(62 days)
Not Found
No
The summary describes an "analysis procedure" and "enhanced software algorithm" for identifying heart sounds, but it does not explicitly mention or provide details about the use of AI or ML techniques. The lack of information on training/test sets and specific AI/ML terminology further supports this conclusion.
No.
The device is used for analysis and identification of heart sounds, providing support for evaluation and diagnosis, but it is not intended as a sole means of diagnosis or for treating a condition, making it a diagnostic rather than a therapeutic device.
Yes
The device acquires, records, and analyzes acoustic signals of the heart to identify specific heart sounds like S1, S2, and suspected murmurs, which are used to evaluate patients' heart sounds and support the physician in diagnosis, even though it's not a sole means of diagnosis.
No
The device description explicitly states that the complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer, and an isolation transformer, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds." It acquires and analyzes acoustic signals from the heart.
- Nature of the Sample: The device analyzes acoustic signals from the patient's heart, which are physical sounds, not biological samples (like blood, urine, tissue, etc.) that are tested in vitro (outside the body).
- Mechanism of Action: The device works by listening to and analyzing sounds produced by the body, not by performing tests on biological specimens.
IVD devices are specifically designed to perform tests on biological samples in vitro to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) by capturing and analyzing sounds.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQD, DQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or trained personnel who are acting on the orders of a licensed physician, in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 needs of the user. A clinical software validation was performed to insure the performance of the enhanced software algorithm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Corporation |
| 2 Research Way, 1st Floor | |
| Princeton, NJ 08540 | |
| Tel: 609.734.4747 | |
| Fax: 609.228.5000 | |
| Summary Prepared By: | John Kallassy |
| President/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.
1
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.
2
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.
3
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
4
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