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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: EarlyVue VS30 Vital Signs Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EarlyVue VS30 are implied by its comparison to the predicate device, Philips SureSigns VS4. The document asserts that the VS30 has the "same fundamental technological characteristics" and that "performance data demonstrates the subject device Early Vue VS30 is as safe and effective as the predicate device for all the measurements." Therefore, the predicate device's specifications serve as the de facto acceptance criteria for each measurement parameter.

Parameter	Acceptance Criteria (Predicate Device VS4 Performance)	Reported Device Performance (EarlyVue VS30)
Non-invasive BP (NBP)	Technique: Oscillometric, stepwise deflation. Measurement Range: Adult: Systolic 30-270mmHg, Diastolic 10-240mmHg, Mean 20-250mmHg; Pediatric: Systolic 30-180mmHg, Diastolic 10-150mmHg, Mean 20-160mmHg; Neonate: Systolic 30-130mmHg, Diastolic 10-100mmHg, Mean 20-120mmHg. Accuracy: Max Std. Dev: 8 mmHg, Max Mean Error: +/- 5 mmHg. Derived PR Accuracy: 40-100 bpm: +/- 5 bpm; 101-200 bpm: +/- 5% of reading; 201-300 bpm: +/- 10% of reading. Initial Cuff Inflation: Adult: 160 mmHg; Pediatric: 140 mmHg; Neonatal: 100 mmHg.	Technique: Oscillometric, stepwise deflation. Measurement Range: Adult: Systolic 30-270mmHg, Diastolic 10-240mmHg, Mean 20-250mmHg; Pediatric: Systolic 30-180mmHg, Diastolic 10-150mmHg, Mean 20-160mmHg; Neonate: Systolic 30-130mmHg, Diastolic 10-100mmHg, Mean 20-120mmHg. Accuracy: Max Std. Dev: 8 mmHg, Max Mean Error: +/- 5 mmHg. Derived PR Accuracy: 40-100 bpm: +/- 5 bpm; 101-200 bpm: +/- 5% of reading; 201-300 bpm: +/- 10% of reading. Initial Cuff Inflation: Adult: 160 mmHg; Pediatric: 140 mmHg; Neonatal: 100 mmHg. Reported as "Identical"
SpO2 (Philips SpO2)	Measurement Range: SpO2: 0-100%, Pulse Rate: 30-300 bpm. PR Accuracy: Greater of +2% or +1 bpm. Resolution: SpO2: 1%. Accuracy (70-100%): Philips reusable sensors: +/- 2% (M1191B, BL, A, AL, M1192A), +/- 3% (M1191T, M1192T, M1193T adult, M1193A, M1194A, M1195A, M1196A, T, S), +/- 4% (M1193T neonatal). Philips disposable sensors: +/- 2% (M1132A, M1133A, M1134A), +/- 3% (M1131A).	Measurement Range: SpO2: 0-100%, Pulse Rate: 30-300 bpm. PR Accuracy: Greater of +2% or +1 bpm. Resolution: SpO2: 1%. Accuracy (70-100%): Philips reusable sensors: +/- 2% (M1191B, BL, A, AL, M1192A), +/- 3% (M1191T, M1192T, M1193T adult, M1193A, M1194A, M1195A, M1196A, T, S), +/- 4% (M1193T neonatal). Philips disposable sensors: +/- 2% (M1132A, M1133A, M1134A), +/- 3% (M1131A). Reported as "Identical"
SpO2 (Masimo SpO2)	Measurement Range: 0-100%. Resolution: 1%. Accuracy: No motion: 60-80 +/- 3% (adult/ped/inf), 70-100 +/- 2% (adult/ped/inf), 70-100 +/- 3% (neonates). Motion: 70-100 +/- 3% (all). Low perfusion: 70-100 +/- 2% (all).	Measurement Range: 0-100%. Resolution: 1%. Accuracy: No motion: 60-80 +/- 3% (adult/ped/inf), 70-100 +/- 2% (adult/ped/inf), 70-100 +/- 3% (neonates). Motion: 70-100 +/- 3% (all). Low perfusion: 70-100 +/- 2% (all). Reported as "Identical"
Pulse Rate (Masimo SpO2)	Range: 25-240 bpm. Resolution: 1 bpm. Accuracy: +/- 5 bpm motion or low perfusion (worst case).	Range: 25-240 bpm. Resolution: 1 bpm. Accuracy: +/- 5 bpm motion or low perfusion (worst case). Reported as "Identical"
SpHb (Masimo)	Range: 0-25 g/dL. Accuracy: 8-17 g/dL (arterial/venous) adults/pediatrics: +/- 1 g/dL. Resolution: 0.1 g/dL.	Range: 0-25 g/dL. Accuracy: 8-17 g/dL (arterial/venous) adults/pediatrics: +/- 1 g/dL. Resolution: 0.1 g/dL. Reported as "Identical"
