(219 days)
No
The document describes standard physiological monitoring parameters and algorithms based on predicate devices, with no mention of AI or ML.
No
The device is described as a multi-parameter unit for monitoring, recording, and alarming multiple physiological parameters; it does not mention treatment or therapy.
Yes
Explanation: The device is described as a "multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters." It specifically lists monitoring and displaying various physiological parameters such as ECG, blood pressure, heart/pulse rate, oxygen saturation, temperature, and respiration. While it monitors and records, these measurements provide data that can be used by a licensed healthcare practitioner to diagnose a patient's condition.
No
The device description explicitly states it is a "multi-parameter patient monitor" with a "12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module." It also interfaces with optional hardware modules and a thermal recorder. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the B40i device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the B40i is a "portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients". This describes a device that monitors physiological signals directly from the patient's body.
- Device Description: The description details the monitoring of parameters like ECG, blood pressure, SpO2, temperature, respiration, and airway gases. These are all measurements taken from the patient, not from samples of bodily fluids or tissues.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are specifically designed for testing samples outside of the body.
Therefore, the B40i is a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner.
The B40i is not intended for use during MRI.
The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
Product codes (comma separated list FDA assigned to the subject device)
MHX, BZQ, CBQ, CBR, CBS, CCK, CCL, DQA, DRT, DSB, DSK, DXN, FLL, GWQ, NHO, NHP, NHQ
Device Description
The proposed monitor B40i is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K133576) platform. The proposed monitor B40i provides support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195). The proposed monitor B40i is also compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) but with disabled spirometry function. The proposed monitor B40i supports Airway Gas Option (N-CAiO). The proposed monitor B40i expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). This parameter feature patient population extension to cover neonatal patient population uses Patient Data Module as predicate (K071073), which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed monitor B40i interfaces with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40, the proposed monitor B40i includes features and subsystems that are optional or configurable. The proposed monitor B40i interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40, the proposed monitor B40i has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
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, and neonatal patients
Intended User / Care Setting
licensed health care practitioner / hospital environment and during intra-hospital transport
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)
No additional clinical tests were performed for proposed monitor B40i.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K061907, K123195, K042642, K052582, K022834
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
GE Healthcare Finland Oy % Joel Kent Regulatory Affairs Manager GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492
Re: K143676
Trade/Device Name: B40i Patient Monitor 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, BZO, CBO, CBR, CBS, CCK, CCL, DSK, DOA, DRT, DSB, DXN, FLL, GWQ, NHO, NHO, NHQ, NHP Dated: June 17, 2015 Received: June 23, 2015
Dear Joel Kent,
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 (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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K143676
Device Name: B40i
Indications for use:
The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner.
The B40i is not intended for use during MRI.
The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharvngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1)):
| Date: | 19 December 2014 |
|---|---|
| Submitter: | GE Healthcare Finland Oy |
| Kuortaneenkatu 2, | |
| 00510 Helsinki | |
| Finland | |
| Phone: +358-40-539 7764 | |
| Primary Contact Person: | Joel Kent |
| Manager, Quality and Regulatory Affairs | |
| GE Medical Systems Information Technologies, Inc. | |
| Telephone: +1 617 851 0943 | |
| Fax at +1 781 433-1344 | |
| E-mail: joel.kent@med.ge.com | |
| Secondary Contact Person: | Anssi Ruokonen |
| Regulatory Affairs Leader | |
| GE Healthcare Finland Oy | |
| Kuortaneenkatu 2, | |
| 00510 Helsinki | |
| Finland | |
| Phone: +358-10-394 3686 | |
| E-mail: anssi.ruokonen@med.ge.com |
Device names (807.92(a)(2)):
Trade Name: B40i Common/Usual Name: Multi-parameter patient monitor
4
