EarlyVue VS30

K190624 · Philips Medizin Systeme Boeblingen GmbH · DSJ · Oct 27, 2019 · Cardiovascular

Device Facts

• Record ID: K190624
• Device Name: EarlyVue VS30
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: DSJ · Cardiovascular
• Decision Date: Oct 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1100
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care settings in which care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.

Device Story

Multi-parameter vital signs monitor; measures NBP, SpO2, SpHb, RRa, CO2, and temperature; inputs via patient-connected sensors; processes signals using established modules (e.g., Masimo rainbow SET, Oridion MicroMediCO2); displays data on 10.1" touch screen; used in hospitals and clinics by healthcare professionals; supports wireless communication with EMR or Philips IGS software; includes RFID scanner for ID entry and monitor-to-monitor data sharing; provides real-time physiological monitoring and alarming; aids clinical decision-making by providing continuous patient status updates; benefits patients through timely detection of physiological changes.

Clinical Evidence

Bench testing only. Performance verified against applicable IEC/ISO standards (e.g., IEC 60601-1, ISO 80601-2-61, ISO 80601-2-56). Verification and integration testing confirmed measurement accuracy and reliability for all parameters. Wireless functionality validated per ANSI C63.27-2017. No clinical data required.

Technological Characteristics

Multi-parameter monitor; 10.1" LCD touch screen; Linux OS; wireless connectivity; RFID scanner; NBP (oscillometric), SpO2 (Masimo rainbow SET/Philips FAST), Temperature (Predictive/Temporal), etCO2 (Oridion MicroMediCO2), RRa (Masimo rainbow SET). Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 80601-2-55, ISO 80601-2-61, ISO 80601-2-56.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospitals and professional out-of-hospital settings (clinics, surgery centers, long-term care, physician offices) for measurement, display, alarm, and recording of physiological parameters (NBP, SpO2, Pulse Rate, Temperature, etCO2, Respiration Rate, SpHb). Contraindicated for mobile settings (ambulances/aircraft) and home use.

Regulatory Classification

Identification

A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

Predicate Devices

• Philips SureSigns VS4 Vital Signs Monitor (K163649, K151761, K133961)

Reference Devices

• Philips Efficia CM patient monitors (K151812)

Submission Summary (Full Text)

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October 29, 2019

Philips Medizin Systeme Boeblingen GmbH Greg Li Regulatory Affairs Specialist Hewlett-Packard Strasse 2 Boeblingen, 71034 DE

Re: K190624

Trade/Device Name: EarlyVue VS30 Regulation Number: 21 CFR 870.1100 Regulation Name: Blood pressure alarm Regulatory Class: Class II Product Code: DSJ, DSK, DXN, DOA, DSA, FLL Dated: September 23, 2019 Received: September 24, 2019

Dear Greg Li:

This letter corrects our substantially equivalent letter of October 27, 2019.

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. 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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Stephen C. Browning -S5

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K190624

Device Name EarlyVue VS30

#### Indications for Use (Describe)

The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.

The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate -- PR -- derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric);

Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric)

Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------|
| <div> <span> 区 Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510K Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807-92(c).

- 1. The submitter and contact person of this pre-market notification is:
The submitter/manufacturer:

Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Strasse 2 71034 Böblingen Germany

Contact person:

Greg Li Philips Healthcare 3000 Minuteman Road Andover, MA 01810 United States

Tel: [phone] Fax: [phone] Email: [e-mail]

- 2. Date this summary is prepared: This summary is prepared on October 24, 2019.
- 3. Subject device

Name of Device: EarlyVue VS30 Vital Signs Monitor Trade Name: EarlyVue VS30 Common or Usual name: multi-parameter patient monitor Regulatory Class: II Classification names and Product Code:

| Device Panel | Classification | Product Code | Description |
|----------------|----------------|--------------|------------------------------------------------------|
| Cardiovascular | 870.1100, II | DSJ | Alarm, Blood Pressure |
| | 870.1110, II | DSK | Computer, Blood Pressure |
| | 870.1130, II | DXN | System, Measurement, Blood<br>Pressure, Non-Invasive |

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| Device Panel | Classification | Product Code | Description |
|--------------------------------------------|----------------|--------------|-------------------------------------------------------|
| | 870.2700, II | DQA | Oximeter |
| | 870.2900, II | DSA | Cable, transducer and electrode,<br>patient connector |
| General<br>Hospital and<br>Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology<br>& Respiratory<br>Therapy | 868.1400, II | CCK | Analyzer, Gas |

#### 4. Predicate Device:

Philips SureSigns VS4 Vital Signs Monitor cleared under K163649, K151761, K133961.