Respiration Rate (RRa - Masimo)	Range: 0-70 bpm. Accuracy: 4-70 bpm: +/- 1 bpm (adults >30kg and adults/pediatrics >10kg). Resolution: 1 bpm.	Range: 0-70 bpm. Accuracy: 4-70 bpm: +/- 1 bpm (adults >30kg and adults/pediatrics >10kg). Resolution: 1 bpm. Reported as "Identical"
Temperature (Predictive)	Measurement Range: 26.7–43.3°C (80–110°F). Accuracy (monitoring mode): +/- 0.1°C (+/- 0.2°F). Measurement Time: Oral: 4-6s, Adult axillary: 12-15s, Pediatric axillary: 10-13s, Rectal: 10-13s. Resolution: 0.1°C. Measurement Sites: Oral, rectal, axillary.	Measurement Range: 26.7–43.3°C (80–110°F). Accuracy (monitoring mode): +/- 0.1°C (+/- 0.2°F). Measurement Time: Oral: 4-6s, Adult axillary: 12-15s, Pediatric axillary: 10-13s, Rectal: 10-13s. Resolution: 0.1°C (+/- 0.1°F). Measurement Sites: Oral, rectal, axillary. Reported as "Identical"
Temperature (Temporal)	Range: 16°C - 43°C. Clinical Accuracy: +/- 0.2°F or 0.1°C per ASTM E1112. Arterial heat balance range: 34.5°C - 43°C (Normal: 35.9°C to 37.5°C). Resolution: 0.1°C or 0.1°F. Response Time: <=1 second.	Range: 16°C - 43°C. Clinical Accuracy: +/- 0.2°F or 0.1°C per ASTM E1112. Arterial heat balance range: 34.5°C - 43°C (Normal: 35.9°C to 37.5°C). Resolution: 0.1°C or 0.1°F. Response Time: <=1 second. Reported as "Identical"
end tidal CO2 (etCO2)	Measurement Range: 0-150 mmHg. Sampling Rate: 20 samples/second. Flow Rate: 50ml/min, +15ml/min, -7.5ml/min. Warm-up Time: 30 seconds (typical). Calibration Interval: Initial: 1200 hrs or 1 year; Subsequent: 1 year or 4000 hrs. Accuracy: 0-38 mmHg: +/- 2 mmHg; 39-150 mmHg: +/-(5% of reading + 0.08% for every 1 mmHg above 38 mmHg). Response Time: ~3.9 seconds.	Measurement Range: 0-150 mmHg. Sampling Rate: 20 samples/second. Flow Rate: Same. Warm-up Time: 30 seconds (typical). Calibration Interval: Initial: 1200 hrs or 1 year; Subsequent: 1 year or 4000 hrs. Accuracy: 0-38 mmHg: +/- 2 mmHg; 39-150 mmHg: +/-(5% of reading + 0.08% for every 1 mmHg above 38 mmHg). Response Time: ~3.9 seconds. Reported as "Identical"
Respiration Rate (awRR - CO2)	Range: 0-150 respirations/minute. Accuracy: +/- 1 rpm (0-70 rpm); +/- 2 rpm (71-120 rpm); +/- 3 rpm (121-150 rpm).	Range: 0-150 respirations/minute. Accuracy: +/- 1 rpm (0-70 rpm); +/- 2 rpm (71-120 rpm); +/- 3 rpm (121-150 rpm). Reported as "Identical"
Battery operation time	3 hours	6 hours (Improved)
User Interface	8.4" resistive touchscreen, fixed key switches.	10.1" LCD touchscreen, soft keys. Verified and validated, passed verification and validation.
Monitor-to-monitor communication	No (for predicate)	Yes (Non-medical application, allows viewing saved patient records remotely, viewing last saved record for up to 100 patients, viewing trends. Fully verified and passed tests.)
RFID scanner	No (for predicate)	Yes (Non-medical application, entry of patient ID and user ID. Fully verified and passed tests.)
Operating Temperature	10°C to 40°C monitor (16°C to 33°C with tympanic, 0°C to 50°C Masimo, 16°C to 40°C Exergen, 10°C to 40°C WelchAllyn)	10°C to 40°C monitor (10°C to 40°C WelchAllyn, 16°C to 40°C Exergen) Reported as "Same"
Software Operating System	Win CE	Linux (recoded software). Implied acceptance through comprehensive software verification and validation.
Hardware Components	VS4 hardware	New CPU, PCAs. Implied acceptance through comprehensive hardware verification and validation.
Wireless Module	VS4 wireless module	Different from VS4, but from same supplier, has FCC certificate and ID. Tested to and passed ANSI C63.27-2017.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of patients, number of measurements) used for performance testing (e.g., NBP accuracy, SpO2 accuracy). It generally refers to "verification and validation" and "performance data."

