design composed of the best features and properties of various phoncardiographic sensors for the purpose of detecting all of the physio-acoustic signals of interest and it also required novel digital signal processing and display software which utilized the well established and medically accepted Fast Fourier Transform technique as the basis for analyzing cardiovascular sounds and murmurs for their spectral content. However the DES was deficient as a viable medical device due to the requirement for operator training in the integral spectral analysis field and the time consuming visual analysis of the spectral signals and the manual measurement and calculations of the signals to discriminate the clinical information contained therein.
SonoMedica, Inc. acquired all rights to the DES predicate device and its original USFDA clearance and commenced a product development effort to reduce the original DES into a viable medical product. This development caused some minor refinements in the data acquisition circuitry but focused primarily upon developing software that automated the time intensive process of analyzing the detected cardiovascular signals in order to present the derived data in an easily accessible and understandable graphical format for ease and rapidity of use by the clinician or other medical user. The CSA hardware is essentially the same as was used and cleared in the predicate device. The CSA software is fully equivalent to the DES software in the CSA simply automates the analysis process as was required by the DES predicate device. The CSA use the Fast Fourier Transform as was used in the DES for signal decomposition as well as all of the same basic displays. The CSA employs features in some of its displays which are improvements upon the DES and the software is much more processing efficient due to its use of improved programming techniques but it is still all based on the same Visual Basic language as was used in the DES. In fact, the clinical data acquired by the DES is 100% compatible with the CSA and data acquired by the CSA is fully backwards compatible and can be processed and analyzed using the DES software.
Appendix G-3
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510(k) submission Cardiovascular Sonospectrographic Analyzer
Conclusion
As the CSA hardware is essentially the same as the DES predicate device; the basic digital signal Its the CD7 marting to dolisplays being equivalent; both devices are based on the same probosing tochards and the full backwards and forward compatibility of the recorded cardiovascular physio-acoustic data, it is concluded that the Cardiovascular Sonospectrographic Analyzer (CSA) is substantially equivalent to the DES predicate device from which is derived. The CSA does not use any form of radiation, contains no physical properties or features that present a risk, use no chemicals and has no design elements that also manifest a risk, it is further concluded that it is safe and effective for its intended use.
Appendix G-4
456
§ 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.