No
The document describes a standard vital signs monitor with various measurement modalities and connectivity features. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic vital sign measurement and display. The "Improved Early Warning Score" is mentioned, but this is a common feature in vital signs monitors and does not inherently imply the use of AI/ML; it typically relies on pre-defined rules and thresholds.
No
Explanation: This device is a vital signs monitor used for data collection and analysis, not for treatment.
Yes
Explanation: The device is explicitly named a "vital signs monitor" and is intended to measure physiological parameters like blood pressure, pulse rate, oxygen saturation, and temperature. While it provides "monitoring" and "measurements," these data are used by healthcare practitioners to assess a patient's health status, which is a key component of diagnosis. The transmission of data to "various hospital information systems" and "EMR (Electronic Medical Record) system" further supports its role in informing clinical decision-making.
No
The device description explicitly mentions a "New hardware platform" and describes physical components like an LCD touch screen, carrying handle, and mounting plate. It also details extensive hardware bench testing and compliance with hardware-related standards (electrical safety, EMC, environmental). While software is a critical component, the device is clearly a physical vital signs monitor with integrated hardware.
Based on the provided text, the Portrait VSM vital signs monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening.
- Portrait VSM Function: The Portrait VSM vital signs monitor measures physiological parameters directly from the patient's body (blood pressure, pulse rate, oxygen saturation, and temperature) using non-invasive methods. It does not analyze samples taken from the body.
The intended use and device description clearly indicate that the device is for monitoring vital signs in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.
The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.
The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.
The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.
The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.
A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.
The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.
The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.
The Portrait VSM vital signs monitor is not intended for use during MRI.
"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, DQA, DPZ, FLL, MHX
Device Description
The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA.
In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements:
● New hardware platform
● Adopted equivalent NIBP design from B105M(K213490)
● Adopted equivalent SpO2 design from B105M(K213490)
● Compatible with Recorder B1X5-REC
● Support Round Advisor in spot check mode
● Support automatically screens brightness adjustment.
● Improved Early Warning Score
● Addtional alarm management enhancement.
● Additional cybersecurity enhancement
The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.
As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).
Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.
Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.
Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb (for NIBP), finger, toe, ear (for SpO2), Oral/Rectal/Axillary/Forehead (for Temperature)
Indicated Patient Age Range
adult, pediatric, and neonatal patients for NIBP, SpO2, and pulse rate.
adult and pediatric patients for Welch Allyn SureTemp Plus electronic thermometer.
patients of all ages for Exergen TemporalScanner thermometer and HeTaiDa electronic infrared non-touch thermometer.
Intended User / Care Setting
Intended User: licensed health care practitioner (under direct supervision)
Care Setting: hospital-type facilities, satellite areas, or alternate care settings (for portable device)
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)
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the Portrait™ VSM Vital Signs Monitor to demonstrate that the design meets the specifications. Non-clinical testing was performed for hardware, alarms, EMC, electrical safety, environmental factors (temperature, humidity, pressure, mechanical stress, fluid ingress, packaging), reprocessing efficacy, human factors/usability, and wireless performance. Summative Usability testing was concluded with 15 US Clinical and 15 US Technical users. Software testing and documentation were provided according to FDA guidance. Clinical studies were not required to support substantial equivalence.
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.
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.
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2024
GE Medical Systems Information Technologies, Inc. Jung William Regulatory Affairs Director 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K233810
Trade/Device Name: Portrait VSM Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, DPZ, FLL, MHX Dated: November 30, 2023 Received: November 30, 2023
Dear Jung William:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology Diagnostics and Monitoring Devices Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233810
Device Name
Portrait VSM
Indications for Use (Describe)
The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.
The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.
The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.
The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.
The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.
A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.
The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.
The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.
The Portrait VSM vital signs monitor is not intended for use during MRI.
"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters are stylized with curved lines, and the frame has decorative flourishes resembling droplets or leaves around the circle.
