(28 days)
No
The description explicitly states the modification incorporates the "Rule of Six algorithm," which is a deterministic calculation, not an AI/ML technique. There are no mentions of AI, ML, DNN, training sets, or test sets related to model performance.
No
The device is a drug calculator software and not intended to directly treat or diagnose a medical condition. It aids clinicians by providing information for treatment, but it does not perform therapeutic action itself.
No
The device is a drug calculator software used for IV drug computations and patient monitoring, not for diagnosing medical conditions.
Yes
The device is described as "Philips Drug Calculator Software" and the modification is "primarily a software based change". While it is served by "Philips IntelliVue application server software", the core function and the described change are purely software-based calculations. There is no mention of new or modified hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters (cardiac arrhythmia, ST segment) and performing drug calculations for patient treatment. This is related to patient care and treatment decisions, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is software for calculating IV drug dosages. This is a clinical tool used in patient management, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis based on laboratory results.
Therefore, this device falls under the category of a clinical monitoring and drug calculation tool, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
74 MHX, 74 DSI, 74 MLD, 74 DSH, 74 MSX, 73 NDC
Device Description
The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV drug computations in 100 mL IV bags.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal patients
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
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.
- 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: 978 685 5624 Fax: e-mail: d.g.osborn@ieee.org
This summary was prepared on October 30, 2002
-
- The name of this device is the Philips Drug Calculator Software. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 74 | |||
| Cardiovascular | None | 74 MHX | Physiological |
| Monitor, Patient | |||
| Monitor | |||
| 870.1025, III | 74 DSI | Arrhythmia Detector | |
| and Alarm | |||
| 870.1025, III | 74 MLD | Monitor, ST Alarm | |
| 870.2800, II | 74 DSH | Recorder, Magnetic | |
| Tape, Medical | |||
| 870.2300, II | 74 MSX | System, Network and | |
| Communication, | |||
| Physiological | |||
| Monitors | |||
| Panel 73 | |||
| General & Plastic | |||
| Surgery | 868.1890, II | 73 NDC | Calculator, Drug |
| Dose |
-
- The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV drug computations in 100 mL IV bags.
-
- 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
1
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.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- 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.
2
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.
3
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 (301) 594-4646. 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 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)