(208 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard physiological monitoring.
No
The device is described as a "patient monitor" intended for "monitoring, analysis, recording and alarming of multiple physiological parameters." It does not mention any therapeutic function.
No
The device is a patient monitor, indicated for monitoring, analysis, recording, and alarming of physiological parameters, not for providing a diagnosis based on these parameters.
No
The device description explicitly states that the monitors come with a variety of display sizes and run on AC power with a secondary battery, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the physiological parameters of patients." This involves measuring vital signs directly from the patient's body (e.g., ECG, blood pressure, oxygen saturation, temperature).
- Device Description: The description reinforces that it's a "family of physiological vital signs monitors."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This document does not mention any analysis of bodily fluids or tissues.
The device is a patient monitor, which is a type of medical device used for real-time physiological monitoring of a patient.
N/A
Intended Use / Indications for Use
The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, Pediatric); ST segment Analysis (Adult);
Contraindications: Not for transport outside the healthcare facility
Product codes (comma separated list FDA assigned to the subject device)
MHX, MLD, DSJ, DSK, DXN, DRT, DQA, DSA, IKD, FLL, CCK, BZQ
Device Description
The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.
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
Adult, Pediatric, Neonatal
Intended User / Care Setting
health care professionals, healthcare environments
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices. Clinical user preference and usability studies support that the customer requirements are met.
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.
K123900, K050762, K042601, K100428, K101521
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
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally. The background is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2016
Philips Medical Systems Mary Kruitwagen OA and Regulatory Affairs 3000 Minuteman Road Andover, MA 01810-1099
Re: K151812
Trade/Device Name: Philips Efficia CM10 863301, Philips Efficia CM12 863303, Philips Efficia CM100 863300. Philips Efficia CM120 863302, Philips Efficia CM150 863304 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, MLD, DSJ, DSK, DXN, DRT, DQA, DSA, FLL, CCK, BZQ Dated: December 16, 2015 Received: December 21, 2015
Dear Mary Kruitwagen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
[signature]
for Pram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K151812 |
| Device Name | Philips Efficia CM10 863301, Philips Efficia CM12 863303, Philips Efficia CM100 863300, Philips Efficia CM120 863302 |
| Philips Efficia CM150 863304 | |
| Indications for Use (Describe) | The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care |
| professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, | |
| CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming | |
| of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the | |
| monitor may be used in transport situations within a healthcare facility. | |
| Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); | |
| Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 | |
| (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); | |
| CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia | |
| (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, | |
| Pediatric); ST segment Analysis (Adult); | |
| Contraindications: Not for transport outside the healthcare facility | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
3
Efficia CM10, CM12, CM100, CM120 and CM150 Patient Monitors 510(k) Summary
| Preparation Date | September 18, 2015 |
|---|---|
| Submission Type: | Traditional 510(k) |
| Regulatory Information | |
| Classification | Physiological Monitor, Patient Monitor |
| Common/ Usual Name | Multi-parameter Patient monitor |
| Trade Name | Philips Efficia |
| Proprietary Name | Efficia CM10 |
| Efficia CM12 | |
| Efficia CM100 | |
| Efficia CM120 | |
| Efficia CM150 | |
| Models (with Reference numbers) | CM10 (863301) |
| CM12 (863303) | |
| CM100 (863300) | |
| CM120 (863302) | |
| CM150 (863304) | |
| Device Sponsor | Philips Medical Systems, |
| 3000 Minuteman Rd, | |
| Andover, MA, USA, 01810-1099 | |
| Device Owner | Philips Medical Systems, |
| 3000 Minuteman Rd, | |
| Andover, MA, USA 01810-1099 | |
| Establishment Registration number: | 1218950 |
| Sponsor/Manufacturer/Owner/Operator: | 1217116 |
| Contact | Mary Kruitwagen |
| Philips Medical Systems, | |
| 3000 Minuteman Rd, | |
| Andover, MA, USA, 01810-1099 | |
| Phone: (978) 659-4932 | |
| Fax: 978-659-7323 | |
| mary.kruitwagen@philips.com |
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Peter Schipelliti, Philips Medical Systems, 3000 Minuteman Rd, Andover, MA 01810-1099 USA Email: peter.schipelliti@philips.com Phone: (978) 659-4744 Fax: 978-659-7323
Device Classification:
The product codes and individual classification monographs applicable to the subject devices are listed below:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | 870.1025, II | MHX | Monitor, Physiological, Patient (with arrhythmia detection or alarms) |
| Cardiovascular | 870.1025, II | MLD | Monitor, St Segment With Alarm |
| Cardiovascular | 870.1110, II | DSJ | Alarm, Blood Pressure |
| Cardiovascular | 870.1110, II | DSK | Computer, Blood Pressure |
| Cardiovascular | 870.1130, II | DXN | System, Measurement, Blood Pressure, Non-Invasive |
| Cardiovascular | 870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Cardiovascular | 870.2700, II | DQA | Oximeter |
| Cardiovascular | 870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient connector |
| Cardiovascular | 890.1175, II | IKD | cable, electrode |
| General Hospital and | |||
| Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology & | |||
| Respiratory Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| Anesthesiology & | |||
| Respiratory Therapy | 868.2375, II | BZQ | Monitor, Breathing Frequency |
Device Description
The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.