For the SpO2 and SpHb measurements using Masimo technology, the document references the Masimo RRa respiration rate K110028 and the Oridion MicroMediCO2 module K123690. The accuracy claims for these integrated modules would presumably be based on studies performed during their original clearance, but specific details about those test sets are not in this document.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. For physiological measurements like NBP, SpO2, and temperature, ground truth is typically established using reference methods (e.g., arterial catheter for NBP, co-oximetry for SpO2, calibrated thermometer for temperature) rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set, as this is typically applicable to subjective interpretations by multiple experts (e.g., radiology reads), not direct physiological measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to this submission. The EarlyVue VS30 is a vital signs monitor that directly measures physiological parameters. It does not involve "human readers" interpreting medical images or other data with or without "AI assistance." The device's function is to provide direct measurements, not to aid in human diagnostic interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary function of the EarlyVue VS30 is as a standalone device that performs physiological measurements without a human-in-the-loop for the measurement process itself. The "performance data" referred to throughout the document would be standalone performance of the device's measurement functions.

7. The Type of Ground Truth Used

The ground truth for the physiological measurements (NBP, SpO2, Temperature, CO2) would typically be established using:

Reference Devices/Methods:
- NBP: Invasive arterial blood pressure measurements or comparison to a validated reference sphygmomanometer.
- SpO2: Co-oximetry for arterial oxygen saturation.
- Temperature: Calibrated reference thermometers (e.g., mercury-in-glass, highly accurate electronic thermometers).
- CO2: Calibrated gas analyzers.

The document states that the technologies used are "identical" to the predicate device, which in turn relied on established measurement technologies (Philips picoNBP, Masimo Rainbow SET, Oridion MicroMediCO2 module). These underlying technologies would have their own validation against established ground truth methods.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is because the EarlyVue VS30 is not described as an AI/ML-based device that learns from a training set in the typical sense (e.g., for image classification or prediction). Its functions are based on established physiological measurement principles and algorithms. The software was "recoded" compared to the predicate, implying engineering-based development and verification, rather than a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

Since no explicit training set is mentioned for an AI/ML context, this question is not directly applicable. The device's "ground truth" refers to its accuracy against established medical standards for physiological measurements. The document outlines a comprehensive verification and validation process (software, hardware, environmental, reliability, safety, performance, applicable consensus standards: IEC 60601 series, ISO 80601 series, etc.) to ensure the device performs as intended and is as safe and effective as the predicate.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)
区 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 978-659-4227 Fax: 978-659-7323 Email: Greg.li@philips.com

1. Date this summary is prepared: This summary is prepared on October 24, 2019.
1. 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, BloodPressure, 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,patient connector
GeneralHospital andPersonal Use	880.2910, II	FLL	Thermometer, Electronic, Clinical
Anesthesiology& RespiratoryTherapy	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 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.
1. 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 orPhilips FAST)	√	√	√
Pulse Rate (PR) derived from SpO2or NBP	√	√	√
Temperature (Predictive, Temporal)	√	√	√
end tidal CO2 (etCO2)	√	√	√
Respiration Rate: airway respiration(awRR)	√	√	√
Respiration Rate: acousticrespiration (RRa)	√	√
Non-invasive Total Hemoglobin(SpHb)	√	√

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

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1. 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.

ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Model/modelnumber/Referencenumbers	SureSigns VS4/863283	EarlyVue VS30/863380	New Model is assigned to VS30

