(245 days)
No
The summary describes standard vital sign measurement technologies (infra-red, finger-based) and does not mention any AI/ML components or algorithms.
No
The device is described as a "monitoring device" for "spot measurements" of vital signs and is explicitly stated as "not intended for continuous monitoring," nor does it mention providing any form of therapy or treatment.
No.
The device is described as a "monitoring" device for "spot measurements" of vital signs and is explicitly stated as "not intended for continuous monitoring," nor does it mention providing a diagnosis.
No
The device description explicitly states it is a "hand-held, portable vital sign monitor" and includes hardware components such as an "inflatable finger-cuff," "infra-red sensor," and a "lithium-polymer battery." While it uses a downloadable application, it is not solely software.
Based on the provided information, the Wellvii VitalDetect™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VitalDetect™ measures physiological parameters directly from the body (blood pressure, pulse rate, temperature) using non-invasive methods (finger-based and infra-red).
- The intended use and device description clearly state that it's for "spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP)" and for "monitoring" physiological parameters. This aligns with the definition of a vital signs monitor, not an IVD.
- There is no mention of analyzing biological specimens. The device uses sensors that interact with the body's surface or internal physiological processes directly.
In summary, the Wellvii VitalDetect™ is a vital signs monitor, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DXN, FLL
Device Description
VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP).
The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel.
The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (for temperature), finger (for other measurements)
Indicated Patient Age Range
individuals 18 years of age or older
Intended User / Care Setting
prescription home use
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)
Clinical Testing (Section 20). Clinical trials were completed to validate the clinical accuracy and functionality of the proposed device. The study was conducted in accordance with 21 CFR 812 for Non-significant Risk Investigational Studies, following ISO 14155:2011 Clinical Investigation of medical devices for human subjects – Good clinical practice, as appropriate. The table below summarizes the study results.
NIBP - Systolic: Criterion 1: +1.66 mmHg Bias, Criterion 1: ± 7.67 mmHg STD, Criterion 2: ± 6.49 mmHg STD
NIBP – Diastolic: Criterion 1: +1.04 mmHg Bias, Criterion 1: ± 6.49 mmHg STD, Criterion 2: ± 5.67 mmHg STD
Pulse Rate: ± 2.7 Arms
Temperature: ± 0.3 °C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
NIBP - Systolic Accuracy: Criterion 1: +1.66 mmHg Bias, Criterion 1: ± 7.67 mmHg STD, Criterion 2: ± 6.49 mmHg STD
NIBP – Diastolic Accuracy: Criterion 1: +1.04 mmHg Bias, Criterion 1: ± 6.49 mmHg STD, Criterion 2: ± 5.67 mmHg STD
Pulse Rate Accuracy: ± 2.7 Arms
Temperature Accuracy: ± 0.3 °C
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 2, 2024
Wellvii Inc Mark Khachaturian CEO 4521 PGA Blvd, PMB 341 Palm Beach Gardens, Florida 33418
Re: K231625
Trade/Device Name: VitalDetect Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, FLL Dated: June 2, 2023 Received: June 2, 2023
Dear Mark Khachaturian:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Robert T. Kazmierski -S for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231625
Device Name Wellvii VitalDetect
Indications for Use (Describe)
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Section 05.01 510(k) Summary
Submitter:
Wellvii Inc. 4521 PGA Blvd PMB 341 Palm Beach Gardens, FL 33418
Contact Person:
Mark Khachaturian, PhD CEO Wellvii Inc. Phone: +1 (561) 559-2945 E-mail: markk(@wellvii.com
Date Prepared:
November 30th, 2023
Device Trade Name:
VitalDetect™
Common Name:
Vital Signs Monitor
Classification Name:
Noninvasive blood pressure measurement system
Classification Panel:
5
Wellvii Inc.
VitalDetect™
Cardiovascular
CFR Section:
21 CFR 870.1130 Non-invasive Blood Pressure (Cardiovascular Panel) 21 CFR 880.2910 Thermometer
Classification:
Class II
Product Codes:
DXN, Blood Pressure FLL, Thermometer, electronic, clinical
Predicate Devices:
Primary: All-in-One Monitor (K170047) Reference A: ARC InstaTemp MD for Temperature (K152905)
Device Description:
VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP).
