(60 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological parameter monitoring without mentioning any advanced analytical or predictive capabilities typically associated with AI/ML.
No
The device is described as a "Health Monitoring System" intended for "physiologic patient monitoring," providing multi-parameter alarms and monitoring vital signs. Its function is to provide data to healthcare professionals, not to provide therapy or treatment.
No
The device is intended for monitoring vital signs and providing alarms based on those parameters. It captures physiological data but does not explicitly state an intention to diagnose any medical condition, rather it functions as a monitoring and data collection system for healthcare professionals.
No
The device description explicitly states the system "consists of a single monitoring device worn on the upper arm, a software platform... and a user interface". It also mentions an "additional adhesive axillary sensor" and integration with other devices for monitoring blood pressure, spirometry, and weight. This indicates the system includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The Current Wearable Health Monitoring System monitors physiological parameters directly from the patient's body (pulse rate, oxygen saturation, temperature, movement, respiration rate, blood pressure, lung function, weight). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "physiologic patient monitoring" and "monitoring temperature at the upper arm." This involves direct measurement of vital signs, not analysis of in vitro samples.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- · Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.
- · Respiration rate
- · Non-invasive blood pressure
- · Lung function & spirometry
- · Weight
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
Product codes
MSX, FLL, DQA, BZQ, DRG, BZG
Device Description
The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.
The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).
While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.
In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, axillary
Indicated Patient Age Range
Adult
Intended User / Care Setting
Trained healthcare professionals; professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home.
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
Non-Clinical Tests (Performance/Physical Data):
The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing:
- Electrical Safety: The Current Health System was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1) - Passed.
- EMC: The Current Health System was tested to confirm that it met the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2) - Passed.
- QI Charger Testing: The Current Health Wearable was tested to confirm the device could be charged using the QI Charger - Passed.
- Environment Testing: The Current Health System was tested to confirm the storage and operating temperature ranges - Passed.
- Alarm Testing: The Current Health System was tested to confirm that it met the applicable standards for basic safety and essential performance for alarm systems (IEC 60601-1-8); Alarm Function Verification Tests for each parameter function were performed - Passed.
- Pulse Rate Testing Validation of the accuracy of pulse rate monitoring: The Current Health System was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007 - Passed.
- Battery Testing: The Current Health Wearable Device Battery Life testing was performed to determine the battery life of the Wearable Device while operating in various modes as well as time to fully charge - Passed.
- PDU Buffering Time Testing: The Current Health system was tested to evaluate the difference between the theoretical maximum PDU buffering time and the observed maximum PDU buffering time - Passed.
- Usability Testing: The Current Health System was assessed with regards to usability for compliance with IEC 62366 - Medical devices - Application of usability engineering to medical devices and IEC 60601-1-11 - Passed.
- Device Ship/Transport Testing: Ensure device, enclosed in the selected shipping container, meets ASTM D4169 specifications - Passed.
- Biocompatibility Testing: Testing and analysis of the Current Health System has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices - Guidance - Passed.
- SpO2 Testing Validation of the accuracy of SpO2 monitoring: Ensure the accuracy and communication of the SpO2 functions within the Current Health system as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013 - Passed.
- Respiratory Rate Testing: Ensure accuracy of the Current Health system measurement of respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures - Passed.
- Temperature Measurement Accuracy: The Current Health System was tested to confirm the Temperature Measurement Accuracy of the system in compliance with ISO 80601-2-56 - Passed.
- Wireless Radio Communication (Wireless Coexistence Testing): The Current Health System was tested to ensure device can communicate via wireless radio in its intended environment - Passed.
- System Verification and Validation Testing: The system verification and validation testing was performed to verify the software and firmware of the Current Health System. This included testing of integration and interoperability of the peripheral devices for blood pressure, axillary temperature, lung function & spirometry and weight - Passed.
Clinical Studies:
No clinical studies were conducted as part of submission to prove substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 12, 2019
Current Health Ltd. Edwin Lindsay QA/RA Manager Playfair House 12A Broughton Street Lane Edinburgh, EH1 3LY United Kingdom
Re: K191272
Trade/Device Name: Current Wearable Health Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, FLL, DQA, BZQ, DRG, BZG Dated: May 6, 2019 Received: May 13, 2019
Dear Edwin Lindsay:
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 (QS) 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 medical devices and radiation-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 Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Current Wearable Health Monitoring System
Indications for Use (Describe)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- · Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.
