(230 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard physiological parameter measurement and wireless communication.
No
The device is described as a monitor intended to measure, display, alarm, and record physiological information, not to administer any form of treatment or therapy.
No.
Explanation: The device is described as a "multi-parameter compact, portable monitor" that measures and monitors physiological parameters, displays, alarms, and records physiological information. It is used to track patient vital signs and does not diagnose a medical condition.
No
The device description explicitly states it is a "multi-parameter compact, portable monitor" and mentions testing involving "software, hardware, environmental and reliability, safety and performance," indicating it is a physical device with integrated software, not software only.
Based on the provided text, the Early Vue VS30 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for measuring, displaying, alarming, and recording physiological information of patients. This involves monitoring vital signs directly from the patient's body.
- Device Description: The description reinforces this by stating it measures or monitors parameters like NBP, SpO2, SpHb, RRa, CO2, and temperature. These are all physiological measurements taken from the patient.
- Lack of Mention of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Early Vue VS30 operates by directly interacting with the patient to gather physiological data.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DSJ, DSK, DXN, DOA, DSA, FLL, CCK
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.
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).
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Pediatric, Neonatal
Intended User / Care Setting
Healthcare professional in hospitals and in out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 EarlyVue VS30 passed the tests of all these standards. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
NBP Accuracy:
Maximum Standard Deviation: 8 mmHg
Maximum Mean Error: +/- 5 mmHg
Pulse Rate (derived from NBP) accuracy:
40 – 100 bpm: +/- 5 bpm
101 - 200 bpm: +/- 5% of reading
201 - 300 bpm: +/- 10% of reading
Philips SpO2:
Pulse rate accuracy: Greater of + 2% or + 1 bmp
Resolution of SpO2 measurement: 1%
SpO2 accuracy: With SpO2 values between 70 - 100% range oxygenation
Philips reusable sensors +/- 2%: M1191B, M1191BL, M1191A, M1191AL, M1192A
+/- 3%: M1191T, M1192T, M1193T with adult use, M1193A, M1194A, M1195A, M1196A, M1196T, M1196S
+/- 4% - M1193T with Neonatal use
Philips disposable sensors +/- 2% - M1132A, M1133A, M1134A
+/- 3% - M1131A
Predictive Temp Measurement:
Accuracy in monitoring mode: +/- 0.1 °C (+/- 0.2°F)
Resolution: 0.1 °C
Masimo SpO2:
Accuracy:
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
Resolution of SpO2 measurement: 1%
Pulse rate derived from Masimo SpO2:
Pulse rate resolution: 1 bpm
Pulse rate accuracy: +/-5 bpm motion or low perfusion worst case
SpHb:
SpHb accuracy: 8-17 g/dL (arterial or venous) adults/pediatrics: +/- 1g/dL
SpHb resolution: 0.1 g/dL
RRa (acoustic respiration):
RRa accuracy: In the range of 4-70 bpm: +/-1 bpm, adults (>30kg)
RRa resolution: 1 breath per minute (bpm)
Temporal Temperature:
Clinical accuracy: +/- 0.2 oF or 0.1 °C per ASTM E1112
Resolution: 0.1 °C or 0.1 oF
Response time:
§ 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).
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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.
1
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
2
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) |
|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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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).
-
- The submitter and contact person of this pre-market notification is:
The submitter/manufacturer:
- The submitter and contact person of this pre-market notification is:
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
-
- Date this summary is prepared: This summary is prepared on October 24, 2019.
-
- 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 | |
| Pressure, Non-Invasive |
4
| Device Panel | Classification | Product Code | Description |
|---|---|---|---|
| 870.2700, II | DQA | Oximeter | |
| 870.2900, II | DSA | Cable, transducer and electrode, | |
| patient connector | |||
| General | |||
| Hospital and | |||
| Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology | |||
| & Respiratory | |||
| 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).
5
- 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.