The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel.
The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
6
In the home environment, the user will have responsibility for charging it prior to use (to disable measurent lock), installing the app, pairing with the device, starting the connection. The left index finger could then be placed in the correct position for the measurement process to begin.
Predicate Devices:
The Primary predicate devices is the: All-in-One Monitor (K170047). Wellvii has also identified the following reference predicate device for the temperature feature: ARC InstaTemp MD for Temperature (K152905)
Indications for Use
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetect™ is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
7
Substantial Equivalence Comparison
| Brand Name | VitalDetect
(aka SmartVS/Vital Moto Mod) | All-in-One Health Monitor,
PC-303 | ARC InstaTemp MD Infrared
Thermometer |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Indications for
Use (Clinical use) | The Wellvii VitalDetect™ is a device designed for spot
measurements with recorded results of non-invasive
blood pressure (NIBP), pulse rate (PR), and temperature
(TMP).
This device uses an infra-red sensor for non-contact
temperature measurement at the forehead. All other
measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home
use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring. | [i]s a device designed for spot-checking
measuring of the patient's physiological
parameters, such as NIBP, SpO2, PR, and body
TEMP.
Additionally, the device is available to
communicate with the compatible Blood
Glucose Monitoring System and ECG 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. | The ARC InstaTemp is an infrared
thermometer that measures temperature from
the forehead in both infants and adults
without contacting the human body. |
8
| Technology Characteristics Comparison | ||||
|---|---|---|---|---|
| Product | Proposed Device | Primary Predicate | Reference A | Discussion |
| Brand Name | VitalDetect | |||
| (aka SmartVS/Vital Moto | ||||
| Mod) | All-in-One Health | |||
| Monitor, PC-303 | ARC InstaTemp MD | |||
| Infrared Thermometer | ||||
| General Characteristics | ||||
| Manufacturer | Wellvii Inc. | Shenzhen Creative Industry Co., | ||
| Ltd. | ARC Devices Ltd. (predecessor to | |||
| Vital USA Inc) | ||||
| 510k number | K231625 | K170047 | K152905 | |
| Regulation | ||||
| Number | 21 CFR 870.1130 | |||
| Cardiovascular Devices | ||||
| Cardiovascular Diagnostic | ||||
| Devices Noninvasive BP | ||||
| measurement system | ||||
| (performance standards) | 21 CFR 870.2300 | |||
| Cardiovascular Devices | ||||
| Patient Monitor | 21 CFR 880.2910 | |||
| General Hospital | ||||
| ODE Anesthesiology, General | ||||
| Hospital Devices | ||||
| Thermometer, Electronic, Clinical | ||||
| Class and Product | ||||
| Code | Class II, DXN, DQA, FLL | Class II, MWI, DQA, DXN, | ||
| FLL, NBW (glucose), DSH | ||||
| (ECG recorder) | Class II, FLL | |||
| Patient | ||||
| Population | Adults aged 18 years and | |||
| older | Children and adults >= 3 years | |||
| old | Both Infants and Adults | (D) Patient Types: | ||
| · The Proposed target population is ≥18 yrs of age. | ||||
| · The Predicate is targeted for those persons ≥3 years of | ||||
| age. | ||||
| · Reference Predicate B is targeted for both infants and | ||||
| adults. | ||||
| SUMMARY: The difference does not cause new | ||||
| questions regarding safety and effectiveness because | ||||
| they are all indicated for adults. | ||||
| Parameters | ||||
| Measured | Heart Rate, Blood Pressure, | |||
| and Temperature | Non-Invasive: BP, PR, SpO2, | |||
| TEMP | Temperature | SAME | ||
| Use Location | Clinical Setting, Home Use | Clinical Setting | Clinical Setting | (D) The Proposed, Primary, and Reference devices can |