Reference Device: Philips Efficia CM patient monitors with 510(k) K151812

#### 5. Product Description

The subject device EarlyVue VS30 is a platform redesigned from the predicate device Suresign VS4 to provide the measurement of the same physiological parameters. It is a multi-parameter compact, portable monitor, offering several configurations and optional features that are intended to meet the customer's needs. The VS30 is designed with a simple, intuitive user interface for ease of operation. It is used to measure or monitor NBP, SpO2, SpHb, RRa, CO2 and optional temperature primarily in non-acute settings.

The subject VS30 also provides the wireless option. The wireless functions for VS30 are for the monitors to communicate with the hospital EMR system or to communicate with Philips IGS software over the hospital's wireless infrastructure.

The differences in the technological characteristics are as follows:

- a) The subject VS30 does not provide Tympanic temperature measure whilst the predicate VS4 does have this option
- b) The outside appearance of the VS30 monitor looks different. User interface is changed comparing to the predicate VS4.
- c) The VS30 has different hardware comparing to VS4, including new Central Processing Unit (CPU), Printed Circuit Board Assemblies (PCAs).

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- d) The VS30 software operating system is Linux while VS4 uses Win CE. The software is recoded.
- e) The wireless module used on VS30 is different from VS4. They are both from the same supplier. The VS30 wireless module has FCC certificate and FCC identification.
- f) The subject VS30 has a new feature called monitor-to-monitor communication.
- g) VS30 added RFID scanner for entry of patient ID and user ID.
- 6. The subject device EarlyVue VS30 has the same Intended Use as the legally marketed predicate device, SureSigns VS4 (the predicate VS4 has Tympanic temperature measurement but the subject VS30 does not have this measurement).

The indications for use for the subject EarlyVue VS30 is as following:

The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care settings in which care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.

The intended use of measurement parameters for each patient type is shown in table below:

| | Patient Types | | |
|-------------------------------------------------|---------------|-----------|----------|
| Parameter | Adult | Pediatric | Neonatal |
| Non-invasive BP (NBP) | √ | √ | √ |
| SpO2 (Masimo rainbow SET or<br>Philips FAST) | √ | √ | √ |
| Pulse Rate (PR) derived from SpO2<br>or NBP | √ | √ | √ |
| Temperature (Predictive, Temporal) | √ | √ | √ |
| end tidal CO2 (etCO2) | √ | √ | √ |
| Respiration Rate: airway respiration<br>(awRR) | √ | √ | √ |
| Respiration Rate: acoustic<br>respiration (RRa) | √ | √ | |
| Non-invasive Total Hemoglobin<br>(SpHb) | √ | √ | |

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Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

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- 7. The subject device EarlyVue VS30 has the same fundamental technological characteristics as the legally marketed predicate device SureSigns VS4. Through the pre-defined verification and validation, the performance data demonstrates the subject device Early Vue VS30 is as safe and effective as the predicate device for all the measurements.

| Comparative<br>Characteristic | Predicate Device<br>SureSigns VS4 Vital Signs Monitor<br>SW A.07<br>Latest 510(k): K163649 | Subject Device<br>EarlyVue VS30 Vital Signs Monitor<br>SW A.00.00 | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------|
| Model/model<br>number/<br>Reference<br>numbers | SureSigns VS4/863283 | EarlyVue VS30/863380 | New Model is assigned to VS30 |

