(17 days)
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
Impresario is an arrhythmia analysis software system that allows the customer to purchase software only and install it on his/her computer. It is compatible with all Del Mar ambulatory ECG (Holter) recorders. It provides 3-channel automated arrhythmia analysis with operator intervention and edit. Reports include summary, totals, trends, histograms, and full disclosure.
The provided text describes a 510(k) summary for the Del Mar Medical Impresario™ Holter Analysis Software. However, it does not contain a detailed study section with acceptance criteria and a comprehensive study that proves the device meets those criteria.
The document states that "The fundamental technology of Impresario is the same as the predicate device. The base arrhythmia algorithm remains unchanged." This implies that substantial equivalence is being claimed based on the existing performance of the predicate device (Del Mar Avionics Model 263 Spectrascan®).
Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions related to sample sizes, ground truth establishment for a new study, expert qualifications, or MRMC studies, as this information is not present in the provided text.
Based on the available information:
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A table of acceptance criteria and the reported device performance: This information is not provided in the document. The device claims substantial equivalence to its predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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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 provided. The device description mentions "operator intervention and edit" and analysis by a "licensed physician," indicating a human-in-the-loop system, but no MRMC study details are given.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but the "operator intervention and edit" suggests it's not purely standalone.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided for the Impresario software itself. The intended use states it is a "screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment," implying clinician review is the ultimate ground truth in clinical practice.
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The sample size for the training set: Not provided.
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How the ground truth for the training set was established: Not provided.
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Image /page/0/Picture/0 description: The image shows the logo for Delmar Medical. The logo consists of a heart shape on the left, followed by the word "delmar." Underneath the word "delmar" is a line, and below the line is the word "MEDICAL" in smaller, capitalized letters. The heart shape is drawn with a single line, and the letters in "delmar" and "MEDICAL" are in a simple, sans-serif font.
NOV 1 2 1999
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510(k) Summary
| Submitted by | Del Mar Medical Systems1621 Alton ParkwayIrvine, California 92606 |
|---|---|
| Contact Person | Nevine Erian |
| Date Prepared | October 22, 1999 |
| ProprietaryName | Impresario™ |
| Common Name | Ambulatory ECG (Holter) Arrhythmia Analysis Software |
| ClassificationName | Programmable Diagnostic Computer |
| PredicateDevice | Del Mar Avionics Model 263 Spectrascan® |
| Description ofDevice | Impresario is an arrhythmia analysis software system that allows thecustomer to purchase software only and install it on his/her computer. It iscompatible with all Del Mar ambulatory ECG (Holter) recorders. Itprovides 3-channel automated arrhythmia analysis with operatorintervention and edit. Reports include summary, totals, trends, histograms,and full disclosure. |
| Intended Useof Device | The Impresario software is intended for the clinical identification ofcardiac arrhythmia and normal functioning. While a trained operator canrun the software, analysis of the resulting data is to be performed by alicensed physician. |
| TechnicalConsiderations | The fundamental technology of Impresario is the same as the predicatedevice. The base arrhythmia algorithm remains unchanged. The porting ofthe software from a DOS based system to a Windows based system allowsfor sale of the software alone, without the accompanying hardwaredependencies. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 2 1999
Mr. Nevine Erian Director, Quality Assurance and Requlatory Affairs Delmar Medical 1621 Alton Parkway Irvine, CA 92606
Re : K993620 Model 263 Spectrasan™ Holter System Regulatory Class: II (two) Product Code: DQK Dated: October 22, 1999 October 26, 1999 Received:
Dear Mr. Erian:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Nevine Erian
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia M. Witten, Ph.D., M.D.
Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Del Mar Medical Systems Impresario™ Holter Analysis Software October 22, 1999
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Impresario™ Holter Analysis Software Device Name:
Indications for Use
The Impresario™ software is intended for the analysis, summary and reporting of prerecorded ambulatory ECG data. At the requirement of a clinician, ambulatory ECG data is recorded in analog or digital form for up to 48 hours in multiple channels. The resultant recordings are segregated into a series of reports presenting significant clinical events as defined by the system, and affirmed by the review and confirmation of a clinician. The system is employed as a screening tool to record ECG events and to present these events to a qualified clinician review, edit and assessment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Bankrith
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993620
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).