- · Respiration rate
- · Non-invasive blood pressure
- · Lung function & spirometry
- · Weight
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
For Current Wearable Health Monitoring System
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
Current Health Ltd
Submitter's Address:
Playfair House, 12A Broughton Street Lane Edinburgh EH1 3LY
Telephone: +44 (0) 131 560 1137
Establishment Registration Number:
3015134004
Contact Person:
Edwin Lindsay
Telephone +44 (0) 7917134922
Date Prepared:
6th May 2019
Note: snap40 Ltd has recently changed their name to Current Health Ltd.
5
For Current Wearable Health Monitoring System
Below summaries the Device Classification Information regarding the Current Wearable Health Monitoring System:
Primary Product Code:
| Regulation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|-----------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 870.2300 | System, Network and
Communication,
Physiological Monitors | Class 2 | MSX | Cardiovascular |
Secondary Product Codes:
| Requlation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|------------------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 880.2910 | Thermometer, Electronic,
Clinical | Class 2 | FLL | General
Hospital |
| 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular |
| 868.2375 | Monitor, Breathing
Frequency | Class 2 | BZQ | Anesthesiology |
| 870.2910 | Transmitters and
Receivers, Physiological
Signal, Radiofrequency | Class 2 | DRG | Cardiovascular |
| 868.1840 | Spirometer, Diagnostic | Class 2 | BZG | Anesthesiology |
Device Trade Name:
Current Wearable Health Monitoring System
Device Common Name:
Current Wearable Health Monitoring System
Intended/ Indications Use:
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- . Pulse rate
- Oxygen saturation ●
- Temperature ●
- Movement
6
For Current Wearable Health Monitoring System
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of:
- Respiration rate ●
- Non-invasive blood pressure .
- . Lung function & spirometry
- Weight .
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
7
For Current Wearable Health Monitoring System
Summary of Substantial Equivalence:
The following predicate devices have been that the Current Wearable Heath Monitoring System can claim equivalence with and these are detailed below
General Comparison
| Property | Proposed Device
Current Wearable
Health Monitoring
System | Primary Predicate
Current Wearable
Health Monitoring
System | Secondary Predicate
Spirobank G | Secondary Predicate
VivaLnk Fever Scout | Comment |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name | System, Network and
Communication,
Physiological
Monitors | System, Network and
Communication,
Physiological
Monitors | Spirometer, Diagnostic | Thermometer, Electronic, Clinical | N/A |
| Device
Manufactur
er | Current Health Ltd | Current Health Ltd | M.I.R Medical International
Research | VivaLnk Inc | N/A |
| Device
Classificati
on | II | II | II | II | N/A |
| 510(k)
Number | N/A | K190073 | K072979 | K181013 | N/A |
| Primary
Product
Code | MSX | MSX | BZG | FLL | N/A |
| Secondary
Product
Code | FLL DQA BZQ DRG
BZG | FLL DQA BZQ DRG
BZG | N/A | N/A | N/A |
| Target
Population | Adult | Adult | Adult | Adult & Children | The proposed device and
predicates are identical |
| Environme
nt | Professional
Healthcare Facilities
& Home | Professional
Healthcare Facilities
& Home | Professional Healthcare
Facilities & Home | Professional Healthcare
Facilities & Home | The proposed device and
predicates are identical |
| Property | Proposed Device
Current Wearable
Health Monitoring
System | Primary Predicate
Current Wearable
Health Monitoring
System | Secondary Predicate
Spirobank G | Secondary Predicate
VivaLnk Fever Scout | Comment |
| Intended
Use/
Indication
for Use | The Current Wearable
Health Monitoring
System is intended
for reusable bedside,
mobile and central
multi-parameter,
physiologic patient
monitoring of adult
patients in
professional
healthcare facilities,
such as hospitals or
skilled nursing
facilities, or their own
home. It is intended
for monitoring of
patients by trained
healthcare
professionals.
The Current Wearable
Health Monitoring
System is intended to
provide visual and
audible physiologic
multi-parameter
alarms. The Current
Wearable Health
Monitoring System is
intended for
temperature
monitoring where
monitoring
temperature at the
upper arm is
clinically indicated.
The Current Wearable
Health Monitoring
System is intended
for continuous
monitoring of the
following parameters | The Current Wearable
Health Monitoring
System is intended
for reusable bedside,
mobile and central
multi-parameter,
physiologic patient
monitoring of adult
patients in
professional
healthcare facilities,
such as hospitals or
skilled nursing
facilities, or their own
home. It is intended
for monitoring of
patients by trained
healthcare
professionals.
