K Number
K021300
Device Name
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
Date Cleared
2002-05-08

(14 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Device Description
The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. The modification is updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module.
More Information

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software updates and connectivity, not advanced analytical capabilities.

No.
The device is indicated for monitoring, recording, and alarming physiological parameters, which are diagnostic and observational functions, not therapeutic.

Yes
The device is described as "monitoring, recording, and alarming of multiple physiological parameters," which are activities associated with diagnostic devices, in order to track and understand a patient's health status.

No

The device description explicitly states the device name is "Philips Medical Systems, M1275B Component Compact Monitor" and the modification is "updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module." This indicates the device is a physical monitor with updated software, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities." This describes a device that measures physiological signals directly from the patient's body (like ECG, potentially blood pressure, etc.).
  • Device Description: The description mentions monitoring physiological parameters and connecting to an Anesthesia Gas Module. This further supports the idea of a patient-connected monitoring device.
  • Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue) or providing information about a disease or condition based on such analysis. IVDs are specifically designed for testing samples in vitro (outside the body).

Therefore, the Philips Medical Systems, M1275B Component Compact Monitor, as described, is a patient monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

· Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.

Product codes (comma separated list FDA assigned to the subject device)

CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, MSX, FLL

Device Description

The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:
The modification is updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module.

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.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

Intended User / Care Setting

health care professionals
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, 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 Component Compact Monitor meets all 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.

K013199, K990125, K951127, K982619, K994188, K971910

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 9.0

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.

  1. The submitter of this premarket notification is: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085

978 659 3178 Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com

This summary was prepared on 23 April, 2002

    1. The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:
Device PanelClassificationProCodeDescription
Panel 73
Anesthesiology868.1400, IICCKAnalyzer, Gas, Carbon-
Dioxide, Gaseous-Phase
868.1500, IICBQAnalyzer, Gas, Enflurane,
Gaseous-Phase (Anesthetic
Concentration)
868.1500, IINHOAnalyzer, Gas, Desflurane,
Gaseous-Phase (Anesthetic
Concentration)
868.1500, IINHPAnalyzer, Gas,
Sevoflurane, Gaseous-Phase
(Anesthetic Concentration)
868.1500, IINHQAnalyzer, Gas, Isoflurane,
Gaseous-Phase (Anesthetic
Concentration)
868.1620, IICBSAnalyzer, Gas, Halothane,
Gaseous-Phase (Anesthetic
Concentration)
868.1700, IICBRAnalyzer, Gas, Nitrous-
Oxide, Gaseous Phase
(Anesthetic Concentration)
868.1720, IICCLAnalyzer, Gas, Oxygen,
Gaseous-Phase
868.2375, IIBZQMonitor, Breathing
Frequency
868.2480, IILKDMonitor, Carbon-Dioxide,
Cutaneous
868.2500, IIKLKMonitor, Oxygen,
Cutaneous, for Infant not
under Gas Anesthesia
Panel 74
Cardiovascular870.1025, IIIDSIDetector and Alarm,
Arrhythmia
870.1025, IIIMLDMonitor, ST Segment with
Alarm
870.1025, IIIMHXMonitor, Physiological,
Patient (with arrhythmia
Detection or alarms)
870.1100, IIDSJAlarm, Blood-Pressure
870.1110, IIDSKComputer, Blood-Pressure

1

Device PanelClassificationProCodeDescription
870.1130, IIDXNSystem, Measurement,
Blood-Pressure, Non-
Invasive
870.1435, IIDXGComputer, Diagnostic, Pre-
Programmed, Single-
Function
870.1915, IIKRBProbe, Thermodilution
870.2060, IIDRQAmplifier and Signal
Conditioner, Transducer
Signal
870.2300, IIDRTMonitor, Cardiac (incl.
Cardiotachometer & Rate
Alarm)
870.2340, IIDPSElectrocardiograph
870.2340, IIMLCMonitor, ST Segment
870.2370, IIKRCTester, Electrode,
Surface,
Electrocardiograph
870.2450, IIDXJDisplay, Cathode-Ray Tube,
Medical
870.2600, IDRJSystem, Signal Isolation
870.2700, IIDQAOximeter
870.2770, IIDSBPlethysmograph, Impedance
870.2800, IIDSHRecorder, Magnetic Tape,
Medical
870.2810, IDSFRecorder, Paper Chart
-MSXSystem,Network and
Communication,
Physiological Monitors
Panel 80
General
Hospital880.2910, IIFLLThermometer, electronic,
clinical
    1. The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910.
  • The modification is updated software and the ability to connect 4. to the Philips M1026A Anesthesia Gas Module.
  • The new device has the same Indications for Use, for use by 5. health care professionals whenever there is a need for monitoring the physiological parameters patients, as the legally marketed predicate device.
  • The new device has the same technological characteristics as the 6. legally marketed predicate device.
    1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of

2

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 Component Compact Monitor meets all reliability requirements and performance claims.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K021300

Trade Name: Philips Medical Systems, M1275B Component Compact Monitor (CCM), Release A.03, with M1026A Anesthetic Gas Module Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 23, 2002 Received: April 24, 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 Osborn

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 or any I vith 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 orth in the quality systems (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Robert Till

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

510(k) Number (if known): _ K02 (300_

Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.03, with M1026A Anesthetic Gas Module.

Indications for Use: · Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.

Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

ﺮ Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021300

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Over-The-Counter