| Classification Names: | 21 CFR 870.1025 Arrhythmia detector and alarm (including
ST-segment measurement and alarm) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Product
Code: | MHX |
| Subsequent Product Codes | BZQ CBQ CBR CBS CCK
CCL DQA DRT DSB DSK DXN
FLL GWQ NHO NHP NHQ |
| Predicate Device(s)
(807.92(a)(3): | K133576 Monitor B40
K071073 Patient Data Module |
| Device Description
(807.92(a)(4)): | The proposed monitor B40i is a multi-parameter patient monitor
that is developed based on the predicate Monitor B40 (K133576)
platform. The proposed monitor B40i provides support for
optional modules (E-Entropy module (K061907) and
CARESCAPE Respiratory modules (E-sCO and E-sCAiO)
(K123195). The proposed monitor B40i is also compatible with
CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV)
(K123195) but with disabled spirometry function. The proposed
monitor B40i supports Airway Gas Option (N-CAiO). The
proposed monitor B40i expands the impedance respiration
parameter feature to cover the neonatal patient population
compared to the predicate Monitor B40 (K133576). This
parameter feature patient population extension to cover neonatal
patient population uses Patient Data Module as predicate
(K071073), which impedance respiration implementation
especially concerning the algorithm used is based on the predicate
Aware Transport (K042642). The proposed monitor B40i utilizes
12 inch LCD display panel and LED backlight with an integrated
keypad and a pre-configuration patient parameter measurement
module. The proposed monitor B40i interfaces with the optional
E-MiniC (K052582) and Thermal Recorder with an extension
rack. As with the predicate Monitor B40, the proposed monitor
B40i includes features and subsystems that are optional or
configurable. The proposed monitor B40i interfaces to a variety
of existing central station systems via a cabled network interface.
As with the predicate Monitor B40, the proposed monitor B40i
has a mounting plate on the bottom of the monitor. The monitor
can be mounted in a variety of ways (e.g. shelf, countertop, table,
wall, pole, or head/foot board) using existing mounting
accessories. |
5
| Intended Use (807.92(a)(5)): | The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. |
|---|---|
| The B40i is intended for use under the direct supervision of a licensed health care practitioner. | |
| The B40i is not intended for use during MRI. | |
| The B40i can be a stand-alone monitor or interfaced to other devices via a network. | |
| The B40i monitors and displays: | |
| ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. | |
| Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. | |
| Technology (807.92(a)(6)): | The proposed monitor B40i is a modified system based on the predicate Monitor B40 (K133576). In addition to the labeling differences with the predicate Monitor B40 (K133576), the proposed monitor B40i also expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). Patient Data Module (K071073) is the predicate, which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The fundamental technology of the proposed monitor B40i is the same as the predicate devices. The proposed monitor B40i is as safe and effective as the predicate devices as summarized in the comparison table below. |
6
| Feature/Function | Current Device/System
the legally marketed
predicate Monitor B40V2.1
(K133576) | Proposed Device/System
Name
proposed Monitor B40i | Change
Explanation/Notes |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use description to include: | | | |
| Claims/ features | The Monitor B40 is a portable
multi-parameter unit to be used
for monitoring and recording of,
and to generate alarms for,
multiple physiological
parameters of adult, pediatric,
and neonatal patients in a
hospital environment and during
intra-hospital transport.
The Monitor B40 is intended for
use under the direct supervision
of a licensed health care
practitioner.
The Monitor B40 is not intended
for use during MRI.
The Monitor B40 can be a
stand-alone monitor or
interfaced to other devices via a
network.
The Monitor B40 monitors and
displays: ECG (including ST
segment, arrhythmia detection),
invasive blood pressure,
heart/pulse rate, oscillometric
non-invasive blood pressure
(systolic, diastolic and mean
arterial pressure), functional
oxygen saturation (SpO2) and
pulse rate via continuous
monitoring (including monitoring
during conditions of clinical
patient motion or low perfusion),
temperature with a reusable or
disposable electronic
thermometer for continual
monitoring.
Esophageal/Nasopharyngeal/Ty
mpanic/Rectal/B ladder/Axi
llary/Skin/Airway/Room/Myocard
ial/Core/Surface temperature,
impedance respiration,
respiration rate, airway gases
(C02, 02, N20, anesthetic
agents, anesthetic agent
identification and respiratory
rate) and Entropy. | The B40i is a portable multi-
parameter unit to be used for
monitoring and recording of, and
to generate alarms for, multiple
physiological parameters of
adult, pediatric, and neonatal
patients in a hospital
environment and during intra-
hospital transport.