| be used in a clinical setting. The Proposed is a | ||||
| prescription home use device. | ||||
| SUMMARY: The difference does not cause new | ||||
| questions regarding safety and effectiveness as the | ||||
| Proposed device was tested to Home Use standards. | ||||
| Form Factor | Handheld Device | Table Top device with | ||
| Accessories | Handheld Device | (S) Similar compact form factors. | ||
| SUMMARY: The difference does not cause new | ||||
| questions regarding safety and effectiveness. | ||||
| Power Source | Rechargeable lithium- | |||
| polymer; low battery | ||||
| indicator, | Rechargeable lithium battery 3.7 | |||
| DC or AC; low battery indicator; | ||||
| quick-button return to power | ||||
| saving mode | N/A | SAME | ||
| Temperature | ||||
| Principle of | ||||
| Operation | TEMP: (body) infrared | |||
| radiation energy technology | ||||
| via the forehead; adjusted | ||||
| mode | N/A | TEMP: (body) infrared radiation | ||
| energy technology via the forehead; | ||||
| adjusted mode | SAME | |||
| Measurement | ||||
| Range | TEMP output range: | |||
| $32.0°C$ - $43.0°C$ ( $89.6°F$ - | ||||
| $109.4°F$ ) | N/A | TEMP output range: | ||
| $32.0°C$ - $43.0°C$ ( $89.6°F$ - $109.4°F$ ) | SAME | |||
| Accuracy | TEMP accuracy: | |||
| $±0.3°C$ ( $36.0°C$ to $39.0°C$ ) | ||||
| $± 0.3°C$ (the rest) | ||||
| $±0.3°F$ ( $96.8°F$ to $102.2°F$ ) | ||||
| $±0.3°F$ (the rest) | N/A | TEMP accuracy: | ||
| $±0.3°C$ ( $36.0°C$ to $39.0°C$ ) | ||||
| $± 0.3°C$ (the rest) | ||||
| $±0.3°F$ ( $96.8°F$ to $102.2°F$ ) | ||||
| $±0.3°F$ (the rest) | SAME | |||
| Blood Pressure | ||||
| Principle of | ||||
| Operation | Blood Pressure: The finger | |||
| cuff occludes blood flow and | ||||
| uses the oscillometric | ||||
| principle to estimate systolic | ||||
| and diastolic. | ||||
| Measurement can be canceled | ||||
| by press-and-hold of the | ||||
| power button. | Blood Pressure: The arm cuff | |||
| occludes blood flow and uses | ||||
| the oscillometric principle to | ||||
| estimate systolic and diastolic. | ||||
| BP can be cancelled /activated | ||||
| by a shortcut button. | N/A | (S) The proposed devices use the oscillometric method. | ||
| (D) The Proposed device measures from the finger and | ||||
| the Primacy predicate measures from the arm. | ||||
| SUMMARY: The differences do not raise new | ||||
| questions regarding safety and effectiveness because | ||||
| they both meet the same blood pressure accuracy | ||||
| standard ISO 80601-2:2018. | ||||
| Measurement | ||||
| Range | 60-230 mmHg Systolic | |||
| 40-130 mmHg Diastolic | 60-240 mmHg | |||
| 30-180 mmHg | N/A | (D) The Primary predicate has larger systolic and | ||
| diastolic range. | ||||
| SUMMARY: The differences do not raise new | ||||
| questions regarding safety and effectiveness because the | ||||
| Proposed device will not display a result if the blood | ||||
| pressure is out of its range. | ||||
| Accuracy | BP accuracy MDV: | |||
| $±5.0$ mmHg ( $± 0.67$ kPa) with | ||||
| SD: $≤$ 8.0 mmHg | BP accuracy MDV: | |||
| $±5.0$ mmHg ( $± 0.67$ kPa) with | ||||
| SD: $≤$ 8.0 mmHg | N/A | SAME | ||
| Over Pressure | ||||
| Limit | Active if cuff pressure | |||
| exceeds 300 mmHg (adult) at | ||||
| any time. | Active if cuff pressure exceeds | |||
| 300 mmHg (adult and pediatric | ||||
| modes) at any time. | N/A | SAME | ||
| Pulse Rate | ||||
| Principle of | ||||
| Operation | Pulse Rate (PR), peak | |||
| detection of 940 nm signal | PR: photoelectric method; | N/A | SAME | |
| Measurement | ||||
| Range | 40-140 bpm | PR range: 30 to 240 bpm | N/A | (D) The Primary predicate has larger measurement |
| range. | ||||
| SUMMARY: The differences do not raise new | ||||
| questions regarding safety and effectiveness because the | ||||
| Proposed device will not display a result if the result is | ||||
| out of its range. | ||||
| Accuracy |