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ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Indications foruse	The SureSigns VS4 vital signs monitoris for use by health care professionalswhenever there is a need formonitoring the physiologicalparameters of patients. The SureSignsVS4 is for monitoring, recording andalarming of multiple physiologicalparameters in healthcare environmentsfor patient types listed below.Additionally, the monitor may be usedin transport situations within ahealthcare facility.Parameter Adult Pediatric Neonatal NBP ✓ ✓ ✓ SpO2 ✓ ✓ ✓ Temperature ✓ ✓ ✓ CO2 ✓ ✓ ✓ RRa ✓ ✓ SpHb ✓ ✓ Contraindications: Not for transportoutside the healthcare facility																													The EarlyVue VS30 is intended to measure,display, alarm and, record physiologicalinformation of adult, pediatric and neonatalpatients in hospitals and in out-of-hospital patientcare settings in which care is administered by ahealthcare professional (such as clinics,outpatient surgery facilities, long-term carefacilities, and physician offices). It is notintended for use in mobile settings such asambulances and aircraft. Clinical users may usethe monitor during patient transport within ahealthcare facility.The intended use of measurement parameters foreach patient type is shown in table below:Parameter Adult Pediatric Neonatal Non-invasive BP (NBP) ✓ ✓ ✓ SpO2 (Masimo rainbowSET or Philips FAST) ✓ ✓ ✓ Pulse Rate (PR)derived from SpO2 orNBP ✓ ✓ ✓ Temperature(Predictive, Temporal) ✓ ✓ ✓ end tidal CO2 (etCO2) ✓ ✓ ✓ Respiration Rate:airway respiration(awRR) ✓ ✓ ✓ Respiration Rate:acoustic respiration(RRa) ✓ ✓ Non-invasive TotalHemoglobin (SpHb) ✓ ✓ Contra-indications: Not for transport outside thehealthcare facility. Not for use in home setting.																																					--both predicate VS4 and subject VS30are intended to measure/ monitor/alar/record patient physiological information;--VS4 identified clinical setting ashealthcare environments, VS30 clarifiesthis with details hospitals and in out-of-hospital patient care settings in whichcare is administered by a healthcareprofessional (such as clinics, outpatientsurgery facilities, long-term carefacilities, and physician offices).Technically the clinical setting is notchanged.--patient types for VS4 and VS30 areidentical--parameters are clarified in VS30comparing to VS4. VS30 will not provideTympanic temperature but VS4 has.Respiration Rate: airway RR (awRR) andPulse Rate (PR) derived from SpO2 orNBP are not new. VS4 had these but notlisted in the indications table.So the parameters are identical except theVS30 will not provide Tympanictemperature.Summary Indications for use andintended use of VS30 and VS4 are thesame.

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ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Physicalspecifications:HeightLengthDepthWeight	Width: 26.0 cm (10.2 in)Height: 22.0 cm (8.6 in)Depth: 14.5 cm (5.7 in)Weight: 3.6 Kg (8 lbs) includingbattery, excluding temperature,excluding optional recorder, optionalconnectivity package or mountinghardware.	Width: 33 cmHeight: 25 cmDepth: 18 cmWeight: <8 kg when fully optioned and withbatteryinstalled	Similar dimensionsSimilar. The weight in VS30 isfor fully optioned and the numberfor VS4 does not include options.VS30 has bigger screen but stillsimilar to VS4
Device keys	Screen type: 8.4" 5-Wire resistivetouch screen display with LEDbacklightThe following fixed key switches arelocated on the front panel with theassociated labelsAlarm silence "Silence" NBP start/stop "NBP" NBP interval "Interval" Main "Main" Print "Print	10.1" (25.7 cm) LCD touch screen with LEDbacklightThe control keys are soft keys.	VS30 changes fixed keys to softkeys.The new user interface has beenverified and validated. The VS30passed the verification andvalidation.
Number ofwaveforms	Two: one for etCO2 and the other onefor SpO2 or RRa, or SpO2 with RRaoverlapped	Two: one for etCO2 and the other one for SpO2or RRa, or SpO2 with RRa overlapped	Identical
PhysiologicalMeasurements:varies byconfigurationor option	Temperature (has Tympanictemperature option), Non-invasiveBlood Pressure, SpO2, Pulse Rate,SpHb, RRa, CO2	Temperature (no Tympanic temperature option),Non-invasive Blood Pressure, SpO2, Pulse Rate,SpHb, RRa, CO2	Same except that the subjectVS30 does not have Tympanictemperature but the predicate VS4has.
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarly Vue VS30 Vital Signs MonitorSW A.00.00	Comparison
NBPSpecifications	Philips picoNBP – K051366Technique: Oscillometric using stepwise deflation pressureIn Adult Mode, the NBP measurement range is:Systolic 30-270mmHg Diastolic 10-240mmHg Mean 20-250mmHg In Pediatric Mode, the NBP measurement range is:Systolic 30-180mmHg Diastolic 10-150mmHg Mean 20-160mmHg In Neonate Mode, the NIBP measurement has the following ranges for its values:Systolic 30-130mmHg Diastolic 10-100mmHg Mean 20-120mmHg accuracy over the listed ranges:Maximum Standard Deviation: 8 mmHgMaximum Mean Error: +/- 5 mmHgA Pulse Rate is derived from the NBP measurement with accuracy:40 – 100 bpm: +/- 5 bpm	Philips picoNBP – K051366Technique: Oscillometric using stepwise deflation pressureIn Adult Mode, the NBP measurement range is:Systolic 30-270mmHg Diastolic 10-240mmHg Mean 20-250mmHg In Pediatric Mode, the NBP measurement range is:Systolic 30-180mmHg Diastolic 10-150mmHg Mean 20-160mmHg In Neonate Mode, the NIBP measurement has the following ranges for its values:Systolic 30-130mmHg Diastolic 10-100mmHg Mean 20-120mmHg accuracy over the listed ranges:Maximum Standard Deviation: 8 mmHgMaximum Mean Error: +/- 5 mmHgA Pulse Rate is derived from the NBP measurement with accuracy: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

ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarly Vue VS30 Vital Signs MonitorSW A.00.00	Comparison
SpO2: PhilipsSpO2	Measurement range- SpO2: 0 - 100%- Pulse rate: 30 - 300 bpm	Measurement range- SpO2: 0 - 100%- Pulse rate: 30 - 300 bpm	Identical
	Pulse rate accuracy: Greater of + 2%or + 1 bmpResolution of SpO2 measurement: 1%	Pulse rate accuracy: Greater of + 2% or + 1 bmpResolution of SpO2 measurement: 1%
	Wavelength range: 500 - 1000 nm forall specified sensors	Wavelength range: 500 - 1000 nm for allspecified sensors
	Maximum optical output power: ≤15mW for all specified sensors	Maximum optical output power: ≤15mW for allspecified sensors
	Variable pitch tone for SpO2	Variable pitch tone for SpO2
	Pleth wave displayed	Pleth wave displayed
	configurable alarm delay times:High/Low SpO2 Alarm delay time,seconds: 0-30Increments of change: 1Desat Alarm: delay time, seconds: 0-30Increments of change: 1Default setting is : 0 seconds	configurable alarm delay times:High/ Low SpO2 Alarm delay time, seconds: 0-30Increments of change: 1Desat Alarm: delay time, seconds: 0-30Increments of change: 1Default setting is : 0 seconds
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
SpO2 Sensors	SpO2 accuracy: With SpO2 valuesbetween 70 - 100% range oxygenationPhilips reusable sensors $\pm$ 2%: M1191B, M1191BL, M1191A, M1191AL, M1192A $\pm$ 3%: M1191T, M1192T, M1193T with adult use, M1193A, M1194A, M1195A, M1196A, M1196T, M1196S $\pm$ 4% - M1193T with Neonatal use Philips disposable sensors $\pm$ 2% - M1132A, M1133A, M1134A $\pm$ 3% - M1131A	SpO2 accuracy: With SpO2 values between 70 –100% range oxygenationPhilips reusable sensors $\pm$ 2%: M1191B, M1191BL, M1191A, M1191AL, M1192A $\pm$ 3%: M1191T, M1192T, M1193T with adult use, M1193A, M1194A, M1195A, M1196A, M1196T, M1196S $\pm$ 4% - M1193T with Neonatal use Philips disposable sensors $\pm$ 2% - M1132A, M1133A, M1134A $\pm$ 3% - M1131A	Identical