The B40i is intended for use
under the direct supervision of a
licensed health care practitioner.
The B40i is not intended for use
during MRI.
The B40i can be a stand-alone
monitor or interfaced to other
devices via a network.
The B40i monitors and displays:
ECG (including ST segment,
arrhythmia detection), invasive
blood pressure, heart/pulse rate,
oscillometric non-invasive blood
pressure (systolic, diastolic and
mean arterial pressure),
functional oxygen saturation
(SpO2) and pulse rate via
continuous monitoring (including
monitoring during conditions of
clinical patient motion or low
perfusion), temperature with a
reusable or disposable
electronic thermometer for
continual monitoring
Esophageal/Nasopharyngeal/Ty
mpanic/Rectal/Bladder/Axillary/S
kin/Airway/Room/Myocardial/Cor
e/Surface temperature,
impedance respiration,
respiration rate, airway gases
(CO2, O2, N2O, anesthetic
agents, anesthetic agent
identification and respiratory
rate) and Entropy. | Identical (only the
name of the monitor is
different) |
| Patient
Population | Adult, pediatric and neonate | Adult, pediatric and neonate | Identical |
| Environment of
Use | hospital environment and during
intra-hospital transport | hospital environment and during
intra-hospital transport | Identical |
| Hardware: | | | |
| Software Media | Embedded | Embedded | Identical |
| Battery Type | Lithium-Ion | Lithium-Ion | Identical |
| Battery run in time | >=2:15
typical monitor configuration:
- ECG, NIBP cycle time 5min,
SpO2, 2x INVP, 2x Temp
and continuous CO2 use - Ambient temperature 25 °C
- Display brightness 70% | >=2:15
typical monitor configuration: - ECG, NIBP cycle time 5min,
SpO2, 2x INVP, 2x Temp and
continuous CO2 use - Ambient temperature 25 °C
- Display brightness 70% | Identical |
| Operating Systems Infrastructure Software: | | | |
| Operating System | Linux | Linux | Identical |
| Networking | | | |
| Networking
Interface | LAN | LAN | Identical |
| User Interface | | | |
| Front Key Pad | 18 hard keys with Trim Knob,
and 1 power On/Standby | 18 hard keys with Trim Knob,
and 1 power On/Standby | Identical |
| Display: | | | |
| Size | 12.1-inch | 12.1-inch | Identical |
| Types | TFT LCD | TFT LCD | Identical |
| Number of
Waveform traces | Up to 6 | Up to 6 | Identical |
| Alarms: | | | |
| Classification | Three levels - Red, Yellow,
Cyan | Three levels - Red, Yellow,
Cyan | Identical |
| Notification | Audible and visual | Audible and visual | Identical |
| Trending: | | | |
| Types of trend
data | Graphic, numeric data | Graphic, numeric data | Identical |
| Storage | Up to 72 hours | Up to 72 hours | Identical |
| Snapshots: | | | |
| Snapshots | A snapshot is a frozen frame of
preconfigured waveforms or
trends
saved in the monitor memory of
time. Snapshots can contain
waveform clips and graphic
trends. | A snapshot is a frozen frame of
preconfigured waveforms or
trends
saved in the monitor memory of
time. Snapshots can contain
waveform clips and graphic
trends. | Identical |
| Printing: | | | |
| Printers Supported | Local Thermal Array Recorder,
Network laser printer,
Strip chart recorder at the
Central Station. | Local Thermal Array Recorder,
Network laser printer,
Strip chart recorder at the
Central Station. | Identical |
| Measurement
technique | Body surface electrical potential | Body surface electrical potential | Identical |
| Leads Available | 3-leads, 5-leads | 3-leads, 5-leads | Identical |
| Severe arrhythmia
analysis | Asystole
Bradycardia
Tachycardia
Ventricular fibrillation
Ventricular tachycardia | Asystole
Bradycardia
Tachycardia
