M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY

K023871 · Philips Medical Systems · MHX · Dec 4, 2002 · Cardiovascular

Device Facts

• Record ID: K023871
• Device Name: M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments. 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.

Device Story

M3046A and MP60/MP70 are multi-parameter patient monitors; they acquire physiological signals (ECG, blood pressure, SpO2, gas analysis, etc.) from patients in hospital or transport settings. The modification introduces a Data Export function; this connection-oriented, message-based request/response protocol enables transfer of monitored data to external computers or data clients. Operated by healthcare professionals; output is displayed on-screen and transmitted to external systems for clinical review. Data export facilitates integration into broader clinical workflows, supporting real-time monitoring and decision-making. Benefits include enhanced data accessibility and centralized patient information management.

Clinical Evidence

No clinical data provided. Verification testing was limited to functional-level tests and safety testing derived from risk analysis.

Technological Characteristics

Multi-parameter patient monitoring system. Connectivity: Data Export function using a connection-oriented, message-based request/response protocol for external data transmission. Software-based modification. No specific materials or hardware standards cited.

Indications for Use

Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients within hospital, medical transport, or healthcare facility environments by healthcare professionals.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Philips Medical Systems (K013427)
• Philips Medical Systems (K021778)

Submission Summary (Full Text)

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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.

1. The submitter of this premarket notification is: David Osborn Philips Medical Systems Cardiac & Monitoring Systems 3000 Minuteman Road 01810-1099 Andover, MA Tel: [phone] 685 5624 Fax: e-mail: [e-mail]

This summary was prepared on November 18, 2002

- 2. 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<br>System Devices<br>(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<br>(with arrhythmia detection or<br>alarms) |
| | \$870.1100, II | DSJ | Alarm, Blood Pressure |
| | \$870.1110, II | DSK | Computer, Blood Pressure |
| | \$870.1130, II | DXN | System, Measurement, Blood-<br>Pressure, Non-Invasive |
| | \$870.1435, II | DXG | Computer, Diagnostic, Pre-<br>Programmed, Single-Function |
| | \$870.1915, II | KRB | Probe, Thermodilution |
| | \$870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer Signal |
| | \$870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate Alarm) |
| | \$870.2340, II | DPS | Electrocardiograph |
| | \$870.2340, II | MLC | Monitor, ST Segment |
| | \$870.2350, II | DRW | Electrocardiograph, Lead<br>Switching Adapter |
| | \$870.2370, II | KRC | Tester, Electrode, Surface,<br>Electrocardiograph |
| | \$870.2450, II | DXJ | Display, Cathode-Ray Tube,<br>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,<br>Medical |
| | \$870.2810, I | DSF | Recorder, Paper Chart |

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| | \$870.2850, II | DRS | Extravascular Blood Pressure<br>Transducer |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
| | - | MSX | System, Network and<br>Communication, Physiological<br>Monitors |
| Anesthesiology<br>and Respiratory<br>Therapy (12624) | \$868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,<br>Gaseous-Phase |
| | \$868.1500, II | CBQ | Analyzer, Gas, Enflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHO | Analyzer, Gas, Desflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHP | Analyzer, Gas, Sevoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHQ | Analyzer, Gas, Isoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1620, II | CBS | Analyzer, Gas, Halothane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-<br>Phase |
| | \$868.2375, II | BZQ | Monitor, Breathing Frequency |
| | \$868.2480, II | LKD | Monitor, Carbon Dioxide,<br>Cutaneous |
| | \$868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for<br>Infant not under Gas Anesthesia |
| General Hospital<br>and Personal Use<br>(12520) | \$880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |
| Neurological<br>(12513) | \$882.1400, II | GWR | Electroencephalograph |
| | \$882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalogram Signal |

- 3. The new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K013427 and K021778.
- 4. 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.
- 5. 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,

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K023871
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and alarming of multiple physiological parameters of adults, pediatrics, and neonates.

- 6. The new devices have the same technological characteristics as the legally marketed predicate devices.
- 7. 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.

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)