510(k) Summary for K233810
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
| Owner/Contact/Date (807.92(a)(1): | |
|---|---|
| Date: | November 30th, 2023 |
| Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| USA | |
| Primary Contact Person: | William Jung |
| Regulatory Affairs Director | |
| GE HealthCare | |
| Phone: 571-396-1558 | |
| E-mail: William.Jung@gehealthcare.com | |
| Secondary Contact Person: | |
| Joel Kent | |
| Director, Regulatory Affairs Strategy | |
| GE HealthCare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@gehealthcare.com | |
| Sun Yanli | |
| Regulatory Affairs Manager | |
| GE HealthCare | |
| Phone: +86-18051597363 | |
| E-mail: yanli.sun@gehealthcare.com | |
| Device names (807.92(a)(2): | |
| Trade Name: | Portrait™ VSM |
| Common/Usual Name: | Multiparameter patient monitor (Monitor, Physiological |
| Patient | |
| (Without Arrhythmia Detection or Alarms)) | |
K233810 510(k) Summary Page 1 of 17
6
| | GE Medical Systems
Information
Technologies, Inc.
9900 Innovation Drive
Wauwatosa, WI 53226, USA |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Names: | 21 C.F.R. §870.2300 Cardiac monitor (including
cardiotachometer and rate alarm).
21 C.F.R. §870.1130 Noninvasive blood pressure measurement
system.
21 C.F.R. §870.2700 Oximeter
21 C.F.R. §870.2710 Ear oximeter.
21 C.F.R. §880.2910 Clinical electronic thermometer.
21 C.F.R. §870.1100 alarm, blood-pressure |
| Product Code:
Subsequent Product
Code:
Predicate Device(s)
(807.92(a)(3)): | MWI
DXN, DQA, DPZ, FLL
Primary Predicate: K133810 Vital Signs Monitor VC150
Additional Predicate Devices:
K213490 B105M Patient Monitor
K171888 Non-contact infrared body thermometer |
| Device Description
(807.92(a)(4)): | The proposed Portrait™ VSM is a vital signs monitor which is
developed based on primary predicate vital signs monitor
VC150(K133810) with integrated NIBP and SpO2 design from a
secondary predicate monitor B105M (K213490) and provided
additional non-contact infrared body temperature measurement
option by supporting OEM thermometer (K171888) previously
cleared by FDA.
In addition to the added non-contact infrared body thermometer,
the proposed monitor Portrait™ VSM also offer several
enhancements:
New hardware platform
●
Adopted equivalent NIBP design from B105M(K213490)
●
Adopted equivalent SpO2 design from B105M(K213490)
●
Compatible with Recorder B1X5-REC
●
Support Round Advisor in spot check mode
●
Support automatically screens brightness adjustment.
●
Improved Early Warning Score
●
Addtional alarm management enhancement.
●
Additional cybersecurity enhancement
●
K233810
510(k) Summary Page |
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circle. The letters are stylized with curved lines, giving them a classic and elegant appearance. The circle surrounding the letters has decorative flourishes at the top and bottom, resembling stylized leaves or swirls. The logo is presented in black against a white background, creating a strong contrast.
The proposed monitor Portrait™ VSM adopts larger 10-inch
LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.
As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).
Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.
Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.
Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.
Indications for Use (807.92(a)(5)):
The Portrait™ VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intrahospital transport.
The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial
K233810 510(k) Summary Page 3 of 17
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circle. There are decorative flourishes resembling water droplets or stylized leaves surrounding the circle, adding a touch of elegance to the design. The logo is presented in black and white, giving it a classic and timeless appearance.
blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.
The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.
The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages.
The optional HeTaiDa electronic infrared non-touch thermometer is intended for the intermittent measurement of human body temperature of patients of all ages.
A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.
K233810 510(k) Summary Page 4 of 17
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized monogram, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves, adding a touch of elegance to the design. The logo is presented in black and white, with the monogram and frame in black against a white background.
The portable device is designed for use in hospitals and hospitaltype facilities. The Portrait™ VSM vital signs monitor can also be used in satellite areas or alternate care settings.
