(14 days)
Not Found
No
The summary describes a software modification for data export and does not mention AI or ML capabilities.
No
The device is described as a monitor that records and alarms physiological parameters, which is a diagnostic function, not a therapeutic one. The description of its use focuses on monitoring and data export, not on treating or alleviating a condition.
No
The device is described as a monitor for physiological parameters, designed for monitoring, recording, and alarming. It does not mention diagnosing conditions, but rather providing data to healthcare professionals.
No
The device description explicitly states the modification is a software-based change to existing patient monitors (M3046A, MP60, MP70), which are hardware devices. The software change adds a data export function to these hardware monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly state the device is for "monitoring, recording and alarming of multiple physiological parameters" of patients. This describes a device that monitors the patient directly, not a device that analyzes samples taken from the patient.
- Device Description: The description focuses on a software modification for data export from patient monitors. This reinforces the idea of a patient-connected monitoring device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to monitor physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.
Indications for Use (MP60 & MP70): Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The modification is primarily a software-based change that incorporates a Data Export function communication protocol to transfer data from the patient monitors to an external computer or external device (a data client). This protocol is a connection oriented, message based request/response protocol.
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
adults, pediatrics, and neonates
Intended User / Care Setting
health care professionals / hospital environment and/or in medical transport, health care 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 testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis.
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.
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
DEC 0 4 2002
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 01810-1099 Andover, MA Tel: 978 659 3178 978 685 5624 Fax: e-mail: d.g.osborn@ieee.org
This summary was prepared on November 18, 2002
-
- The names of the devices are the M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | |||
| (12625) | $870.1025, III | DSI | Detector and alarm, arrhythmia |
| $870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, III | MHX | Monotor, Physiological, Patient | |
| (with arrhythmia detection or | |||
| alarms) | |||
| $870.1100, II | DSJ | Alarm, Blood Pressure | |
| $870.1110, II | DSK | Computer, Blood Pressure | |
| $870.1130, II | DXN | System, Measurement, Blood- | |
| Pressure, Non-Invasive | |||
| $870.1435, II | DXG | Computer, Diagnostic, Pre- | |
| Programmed, Single-Function | |||
| $870.1915, II | KRB | Probe, Thermodilution | |
| $870.2060, II | DRQ | Amplifier and Signal | |
| Conditioner, Transducer Signal | |||
| $870.2300, II | DRT | Monitor, Cardiac (incl. | |
| Cardiotachometer & Rate Alarm) | |||
| $870.2340, II | DPS | Electrocardiograph | |
| $870.2340, II | MLC | Monitor, ST Segment | |
| $870.2350, II | DRW | Electrocardiograph, Lead | |
| Switching Adapter | |||
| $870.2370, II | KRC | Tester, Electrode, Surface, | |
| Electrocardiograph | |||
| $870.2450, II | DXJ | Display, Cathode-Ray Tube, | |
| Medical | |||
| $870.2600, I | DRJ | System, Signal Isolation | |
| $870.2700, II | DQA | Oximeter | |
| $870.2770, II | DSB | Plethysmograph, Impedance | |
| $870.2800, II | DSH | Recorder, Magnetic tape, | |
| Medical | |||
| $870.2810, I | DSF | Recorder, Paper Chart |
1
| | $870.2850, II | DRS | Extravascular Blood Pressure
Transducer |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | $870.2900, I | DSA | Cable, Transducer and
Electrode, incl. Patient
Connector |
| | - | MSX | System, Network and
Communication, Physiological
Monitors |
| Anesthesiology
and Respiratory
Therapy (12624) | $868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,
Gaseous-Phase |
| | $868.1500, II | CBQ | Analyzer, Gas, Enflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHO | Analyzer, Gas, Desflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1620, II | CBS | Analyzer, Gas, Halothane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-
Phase |
| | $868.2375, II | BZQ | Monitor, Breathing Frequency |
| | $868.2480, II | LKD | Monitor, Carbon Dioxide,
Cutaneous |
| | $868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for
Infant not under Gas Anesthesia |
| General Hospital
and Personal Use
(12520) | $880.2910, II | FLL | Thermometer, Electronic,
Clinical |
| Neurological
(12513) | $882.1400, II | GWR | Electroencephalograph |
| | $882.1420, I | GWS | Analyzer, Spectrum,
Electroencephalogram Signal |
-
- The modification is primarily a software-based change that incorporates a Data Export function communication protocol to transfer data from the patient monitors to an external computer or external device (a data client). This protocol is a connection oriented, message based request/response protocol.
-
- The new devices have the same intended use as the legally marketed predicate devices. When used in the hospital environment and/or in medical transport, they are intended for the monitoring, recording,
2
K023871
page 3 of 3
and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
-
- The new devices have 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. Testing involved functional level tests and safety testing from the risk analysis.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 04 2002
Philips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810
Re: K023871
Trade Name: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: November 19, 2002 Received: November 20, 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 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 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.
4
Page 2 - Mr. Dave Osbo
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.
Q.G.Tich
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1.
510(k) Number (if known):
The M3046A (M2/M3/M4) Compact Portable Patient Device Name: Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology
Indications for Use (M3046A): For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.
Indications for Use (MP60 & MP70): Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in health care facilities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(21 CFR 801.109) X
OR
10
Over-The-Counter (Per
Yolanda
(Division Sign Off)
510(k) Number K023374
(Optional Format 1-2-96)