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| Comparative<br>Characteristic | Predicate Device<br>SureSigns VS4 Vital Signs Monitor<br>SW A.07<br>Latest 510(k): K163649 | Subject Device<br>EarlyVue VS30 Vital Signs Monitor<br>SW A.00.00 | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The SureSigns VS4 vital signs monitor<br>is for use by health care professionals<br>whenever there is a need for<br>monitoring the physiological<br>parameters of patients. The SureSigns<br>VS4 is for monitoring, recording and<br>alarming of multiple physiological<br>parameters in healthcare environments<br>for patient types listed below.<br>Additionally, the monitor may be used<br>in transport situations within a<br>healthcare facility.<br>Parameter Adult Pediatric Neonatal NBP ✓ ✓ ✓ SpO2 ✓ ✓ ✓ Temperature ✓ ✓ ✓ CO2 ✓ ✓ ✓ RRa ✓ ✓ SpHb ✓ ✓ Contraindications: Not for transport<br>outside the healthcare facility | | | | | | | | | | | | | | | | | | | | | | | | | | | | | The EarlyVue VS30 is intended to measure,<br>display, alarm and, record physiological<br>information of adult, pediatric and neonatal<br>patients in hospitals and in out-of-hospital patient<br>care settings in which care is administered by a<br>healthcare professional (such as clinics,<br>outpatient surgery facilities, long-term care<br>facilities, and physician offices). It is not<br>intended for use in mobile settings such as<br>ambulances and aircraft. Clinical users may use<br>the monitor during patient transport within a<br>healthcare facility.<br>The intended use of measurement parameters for<br>each patient type is shown in table below:<br>Parameter Adult Pediatric Neonatal Non-invasive BP (NBP) ✓ ✓ ✓ SpO2 (Masimo rainbow<br>SET or Philips FAST) ✓ ✓ ✓ Pulse Rate (PR)<br>derived from SpO2 or<br>NBP ✓ ✓ ✓ Temperature<br>(Predictive, Temporal) ✓ ✓ ✓ end tidal CO2 (etCO2) ✓ ✓ ✓ Respiration Rate:<br>airway respiration<br>(awRR) ✓ ✓ ✓ Respiration Rate:<br>acoustic respiration<br>(RRa) ✓ ✓ Non-invasive Total<br>Hemoglobin (SpHb) ✓ ✓ Contra-indications: Not for transport outside the<br>healthcare facility. Not for use in home setting. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | --both predicate VS4 and subject VS30<br>are intended to measure/ monitor/alar/<br>record patient physiological information;<br><br>--VS4 identified clinical setting as<br>healthcare environments, VS30 clarifies<br>this with details hospitals and in out-of-<br>hospital patient care settings in which<br>care is administered by a healthcare<br>professional (such as clinics, outpatient<br>surgery facilities, long-term care<br>facilities, and physician offices).<br>Technically the clinical setting is not<br>changed.<br><br>--patient types for VS4 and VS30 are<br>identical<br><br>--parameters are clarified in VS30<br>comparing to VS4. VS30 will not provide<br>Tympanic temperature but VS4 has.<br>Respiration Rate: airway RR (awRR) and<br>Pulse Rate (PR) derived from SpO2 or<br>NBP are not new. VS4 had these but not<br>listed in the indications table.<br>So the parameters are identical except the<br>VS30 will not provide Tympanic<br>temperature.<br><br>Summary Indications for use and<br>intended use of VS30 and VS4 are the<br>same. |