The Portrait™ VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner. The Portrait™ VSM vital signs monitor is not intended for use during MRI.
"Portable" refers to the ability of the Portrait™ VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.
Contraindications for using the monitor
The Portrait™ VSM vital signs monitor is not intended for use during MRI.
Technology (807.92(a)(6)):
The proposed monitor Portrait™ VSM is a vital signs monitor where features and parameters are essentially same as in predicate monitor VC150 (K133810). This 510 (k) introduces non-contact infrared body thermometer by supporting additional optional OEM module (K171888) previously cleared by FDA and enhancements of several features.
The fundamental technology of the proposed monitor Portrait™ VSM is same as the predicate device.
The proposed monitor Portrait™ VSM are substantially equivalent to the predicate devices.
A summary of the main changes compared to the predicate are listed below in the comparison table.
10
Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular emblem with the letters "GE" intertwined in the center. The letters are stylized and have a classic, elegant design. The logo is black and white.
Product Comparison versus Predicate Main Features:
The proposed monitor Portrait™ VSM shares equivalent indications for use, intended use patient
populations, and functional features as the predicate devices. The proposed monitor Portrait™ VSM consists of improvements and optional features outlined below that are substantially equivalent to the predicate device.
| Specification | Primary Predicate Vital Sings Monitor
VC150(K133810) | Proposed Portrait™ VSM Vital Signs Monitor | Differences |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| • Indications
for Use | The VC150 is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport. | The Portrait™ VSM is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport. | Equivalent. |
| | The noninvasive oscillometric blood pressure
parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. | The noninvasive oscillometric blood pressure
parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. | Same features found in the predicate Monitor VC150 are retained, with the addition of infrared non-touch intermittent temperature measurement. |
| | The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients. | The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients. | The addition of the infrared non-touch intermittent temperature measurement is supported through previously cleared HeTaida thermometer (K203332) |
| | The optional Masimo SET® pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients. | The optional Masimo SET® pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients. | The proposed device only displays the measurement result from The HeTaida thermometer. |
| | The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. | The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. | |
| | The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. | The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. | |
| | | The optional HeTaiDa electronic infrared non-touch thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. | |
11
| | A wireless network connection is provided to
transmit clinical data into various hospital
information systems. An optional remote alarm
cable connection is intended to complement visual
and audible alarms and not replace the need for
the presence of a caregiver.
The portable device is designed for use in hospitals
and hospital-type facilities. The VC150 can also be
used in satellite areas or alternate care settings.
"Portable" refers to the ability of the VC150 to be
easily moved by the caregiver, such as on a roll
stand. The VC150 is not intended to be used for
continuous monitoring during patient transport. | A wireless network connection is provided to
transmit clinical data into various hospital
information systems. An optional remote alarm
cable connection is intended to complement visual
and audible alarms and not replace the need for
the presence of a caregiver.
The portable device is designed for use in hospitals
and hospital-type facilities. The Portrait™ VSM can
also be used in satellite areas or alternate care
settings.
The Portrait™ VSM is intended for use under the
direct supervision of a licensed health care
practitioner.
"Portable" refers to the ability of the Portrait™
VSM to be easily moved by the caregiver, such as
on a roll stand. The Portrait™ VSM is not intended
for use during MRI. | Add few clarification to clarify the
device need be used under the
direct supervision of a licensed
health care practitioner and can't
be used during the MRI and
removed one sentence regarding
continuous monitoring to keep
consistent with GE other monitors.
Nothing change for the device
itself. Both the predicate and the
proposed device can use in the
same condition, the modification
of the description in indication for
use is only to keep consistent
description with GE other family
products.