-
- 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 | |||
| Philips FAST) | √ | √ | √ |
| Pulse Rate (PR) derived from SpO2 | |||
| or NBP | √ | √ | √ |
| Temperature (Predictive, Temporal) | √ | √ | √ |
| end tidal CO2 (etCO2) | √ | √ | √ |
| Respiration Rate: airway respiration | |||
| (awRR) | √ | √ | √ |
| Respiration Rate: acoustic | |||
| respiration (RRa) | √ | √ | |
| Non-invasive Total Hemoglobin | |||
| (SpHb) | √ | √ |
6
Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.
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
Characteristic | Predicate Device
SureSigns VS4 Vital Signs Monitor
SW A.07
Latest 510(k): K163649 | Subject Device
EarlyVue VS30 Vital Signs Monitor
SW A.00.00 | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------|
| Model/model
number/
Reference
numbers | SureSigns VS4/863283 | EarlyVue VS30/863380 | New Model is assigned to VS30 |
8
| Comparative
Characteristic | Predicate Device
SureSigns VS4 Vital Signs Monitor
SW A.07
Latest 510(k): K163649 | Subject Device
EarlyVue VS30 Vital Signs Monitor
SW A.00.00 | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The SureSigns VS4 vital signs monitor
is for use by health care professionals
whenever there is a need for
monitoring the physiological
parameters of patients. The SureSigns
VS4 is for monitoring, recording and
alarming of multiple physiological
parameters in healthcare environments
for patient types listed below.
Additionally, the monitor may be used
in transport situations within a
healthcare facility.
Parameter Adult Pediatric Neonatal NBP ✓ ✓ ✓ SpO2 ✓ ✓ ✓ Temperature ✓ ✓ ✓ CO2 ✓ ✓ ✓ RRa ✓ ✓ SpHb ✓ ✓ Contraindications: Not for transport
outside the healthcare facility | | | | | | | | | | | | | | | | | | | | | | | | | | | | | The EarlyVue 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:
Parameter Adult Pediatric Neonatal Non-invasive BP (NBP) ✓ ✓ ✓ SpO2 (Masimo rainbow
SET or Philips FAST) ✓ ✓ ✓ Pulse Rate (PR)
derived from SpO2 or
NBP ✓ ✓ ✓ Temperature
(Predictive, Temporal) ✓ ✓ ✓ end tidal CO2 (etCO2) ✓ ✓ ✓ Respiration Rate:
airway respiration
(awRR) ✓ ✓ ✓ Respiration Rate:
acoustic respiration
(RRa) ✓ ✓ Non-invasive Total
Hemoglobin (SpHb) ✓ ✓ Contra-indications: Not for transport outside the
healthcare facility. Not for use in home setting. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | --both predicate VS4 and subject VS30
are intended to measure/ monitor/alar/
record patient physiological information;
--VS4 identified clinical setting as
healthcare environments, VS30 clarifies
this with details 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).
Technically the clinical setting is not
changed.
--patient types for VS4 and VS30 are
identical
--parameters are clarified in VS30
comparing to VS4. VS30 will not provide
Tympanic temperature but VS4 has.
Respiration Rate: airway RR (awRR) and
Pulse Rate (PR) derived from SpO2 or
NBP are not new. VS4 had these but not
listed in the indications table.
So the parameters are identical except the
VS30 will not provide Tympanic
temperature.
