(33 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 a computer-assisted auscultatory device, intended to provide support to the target users in the evaluation of heart sounds and murmurs. The product will acquire and record the acoustic signal of the heart, over appropriate regions of the chest, and then analyze these signals. The analysis procedure will evaluate sounds of the heart and aid healthcare providers in identifying murmurs. Results are presented to the user in near real-time.
As a complete system, the ZAC consists of an electronic stethoscope, a laptop computer. software, and a printer.
The provided text describes a Special 510(k) Premarket Notification for a revised Zargis Acoustic Cardioscan (ZAC) system. However, it does not contain acceptance criteria for a study, nor does it present the results of a study proving the device meets specific acceptance criteria.
The document focuses on the changes made to a previously cleared device and argues for substantial equivalence based on these changes not affecting the core method of operation, data acquisition, processing, or existing data analysis. It also discusses safety information and compliance with performance standards in a general sense, but no specific performance metrics or thresholds are provided.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets these criteria. The document explicitly states: "The proposed revisions, included as part of this submission, do not affect the current method of operation, data acquisition, processing, or existing data analysis in any way." This suggests that a new comprehensive performance study with acceptance criteria was not deemed necessary for this specific 510(k) submission, as it relates to minor display and software revisions.
To elaborate on what is available in the document regarding its performance context:
- Device Name: Zargis Acoustic Cardioscan (ZAC)
- Intended Use: To provide support to physicians in the evaluation of heart sounds in patients, by acquiring, recording, and analyzing acoustic signals of the heart to identify S1, S2, and suspected murmurs. It is not intended as a sole means of diagnosis and requires physician over-read.
- Regulatory Class: Class II
- Predicate Device: The original ZAC system, which was cleared by the FDA on May 26, 2004.
- Changes described in this 510(k):
- Adding a graphical display of timing and energy of suspected murmurs.
- Revising the Heart Sound Recording Display to remove "mm" label from shaded areas.
- Changing the wording of summary reports to include heartbeat interval designation for suspected murmurs.
- Minor software revisions (e.g., shortened analysis time, storing revision level, license expiration, security enhancements).
The key argument for this 510(k) is substantial equivalence to the previously cleared device, not new performance data against acceptance criteria. The document states "There are no changes in intended use of the product, nor any changes in technology."
In summary, the provided text does not contain the information required to answer your specific questions about acceptance criteria and a study proving their fulfillment.
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SEP = 8 2004
Image /page/0/Picture/1 description: The image shows the logo for Zargis Medical. The word "ZARGIS" is in large, bold, black letters. Below that, the word "MEDICAL" is in smaller, thinner, black letters. To the left of the word "MEDICAL" is a small graphic that looks like a sound wave.
Summary of Safety and Effectiveness
Special 510(k) Premarket Notification - ZAC Energy and Timing Display
| CLASSIFICATION NAME: | Phonocardiograph with Waveform Analysis21CFR 870.2390 |
|---|---|
| This device is categorized as DQCIt is regulated as Class II | |
| COMMON/USUAL NAME: | Heart Sound Analyzer |
| TRADE NAME: | Zargis Acoustic Cardioscan (ZAC) |
| MANUFACTURER | Zargis Medical Corp.755 College Road EastPrinceton, NJ 08540 |
| MANUFACTURING LOCATION | Zargis Medical Corp.755 College Road EastPrinceton, NJ 08540 |
| ESTABLISHMENT No. | FDA Form 2891 Submitted |
PERFORMANCE STANDARDS:
The device complies or will comply with the relevant international Safety Standards. It has been manufactured in compliance with the Quality System Regulation.
SYSTEM DESCRIPTION:
The ZAC is a computer-assisted auscultatory device, intended to provide support to the target users in the evaluation of heart sounds and murmurs. The product will acquire and record the acoustic signal of the heart, over appropriate regions of the chest, and then analyze these signals. The analysis procedure will evaluate sounds of the heart and aid healthcare providers in identifying murmurs. Results are presented to the user in near real-time.
As a complete system, the ZAC consists of an electronic stethoscope, a laptop computer. software, and a printer.
The ZAC system was cleared by FDA on 26 May 2004. The proposed revisions, included as part of this submission, do not affect the current method of operation, data acquisition, processing, or existing data analysis in any way.
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Zargis wishes to submit, for FDA review, a revision to the previously cleared ZAC system. The proposed changes to the system:
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- Add, to the existing user interface, a graphical display of timing and energy of any suspected murmurs that may have been identified.
- Revise the existing Heart Sound Recording Display to remove the "mm" label from 2. shaded areas designating the location of suspected murmurs
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- The wording of the summary reports returned when suspected murmurs identified have been changed to include a designation of the heartbeat interval in which the suspected murmur occurs
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- Minor software revisions to correct or adjust operational anomalies identified since the previous submission
- a. Adjusted sequence of software routine calls to shorten analysis time
- b. Store software revision level as part of patient record
- Have software license expire annually c.
- d. For increased security, disable Windows shortcut keys
- For increased security, disable Ethernet card and jump drive e.
EQUIVALENCE INFORMATION:
Zargis wishes to receive FDA clearance to market this revised product based on its substantial equivalence to the original device cleared by FDA. There are no changes in intended use of the product, nor any changes in technology. The previously cleared system included a graphical display of the heart sound and graphically highlighted the suspected murmur. The new display will identify in which of 4 time periods (subdivisions of the cardiac waveform) the suspected murmur occurs and provides a metric that establishes the onset and duration timing of the suspected murmur. The graphical display also presents, in histogram format, the sound energy during each time period. The revised graphical representation allows an increased level of quantification of the display.
SAFETY INFORMATION:
The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the change to the ZAC, as the ZAC itself, is of minor level of concern, per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
The ZAC device continues to have no patient contacting materials and is utilized only by trained professionals. As it was for the original ZAC, the output of the improved device is evaluated by trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction. Device output and analysis is used to indicate the appropriateness of a referral. The device impacts the quality or status of the original acquired data only in the validated manner described.
Zargis feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence within a reasonable time period. In the event that additional information is required, please contact Zargis Medical Corp.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Zargis Medical Corporation c/o Mr. Donald Brooks Vice President, Operations 755 College Rd. East Princeton, NJ 08540
Re: K042128
Trade Name: Zargis Acoustic CardioScan (ZAC) Regulation Number: 21 CFR 870.1875, 870.2390 Regulation Name: Stethoscope, Phonocardiograph Regulatory Class: Class II (two) Product Code: DQD, DQC Dated: August 4, 2004 Received: August 6, 2004
Dear Mr. Brooks:
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 – Mr. Donald Brooks
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 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,
B.Jimmerman for
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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510(k) Number (if known):
Device Name:
Zargis Acoustic Cardioscan (ZAC)
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
B. Simmon
ovascular Devicesver the Counter Use
510(k) Number K12114
§ 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.