(377 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. Heart sounds identified are S1, S2 and suspected murmurs.
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) and its 510(k) summary, but it does not contain the specific details required to answer all parts of your request comprehensively. The document focuses on showing substantial equivalence to predicate devices and general validation, rather than an in-depth clinical study with detailed performance metrics and ground truth establishment.
However, based on the available information, here's what can be extracted and what remains unknown:
Acceptance Criteria and Study Details for Zargis Acoustic Cardioscan (ZAC)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity for murmur detection) or report precise numerical device performance results against such criteria. It 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 that "A clinical software validation was performed to insure the performance of the heart sound detection algorithm."
| Metric / Aspect | Acceptance Criterion (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Heart Sound Detection | Sufficient accuracy and reliability in identifying S1, S2, and suspected murmurs to support a physician in evaluation, without being a sole means of diagnosis. (Inferred) | "A clinical software validation was performed to insure the performance of the heart sound detection algorithm." (No specific numerical performance, e.g., sensitivity/specificity, is reported). |
| Intended Use | Consistently fulfills intended use and user needs. (Stated) | "Validation of the ZAC was performed to ensure that the ZAC device consistently fulfills its intended use and the needs of the user." |
| Safety | Safe for clinical use. (Inferred) | "Safety and Performance: A comprehensive list of verification and validation testing was performed..." (No specific safety metrics reported). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document mentions "A clinical software validation was performed," but does not specify the number of cases or the origin (country, retrospective/prospective) of the data used for this validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. While the device's output "is only significant when used in conjunction with physician over-read," the number and qualifications of experts involved in establishing ground truth for the validation set are not detailed.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document.
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
This information is not provided in the document. The document states the device "is intended to provide support to the physician" and "is not intended as a sole means of diagnosis," implying a human-in-the-loop scenario. However, a formal MRMC study demonstrating improvement with AI assistance is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document states, "A clinical software validation was performed to insure the performance of the heart sound detection algorithm." This implies a standalone evaluation of the algorithm's performance in identifying heart sounds (S1, S2, suspected murmurs). However, no specific performance metrics from this standalone evaluation are reported.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for its "clinical software validation." Given the nature of heart sound analysis, it is highly likely that ground truth would have been established by a panel of expert cardiologists or auscultation specialists, potentially using a combination of clinical assessment, echocardiography, or other diagnostic information, but this is an inference, not directly stated.
8. The Sample Size for the Training Set
This information is not provided in the document. The document mentions "software verification was performed," but does not detail the size or nature of any training data used for the algorithm's development.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
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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 |
| Classification Name: | Phonocardiograph with Waveform Analysis - 21 CFR870.2390. This device is categorized as DQC and isregulated as Class II. |
| Submitter Information: | Zargis Medical Corporation755 College Road EastPrinceton, NJ 08540Tel: 609.734.6510Fax: 609. 734-6565 |
| Summary Prepared By: | Shahram Hejazi, Ph.D.President/CEO |
| Date Prepared: | March 26, 2004 |
| Predicate Devices: | ELI 200+ Audicor -- K0311822010 Holter Plus Monitor - K010949 |
Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart sounds identified are S1, S2 and suspected murmurs.
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 heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these
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signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include $1, $2, 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 ZAC is similar in design/technological characteristics. indications for use, and performance characteristics to the other commercialized devices named above. 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 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 heart sound detection algorithm. In addition, usability validation (i.e., simulated use), reproducibility validation, and software component validation were performed.
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 legally marketed predicate devices under the Federal Food. Drug, and Cosmetic Act.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2004
Zargis Medical Corporation c/o Shahram Hejazi, Ph.D. President/CEO 755 College Rd. East Princeton, NJ 08540
Re: K031517
Trade Name: Zargis Acoustic Cardioscan (ZAC) Regulation Number: 21 CFR 870.1875, 870.2390 Regulation Name: Stethoscope, Phonocardiograph Regulatory Class: II (two) Product Code: DQD, DQC Dated: March 29, 2004 Received: March 30, 2004
Dear Dr. Hejazi:
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 - Shahram Hejazi, Ph.D.
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 presided 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) 594-4648. 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/dsma/dsmamain.html
Sincerely yours,
Neat K.P. Ogden
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):
Zargis Acoustic Cardioscan (ZAC) Device Name:
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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
evice Evaluation (ODE) Concurrence of CDRH.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031517
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§ 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.