(19 days)
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.
The M3290A IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A TelePac+. 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 provided text is a 510(k) summary for the Philips IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A TelePac+. While it outlines the device's substantial equivalence to predicate devices and its indications for use, it does not include detailed information regarding specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology for establishing ground truth as requested in your prompt.
The document states: "Verification, validation, and testing activities have successfully established the performance, functionality, and reliability established the performance, and many and the predicates. Charactercriberob testing involved by bean environmental ceseb, and based on the specifications cleared for the Pass/rail Criteria Were Dabstantial equivalential equivalence." This is a general statement and does not provide the specifics you're looking for.
Therefore,Based on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria. The 510(k) summary focuses on substantial equivalence to predicate devices and general statements about verification and validation, rather than a specific performance study with detailed methodology and results.
Here's a breakdown of what cannot be found in the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document mentions "Pass/fail Criteria Were Dabstantial equivalential equivalence" but does not define these criteria or report the device's performance against them.
- Sample Size Used for the Test Set and Data Provenance: Not mentioned.
- Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. The document primarily discusses the device itself, not its impact on human reader performance.
- Standalone (Algorithm Only) Performance Study: Not mentioned. The focus is on the device as a whole system.
- Type of Ground Truth Used: Not mentioned.
- Sample Size for the Training Set: Not mentioned. (It's worth noting that for a 510(k) in 2004, a "training set" in the modern AI sense might not have been a primary focus or explicitly documented in this manner for a re-submission involving software updates.)
- How Ground Truth for the Training Set Was Established: Not mentioned.
Conclusion based on the provided text:
The provided document is a 510(k) summary from 2004, which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a detailed performance study with explicit acceptance criteria and corresponding results in the format you've requested. It indicates that the device has undergone verification, validation, and testing to establish its performance, functionality, and reliability, but it does not present the specifics of these tests or their outcomes as a dedicated performance study.
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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 OsbornQuality Program ManagerCardiac and Monitoring SystemsPhilips Medical Systems3000 Minuteman RoadAndover, MA 01810-1085 | Tel: 978 659 3178Fax: 978 685 5624Email: 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.
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- 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.
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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.
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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
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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 |
Page 1 of 1
§ 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.