Ventricular fibrillation
Ventricular tachycardia | Identical |
| Arrhythmia
algorithm | EKPRO V12
Fulfils AAMI EC57-1998
standard | EKPRO V12
Fulfils AAMI EC57-1998
standard | Identical |
| Monitored Parameter: SpO2 | | | |
| Measurement
Technique | GE SpO2
Nellcor OxiMax SpO2
(Nell1-S OEM board)
Masimo SET Radical SpO2
(MS-2011 OEM board) | GE SpO2
Nellcor OxiMax SpO2
(Nell1-S OEM board)
Masimo SET Radical SpO2
(MS-2011 OEM board) | Identical |
| Measurement
Range | GE: 1 to 100%
Masimo: 1 to 100%
Nellcor: 1 to 100% | GE:1 to 100%
Masimo: 1 to 100%
Nellcor: 1 to 100% | Identical |
| Accuracy | GE Trusingal SpO2:
Adult/Pediatric:
Without motion: 70 to 100% $\pm$ 2
digits ( $\pm$ 3 digits with ear sensor)
With motion: 70 to 100% $\pm$ 3
digits
Low perfusion : 70 to 100% $\pm$ 3
digits
1 to 69%: unspecified
Neonatal:
without motion: 100 to 70% $\pm$ 3
digits
with motion: 100 to 70% $\pm$ 3
digits
1 to 69%: unspecified
Nellcor:
Adult: 70 to 100% $\pm$ 2 digits
Neonate: 70 to 100% $\pm$ 3 digits
Low Perfusion: 70 to 100% $\pm$ 2
digits
Masimo:
Without Motion - Adult/Pediatric:
70 to 100% $\pm$ 2 digits
Without Motion - Neonate: 70 to
100% $\pm$ 3 digits
With Motion -
Adult/Pediatric/Neonate: 70 to
100% $\pm$ 3 digits
Low Perfusion 70 to 100% $\pm$ 2
digits 0 to 69% unspecified | GE Trusingal SpO2:
Adult/Pediatric:
Without motion: 70 to 100% $\pm$ 2
digits ( $\pm$ 3 digits with ear sensor)
With motion: 70 to 100% $\pm$ 3
digits
Low perfusion : 70 to 100% $\pm$ 3
digits
1 to 69%: unspecified
Neonatal:
without motion: 100 to 70% $\pm$ 3
digits
with motion: 100 to 70% $\pm$ 3
digits
1 to 69%: unspecified
Nellcor:
Adult: 70 to 100% $\pm$ 2 digits
Neonate: 70 to 100% $\pm$ 3 digits
Low Perfusion: 70 to 100% $\pm$ 2
digits
Masimo:
Without Motion - Adult/Pediatric:
70 to 100% $\pm$ 2 digits
Without Motion - Neonate: 70 to
100% $\pm$ 3 digits
With Motion -
Adult/Pediatric/Neonate: 70 to
100% $\pm$ 3 digits
Low Perfusion 70 to 100% $\pm$ 2
digits 0 to 69% unspecified | Identical |
| Pulse Rate | GE Trusingal SpO2 : | GE Trusingal SpO2 : | Identical |
| Detection | 30- 250 bpm | 30- 250 bpm | |
| | Without motion: 30- 250 bpm ±
2 bpm (Adult/Pediatric/Neonatal) | Without motion: 30- 250 bpm ± 2
bpm (Adult/Pediatric/Neonatal) | |
| | With motion: 30- 250 bpm ± 3
bpm | With motion: 30- 250 bpm ± 3
bpm | |
| | (Adult/Pediatric/Neonatal) | (Adult/Pediatric/Neonatal) | |
| | Low Perfusion: ±5 bpm
(Adult/Pediatric) | Low Perfusion: ±5 bpm
(Adult/Pediatric) | |
| | Nellcor: | Nellcor: | |
| | 20 to 250 beats/min ±3 digits | 20 to 250 beats/min ±3 digits | |
| | Low Perfusion 20 to 250
beats/min ±3 digits | Low Perfusion 20 to 250
beats/min ±3 digits | |
| | Masimo | Masimo | |
| | Without Motion | Without Motion | |
| | 25 to 240 beats/min ±3 digits, | 25 to 240 beats/min ±3 digits, | |
| | With Motion | With Motion | |
| | normal physiologic range 25 to
240 beats/min ±5 digits | normal physiologic range 25 to
240 beats/min ±5 digits | |
| Monitored Parameter: Invasive Blood Pressure | | | |
| Measurement
technique | Bridge type defibrillator proof
transducers | Bridge type defibrillator proof
transducers | Identical |
| Measurement
range | -40 ... 320mmHg | -40 ... 320mmHg | Identical |
| Accuracy of
systolic, diastolic,
and mean
pressures | ±5% or ±2mmHg (whichever is
greater) | ±5% or ±2mmHg (whichever is
greater) | Identical |
| Pulse rate range | 30 ... 250 bpm | 30 ... 250 bpm | Identical |
| Pulse rate
accuracy | ± 5% or ± 5 bpm, whichever is
greater | ± 5% or ± 5 bpm, whichever is
greater | Identical |
| Monitored Parameter: Temperature | | | |