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ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
PredicativeTempMeasurementrange:(optional)	Measurement Range: 26.7 – 43.3°C(80 – 110°F)Accuracy in monitoring mode: $\pm$ 0.1 °C( $\pm$ 0.2°F)Measurement Time Oral: 4-6 seconds Adult axillary: 12-15 sec Pediatric axillary: 10-13 sec.(17 year and younger) Rectal: 10-13 seconds Resolution: 0.1 °CMeasurement sites: Oral, rectal andaxillary	Measurement Range: 26.7 – 43.3°C (80 – 110°F)Accuracy in monitoring mode: $\pm$ 0.1 °C ( $\pm$ 0.2°F)Measurement Time Oral: 4-6 seconds Adult axillary: 12-15 sec Pediatric axillary: 10-13 sec. (17 yearand younger) Rectal: 10-13 seconds Resolution: 0.1 °C ( $\pm$ 0.1 °F)Measurement sites: Oral, rectal and axillary	Identical
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Tympanic Tempmeasurement(optional)	The ear measurement algorithm hasthese correction factors for these modebuilt in depending on setting:Ear = NoneCore = Ear mode + 1.04 °COral = Ear mode + 0.60 °CRectal = Ear mode + 1.16 °CThe overall range of the temperaturemeasurement is 33.0 °C to 42.0 °C(91.4 °F to 107.6 °F)Accuracy at overall temperature rangeis + 0.2 °C (+ 0.4 °F)The displayed resolution of thetympanic temperature measurement is0.1 °C or 0.1 °FApproximate measurement time isequal to or better than 2 seconds.Pulse timer beeps once at each of theseintervals: 15, 30, 45 and 60 seconds.	The VS30 will not provide this option	This option is not provided by thesubject VS30
Masimo SpO2,SpHb, RRameasurement	yes	yes	Identical
Range ofMasimo SpO2measurement	0-100%	0-100%	Identical
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarly Vue VS30 Vital Signs MonitorSW A.00.00	Comparison
Resolution ofSpO2measurement	1%	1%	Identical
Accuracy ofMasimo SpO2	No motion:60-80 +/- 3%, for adults/pediatrics/infants 70-100 +/-2%, for adults/pediatrics/infants, 70-100 +/-3%, for neonates Motion: 70-100 +/-3%, for adults/pediatrics/infants/ neonates Low perfusion: 70-100 +/-2%, for adults/pediatrics/infants/ neonates	No motion:60-80 +/- 3%, for adults/pediatrics/infants 70-100 +/-2%, for adults/pediatrics/infants, 70-100 +/-3%, for neonates Motion: 70-100 +/-3%, for adults/pediatrics/infants/ neonates Low perfusion: 70-100 +/-2%, for adults/pediatrics/infants/ neonates	Identical
Pleth waveform	A pleth waveform is derived from measurement	A pleth waveform is derived from measurement	Identical
Pulse ratederived fromthe MasimoSpO2measurement	Yes	Yes	Identical
Pulse rate range	25-240 bpm	25-240 bpm	Identical
Pulse rateresolution	1 bpm	1 bpm	Identical
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Pulse rateaccuracy	+/-5 bpm motion or low perfusionworst case	+/-5 bpm motion or low perfusion worst case	Identical
Range of SpHbmeasurement	0-25 g/dL	0-25 g/dL	Identical
SpHb accuracy	8-17 g/dL (arterial or venous)adults/pediatrics: +/- 1g/dL	8-17 g/dL (arterial or venous) adults/pediatrics:+/- 1g/dL	Identical
SpHbresolution	0.1 g/dL	0.1 g/dL	Identical
Range ofrespiratory rate(RRa)	0-70 breaths per minute (bpm)	0-70 breaths per minute (bpm)	Identical
RRa accuracy	In the range of 4-70 bpm: +/-1 bpm,adults (>30kg)	In the range of 4-70 bpm: +/-1 bpm, adults(>30kg)	Identical
Technologyused for RRameasurementand calculation	Rainbow SET technology (K110028)	Rainbow SET technology (K110028)	IdenticalPlease refer to section 7.2 forrespiration rate comparisonbetween the VS30 and MasimoRainbow SET RRa
RRa resolution	1 breath per minute (bpm)	1 breath per minute (bpm)	Identical
Firmware	Rainbow SET Technology, MXboard/circuitry from Masimo	Rainbow SET Technology, MX board/circuitryfrom Masimo	Identical
Wavelengthrange	653 to 905 nm for all specified sensors	500 nm to 1400 for all specified sensors	Identical
Maximumoptical outputpower	<=25mW for all specified sensors	<=25mW for all specified sensors	Identical
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarly Vue VS30 Vital Signs MonitorSW A.00.00	Comparison
TemporalTemperaturemeasurement	yes	yes	Identical
Can displayboth °C and oF	yes	yes	Identical
Range oftemperaturemeasurement	16 °C - 43 °C	16 °C - 43 °C	Identical
Clinicalaccuracy	+/- 0.2 oF or 0.1 °C per ASTM E1112	+/- 0.2 oF or 0.1 °C per ASTM E1112	Identical
Arterial heatbalance rangefor bodytemperature	34.5 °C -43 °CNormal range is defined as 35.9℃ to37.5℃, with mean of 37℃.	34.5 °C -43 °CNormal range is defined as 35.9℃ to 37.5℃,with mean of 37°C.	Identical
Resolution	Both on probe and on monitor 0.1 °Cor 0.1 oF	Both on probe and on monitor 0.1 ℃ or 0.1 oF	Identical
