(62 days)
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.
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.
The provided text describes the Zargis Acoustic Cardioscan (ZAC) device and its 510(k) submission (K060197). However, it does not contain specific acceptance criteria, detailed study results, or the methodological specifics requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or types of ground truth used to define criteria or evaluate performance).
The documentation states that:
- "non-clinical performance testing has been conducted to demonstrate the performance of the ZAC device and that it meets its intended use."
- "A comprehensive list of verification and validation testing was performed..."
- "Software verification... 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."
Despite these statements, the document does not elaborate on the specific metrics, thresholds, or outcomes of these tests that would constitute 'acceptance criteria' or 'reported device performance' in a measurable way. It largely focuses on substantial equivalence to a predicate device (K031517, K042128) based on design, technological characteristics, indications for use, and a general assertion of performance testing.
Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.
Here's what can be extracted and what cannot:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Specific quantitative metrics and thresholds for identifying S1, S2, and suspected murmurs are not provided in the document. | The document generally states that "non-clinical performance testing has been conducted to demonstrate the performance of the 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." However, no specific performance metrics (e.g., sensitivity, specificity, accuracy for murmur detection, recall/precision for S1/S2 identification) are given. |
Detailed Study Information
- Sample size used for the test set and the data provenance: Not specified in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
- 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 specified in the provided text. The device is intended to "provide support to the physician" and "is not intended as a sole means of diagnosis," implying an AI-assisted workflow, but no MRMC study or effect size is reported.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The phrase "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" suggests that standalone performance, if evaluated, was not considered sufficient for clinical use. No specific standalone performance metrics are provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified in the provided text. It only mentions "identif[ying] specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs." How the "presence" of these sounds was definitively established for validation is not detailed.
- The sample size for the training set: Not specified in the provided text.
- How the ground truth for the training set was established: Not specified in the provided text.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence and general safety/performance rather than providing detailed clinical study results with specific quantitative metrics and methodologies.
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MAR 2 9 2005
510(k) Summary of Safety and Effectiveness
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 KallassyPresident/CEO |
| Date Prepared: | January 23, 2006 |
| Predicate Devices: | Zargis Acoustic Cardioscan, K031517, K042128 |
Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.
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.
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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. In addition, non-clinical performance testing has been conducted to demonstrate the performance of the 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.
The ZAC product consists of hardware and software components. The electronic stethoscope, processing platform, and isolation transformer were independently evaluated as hardware components. The printer and interface cabling were verified at the system level.
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 necds of the user. A clinical software validation was performed to insure the performance of the enhanced software algorithm.
Conclusion: Based upon the indications for use, technological characteristics and safety and performance testing, the Zargis Acoustic Cardioscan has been shown to be substantially equivalent to the currently cleared ZAC predicate device under the Federal Food, Drug, and Cosmetic Act.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Zargis Medical Corp. c/o Mr. John Kallassy CHO 2 Research Way Princeton, NJ 08540
Re: K060197
Trade Name: Zargis Acoustic Cardioscan (ZAC) Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: March 1, 2006 Received: March 2, 2006
Dear Mr. Kallassy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abo based in 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). and Cosmotive fore, market the device, subject to the general controls provisions of the Act. The r ou may) ateres 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 cither 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 cquivalence determination does not mean I Nase be advised that 1 1971 viewalls of our device complies with other requirements of the Act that 117A has made a acterinanceions administered by other Federal agencies. You must of any I caeral statuted und regularients, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro harens (2) consisting your device as described in your Section 510(k) This letter will anow you'lo begin hanceling of substantial equivalence of your device to a legally premaired predicated 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 rr you desire specific dario at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Comptimated notification" (21CFR Part 807.97). You may obtain Whisoranding of Yererents on your responsibilities under the Act from the Division of Small other general mionmational 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,
Blumenauer for
Bram D. Zuckerman, M.IS. 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): Not known at this time
Device Name: Zargis Acoustic Cardioscan (ZAC)
Indications for Use:
The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory Inc Eargs Hebranded 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 rne produce these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include SI, 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 (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 OF NEEDED)
CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060197
§ 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.