The Current Wearable
Health Monitoring
System is intended to
provide visual and
audible physiologic
multi-parameter
alarms. The Current
Wearable Health
Monitoring System is
intended for
temperature
monitoring where
monitoring
temperature at the
upper arm is
clinically indicated.
The Current Wearable
Health Monitoring
System is intended
for continuous
monitoring of the
following parameters | The Spirobank G spirometer is
intended to be used by a physician or
by a patient under the instruction of a
physician or paramedic. The device is
intended to test lung function and can
make spirometry testing in people of
all ages, excluding infants and
neonates. It can be used in any
setting. | The wireless Fever Scout
Continuous Monitoring
thermometer is a non-invasive
and re-usable electronic device
for home use and a non-invasive
and single patient use in the
home. This product is intended
for non-urgent ambulatory
continuous armpit body
temperature monitoring from
ages 29 days and older. | The intended use and indications for
use of the proposed device and the
primary predicate are identical in that
they both offer multi-parameter
physiologic monitoring in professional
healthcare facilities and the home.
The intended use and indications for
use of the proposed device and the
secondary predicate, the Spirobank G,
are the same in that they both
monitor lung function and spirometry.
The intended use and indications for
use of the proposed device and the
secondary predicate, the VivaLnk
Fever Scout, are the same in that they
both monitor temperature. |
| Property | Proposed Device
Current Wearable
Health Monitoring
System
in adults: | Primary Predicate
Current Wearable
Health Monitoring
System
in adults: | Secondary Predicate
Spirobank G | Secondary Predicate
VivaLnk Fever Scout | Comment |
| | Pulse rate
Oxygen saturation
Temperature
Movement | Pulse rate
Oxygen saturation
Temperature
Movement | | | |
| | The Current Wearable
Health Monitoring
System is intended
for intermittent or
spot-check
monitoring, in adults,
of: | The Current Wearable
Health Monitoring
System is intended
for intermittent or
spot-check
monitoring of
respiration rate, non-
invasive blood
pressure and weight
in adults. | | | |
| | Respiration rate
Non-invasive blood
pressure
Lung function &
spirometry
Weight | The Current Wearable
Health Monitoring
System is not
intended for use in
high-acuity
environments, such
as ICU or operating
rooms. | | | |
| | The Current Wearable
Health Monitoring
System is not
intended for use in
high-acuity
environments, such
as ICU or operating
rooms. | The Current Wearable
Health Monitoring
System is not
intended for use on
acutely ill cardiac
patients with the
potential to develop
life threatening
arrhythmias e.g. very
fast atrial fibrillation.
For these patients,
they should be
monitored using a
device with
continuous ECG. The
Current Wee | | | |
| | The Current Wearable
Health Monitoring
System is not
intended for use on
acutely ill cardiac
patients with the
potential to develop
life threatening
arrhythmias e.g. very
fast atrial fibrillation.
For these patients, | | | | |
| Property | Proposed Device
Current Wearable
Health Monitoring
System | Primary Predicate
Current Wearable
Health Monitoring
System | Secondary Predicate
Spirobank G | Secondary Predicate
VivaLnk Fever Scout | Comment |
| | monitored using a
device with
continuous ECG. The
Current Wearable
Health Monitoring
System is not a
substitute for an ECG
monitor. | Health Monitoring
System is not a
substitute for an ECG
monitor. | | | |
| | The Current Wearable
Health Monitoring
System is not
intended for SpO2
monitoring in
conditions of high
motion or low
perfusion. | The Current Wearable
Health Monitoring
System is not
intended for SpO2
monitoring in
conditions of high
motion or low
perfusion. | | | |
8
Current Health Ltd.
For Current Wearable Health Monitoring System
9
For Current Wearable Health Monitoring System
10
For Current Wearable Health Monitoring System
There are no technical differences.
11
For Current Wearable Health Monitoring System
Device Description:
The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.
The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).
While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.
In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.
Technological Characteristics:
A comparative review of the Current Wearable Health Monitoring System with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device.