Therefore, the changes do not
significantly affect safety and/or
effectiveness. |
|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Patient
Population | Adult, pediatric and neonate | Adult, pediatric and neonate | Identical |
| • Use
Environment | The Patient Monitor is intended for use in multiple
areas within a professional healthcare facility | The Patient Monitor is intended for use in multiple
areas within a professional healthcare facility | Identical |
| • Intrahospital
transport within
a professional
healthcare
facility | Yes | Yes | Identical |
| • Intended
application site | NIBP- limb
SpO2- finger, toe, ear
Temperature- Oral/Rectal/Axillary/Forehead | NIBP- limb
SpO2- finger, toe, ear
Temperature- Oral/Rectal/Axillary/Forehead | Identical |
| GE Medical Systems
Information
Technologies, Inc.
9900 Innovation Drive
Wauwatosa, WI 53226, USA | | | |
| • Available
Parameters | Pulse rate
Non-invasive blood pressure (NIBP)
Oxygen saturation (SpO2)
Temperature
Respiration rate (only available with Masimo
technology) | Pulse rate
Non-invasive blood pressure (NIBP)
Oxygen saturation (SpO2)
Temperature
Respiration rate (only support manually entered
values of Respiration Rate) | Equivalent
The predicate monitor could
support measure respiration rate by
choose Masimo technology.
The proposed monitor doesn't
provide the respiration rate
measurement due to employ
different Masimo technology.
respiration rate measurement is not
provided in Masimo board MS-
2011SB (K053269). However, the
proposed monitor supports care
giver to enter the respiration rate
value manually for patient.
The change does not affect safety
or effectiveness. |
| • Peripheral
Interfaces | Network interface
Mains input
Nurse call Connector
3 USB Connector
SpO2 connector
NIBP hose connection | Network interface
Mains input
Nurse call Connector
3 USB Connector
SpO2 connector
NIBP hose connection
HDMI Connector
Recorder Connector | Equivalent
The proposed device adds HDMI
(High-Definition Multimedia
Interface) as connector to provide a
slave video interface for a
secondary display.
The proposed device also supports
connect to thermal recorder B1X5-
REC(K213490) for printing
through recorder connector. The
recorder B1x5-REC(K213490) is
identical and cleared in the
predicate monitor B105M
(K213490).
The function was verified on the
proposed device, and it
demonstrated has equivalence to
the predicate device.
The change does not affect safety
or effectiveness. |
| Display size | 8.4-inch LCD display | 10.1-inch LCD display | Equivalent
The proposed device supports
larger LCD display with better user
experience.
The change does not affect safety
or effectiveness. |
| Display type | Resistive touch screen | Capacitive touch screen | Equivalent
The proposed device uses the
capacitive touch screen due to
technology improvement as
capacitive touch screen has low
power, long service life and stable
operation compare with resistive
touch screen.
The change does not affect safety
or effectiveness. |
| Operating
System | Linux | Linux | Identical |
| Networking
Interface | WLAN | WLAN
LAN | Equivalent
The proposed device additional
support wired network
connectivity.
The proposed device adopts
equivalent LAN design as B105M
(K213490)
The change does not affect safety
or effectiveness. |
| Networking
Protocol | HL7
Cerner-iBus
LDAP
NTP | HL7
Cerner-iBus
LDAP
NTP | Identical |
| Networks
Supported
Devices | CARESCAPE Gateway | EMR Gateway Pro V2 | Equivalent
The proposed device supports
EMR Gateway Pro V2 which has
better cost/product ratio.
Both CARESCAPE Gateway
and EMR Gateway Pro V2 acts as
a communication conduit between
the EMR system and the monitor
and use the same HL7 interface
engine.
The change does not affect safety
or effectiveness. |
| Audible
Indicators | High, Medium, and Low alarm have audible tones
that differentiate them from each other. | High, Medium, and Low alarm have audible tones
that differentiate them from each other. | Identical |
| Visual
Indicators | Alarm light. Highly visible Red/Yellow/Cyan light
LCD Display: Red/Yellow/Cyan alarm notification | Alarm light. Highly visible Red/Yellow/Cyan light
LCD Display: Red/Yellow/Cyan alarm notification. | Identical |
| Alarm Volume | Adjustable.
- Minimum level >= 40dBA,
- Maximum level= 45dBA,
- Maximum level