Summary Indications for use and
intended use of VS30 and VS4 are the
same. |
9
| Comparative
Characteristic | Predicate Device
SureSigns VS4 Vital Signs Monitor
SW A.07
Latest 510(k): K163649 | Subject Device
EarlyVue VS30 Vital Signs Monitor
SW A.00.00 | Comparison |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
specifications:
Height
Length
Depth
Weight | 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) including
battery, excluding temperature,
excluding optional recorder, optional
connectivity package or mounting
hardware. | Width: 33 cm
Height: 25 cm
Depth: 18 cm
Weight: 30kg) | In the range of 4-70 bpm: +/-1 bpm, adults
(>30kg) | Identical |
| Technology
used for RRa
measurement
and calculation | Rainbow SET technology (K110028) | Rainbow SET technology (K110028) | Identical
Please refer to section 7.2 for
respiration rate comparison
between the VS30 and Masimo
Rainbow SET RRa |
| RRa resolution | 1 breath per minute (bpm) | 1 breath per minute (bpm) | Identical |
| Firmware | Rainbow SET Technology, MX
board/circuitry from Masimo | Rainbow SET Technology, MX board/circuitry
from Masimo | Identical |
| Wavelength
range | 653 to 905 nm for all specified sensors | 500 nm to 1400 for all specified sensors | Identical |
| Maximum
optical output
power | 30 kg) and Adults/Pediatrics
(> 10 kg) | ± 1 breath per minute in the range 4 – 70 breaths
per minute,
Adults (> 30 kg) and Adults/Pediatrics (> 10 kg) | Identical |
23
-
- 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:
- 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.
| Standard and Year | Description | FDA recognition number |
|---|---|---|
| IEC 60601-1 ed 3.1:2012 | ||
| Issue Date: 2012-08-30 | Medical electrical equipment. Part 1: General requirements | |
| for basic safety and essential performance | 19-4 | |
| IEC 60601-1-2 ed 4.0:2014 | ||
| Issue Date: 2014-02-28 | Medical electrical equipment. Part 1-2: General requirements | |
| for basic safety and essential performance. Collateral | ||
| standard: Electromagnetic compatibility. Requirements and | ||
| tests | 19-8 | |
| IEC 60601-1-6 ed 3.1:2013 | ||
| Issue Date: 2013-10-31 | Medical electrical equipment. Part 1-6: General requirements | |
| for basic safety and essential performance. Collateral | ||
| standard: Usability | 5-89 | |
| IEC 62366-1 ed 1.0:2015 | ||
| Issue Date: 2015-02-28 | Medical devices. Part 1: Application of usability engineering | |
| to medical devices | 5-114 | |
| IEC 62304 ed 1.1:2015 | ||
| Issue Date: 2015-06-29 | Medical device software. Software life cycle processes | 13-79 |
| IEC 60601-1-8 ed 2.1:2012 | ||
| Issue Date: 2012-11-30 | Medical electrical equipment. Part 1-8: General requirements | |
| for basic safety and essential performance. Collateral | ||
| Standard: General requirements, tests and guidance for alarm | ||
| systems in medical electrical equipment and medical | ||
| electrical systems | 5-76 | |
| IEC 80601-2-30 ed 1.1:2013 | ||
| Issue Date: 2013-07-30 | Medical electrical equipment. Part 2-30: Particular | |
| requirements for the basic safety and essential performance of | ||
| automated non-invasive sphygmomanometers | 3-152 | |
| IEC 60601-2-49 ed 2.0:2011 | ||
| Issue Date: 2011-02-28 | Medical electrical equipment. Part 2-49: Particular | |
| requirements for the basic safety and essential performance of | ||
| multifunction patient monitoring equipment | Not | |
| recognized | ||
| ISO 80601-2-55:2011 | ||
| Issue Date: 2011-12-15 | Medical electrical equipment, part 2-55 — Particular | |
| requirements for the basic safety and essential performance of | ||
| respiratory gas monitor | 1-96 | |
| ISO 80601-2-56:2017 | ||
| Issue Date: 2017-03 | Medical electrical equipment. Part 2-56: Particular | |
| requirements for basic safety and essential performance of | ||
| clinical thermometers for body temperature measurement | 6-403 | |
| ISO 80601-2-61:2011 | ||
| Issue Date: 2011-03-31 | Medical electrical equipment. Part 2-61: Particular | |
| requirements for basic safety and essential performance of | ||
| pulse oximeter equipment | 1-85 | |
| ISO 15223-1:2017 | ||
| Issue Date: 2016-11 | Medical devices - Symbols to be used with medical device | |
| labels, 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.