(19 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like training/test sets, image processing, or specific algorithms typically associated with AI/ML in medical devices. The changes described are related to ECG processing, SpO2 alarms, waveform export, and radio technology.
No
The device is described as a monitoring system that gathers information for treatment and to monitor the adequacy of treatment, but it does not directly administer therapy.
No
The devices are for monitoring cardiac arrhythmia and ST segment, and ECG and SpO2 parameters, to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms. Monitoring is for providing ongoing information about a patient's physiological state, rather than establishing a diagnosis.
No
The device description explicitly mentions hardware components (M4840A Telemetry System II with M4841A TelePac+) and changes to radio technology, indicating it is not solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes monitoring physiological parameters (ECG and SpO2) of patients. This is a clinical monitoring function, not a diagnostic test performed on samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on software and hardware for monitoring and processing physiological signals. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes in samples
- Diagnostic interpretation based on sample analysis
The device is designed to provide real-time physiological information to clinicians for monitoring and managing patients, which falls under the category of patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
M3290A: 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. M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities 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)
74 DSI, 74 MHX, 74 MLD, 74 DXN, 74 MSX, 74 DQA, 74 DSH, 74 DRG
Device Description
The modification is a change that modifies the ECG processing, adds 4 high priority SpO2 limit alarm conditions and waveform export, and changes the radio technology.
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
Healthcare facilities
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)
Verification, validation, and testing activities have successfully established the performance, functionality, and reliability and many and the predicates. Characterized resting involved by environmental ceseb, and based on the specifications cleared for the Pass/rail Criteria Were Dabstantial equivalential equivalence. predicate devices and cobs assessment monitoring system file resures backs all reliability requirements and performance runctionally mood ntially equivalent to the predicate devices.
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.
K031403, K021251, K993516, K021300, K030038
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
§ 870.1025 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
510 (k) Summary 8.0
information i s safety and effectiveness 510 (k) of This summary accordance with the requirements of Safe Medical the submitted in Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is:
| Dave Osborn
Quality Program Manager
Cardiac and Monitoring Systems
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1085 | Tel: 978 659 3178
Fax: 978 685 5624
Email: dave.osborn@philips.com |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| This summary was prepared on 12 February, 2004. | |
-
- The name of this device is the M3290A IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A Classification names are as follows: TelePac+.
| Classification | ProCode | Description | |
|---|---|---|---|
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm | |
| 870.1025, II | 74 MHX | Physiological Monitor, Patient Monitor | |
| (with arrhythmia detection or alarms) | |||
| 870.1025, II | 74 MLD | Monitor, ST Alarm | |
| 870.1130, II | 74 DXN | System, Measurement, Blood-Pressure, | |
| Non-Invasive | |||
| 870.2300, II | 74 MSX | System, Network and Communication, | |
| Physiological Monitors | |||
| 870.2700, II | 74 DQA | Oximeter | |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical | |
| 870.2910, II | 74 DRG | Transmitters and Receivers, | |
| Physiological Signal, Radiofrequency |
- The new device is substantially equivalent to the previously ന്ന cleared IntelliVue Information Center Software with ST/AR cleared under K031403 & K021251, the Philips Telemetry System under K993516, and IntelliVue Patient Monitors under K021300 & K030038.
- The modification is a change that modifies the ECG processing, adds 4 high priority SpO2 limit alarm conditions and waveform export, and changes the radio technology.
- The new device has the same Indications for Use as the legally ్ . marketed predicate device. M3290A: 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. M4840A: For creatment, or o do dside monitoring of ECG and Spo, parameters of adult and pediatric patients in healthcare facilities.
1
- The new device has the same technological characteristics as the 6. legally marketed predicate device.
-
- Verification, validation, and testing activities have successfully verification, Variablem.
established the performance, functionality, and reliability established the performance, and many and the predicates. Charactcriberob resting involved by bean _____________________________________________________________________________________________________________________________________________________ environmental ceseb, and based on the specifications cleared for the Pass/rail Criteria Were Dabstantial equivalential equivalence. predicate devices and cobs assessment monitoring system file resures backs all reliability requirements and performance runctionally mood ntially equivalent to the predicate devices.
- Verification, validation, and testing activities have successfully verification, Variablem.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is stylized with thick, black lines, and the text is in a simple, sans-serif font. The overall design is clean and professional.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Philips Medical Systems, Inc. c/o Mr. Dave Osborn Quality Program Manager 3000 Minuteman Road Andover, MA 01810
Re: K040357
Trade Name: M3290A IntelliVue Information Center Software, Release F.0 and M4840A Philips Telemetry System II including M4841A TelePac+ Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: February 12, 2004 Received: February 13, 2004
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 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). 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 may or saejoes to access will and 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 Please be advised that FDA $ Issualite of a substance orgalies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmanon ana Jour as Jour Second agencies. You must a or any Federal statutes and regulations adminitied to registration and listing (21
comply with all the Act's requirements, including, but not the newstige aget comply with an the Act 3 requirements, mercesses communicaturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the elect CFR Part 807), labeling (21 CFR Part 801), good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 200), and 11 CFR 100 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (occions of the as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to legal This letter will anow you to begin manketing of substantial equivalence of your device to a legally premarket notification. The FDA inding of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our lated it (21 CFR Part 801), please If you desire specific advice for your ac not as a loo, please note the regulation entitled, contact the Office of Compliance at (501) 997 16 re (21CFR Part 807.97). You may obtain "Misbranding by reference to premarker its articlearences in the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-idemamain http:// Manufacturers, International and Consumer Parssons Prists on Podrh/dsma/dsmamain.html
Sincerely yours,
MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ستر
4
Indications for Use
K040357 510(k) Number (if known):
M3290A IntelliVue Information Center Software, Device Name: Release F.0 and M4840A Philips Telemetry System II including M4841A TelePac+
M3290A: For central monitoring of multiple adult, Indications For Use: 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.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 110(K) Number | K04 0357 |
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