(70 days)
Not Found
No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies.
No
The device is described as a "Health Monitoring System" intended for sensing and monitoring physiological parameters, not for treating or mitigating a disease.
Yes
Explanation: The device is intended for continuous and intermittent monitoring of various physiological parameters (pulse rate, oxygen saturation, temperature, movement, respiration rate, non-invasive blood pressure, and weight) in adult patients. Monitoring of physiological parameters is a key function of diagnostic devices, as it provides data that healthcare professionals can use to assess a patient's health status and identify potential medical conditions.
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 integration with specific devices for blood pressure and weight monitoring. This indicates the system includes 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Current Wearable Health Monitoring System directly measures physiological parameters on the patient's body (pulse rate, oxygen saturation, temperature, movement, respiration rate, blood pressure, weight). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states monitoring of patients and providing physiological data and alarms. It does not mention the analysis of biological samples for diagnostic purposes.
Therefore, the Current Wearable Health Monitoring System falls under the category of a patient monitoring device, 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 of respiration rate, non-invasive blood pressure and weight in adults.
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 arrhythmas 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 (comma separated list FDA assigned to the subject device)
MSX, FLL, DQA, BZQ, DRG
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 specific devices for monitoring of blood pressure 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) and weight (WEIGHT).
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.q. 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
Indicated Patient Age Range
Adult
Intended User / Care Setting
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.
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)
The Current Wearable Health Monitoring System underwent non-clinical performance/physical testing including Electrical Safety, EMC, QI Charger Testing, Environment Testing, Alarm Testing, Pulse Rate Testing, Battery Testing, PDU Buffering Time Testing, Usability Testing, Device Ship/Transport Testing, Biocompatibility Testing, SpO2 Testing, Respiratory Rate Testing, Temperature Measurement Accuracy, Wireless Radio Communication (Wireless Coexistence Testing), and System Verification and Validation Testing. All tests were reported as "Passed".
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.
No animal studies or clinical studies were conducted as part of the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2019
Current Health Ltd. Edwin Lindsay OA/RA Manager Playfair House. 12A Broughton Street Lane Edinburgh, EH1 3LY Gb
Re: K190073
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, DQA, FLL, BZQ, DRG Dated: January 11, 2019 Received: January 16, 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190073
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 of respiration rate, non-invasive blood pressure and weight in adults.
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 arrhythmas 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:
Still to be established
Contact Person:
Edwin Lindsay
Telephone +44 (0) 7917134922
Date Prepared:
11th January 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:
| Regulation
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 |
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 of respiration rate, non-invasive blood pressure and weight in adults.
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.q. 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
snap40 Wearable Vital
Signs Monitoring System | Secondary Predicate:
VitalConnect Platform | Secondary Predicate:
IACS | Comment |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name | System, Network and
Communication,
Physiological Monitors | System, Network and
Communication,
Physiological Monitors | Transmitters and
Receivers, Physiological
Signal, Radiofrequency | Monitor, Physiological,
Patient (With Arrhytmia
Detection or Alarms) | N/A |
| Device
Manufacturer | Current Health Ltd | Current Health Ltd | Philips | Draeger | N/A |
| Device
Classification | II | II | II | II | N/A |
| 510(k)
Number | N/A | K182543 | K141167 | K113798 | N/A |
| Primary
Product Code | MSX | MSX | DRG | MHX | N/A |
| Secondary
Product Code | FLL DQA BZQ DRG | FLL DQA BZQ DRG | DSI MHX | MSX, DRT, DQA, BZQ,
FLL, DSK, FLS, MLD,
DXN, CCK | N/A |
| Target
Population | Adult | Adult | Adult | Adult, Paediatric and
Neonatal | The proposed device and
predicates are identical |
| Environment | Professional Healthcare
Facilities & home | Hospital | Professional Healthcare
Facilities & Home | Hospital | The proposed device and
secondary predicate are identical |
| Property | Proposed Device
Current Wearable Health
Monitoring System | Primary Predicate
snap40 Wearable Vital
Signs Monitoring System | Secondary Predicate:
VitalConnect Platform | Secondary Predicate:
IACS | 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. | snap40 is intended for
reusable bedside,
mobile and central
multi-parameter,
physiologic patient
monitoring of adult
patients in
environments where
patient care is
provided by trained
healthcare
professionals.
snap40 is intended to
provide visual and
audible physiologic
multi-parameter
alarms.