Response time	<=1 second	<=1 second	Identical
CO2Measurement	yes	yes	Identical
Measurementrange	0 - 150 mmHg	Same	Identical
Sampling rate	Waveform sampling, 20 samples persecond	Same	Identical
Flow rate	50 ml/min, + 15 ml/min, - 7.5 ml/min	Same	Identical
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarly Vue VS30 Vital Signs MonitorSW A.00.00	Comparison
Warm-up timefor CO2measurement	30 seconds (typical)	30 seconds (typical)	Identical
Calibrationinterval	Initial Calibration after 1,200 hours orafter one year whichever comes first,then once per year or every 4000hours, whichever comes first	Initial Calibration after 1,200 hours or after oneyear whichever comes first, then once per year orevery 4000 hours, whichever comes first	Identical
Accuracy ofetCO2measurement	0 – 38 mmHg: ±2 mmHg39 - 150 mmHg: ±(5% of reading +0.08% for every 1 mmHg above 38mmHg)	0 – 38 mmHg: ±2 mmHg39 - 150 mmHg: ±(5% of reading + 0.08% forevery 1 mmHg above 38 mmHg)	Identical
Range ofRespiration rate	Respiration rate can be displayed witha range of 0-150 respirations/ minute	Respiration rate can be displayed with a range of0-150 respirations/ minute	Identical
accuracy ofRespirationRate	±1 rpm in the range of 0- 70 rpm±2 rpm in the range of 71 - 120 rpm±3 rpm in the range of 121 - 150 rpm	±1 rpm in the range of 0- 70 rpm±2 rpm in the range of 71 - 120 rpm±3 rpm in the range of 121 - 150 rpm	Identical
Technologyused forrespiration ratecalculation	Oridion MicroMediCO2 module(K123690)	Oridion MicroMediCO2 module (K123690)	IdenticalPlease refer to section 7.1 forrespiration rate comparisonbetween the VS30 and theOridion MicroMediCO2.
CO2 responsetime	CO2 Response Time (Delay time +Rise time + System time) isapproximately 3.9 seconds.Long lines add an additional 3 secondsto the overall response time.	CO2 Response Time (Delay time + Rise time +System time) is approximately 3.9 seconds.Long lines add an additional 3 seconds to theoverall response time.	Identical
Battery poweroperation	3 hour	6 hour	Battery can operate with longertime
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07Latest 510(k): K163649	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Bar Codescanner	Yes – the bar code reader allows forentry of patient identificationinformation and user ID	Yes – the bar code reader allows for entry ofpatient identification information and user ID	Identical
RFID scanner	No	Yes-- allows for entry of patient identificationinformation and user ID	This application is a non-medicalapplication.The subject VS30 has an optionof RFID scanner for entry ofpatient identification informationand user ID. This is fully verifiedand verification passed all tests.
Quick Capture	Yes	Yes	Identical
Quick Check	Yes	Yes	Identical
Quick Alerts	Yes	Yes	Identical
Connectionwith PhilipsIGS software	Yes	Yes	Identical
Get EWS fromIGS	Yes	Yes	Identical
On-deviceEWS	Yes	Yes	Identical
Deviceoperatingtemperature	10°C to 40°C monitor16°C to 33°C monitor with tympanic10°C to 40°C for WelchAllyn0°C to 50°C for Masimo16°C to 40°C for Exergen	10°C to 40°C monitor10°C to 40°C for WelchAllyn16°C to 40°C for Exergen	Same
ComparativeCharacteristic	Predicate DeviceSureSigns VS4 Vital Signs MonitorSW A.07	Subject DeviceEarlyVue VS30 Vital Signs MonitorSW A.00.00	Comparison
Storagetemperature	Latest 510(k): K163649-20°C to 50°C for the monitor-20°C to 40°C for the monitor plusaccessories-20°C to 50°C for WelchAllyn-40°C to 70°C for Masimo-20°C to 50°C for Exergen	20°C to 50°C for the monitor-20°C to 40°C for the monitor plus accessories	Same
Operation andstorageHumidity	Up to 90% Relative Humidity non-condensingUp to 80% Relative Humidity non-condensing with recorder and paper15-90% for Welch Allyn predictivetemperature (non-condensing)10-90% Masimo SpO2	Composite test range 10% to 90% RH (non-condensing) for monitorComposite test range 10% to 80% RH formonitor with print recorder and paper	Same
Monitor tomonitor sharing	No	Yes---view saved patient records remotely on up to15 monitors---view the last saved record for up to 100patients---view patient data trends in graphical or tabularformat, up to 35 records.	This is a non-medical application.This is a new feature . The view isonly to view records. The user cannot use one monitor tomonitor/measure patient who isconnected to other monitors. Thisis a hospital work flowimprovement feature but not amedical application.This feature is fully verified andthe verification passed the tests.

