(17 days)
Del Mar Avionics Model 263 Spectrascan®
Not Found
No
The summary describes "automated arrhythmia analysis" but does not mention AI, ML, or any related terms, and there is no information about training or test sets which are typical for AI/ML devices.
No
The device is described as "arrhythmia analysis software" that provides "summary, totals, trends, histograms, and full disclosure" of recorded ECG data. Its intended use is for "analysis, summary and reporting" of ECG data as a "screening tool." It does not directly treat or prevent any medical condition; rather, it provides information to a clinician for review and assessment.
Yes
The Impresario™ software is designed for the "analysis, summary and reporting of prerecorded ambulatory ECG data" to identify "significant clinical events" and present them for "clinician review, edit and assessment." This process of analyzing medical data to aid in the identification of clinical events is inherently diagnostic.
Yes
The device description explicitly states that the customer purchases "software only" and installs it on their computer, and the intended use describes the analysis of prerecorded ECG data, not the recording hardware itself.
Based on the provided information, the Impresario™ software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Impresario's function: The Impresario software analyzes prerecorded ambulatory ECG data. ECG data is a measurement of electrical activity of the heart, recorded externally from the body. It does not involve the analysis of biological samples taken from the body.
- Intended Use: The intended use clearly states it's for the analysis, summary, and reporting of ECG data, not for testing biological samples.
Therefore, the Impresario software falls under the category of a medical device that analyzes physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Impresario software is intended for the clinical identification of cardiac arrhythmia and normal functioning. While a trained operator can run the software, analysis of the resulting data is to be performed by a licensed physician.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
While a trained operator can run the software, analysis of the resulting data is to be performed by a licensed physician.
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)
Not Found
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.
Del Mar Avionics Model 263 Spectrascan®
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
§ 870.1425 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).
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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
Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '99362', and ends with the number '0'. The characters are written in a bold, slightly irregular style, giving them a casual, handwritten appearance.
510(k) Summary
| Submitted by | Del Mar Medical Systems
1621 Alton Parkway
Irvine, California 92606 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Nevine Erian |
| Date Prepared | October 22, 1999 |
| Proprietary
Name | Impresario™ |
| Common Name | Ambulatory ECG (Holter) Arrhythmia Analysis Software |
| Classification
Name | Programmable Diagnostic Computer |
| Predicate
Device | Del Mar Avionics Model 263 Spectrascan® |
| Description of
Device | 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. |
| Intended Use
of Device | The Impresario software is intended for the clinical identification of
cardiac arrhythmia and normal functioning. While a trained operator can
run the software, analysis of the resulting data is to be performed by a
licensed physician. |
| Technical
Considerations | The fundamental technology of Impresario is the same as the predicate
device. The base arrhythmia algorithm remains unchanged. The porting of
the software from a DOS based system to a Windows based system allows
for sale of the software alone, without the accompanying hardware
dependencies. |
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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.
2
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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Image /page/3/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" in lowercase letters. Below the word "delmar" is a line, and below the line is the word "MEDICAL" in uppercase letters with spaces between each letter.
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