Fundamental Scientific Technology:
The subject Efficia CM10, CM120 and CM150 patient monitors include the following parameters (some optional): ECG, Respiration, NBP, SpO, Temperature, Invasive Blood Pressure, Cardiac Output, Arrhythmia Analysis, ST-Segment monitoring, and CO2 .monitoring.
- . The ECG algorithm is a Philips algorithm which is well established in the marketplace and is used in the primary predicate devices (K123900).
- Respiration rate can be measured through impedance technology, from capnography or via acoustic respiration. The Impedance respiration algorithm is the same algorithm as used in the primary predicate devices (K123900).
- Respiration from capnography, shown as awRR, is either from Microstream from the Oridion algorithm or main stream CO2.
- The Sidestream method is the same as in the primary predicate (K123900). The main stream CO2 including O respiration is from Respironics.
- The algorithm of the respirations from the mainstream CO₂ is from Respironics M2105A sensor (K042601 O and K050762) and is used unchanged in the subject devices.
- The acoustic respirations (awRR) measurement is achieved via the Masimo rainbow Set using their O algorithm unchanged and previously cleared (K100428).
5
- The NBP algorithm is proprietary Philips algorithm and is the same algorithm as in the primary predicate device (K123900).
- The subject devices offer two different SpO3 algorithms. The default SpO3 algorithm is a Philips proprietary algorithm and is unchanged from the primary predicate device (K123900). Optionally, the user can select the Masimo Set or Masimo rainbow Set. This option uses Masimo's algorithm unchanged from its predicate (K100428). SpHb and SpCO are part of Masimo's algorithm and are implemented unchanged from the Masimo predicate.
- . The temperature measurement is similar algorithm of primary predicate (K123900).
- The invasive blood pressure algorithm is a Philips algorithm which is unchanged from that in the primary predicate device (K123900).
- . The arrhythmia algorithm and the ST-Segment analysis algorithm used the Philips ST/AR algorithm and incorporate a subset of the STAR algorithm as cleared by K101521.
Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices. Clinical user preference and usability studies support that the customer requirements are met. The subject devices are in compliance with the following standards:
| IEC 60601-1 | IEC 60601-2-27 | ISO 80601-2-55 |
|---|---|---|
| IEC 60601-1-2 | IEC 80601-2-30 | ISO 80601-2-56 |
| IEC 60601-1-6 | IEC 60601-2-34 | ISO 80601-2-61 |
| IEC 62366 included IEC 62304 | IEC 60601-2-49 | ANSI/AAMI EC-13 |
| IEC 60601-1-8 |
The predicates for the subject devices are:
| K123900 | 03/19/2013 | Philips SureSigns VM Series Patient Monitors |
|---|---|---|
| K050762 | 04/22/2005 | Philips MP20, MP30, MP40, MP50, MP60, MP70 MP90 IntellliVue Patient Monitor |
| K042601 | 11/19/2004 | Respironics CAPNOSTAT 5 CO2 sensor |
| K100428 | 07/09/2010 | Masimo Rainbow SET® Radical 7R CO-Oximeter and Accessories |
| K101521 | 07/25/2010 | Philips ST/AR ST and Arrhythmia Software, Release K.O |
| Primary 510(k) Predicate |
Philips SureSigns VM Series Patient Monitors
K123900 03/19/2013
Indications for Use:
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The intended uses are for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
| Patient Types | |||
|---|---|---|---|
| Parameter | Adult | Pediatric | Neonatal |
| ECG | √ | √ | √ |
| Respiration - Impedance | √ | √ | √ |
| Respiration - RRa | √ |
6
| Patient Types | |||
|---|---|---|---|
| Parameter | Adult | Pediatric | Neonatal |
| Respiration - awRR | √ | √ | √ |
| NBP | √ | √ | √ |
| SpO2 | √ | √ | √ |
| SpHb | √ | √ | |
| SpCO | √ | √ | |
| Temperature | √ | √ | √ |
| CO2 | √ | √ | √ |
| IBP | √ | √ | √ |
| Cardiac Output | √ | √ | |
| Arrhythmia (Cardiotach) | √ | √ | √ |
| Arrhythmia (Basic) | √ | √ | |
| Arrhythmia (Advanced) | √ | √ | |
| ST segment Analysis | √ |
Contraindications: Not for transport outside the healthcare facility
Conclusion
The subject Efficia CM10, CM120 and CM150 patient monitors utilize the same fundamental scientific technology as the predicate devices on the market. The energy source is electrical with secondary battery back like the primary predicate. The subject Efficia CM10, CM120 and CM150 patient monitors use the same algorithms and have the similar performance to their predicates. They have the same or better level of safety and essential performance as compared to their predicate devices when reviewing the data of the device history file. It is our assessment that the subject devices demonstrate that they are substantially equivalent to the identified predicates and have the same level of safety and effectiveness.