IMPRESARIO

K993620 · Del Mar Medical Systems, LLC · DQK · Nov 12, 1999 · Cardiovascular

Device Facts

• Record ID: K993620
• Device Name: IMPRESARIO
• Applicant: Del Mar Medical Systems, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Impresario is an ambulatory ECG (Holter) arrhythmia analysis software system. It accepts prerecorded analog or digital ECG data from Del Mar ambulatory recorders. The software performs 3-channel automated arrhythmia analysis, generating reports including summaries, totals, trends, histograms, and full disclosure. It is designed for installation on a customer's computer. A trained operator runs the software, but a licensed physician must perform the final analysis and assessment of the output. The system serves as a screening tool to identify cardiac arrhythmias and normal functioning, facilitating clinical decision-making through the presentation of significant clinical events for physician review and confirmation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Windows-based software for 3-channel ambulatory ECG arrhythmia analysis. Utilizes the same base arrhythmia algorithm as the predicate device. Designed for installation on standard PC hardware.

Indications for Use

Indicated for the analysis, summary, and reporting of prerecorded ambulatory ECG data (up to 48 hours, multiple channels) as a screening tool for cardiac arrhythmia and normal functioning. Requires clinician review, edit, and assessment of reported events.

Regulatory Classification

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.

Predicate Devices

• Del Mar Avionics Model 263 Spectrascan®

Submission Summary (Full Text)

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NOV 1 2 1999

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## 510(k) Summary

| Submitted by | Del Mar Medical Systems<br>1621 Alton Parkway<br>Irvine, California 92606 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Nevine Erian |
| Date Prepared | October 22, 1999 |
| Proprietary<br>Name | Impresario™ |
| Common Name | Ambulatory ECG (Holter) Arrhythmia Analysis Software |
| Classification<br>Name | Programmable Diagnostic Computer |
| Predicate<br>Device | Del Mar Avionics Model 263 Spectrascan® |
| Description of<br>Device | Impresario is an arrhythmia analysis software system that allows the<br>customer to purchase software only and install it on his/her computer. It is<br>compatible with all Del Mar ambulatory ECG (Holter) recorders. It<br>provides 3-channel automated arrhythmia analysis with operator<br>intervention and edit. Reports include summary, totals, trends, histograms,<br>and full disclosure. |
| Intended Use<br>of Device | The Impresario software is intended for the clinical identification of<br>cardiac arrhythmia and normal functioning. While a trained operator can<br>run the software, analysis of the resulting data is to be performed by a<br>licensed physician. |
| Technical<br>Considerations | The fundamental technology of Impresario is the same as the predicate<br>device. The base arrhythmia algorithm remains unchanged. The porting of<br>the software from a DOS based system to a Windows based system allows<br>for sale of the software alone, without the accompanying hardware<br>dependencies. |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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