Snap40 is intended for
temperature
monitoring where
monitoring
temperature at the
upper arm is clinically
indicated.
Snap40 is intended for
continuous
monitoring of the
following parameters
in adults:
Pulse rate
Oxygen saturation
Temperature
Movement
snap40 is intended for
intermittent or spot-
check monitoring of
respiration rate in
adults. | The VitalConnect
Platform is a wireless
remote monitoring
system intended for use
by healthcare
professionals for
continuous collection of
physiological data in
home and healthcare
settings. This includes
heart rate,
electrocardiography
(EGG), heart rate
variability (R-R interval),
respiratory rate, skin
temperature, activity
(including step count),
and posture (body
position relative to
gravity including fall).
Data is transmitted
wirelessly to a central
location where it is
stored for analysis. The
Vital Connect Platform
can be configured by
Authorized Persons to
notify healthcare
professionals when
physiological data falls
outside selected
parameters.
The device is intended
for use on general care
patients who are 18 years
of age or older as a
general patient monitor,
to provide physiological
information. The data
from the VitalConnect
Platform is intended for
use by healthcare | The IACS is intended
for multi-parameter,
physiologic patient
monitoring of adult,
pediatric and neonatal
patients in
environments where
patient care is
provided by trained
healthcare
professionals.
The IACS obtains the
physiologic, multi-
parameter data from
the connection to the
M540 monitor and
optional medical
devices and displays.
The transfer of this
data is accomplished
by the Infinity
network.
The Infinity M540 is
intended for the
monitoring of multi-
parameter,
physiological patient
information obtained
from connected
hardware in
environments where
patient care is
provided by trained
healthcare
professional. The
M540 is intended to
monitor one patient at
a time.
The M540 monitors
the following
parameters. | The intended use and indications for use of
the proposed device and the predicates are
the same except that the primary predicate
is only intended for use in the hospital.
The intended use and indications for use of
the proposed device and the secondary
predicate, the Vital Connect, are the same in
that they both offer multi-parameter
physiologic monitoring in healthcare setting
and in the home.
The intended use and indications for use
of the proposed device and the
secondary predicate, the Draeger IACS,
are the same in that they both monitor
blood pressure non-invasively. |
| Property | Proposed Device
Current Wearable Health
Monitoring System | Primary Predicate
snap40 Wearable Vital
Signs Monitoring System | Secondary Predicate:
VitalConnect Platform | Secondary Predicate:
IACS | Comment |
| | 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. | Snap40 is not
intended for use in
high-acuity
environments, such
as ICU or operating
rooms or for use in
the home | professionals as an aid
to diagnosis and
treatment. It is not
intended for use on
critical care patients. | · Heart rate
· Arrhythmia (adult
and pediatric only)
· 12-lead analysis
· ST segment
analysis including
TruST® (adult and
pediatric only)
· 12-lead ST segment
analysis (adult and
pediatric only)
· Apnea
· Respiration rate
· Invasive pressure
· Non-invasive
pressure
· Temperature
· Cardiac output
(only available when
the M540 is docked in
an IACS
configuration)
· Arterial oxygen
saturation (SpO 2)
· Pulse rate
· Perfusion Index
(P1)
· Total hemoglobin
(SpHb) - adult and
pediatric only
· Total oxygen
content (SpCO) - adult
and pediatric only
· Methemoglobin
saturation (SpMet)
· Pleth variability
index (PVI)
· Mainstream etCO2 | |
| | The Current Wearable
Health Monitoring
System is not intended
for use in high-acuity
environments, such as
ICU or operating rooms. | snap40 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.
Snap40 is not a
substitute for an ECG
monitor. | | | |
| | 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. | Snap40 is not
intended for SpO2
monitoring in
conditions of high
motion or low
perfusion | | | |
8
For Current Wearable Health Monitoring System
Page 5 of 10
9
For Current Wearable Health Monitoring System
Any technical differences have been justifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.
10
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 specific devices for monitoring of blood pressure 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) and weight (WEIGHT).
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.q. 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 |
| Environment Testing | The Current Health System was tested to confirm
the storage and operating temperature ranges. | Passed |
| Test Name | Test Description | Results |
| 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 |
| Test Name | Test Description | Results |
| 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 and weight. | Passed |
11
For Current Wearable Health Monitoring System
12
For Current Wearable Health Monitoring System
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.
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.
13
For Current Wearable Health Monitoring System
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.