PHILIPS DRUG CALCULATOR SOFTWARE

K023674 · Philips Medical Systems · MHX · Nov 29, 2002 · Cardiovascular

Device Facts

• Record ID: K023674
• Device Name: PHILIPS DRUG CALCULATOR SOFTWARE
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Story

Philips Drug Calculator Software, integrated into IntelliVue application server (M2387A), provides automated IV drug dose computations. Device utilizes 'Rule of Six' algorithm for IV drug calculations in 100 mL bags. System functions as centralized monitoring platform for physiologic waves, parameters, and trends; supports alarm annunciation, retrospective review, and configuration/control of networked telemetry monitors. Operated by clinicians in clinical settings. Output displayed on centralized monitors to assist healthcare providers in treatment decisions and monitoring adequacy of therapy. Benefits include standardized drug dosing calculations and centralized patient oversight.

Clinical Evidence

Bench testing only. Verification activities included system-level tests, integration tests, and safety testing based on risk analysis. Pass/Fail criteria were established based on predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Software-based drug calculator integrated into M2387A IntelliVue application server. Features 'Rule of Six' algorithm for IV drug dose computation. Operates within networked physiological monitoring system. Connectivity via network/communication system for centralized data display and alarm management.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients requiring cardiac arrhythmia monitoring and/or adult patients requiring ST segment monitoring for treatment guidance or symptom evaluation.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• K922058
• K992636
• K021422

Submission Summary (Full Text)

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K023674
RA12

# NOV 2 9 2002

#### 9.0 510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is: David Osborn Philips Medical Systems Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099 978 659 3178 Tel: [phone] Fax: e-mail: [e-mail]

This summary was prepared on October 30, 2002

- 2. The name of this device is the Philips Drug Calculator Software. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|------------------------------------------|----------------|---------|--------------------------------------------------------------------|
| Panel 74<br>Cardiovascular | None | 74 MHX | Physiological<br>Monitor, Patient<br>Monitor |
| | 870.1025, III | 74 DSI | Arrhythmia Detector<br>and Alarm |
| | 870.1025, III | 74 MLD | Monitor, ST Alarm |
| | 870.2800, II | 74 DSH | Recorder, Magnetic<br>Tape, Medical |
| | 870.2300, II | 74 MSX | System, Network and<br>Communication,<br>Physiological<br>Monitors |
| Panel 73<br>General & Plastic<br>Surgery | 868.1890, II | 73 NDC | Calculator, Drug<br>Dose |

- 3. The new device is substantially equivalent to previously cleared Philips devices marketed pursuant to K922058, K992636, and K021422.
- 4. The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV drug computations in 100 mL IV bags.
- 5. The new device has the same intended use as the legally marketed predicate devices. They are used to display physiologic waves, parameters and, trends, to format data for compliant strip chart recorders, to format data for printed reports, and the secondary annunciation of alarms for multiple patients from other networked medical devices at a centralized location. To provide retrospective

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review of alarms, physiologic waves and parameters. And to provide primary annunciation of alarms, and confiquration and control access for networked telemetry monitors at a centralized location.

- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, and safety testing from risk analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2002

Philips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810

Re: K023674

Trade Name: Philips Drug Calculator Software served by the Philips IntelliVue application server software (M2387A Application Server Software) Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: October 31, 2002 Received: November 1, 2002

Dear Mr. Osborn:

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 10 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. Dave Osborn

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 [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Elias Mallés

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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Page -

## 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

The Philips Drug Calculator Software served by the Device Name: Philips IntelliVue application server software (M2387A Application Server Software)

Indications for Use:

For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K0236 513(k) Number

Over-The-Counter Use Prescription Use X OR

(Per 21 CFR 801.109)

(Optional Format 1-2-96)