Who is the manufacturer of Portrait VSM?

Ge Medical Systems Information Technologies, Inc. filed the 510(k) submission for Portrait VSM (K233810).

What is the FDA product code for Portrait VSM?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Portrait VSM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Portrait VSM?

Vital Signs Monitor VC150 (K133810); B105M Patient Monitor (K213490); Non-contact infrared body thermometer (K171888).

Who can help prepare an FDA 510(k) submission like Portrait VSM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Portrait VSM

K233810 · Ge Medical Systems Information Technologies, Inc. · MWI · Apr 25, 2024 · Cardiovascular

Device Facts

Record ID	K233810
Device Name	Portrait VSM
Applicant	Ge Medical Systems Information Technologies, Inc.
Product Code	MWI · Cardiovascular
Decision Date	Apr 25, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

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 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.

Device Story

Portrait VSM is a portable vital signs monitor for hospital use; inputs include NIBP (oscillometric), SpO2 (GE TruSignal, Masimo SET, or Nellcor), and temperature (Welch Allyn, Exergen, or HeTaiDa). Device processes physiological signals to display real-time measurements on a 10.1-inch capacitive touch screen; supports spot-check or continuous monitoring modes. Clinicians use the device at the bedside or during transport; data transmits to EMR via wired/wireless networks. Output includes visual/audible alarms and patient data; supports clinical decision-making by providing current vital sign status. Features include Early Warning Score, automatic screen brightness, and remote alarm connectivity. Powered by AC or internal battery; designed for use under licensed practitioner supervision.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including hardware, software, alarm performance, EMC, electrical safety, and usability testing (15 US clinical and 15 US technical users).

Technological Characteristics

10.1-inch capacitive LCD touch screen; NIBP (oscillometric), SpO2 (GE, Masimo, or Nellcor modules), and temperature (electronic/infrared) sensing. Connectivity via WLAN/LAN (HL7, Cerner-iBus, LDAP, NTP). Powered by AC or internal Lithium-Ion battery. Software runs on Linux OS. Complies with IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, ISO 80601-2-56, and ISO 80601-2-61.

Indications for Use

Indicated for monitoring vital signs (NIBP, pulse rate, SpO2, temperature) in adult, pediatric, and neonatal patients at the site of care or during intra-hospital transport. Not for use during MRI.

Regulatory Classification

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.

Predicate Devices

Vital Signs Monitor VC150 (K133810)
B105M Patient Monitor (K213490)
Non-contact infrared body thermometer (K171888)

Reference Devices

HeTaida thermometer (K203332)
Masimo board MS-2011SB (K053269)
Nellcor NELL1-SR OxiMax OEM (K060576)
B1X5-REC thermal recorder (K213490)

Submission Summary (Full Text)

{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}------------------------------------------------ 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 of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {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<= 90dBA | Adjustable. - Minimum level >= 45dBA, - Maximum level<= 85dBA | Equivalent Slight difference for range due to different hardware. Both ranges meet the requirements of IEC60601-1-8 standard. The change does not affect safety or effectiveness. | | Alarm Volume adjustment | High/medium/low three priorities share same alarm volume setting. | Provide two options: Option 1: High/Medium/Low three priorities share same alarm volume setting. Option 2: Separate alarm volume setting for Low priority alarms | Equivalent The proposed device provided the additional option for Separate alarm volume setting for low priority alarms. Separate alarm volume setting for low priority alarms already implemented in the predicate monitor B105M (K213490) in the identical way. The change does not affect safety or effectiveness. | | Allowed Minimum Alarm Volume Adjustment Range | The allowed minimum volume adjustment range is 50%-100% Adjustment the minimum volume is password protected | The allowed minimum volume adjustment range is 1-10 (equivale to 10% -100%) Adjustment the minimum volume is password protected | Equivalent The proposed device changed the minimum volume level range to 10% to 100% to align with GE other monitors. Minimum volume adjustment range to 10% to 100% has been implemented in the predicate monitor B105M (K213490) with the identical way. The change does not affect safety or effectiveness. | | Work mode | Spot check mode Monitoring mode | Spot check mode Monitoring mode | Identical | | |…

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