(42 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on software release and comparison to a predicate device.
No
The device is indicated for central monitoring and provides information for treatment, but it does not directly treat a disease or condition.
Yes
The device is indicated for monitoring cardiac arrhythmia and ST segments to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which are all diagnostic purposes.
Yes
The device description explicitly states "M3290A IntelliVue Information Center Software, Release L.0", indicating it is a software product. The performance studies and testing focus on system level tests, performance tests, and safety testing related to the software's functionality and reliability, without mentioning any associated hardware components being part of the submission or requiring hardware-specific testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description clearly indicate that this software is for central monitoring of patients and analyzing cardiac arrhythmia and ST segments. This involves monitoring physiological signals directly from the patient, not analyzing samples taken from the patient.
- The description focuses on patient monitoring and analysis of real-time physiological data. There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, this device falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for central monitoring of multiple 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 (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DSH, MSX
Device Description
The name of this device is the M3290A IntelliVue Information Center Software, Release L.0. The modification made to the device include the addition of the following features: Support for the Wireless TAAP feature, Addition of the Manual Data Laboratory (Lab) Entry application, Support of the ST baseline synchronization with the IntelliVue MPxx Patient Monitors, Support for the printing of the predefined reports generated from the wireless IntelliVue MPxx Patient Monitors, New data communication protocol used between the IntelliVue Patient Monitors and the IIC (SCADA protocol), Support for the Philips patient monitors operating in the Customer Supplied Clinical Network (wireless network), Addition of HL7 parameters for VistA compliance, Integration of the ST/AR J.0 algorithm (K080461).
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
central monitoring
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
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that M3290A IntelliVue Information Center Software, Release L.0 meets all defined reliability requirements and performance claims.
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.
K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, K964832
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.
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
§ 870.1025 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
Image /page/0/Picture/1 description: The image is a black and white line drawing of a person's face. The face is slightly tilted to the right. The person has a round face, with a small nose and mouth. The person's eyes are closed. The person's hair is short and curly. The person is wearing a shirt with a collar.
Philips Medical Systems
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 CFR §807.92.
The submitter of this premarket notification is:
Claire Arakaki Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Tel: 978 659 4348 Fax: 978 685 5624 Email: claire.arakaki@philips.com
This summary was prepared on 8 July 2008.
The name of this device is the M3290A IntelliVue Information Center Software, Release L.0 Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| none | 74 MHX | Physiological Monitor, Patient Monitor |
| 870.1025, II | 74 MLD | Arrhythmia Detector and Alarm |
| 870.1025, II | 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 |
-
- The modification made to the device include the addition of the following features:
- . Support for the Wireless TAAP feature
- Addition of the Manual Data Laboratory (Lab) Entry application .
- Support of the ST baseline synchronization with the IntelliVue MPxx Patient Monitors
- Support for the printing of the predefined reports generated from the wireless IntelliVue MPxx . Patient Monitors
- . New data communication protocol used between the IntelliVue Patient Monitors and the IIC (SCADA protocol)
Tel: (978) 687 1501 Fax: 1978) 794 764
Confidential
1
- Support for the Philips patient monitors operating in the Customer Supplied Clinical Network . (wireless network)
- Addition of HL7 parameters for VistA compliance .
- Integration of the ST/AR J.0 algorithm (K080461) .
- న. The new device has the same Indications for Use and Intended Use as the legally marketed predicate devices.
- The new device has the same technological characteristics as the legally marketed 6. predicate devices.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that M3290A IntelliVue Information Center Software, Release L.0 meets all defined reliability requirements and performance claims.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2008
Philips Medical Systems c/o Ms. Claire Arakaki Regulatory Affairs Specialist 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Re: K081983
Trade/Device Name: M3290A IntelliVue Information Center Software, Release L.0 Regulation Number: 21 CFR 870.1025 Regulation Names: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DSH, MSX Dated: August 6, 2008 Received: August 8, 2008
Dear Ms. Arakaki:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for woo cavaior 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) that do not require approval of a premarket approval application (PMA). and Cosmotic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, alerte or visions of the Act include requirements for annual registration, listing of general bonative profice, 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 ic may of receive for 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 - Ms. Claire Arakaki
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
ellomell
Bram D. Zuckerman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K08198 3
Device Name: M3290A IntelliVue Information Center Software Release L.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177)
Indications for Use:
Indicated for central monitoring of multiple 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.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lee
n of Cardiovascular Devices
Kogleg 510(k) Number