| Temperature
range | 10 ... 45°C | 10 ... 45°C | Identical |
| Accuracy | ± 0.1°C | ± 0.1°C | Identical |
| Measurement | Esophageal/Nasopharyngeal/Ty
mpanic/Rectal/Bladder/Axillary/s
kin/Airway/Room/Myocardial/Co
re/Surface | Esophageal/Nasopharyngeal/Ty
mpanic/Rectal/Bladder/Axillary/s
kin/Airway/Room/Myocardial/Cor
e/Surface. | Identical |
| Measurement
technique | Thermally sensitive resistor | Thermally sensitive resistor | Identical |
| Monitored Parameter: CO2 | | | |
| Measurement | S/5TM Single-width Airway | S/5TM Single-width Airway | Identical |
| Technique | Module, E-miniC (K052582). | Module, E-miniC (K052582). | |
| Measurement | Side stream, FiCO2 and EtCO2
values, respiration rate (RR) | Side stream, FiCO2 and EtCO2
values, respiration rate (RR) | Identical |
| Monitored Parameter: Full Gas | | | |
| Measurement
technique | Non-dispersive infrared
absorption, paramagnetic
differential oxygen
measurement | Non-dispersive infrared
absorption, paramagnetic
differential oxygen measurement | Identical |
| Measurement
Module Support | CARESCAPE Respiration
module(K123195) ( E-sCO,E-
sCAIO, and compatible with E-
sCOV and E-sCAIOV but
disabled spirometry function) | CARESCAPE Respiration
module(K123195) ( E-sCO,E-
sCAIO, and compatible with E-
sCOV and E-sCAIOV but
disabled spirometry function) | Identical |
| Airway Gas Option (N-CAIO) | Measurement parameter:
C - EtCO2, FiCO2 , and N2O
Ai - Anesthetic agents w/
identification and agent mixture
detection
0 - FiO2, EtO2 and FiO2/EtO2
difference | Measurement parameter:
C - EtCO2, FiCO2 , and N2O
Ai - Anesthetic agents w/
identification and agent mixture
detection
O - FiO2, EtO2 and FiO2/EtO2
difference | Identical |
| Monitored Parameter: Entropy | | | |
| Measurement | RE value, SE value, BSR value | RE value, SE value, BSR value | Identical |
| Measurement
technique | Entropy monitoring is based
on acquisition and processing
of raw EEG and FEMG signals
using the Entropy algorithm. | Entropy monitoring is based
on acquisition and processing
of raw EEG and FEMG signals
using the Entropy algorithm. | Identical |
| Monitored Parameter: Non-Invasive Blood Pressure | | | |
| Measurement
Technique | Oscillometric with step deflation | Oscillometric with step deflation | Identical |
| Algorithm
Selection | SuperStat (DINAMAP) K022834 | SuperStat (DINAMAP) K022834 | Identical |
| Displayed
Parameters | Systolic, diastolic, and mean
pressures, auto cycle time and
the time since the last
determination(when manual
mode) , and cuff/hose type,
inflation cuff pressure(When
measurement start) | Systolic, diastolic, and mean
pressures, auto cycle time and
the time since the last
determination(when manual
mode) , and cuff/hose type,
inflation cuff pressure(When
measurement start) | Identical |
| Measurement
Ranges | Systolic:
30 to 290 mmHg
(adult/pediatric)
30 to 140 mmHg (neonate)
Map:
20 to 260 mmHg
(adult/pediatric)
20 to 125 mmHg (neonate)
Diastolic:
10 to 220 mmHg
(adult/pediatric)
10 to 110 mmHg (neonate) | Systolic:
30 to 290 mmHg (adult/pediatric)
30 to 140 mmHg (neonate)
Map:
20 to 260 mmHg (adult/pediatric)
20 to 125 mmHg (neonate)
Diastolic:
10 to 220 mmHg (adult/pediatric)
10 to 110 mmHg (neonate) | Identical |
| Feature/Function | Current Device/System
the legally marketed
predicate Monitor B40V2.1
(K133576) | Proposed Device/System
Name
proposed Monitor B40i | Change
Explanation/Notes |
| Monitored Parameter: Impedance Respiration on adult and pediatric patient populations | | | |
| Measurement
Technique | Impedance variation detection.