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7.1 Respiration rate comparison between Early VS30 and Oridion MicroMediCO2

Parameter	Oridion MicroMediCO2	EarlyVue VS30	Comparison
-----------	----------------------	---------------	------------

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	K123690	K190624
CO2Respiration raterange	0-150 bpm	0 breaths/min to 150 breaths/min	Identical
CO2Respiration rateaccuracy	0-70 bpm: $\u00b1$ 1 bpm71-120 bpm: $\u00b1$ 2 bpm121-150 bpm: $\u00b1$ 3 bpm	$\u00b1$ 1 rpm in the range of 0 rpm-70 rpm$\u00b1$ 2 rpm in the range of 71 rpm−120 rpm$\u00b1$ 3 rpm in the range of 121 rpm-150 rpm	Identical

7.2 RRa respiration rate comparison between the VS30 and the Masimo RRa

Parameter	Masimo RRa respiration rateK110028	Early Vue VS30K190624	Comparison
RRaMeasurementRange	4 – 70 breaths per minute	4 – 70 breaths per minute	Identical
RRa Accuracy	± 1 breath per minute in the range 4 –70 breaths per minute,Adults (> 30 kg) and Adults/Pediatrics(> 10 kg)	± 1 breath per minute in the range 4 – 70 breathsper minute,Adults (> 30 kg) and Adults/Pediatrics (> 10 kg)	Identical

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1. Verification and testing activities establish the performance, functionality, and reliability characteristics of the subject device VS30. Testing involved software, hardware, environmental and reliability, safety and performance.
  The VS30 is tested against applicable FDA consensus IEC/ISO standards. The following standards were tested and the EarlyVue VS30 passed the tests of all these standards:

Standard and Year	Description	FDA recognition number
IEC 60601-1 ed 3.1:2012Issue Date: 2012-08-30	Medical electrical equipment. Part 1: General requirementsfor basic safety and essential performance	19-4
IEC 60601-1-2 ed 4.0:2014Issue Date: 2014-02-28	Medical electrical equipment. Part 1-2: General requirementsfor basic safety and essential performance. Collateralstandard: Electromagnetic compatibility. Requirements andtests	19-8
IEC 60601-1-6 ed 3.1:2013Issue Date: 2013-10-31	Medical electrical equipment. Part 1-6: General requirementsfor basic safety and essential performance. Collateralstandard: Usability	5-89
IEC 62366-1 ed 1.0:2015Issue Date: 2015-02-28	Medical devices. Part 1: Application of usability engineeringto medical devices	5-114
IEC 62304 ed 1.1:2015Issue Date: 2015-06-29	Medical device software. Software life cycle processes	13-79
IEC 60601-1-8 ed 2.1:2012Issue Date: 2012-11-30	Medical electrical equipment. Part 1-8: General requirementsfor basic safety and essential performance. CollateralStandard: General requirements, tests and guidance for alarmsystems in medical electrical equipment and medicalelectrical systems	5-76
IEC 80601-2-30 ed 1.1:2013Issue Date: 2013-07-30	Medical electrical equipment. Part 2-30: Particularrequirements for the basic safety and essential performance ofautomated non-invasive sphygmomanometers	3-152
IEC 60601-2-49 ed 2.0:2011Issue Date: 2011-02-28	Medical electrical equipment. Part 2-49: Particularrequirements for the basic safety and essential performance ofmultifunction patient monitoring equipment	Notrecognized
ISO 80601-2-55:2011Issue Date: 2011-12-15	Medical electrical equipment, part 2-55 — Particularrequirements for the basic safety and essential performance ofrespiratory gas monitor	1-96
ISO 80601-2-56:2017Issue Date: 2017-03	Medical electrical equipment. Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurement	6-403
ISO 80601-2-61:2011Issue Date: 2011-03-31	Medical electrical equipment. Part 2-61: Particularrequirements for basic safety and essential performance ofpulse oximeter equipment	1-85
ISO 15223-1:2017Issue Date: 2016-11	Medical devices - Symbols to be used with medical devicelabels, labelling and information to be supplied - Part 1:General requirements	5-117

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In summary, the subject device VS30 has the same intended use as the predicate device VS4. The VS30 does not add any new measurement comparing to the predicate device VS4 and the measurement technologies used are identical.

Any new or different features have been verified and validated, such as the monitor to monitor sharing, the new user interface including the function keys. The result supports a determination of substantial equivalence of VS30 to the predict device VS4.

The VS30 has been tested to all applicable IEC/ISO safety, EMC and performance standards and passed all the tests.

All the VS30 measurement functions were verified through verification test/integration test.

The VS30 with the wireless module was tested to and passed the ANSI C63.27-2017 standard and comply with the FDA guidance "Radio Frequency Wireless Technology in Medical Devices Guidance".

The VS30 software has been verified according to the design control process which was designed according to the FDA quality management system regulation.

All the VS30 electric interfaces has been tested and verified and comply with the FDA guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.

In conclusion, the subject VS30 successfully passed all verifications, testing and validations. The results demonstrate that the Philips Early Vue VS30 Vital Signs Monitor meets all safety, effectiveness and performance requirements. The subject Early Vue VS30 is as safe, as effective and performs as well as the predicate device SureSigns VS4. The EarlyVue VS30 is substantially equivalent to the predicate device VS4.

Regulation Number and Section

§ 870.1100 Blood pressure alarm.

(a)
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.(b)
Classification. Class II (performance standards).