Non-Clinical Tests (Performance/Physical Data):
The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing:
| Test Name | Test Description | Results |
|---|---|---|
| Electrical Safety | The Current Health System was tested to confirm | |
| that it met the applicable standards for electrical | ||
| safety (IEC 60601-1) | Passed | |
| EMC | The Current Health System was tested to confirm | |
| that it met the applicable standards for | ||
| electromagnetic compatibility (EMC) (IEC 60601-1- |
- | Passed |
| QI Charger Testing | The Current Health Wearable was tested to confirm
the device could be charged using the QI Charger | Passed |
12
: Wearable Health Monitoring System
For Current Wearable Health Monitoring System
| Test Name | Test Description | Results |
|---|---|---|
| Environment Testing | The Current Health System was tested to confirm | |
| the storage and operating temperature ranges. | Passed | |
| Alarm Testing | The Current Health System was tested to confirm | |
| that it met the applicable standards for basic safety | ||
| and essential performance for alarm systems (IEC | ||
| 60601-1-8) | ||
| Alarm Function Verification Tests for each | ||
| parameter function were performed. | Passed | |
| Pulse Rate Testing | ||
| Validation of the | ||
| accuracy of pulse rate | ||
| monitoring | The Current Health System was tested to confirm | |
| the accuracy of pulse rate monitoring of the system | ||
| in accordance with ISO 80601-2-61 and the FDA | ||
| Pulse Oximeters - Premarket Notification | ||
| Submissions: Guidance for Industry and FDA Staff. | ||
| 2007 | Passed | |
| Battery Testing | The Current Health Wearable Device Battery Life | |
| testing was performed to determine the battery life | ||
| of the Wearable Device while operating in various | ||
| modes as well as time to fully charge. | Passed | |
| PDU Buffering Time | ||
| Testing | The Current Health system was tested to evaluate | |
| the difference between the theoretical maximum | ||
| PDU buffering time and the observed maximum | ||
| PDU buffering time. | Passed | |
| Usability Testing | The Current Health System was assessed with | |
| regards to usability for compliance with IEC 62366 - | ||
| Medical devices - Application of usability | ||
| engineering to medical devices and IEC 60601-1-11 | Passed | |
| Device Ship/Transport | ||
| Testing | Ensure device, enclosed in the selected shipping | |
| container, meets ASTM D4169 specifications. | Passed | |
| Biocompatibility | ||
| Testing | Testing and analysis of the Current Health System | |
| has demonstrated compliance to ISO 10993-1: | ||
| Biological evaluation of medical devices - Guidance | Passed |
13
For Current Wearable Health Monitoring System
| Test Name | Test Description | Results |
|---|---|---|
| SpO2 Testing | ||
| Validation of the | ||
| accuracy of SpO2 | ||
| monitoring | Ensure the accuracy and communication of the | |
| SpO2 functions within the Current Health system as | ||
| per ISO80601-2-61 and the FDA SpO2 guidance; | ||
| Pulse Oximeters-Premarket Notification | ||
| Submissions Guidance for Industry and Food and | ||
| Drug Staff, March 4, 2013 | Passed | |
| Respiratory Rate | ||
| Testing | Ensure accuracy of the Current Health system | |
| measurement of respiration rate in comparison to | ||
| respiration rate measured via end-tidal CO2 in a | ||
| variety of postures | Passed | |
| Temperature | ||
| Measurement | ||
| Accuracy | The Current Health System was tested to confirm | |
| the Temperature Measurement Accuracy of the | ||
| system in compliance with ISO 80601-2-56 | Passed | |
| Wireless Radio | ||
| Communication | ||
| (Wireless Coexistence | ||
| Testing) | The Current Health System was tested to ensure | |
| device can communicate via wireless radio in its | ||
| intended environment | Passed | |
| System Verification | ||
| and Validation Testing | The system verification and validation testing was | |
| performed to verify the software and firmware of the | ||
| Current Health System. This included testing of | ||
| integration and interoperability of the peripheral | ||
| devices for blood pressure, axillary temperature, | ||
| lung function & spirometry and weight. | Passed |
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
14
For Current Wearable Health Monitoring System
Clinical Studies
No clinical studies were conducted as part of submission to prove substantial equivalence.
Safety and Effectiveness/Conclusion:
Based on the information presented in these 510(k) premarket notifications the Current Wearable Health Monitoring System is considered substantially equivalent. The Current Wearable Health Monitoring System is as safe and effective as the currently marketed predicate devices.
Based on testing and comparison with the predicate devices, the Current Wearable Health Monitoring System indicated no adverse indications or results. It is our determination that the Current Wearable Health Monitoring System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.