(127 days)
No reference devices were used in this submission.
No
The summary describes a device that measures and displays standard physiological parameters using established technologies (photoelectric, oscillating, infrared). There is no mention of AI/ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended for measuring, displaying, reviewing, and storing physiological parameters, not for treating a condition.
No
The device is described as measuring, displaying, reviewing, and storing physiological parameters. While these measurements can contribute to a diagnosis, the document does not state that the device itself performs any diagnostic interpretation or provides a diagnosis. It is a measurement device, not a diagnostic one.
No
The device description explicitly states it is a "device designed for spot-checking measuring of the patient's physiological parameters" and describes hardware components like photoelectric methods, oscillating methods, and infrared radiation energy technology for measurements. It also mentions biocompatibility testing and testing according to various IEC and ISO standards for medical electrical equipment, indicating a physical device.
Based on the provided information, the Vitals360® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Vitals360® device measures physiological parameters directly from the patient's body (blood pressure, SpO2, pulse rate, temperature, ECG, weight, height). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state direct patient measurements. The device description details how it measures parameters non-invasively using methods like photoelectric, oscillating, and infrared radiation.
- There is no mention of analyzing biological samples. The entire description focuses on the device's ability to measure and display vital signs from the patient.
Therefore, the Vitals360® device falls under the category of a medical device that performs direct physiological measurements, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
Product codes
MWI, DQA, DSH, DXN, FLL
Device Description
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead (for temperature measurement)
Indicated Patient Age Range
adults no less than 18 years of age.
Intended User / Care Setting
trained adults only who can use smartphones proficiently.
clinical or home environment.
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)
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate devices.
Biocompatibility testing:
The biocompatibility evaluation for VC-001 was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject devices are considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data:
The Pulse Oximeter has been tested according to the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-1-11: 2015 Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-47: 2012 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic . Safety and Essential Performance of ambulatory electrocardiographic systems.
- ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- ISO 80601-2-30: 2018 Medical Electrical Equipment - Part 2-30: Particular Requirements for Basic Safety and Essential Performance of automated non-invasive sphygmomanometers.
- ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.
- IEC 62133: 2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data:
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
- ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
- ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical test results support device accuracy claims for the specified measurement range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 measurement accuracy: Displayed range: 70%100% ±2% (during 90100%), ±4% (during 70~89%)
Pulse rate measurement range: 30 to 150 bpm
Pulse rate accuracy: ±2bpm or ±2%, whichever is greater
BP accuracy: Mean deviation values: ±5 mmHg. Standard deviation
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
VoCare, Inc. Deon Vigilance Chief Medical Officer 4950 Turkev Foot Road Zionsville, Indiana 46077
Re: K210086
Trade/Device Name: Vitals360® Multi-Vitals Mobile Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DSH, DXN, FLL Dated: April 19, 2021 Received: April 19, 2021
Dear Deon Vigilance:
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.
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
1
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,
for
LT 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) K210086
Device Name
Vitals360® Multi-Vitals Mobile Monitor
Indications for Use (Describe)
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY - K210086
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
I. SUBMITTER
Contact Person: Steve Peabody VoCare, Inc. 4950 Turkey Foot Road Zionsville, IN 46077 USA Tel: +1 (317) 658-0005 Fax: N/A Submission Contact: Deon Vigilance Date Prepared: April 15, 2021
II. DEVICE
| Name of Device: | Vitals360® Multi-Vitals Mobile Monitor – Model: VC-001 |
|---|---|
| Classification Name: | Monitor, Physiological, Patient (Without Arrhythmia Detection On |
| Alarms) | |
| Regulation: | 21 CFR §870.2300 |
| Regulatory Class: | Class II |
| Product Classification Code: | MWI, DQA, DSH, DXN, and FLL |
PREDICATE DEVICE III.
| Primary Predicate Manufacturer: | Shenzhen Creative Industry Co., Ltd. |
|---|---|
| Primary Predicate Trade Name: | All-in-One Health Monitor, PC-303 |
| Primary Predicate 510(k): | K170047 |
| Secondary Predicate Manufacturer: | Ningbo Ranor Medical Science & Technology Co., Ltd. |
|---|---|
| Secondary Predicate Trade Name: | Infrared Thermometer, RN-50A, RN-50B |
| Secondary Predicate 510(k): | K200578 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It
4
can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
INTENDED USE & INDICATION FOR USE V.
Vitals360® device is intended to be used for measuring, displaying and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 vears of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
5
COMPARISON TO THE PREDICATE DEVICE VI.
| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-
303 (K170047) | Secondary Predicate Device -
Infrared Thermometer RN-
50A, RN-50B (K200578) | Justification for Differences |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | VoCare Inc. | Shenzhen Creative Industry
Co., Ltd. | Ningbo Ranor Medical Science
& Technology Co., Ltd. | N/A |
| Classification
Regulation | 21 CRF 870.2300 | 21 CRF 870.2300 | 21 CFR 880.2910 | The secondary predicate is
limited to the regulation for
clinical thermometers. |
| Classification
and Code | Class II, MWI, DQA, DSH,
DXN, and FLL | Class II, MWI, DQA, DXN,
FLL, NBW, DSH | Class II, FLL | The subject device does not
include a glucometer function,
and therefore the NBW code is
not applicable to the subject
device. The secondary predicate
is limited to the clinical
thermometer product code. |
| Common name | Patient Monitor | Patient Monitor | Thermometer, electronic, clinical | The secondary predicate is
limited to the clinical
thermometer function. |
| Intended use | Vitals360® device is intended to
be used for measuring,
displaying, reviewing and storing
of non-invasive blood pressure
(NIBP), non-invasive monitoring
of functional oxygen saturation
of arterial hemoglobin (SpO2),
pulse rate (PR), forehead
temperature (TEMP), ECG,
weight and height in adults no
less than 18 years of age.