Excitation frequency 31.25 kHz | Impedance variation detection.
Excitation frequency 31.25 kHz | Identical |
| Displayed
Parameters | RESP rate | RESP rate | Identical |
| Measurement
range | 4 - 120 breaths/minute | 4-120 breaths/minute | Identical |
| Measurement | +-5% or +-5 bpm, whichever is
greater | +-5% or +-5 bpm, whichever is
greater | Identical |
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8
9
10
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Summary of Non-Clinical Tests:
Determination of Substantial Equivalence (807.92(b)(1):
The CARESCAPE Monitor B40i and its applications comply with voluntary standards as detailed below. The following quality assurance measures were applied in the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Final acceptance testing (Validation)
- · Performance testing (Verification)
- · Safety testing (Verification)
The CARESCAPE Monitor B40i was designed and tested for compliance to the following standards:
-
- IEC 60601-1: 1988+A1: 1991+A2: 1995 Medical electrical equipment - Part 1: General requirements for safety
-
- IEC60601-1-2: 2007 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC60601-1-4: 2000 Medical electrical equipment Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
-
- IEC60601-1-8: 2006 Medical electrical equipment Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
- IEC 60601-2-27:2005- Medical Electrical Equipment-Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment, except for the clause 50.102.8 a). Frequency response
-
- IEC 60601-2-30:1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
-
- IEC 60601-2-34:2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including
12
essential performance, of invasive blood pressure monitoring equipment
-
- IEC 60601-2-49:2001, Medical electrical equipment Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
-
- AAMI / ANSI EC13:2002/(R)2007 Cardiac devices, heart rate meters, and alarms
-
- AAMI SP10:2002+A1:2003+R:2008 +A2:2006 +R:2008 Manual, electronic, or automated sphygmomanometers
-
- EN 12470-4:2000, A1:2009, Clinical Thermometers Part 4: Performance of Electrical Thermometers for Continuous Measurement. Except for the clause 6.3 b) Temperature measurement error with single use probes exceeded maximum permissible error.
-
- ISO 21647:2004 + C1:2005. Medical electrical equipment -Particular requirements for the basic safety and essential performance of respiratory gas monitors
-
- ISO9919:2005, Medical electrical equipment Particular requirements for the safety and essential performance of pulse oximeter equipment for medical use
-
- IEC 62304:2006, Medical devices Medical device software - Software life cycle processes
-
- IEC 60601-2-26:2002. Medical electrical equipment Part 2-26: Particular requirements for the safety of electroencephalographs.
-
- IEC 62366:2007. Medical devices Application of usability engineering to medical devices
| Clinical (807.92(b)(2)): | Summary of Clinical Tests: |
|---|---|
| No additional clinical tests were performed for proposed monitor | |
| B40i | |
| Conclusion (807.92(b)(3)): GE Healthcare considers the proposed monitor B40i to be as safe |
- C as effective, and performance is substantially equivalent to the predicate devices.