MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
Device Facts
| Record ID | K021300 |
|---|---|
| Device Name | MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B |
| Applicant | Philips Medical Systems |
| Product Code | DSI · Cardiovascular |
| Decision Date | May 8, 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 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 Story
Philips M1275B Component Compact Monitor (CCM) is a multi-parameter physiological monitor used in clinical settings by healthcare professionals. Device processes inputs including ECG, blood pressure, gas concentrations (via M1026A Anesthesia Gas Module), and transcutaneous gas levels. System performs signal conditioning, arrhythmia detection, and ST segment analysis; provides real-time monitoring, recording, and alarming of patient status. Output displayed for clinician review to support clinical decision-making. Modification includes updated software and integration with M1026A Anesthesia Gas Module. Benefits include continuous patient surveillance and timely notification of physiological changes.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including system-level performance tests and safety testing derived from hazard analysis, demonstrating the device meets reliability requirements and performance claims.
Technological Characteristics
Multi-parameter physiological monitor. Connectivity: Network and communication system for physiological monitors. Software: Updated version A.03. Integrates with M1026A Anesthesia Gas Module for gas analysis. Sensing: ECG, blood pressure, transcutaneous gas, and anesthetic gas monitoring. Form factor: Compact monitor.
Indications for Use
Indicated for use by health care professionals for monitoring physiological parameters in adult, pediatric, and neonatal patients in health care facilities. EASI 12-lead ECG limited to adults/pediatrics; ST segment monitoring limited to adults; transcutaneous gas measurement limited to neonates.
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 Component Compact Monitor (M1275B) (K013199)
- Philips Component Monitoring System (K990125)
- Philips M1026A Anesthesia Gas Module (K951127, K982619, K994188)
- Philips M3 (K971910)
Related Devices
- K021778 — PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B · Philips Medical Systems · Jul 17, 2002
- K020531 — PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B · Philips Medical Systems · Mar 20, 2002
- K013199 — PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B · Philips Medical Systems, Inc. · Nov 28, 2001
- K013427 — MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A · Philips Medical Systems, Inc. · Nov 29, 2001
- K091395 — MP5 INTELLIVUE PATIENT MONITOR · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 5, 2009
Submission Summary (Full Text)
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## 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
- 2. The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|----------------------------|----------------|---------|-------------------------------------------------------------------------------|
| Panel 73<br>Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-<br>Dioxide, 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,<br>Sevoflurane, Gaseous-Phase<br>(Anesthetic 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-<br>Oxide, Gaseous Phase<br>(Anesthetic Concentration) |
| | 868.1720, II | CCL | Analyzer, Gas, Oxygen,<br>Gaseous-Phase |
| | 868.2375, II | BZQ | Monitor, Breathing<br>Frequency |
| | 868.2480, II | LKD | Monitor, Carbon-Dioxide,<br>Cutaneous |
| | 868.2500, II | KLK | Monitor, Oxygen,<br>Cutaneous, for Infant not<br>under Gas Anesthesia |
| Panel 74<br>Cardiovascular | 870.1025, III | DSI | Detector and Alarm,<br>Arrhythmia |
| | 870.1025, III | MLD | Monitor, ST Segment with<br>Alarm |
| | 870.1025, III | MHX | Monitor, Physiological,<br>Patient (with arrhythmia<br>Detection or alarms) |
| | 870.1100, II | DSJ | Alarm, Blood-Pressure |
| | 870.1110, II | DSK | Computer, Blood-Pressure |
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| Device Panel | Classification | ProCode | Description |
|---------------------------------|----------------|---------|----------------------------------------------------------------|
| | 870.1130, II | DXN | System, Measurement,<br>Blood-Pressure, Non-<br>Invasive |
| | 870.1435, II | DXG | Computer, Diagnostic, Pre-<br>Programmed, Single-<br>Function |
| | 870.1915, II | KRB | Probe, Thermodilution |
| | 870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer<br>Signal |
| | 870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate<br>Alarm) |
| | 870.2340, II | DPS | Electrocardiograph |
| | 870.2340, II | MLC | Monitor, ST Segment |
| | 870.2370, II | KRC | Tester, Electrode,<br>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 |
| | - | MSX | System,Network and<br>Communication,<br>Physiological Monitors |
| Panel 80<br>General<br>Hospital | 880.2910, II | FLL | Thermometer, electronic,<br>clinical |
- 3. 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.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of
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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.
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## 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.
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## 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
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## 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
11
Over-The-Counter