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| Comparative<br>Characteristic | Predicate Device<br>SureSigns VS4 Vital Signs Monitor<br>SW A.07<br>Latest 510(k): K163649 | Subject Device<br>EarlyVue VS30 Vital Signs Monitor<br>SW A.00.00 | Comparison |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical<br>specifications:<br>Height<br>Length<br>Depth<br>Weight | Width: 26.0 cm (10.2 in)<br>Height: 22.0 cm (8.6 in)<br>Depth: 14.5 cm (5.7 in)<br>Weight: 3.6 Kg (8 lbs) including<br>battery, excluding temperature,<br>excluding optional recorder, optional<br>connectivity package or mounting<br>hardware. | Width: 33 cm<br>Height: 25 cm<br>Depth: 18 cm<br>Weight: <8 kg when fully optioned and with<br>battery<br>installed | Similar dimensions<br>Similar. The weight in VS30 is<br>for fully optioned and the number<br>for VS4 does not include options.<br><br>VS30 has bigger screen but still<br>similar to VS4 |
| Device keys | Screen type: 8.4" 5-Wire resistive<br>touch screen display with LED<br>backlight<br><br>The following fixed key switches are<br>located on the front panel with the<br>associated labels<br>Alarm silence "Silence" NBP start/stop "NBP" NBP interval "Interval" Main "Main" Print "Print | 10.1" (25.7 cm) LCD touch screen with LED<br>backlight<br><br>The control keys are soft keys. | VS30 changes fixed keys to soft<br>keys.<br>The new user interface has been<br>verified and validated. The VS30<br>passed the verification and<br>validation. |
| Number of<br>waveforms | Two: one for etCO2 and the other one<br>for SpO2 or RRa, or SpO2 with RRa<br>overlapped | Two: one for etCO2 and the other one for SpO2<br>or RRa, or SpO2 with RRa overlapped | Identical |
| Physiological<br>Measurements:<br>varies by<br>configuration<br>or option | Temperature (has Tympanic<br>temperature option), Non-invasive<br>Blood Pressure, SpO2, Pulse Rate,<br>SpHb, RRa, CO2 | Temperature (no Tympanic temperature option),<br>Non-invasive Blood Pressure, SpO2, Pulse Rate,<br>SpHb, RRa, CO2 | Same except that the subject<br>VS30 does not have Tympanic<br>temperature but the predicate VS4<br>has. |
| Comparative<br>Characteristic | Predicate Device<br>SureSigns VS4 Vital Signs Monitor<br>SW A.07<br>Latest 510(k): K163649 | Subject Device<br>Early Vue VS30 Vital Signs Monitor<br>SW A.00.00 | Comparison |
| NBP<br>Specifications | Philips picoNBP – K051366<br>Technique: Oscillometric using stepwise deflation pressure<br>In Adult Mode, the NBP measurement range is:<br>Systolic 30-270mmHg Diastolic 10-240mmHg Mean 20-250mmHg In Pediatric Mode, the NBP measurement range is:<br>Systolic 30-180mmHg Diastolic 10-150mmHg Mean 20-160mmHg In Neonate Mode, the NIBP measurement has the following ranges for its values:<br>Systolic 30-130mmHg Diastolic 10-100mmHg Mean 20-120mmHg accuracy over the listed ranges:<br>Maximum Standard Deviation: 8 mmHg<br>Maximum Mean Error: +/- 5 mmHg<br>A Pulse Rate is derived from the NBP measurement with accuracy:<br>40 – 100 bpm: +/- 5 bpm | Philips picoNBP – K051366<br>Technique: Oscillometric using stepwise deflation pressure<br>In Adult Mode, the NBP measurement range is:<br>Systolic 30-270mmHg Diastolic 10-240mmHg Mean 20-250mmHg In Pediatric Mode, the NBP measurement range is:<br>Systolic 30-180mmHg Diastolic 10-150mmHg Mean 20-160mmHg In Neonate Mode, the NIBP measurement has the following ranges for its values:<br>Systolic 30-130mmHg Diastolic 10-100mmHg Mean 20-120mmHg accuracy over the listed ranges:<br>Maximum Standard Deviation: 8 mmHg<br>Maximum Mean Error: +/- 5 mmHg<br>A Pulse Rate is derived from the NBP measurement with accuracy:<br>40 – 100 bpm: +/- 5 bpm | Identical |
| | Predicate Device | Subject Device | Comparison |
| Comparative | SureSigns VS4 Vital Signs Monitor | EarlyVue VS30 Vital Signs Monitor | |
| Characteristic | SW A.07 | SW A.00.00 | |
| | Latest 510(k): K163649 | | |
| | 101 - 200 bpm: +/- 5% of reading | 101 - 200 bpm: +/- 5% of reading | |
| | 201 - 300 bpm: +/- 10% of reading | 201 - 300 bpm: +/- 10% of reading | |
| | (average over NIBP measurement | (average over NIBP measurement cycle)Initial | |
| | cycle) | cuff inflation | |
| | Initial cuff inflation | - Adult: 160 mmHg | |
| | - Adult: 160 mmHg | - Pediatric: 140 mmHg | |
| | - Pediatric: 140 mmHg | - Neonatal: 100 mmHg | |
| | - Neonatal: 100 mmHg | Subsequent cuff inflation: 30 mmHg above the | |
| | Subsequent cuff inflation: 30 mmHg | last measured Systolic value | |
| | above the last measured Systolic value | -one programmable interval with up to five | |
| | -one programmable interval with up to | periods. Each period can be composed of a | |
| | five periods. Each period can be | duration and interval. The options for each are: | |
| | composed of a duration and interval. | Duration: Off, 2, 5, 15, 30, 60, 90, 120, 150, 180, | |
| | The options for each are: | 210, 240, 270, 300 Minutes | |
| | Duration: Off, 2, 5, 15, 30, 60, 90, 120, | Interval: Off, 1, 2, 3, 5, 10, 15, 30, 60, 90, 120 | |
| | 150, 180, 210, 240, 270, 300 Minutes | Minutes | |
| | Interval: Off, 1, 2, 3, 5, 10, 15, 30, 60, | | |
| | 90, 120 Minutes | | |
| | | | |
| Comparative<br>Characteristic | Predicate Device<br>SureSigns VS4 Vital Signs Monitor<br>SW A.07<br>Latest 510(k): K163649 | Subject Device<br>Early Vue VS30 Vital Signs Monitor<br>SW A.00.00 | Comparison |
| SpO2: Philips<br>SpO2 | Measurement range<br>- SpO2: 0 - 100%<br>- Pulse rate: 30 - 300 bpm | Measurement range<br>- SpO2: 0 - 100%<br>- Pulse rate: 30 - 300 bpm | Identical |
| | Pulse rate accuracy: Greater of + 2%<br>or + 1 bmp<br>Resolution of SpO2 measurement: 1% | Pulse rate accuracy: Greater of + 2% or + 1 bmp<br>Resolution of SpO2 measurement: 1% | |
| | Wavelength range: 500 - 1000 nm for<br>all specified sensors | Wavelength range: 500 - 1000 nm for all<br>specified sensors | |
| | Maximum optical output power: ≤<br>15mW for all specified sensors…