This VITALS360® device is
intended for use by trained adults
only who can use smartphones | The All-in-One Health
Monitor, PC- 303 is a device
designed for spot- checking
measuring of the patient's
physiological parameters, such
as Non-Invasive Blood
Pressure (NIBP), Oxygen
saturation (SpO2), Pulse Rate
(PR) and Body Temperature
(TEMP);
Additionally, the device is
available to communicate with
the compatible Blood Glucose
Monitoring System and ECG | The Infrared thermometer is a
non-contact infrared
thermometer intended for the
intermittent measurement of
human body temperature
from forehead for people of
all ages. The device is
reusable for home use and
clinical use. | The subject device is limited
to patients 18 years of age
and older and does not
include indications for
glucose measurement. These
omissions do not introduce
any additional risks, and
otherwise the indications are
equivalent to the primary
predicate. The secondary
predicate is limited to body
temperature measurement and
also applies to a wider patient
range. |
| | | | | |
| | proficiently.
This VITALS360® device is
intended for use in a clinical or
home environment.
This VITALS360® device is
a reusable device following
thorough cleaning between
uses. | monitor to make the
measurement.
This device is applicable for
Adult and Pediatric (age≥3
years old) use in clinical
institutions and has no
conditions or factors of
contraindication. | | |
| Physical
dimension(mm)
/weight(kg) | 145(L) × 80(W) × 25(H) / 0.25kg | 165(L) × 96(W) × 68(H) / 0.44kg | N/A | The subject device is smaller than
the primary predicate which does
not create any negative issues
regarding portability or usability
of the device, and the smaller
size of the clinical thermometer
is due to its limited functionality. |
| Display | 3.66 inch | 4.3 inch | LCD Display | The display size of the subject
device and the predicate are
equivalent, and no readability
issues were identified during
usability testing. The LCD
display for the clinical
thermometer is appropriate only
for the display of a single
temperature. |
| Type, Degree of
protection
against electric
shock | Class II with internal electric
power supply.
SpO2/NIBP/TEMP: Type BF
applied part. | Class II with internal electric
power supply.
SpO2/NIBP/TEMP: Type BF
applied part. | Class II with internal electric
power supply.
TEMP: Type BF applied part. | The subject device and the
primary predicate are identical.
The applicable applied part of the
subject device is also equivalent
to the clinical thermometer. |
| Power supply | Battery or AC | Battery or AC | Battery | The subject device and the
primary predicate are identical.
The lack of AC charging for the
clinical thermometer is
appropriate for the lower power
requirements. |
| Power
requirement | (100-240) VAC, 50/60Hz, 0.5A,
Rechargeable lithium battery,
3.7VDC | (100-240) VAC, 50/60Hz,
15VA,
Rechargeable lithium battery,
3.7VDC | AAA*3, DC 3V | The subject device and the
primary predicate are equivalent.
The lack of AC charging for the
clinical thermometer is
appropriate for the lower power
requirements. |
| Alarm | No alarm | No alarm | Low Battery Indication | The subject device and primary
predicate do not include alarms
for low battery indication,
because the display is able to
show a battery icon that indicates
the remaining battery % and the
device will not take
measurements if the battery level
is too low. |
| Features | Subject Device - Vitals360 | Primary Predicate Device -
PC-303 (K170047) | Secondary Predicate Device -
Infrared Thermometer RN-
50A, RN-50B (K200578) | Justification for Differences |
| SpO2 / Pulse Rate | | | | |
| Patient | 18 years and older | Adult, pediatric | Adult, pediatric | The subject device is limited to
patients 18 years of age and
older, while both predicates are
indicated for adult and pediatric
patients. This omission does not
introduce any additional risks. |
| SpO2
measure
ment
accuracy | Displayed range: 70%100%100%),
±2% (during 90
±4% (during 70~89%) | Displayed range: 70%~100%
±3% (during 70%-100%)
Undefined (during 0-70%) | N/A | Subject device and primary
predicate are equivalent, and
secondary predicate does not
include SpO2 feature. |
| Pulse rate
measurement
range | 30 to 150 bpm | 30 bpm-240 bpm | N/A | Subject device and primary
predicate are equivalent, and
secondary predicate does not
include SpO2 feature. |
| Pulse rate
accuracy | ±2bpm or ±2%, whichever is
greater | ±2bpm or ±2% (whichever is
greater) | N/A | Subject device and primary
predicate are identical, and |
6
7
8
| | | | | secondary predicate does not
include SpO2 feature. |
|-------|----------|----------|-----|---------------------------------------------------------------------------------------------------------------------|
| Alarm | No alarm | No alarm | N/A | Subject device and primary
predicate are identical, and
secondary predicate does not
include SpO2 feature. |
| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-303 (K170047) | Secondary Predicate Device -
Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|----------------------------------------|----------------------------|---------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NIBP | | | | |
| Method | Oscillometric method | Oscillometric method | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Patient type | 18 years and older | Adult and Pediatric patients | N/A | The subject device is limited to patients 18 years of age and older and does not include indications for glucose measurement. These omissions do not introduce any additional risks, and otherwise the indications are equivalent to the primary predicate. The secondary predicate does not include NIBP feature. |
| Unit of measure | mmHg & kPa | mmHg & kPa | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Systolic | 60 mmHg ~230mmHg | 60 mmHg - 255mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Diastolic | 40 mmHg ~130mmHg | 30 mmHg - 195mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not |
9
| include NIBP feature. | ||||
|---|---|---|---|---|
| BP accuracy | Mean deviation values: ±5 mmHg. | |||
| Standard deviation |