(95 days)
The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds. that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless communication with a Bluetooth-enabled electronic stethoscope.
Here's an analysis of the acceptance criteria and study information for the Zargis Acoustic Cardioscan (ZAC), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K083309) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance metrics for a novel technology. Therefore, specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding numerical performance results are not explicitly stated in this document.
The document broadly states: "non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use." and "A clinical software validation was performed to insure the performance of the enhanced software algorithm."
Based on the limited information, we can infer the implied performance goal is to "identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." However, no specific metrics for the accuracy of this identification are provided.
| Acceptance Criterion (Inferred from Intended Use) | Reported Device Performance |
|---|---|
| Identification of specific heart sounds: | |
| - S1 presence | Performance not quantified |
| - S2 presence | Performance not quantified |
| - Suspected murmurs presence | Performance not quantified |
| Acquire and record acoustic signals | Verified through "verification and validation testing" |
| Analyze acoustic signals | Verified through "verification and validation testing" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "A clinical software validation was performed," but does not provide the number of cases or patients included in this validation.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The device's intended use emphasizes "physician over-read" and "consideration of all other relevant patient data," implying medical professionals are involved in the overall diagnostic process, but their role in establishing ground truth for the validation study is not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The document does not describe how discrepancies in ground truth or interpretation were resolved, if multiple experts were involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study.
- Effect Size: Therefore, no effect size of human readers improving with AI assistance is provided. The device is intended to "provide support to the physician" and is "not intended as a sole means of diagnosis," requiring "physician over-read." This implies human-in-the-loop, but a comparative study assessing its impact is not described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance Study: The document does not explicitly present standalone (algorithm-only) performance metrics such as sensitivity or specificity. While "analysis procedure will identify specific heart sounds," the performance of this identification in isolation is not separately quantified. The emphasis is on its use "in conjunction with physician over-read."
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not explicitly stated. Given the nature of heart sound analysis, it's highly probable that the ground truth would have been established by expert clinical assessment (e.g., cardiologists interpreting auscultation, possibly combined with other diagnostic tests like echocardiography), but this is an inference, not a direct statement from the document.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not mentioned or provided in the document.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: Not mentioned or provided in the document.
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K083309
R1/2
510(k) Summary of Safety and Effectiveness FEB 1 3 2009
Zargis Acoustic Cardioscan
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Zargis Medical Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Zargis Medical chooses to submit a summary of information respecting safety and effectiveness.
| Trade Name: | Zargis Acoustic Cardioscan (ZAC) |
|---|---|
| Common Name: | Heart Sound Analyzer |
| Regulation Number: | 21 CFR 870.1875, 870.2390 |
| Classification Name: | Stethoscope, Electronic; Phonocardiograph |
| Product Code: | DQD, DQC |
| Regulatory Class: | Class II |
| Submitter Information: | Zargis Medical Corporation2 Research Way, 1st FloorPrinceton, NJ 08540Tel: 609.734.4747Fax: 609.228.5000 |
| Summary Prepared By: | John KallassyCEO |
| Date Prepared: | November 3, 2008 |
| Predicate Devices: | Zargis Acoustic Cardioscan, K031517, K042128, K060197AViTA Bluetooth Blood Pressure Monitor, K072137CardioBelffM Electrode Belt, K063044Nonin Medical, Inc. Model 4100 Patient Oximeter ModuleK043359 |
Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless
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communication with a Bluetooth-enabled electronic stethoscope.
Intended Use: The Zargis Acoustic Cardioscan; (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds.
The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Substantial Equivalence: The modified ZAC is similar in design/technological characteristics, indications for use, and performance characteristics to the currently cleared ZAC product and other medical devices capable of wireless transmission of physiological data through use of Bluetooth technology. In addition, non-clinical performance testing has been conducted to demonstrate the performance of the modified ZAC device and that it meets its intended use.
Safety and Performance: A comprehensive list of verification and validation testing was performed in accordance with Zargis' Design Control procedures.
Software verification of the modified components was performed at the module and system level. The integrated ZAC system was further evaluated to verify the graphic user interface software and the ZAC system as an integrated product.
Validation of the ZAC was performed to ensure that the ZAC device consistently fulfills its intended use and the needs of the user. A clinical software validation was performed to insure the performance of the enhanced software algorithm.
The Bluetooth transceiver complies with all relevant FCC requirements.
Conclusion: Based upon the indications for use, technological characteristics and safety and performance testing, the Zargis Acoustic Cardioscan (ZAC) has been shown to be substantially equivalent to the currently cleared predicate devices under the Federal Food, Drug, and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
Zargis Medical Corp. c/o Mr. John Kallassy, CEO 2 Research Way, 1st floor Princeton, NJ 08540
Re: K083309
Trade/Device Name: Zargis Acoustic Cardioscan Regulation Number: 21 CFR 8.70.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DQC Dated: January 13, 2009 Received: January 14, 2009
Dear Mr. Kallassy:
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 preinarket 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. John Kallassy
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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INDICATION FOR USE
510(k) Number (if known): Not Assigned
Device Name:
Zargis Acoustic Cardioscan
Indications for Use:
The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds. that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
| Prescription Use: | X | AND/OR | Over-The Counter Use: |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 | ||
| SubpartC) |
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | for B Zuckerman |
|---|---|
| Division of Cardiovascular Devices | 2/13/09 |
| 510(k) Number | K083309 |
|---|---|
| --------------- | --------- |
016
§ 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.