(92 days)
No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies.
No
The description explicitly states its purpose for monitoring physiological parameters and providing alarms, not for treating any conditions.
No
The provided text explicitly states that the device is a "Health Monitoring System" intended for "physiologic monitoring" and "continuous monitoring of ... parameters" such as pulse rate, oxygen saturation, and temperature. It focuses on collecting and presenting vital signs data and alarms, which falls under monitoring, not diagnosing a condition. The text does not mention the identification or determination of the nature of a disease or condition.
No
The device description explicitly states that the system consists of a "monitoring device (the wearable)" which is a hardware component worn on the upper arm. While it includes software, it is not solely software.
Based on the provided text, 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.
- Device function: The description clearly states that the Current Wearable Health Monitoring System is a remote patient monitoring system that measures physiological parameters directly from the patient's body (upper arm) using a wearable device. It does not analyze samples taken from the body.
- Parameters measured: The parameters measured (pulse rate, oxygen saturation, temperature, movement, respiration rate, non-invasive blood pressure, lung function & spirometry, weight) are all physiological measurements taken in vivo (within the living body), not in vitro (in a test tube or lab setting).
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 monitoring of patients aged 14 years old and above 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:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring 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 (comma separated list FDA assigned to the subject device)
MSX, FLL, DQA, BZQ, DRG, BZG
Device Description
The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.
The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
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
14 years old and above
Intended User / Care Setting
trained healthcare professionals in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is based on an assessment of non-clinical performance data and no animal or clinical performance data is included.
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.
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2023
Current Health Ltd Giovanni Maggi Regulatory Affairs Manager The Stamp Office, Level 3, 10 Waterloo Place Edinburgh, EH1 3EG United Kingdom
Re: K231506
Trade/Device Name: Current Health 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: July 28, 2023 Received: July 28, 2023
Dear Giovanni Maggi:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231506
Device Name Current Health System
Indications for Use (Describe)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above 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:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring 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)
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
Special 510(k) Ref: K231506
Special 510(k) Summary
Version: 1.0
Special 510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirement of 21 CFR 807.92
| Submitter Information: | |
|---|---|
| Name: | Current Health Ltd. |
| Address: | The Stamp Office |
| Level 3, 10 Waterloo Place | |
| Edinburgh | |
| EH1 3EG | |
| United Kingdom | |
| Establishment Registration Number: | 3015134004 |
| Owner/Operator Number: | 10059040 |
| Phone: | +44 (0) 131 285 8101 |
| Contact: | Giovanni Maggi |
| Regulatory Affairs Manager | |
| E-mail: | giovanni.maggi@currenthealth.com |
| Date of Summary: | 27-Jul-2023 |
Device Information:
Below summarises the Device Classification information regarding the Current Health System.
| Device Proprietary Name | Current Health System |
|---|---|
| Common Name: | Remote Patient Monitor |
| Trade Name: | Current Wearable Health Monitoring System |
| Product Code(s): | MSX; FLL; DQA; BZQ; DRG; BZG (see below) |
Primary Product Code
| Regulation
| Number (21 CFR) | Device | Product Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 870.2300 | System, Network and | |||
| Communication, | ||||
| Physiological Monitors | Class II | MSX | Cardiovascular |
Secondary Product Codes
| Regulation
| Number (21 CFR) | Device | Device Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 880.2910 | Thermometer, | |||
| Electronic, Clinical | Class II | FLL | General Hospital |
5
Image /page/5/Picture/0 description: The image shows a blue abstract shape. The shape is a closed loop that resembles a combination of a figure eight and a circle. The loop is not perfectly symmetrical, and the lines are smooth and rounded.
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
Version: 1.0
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
|---|---|---|---|---|
| 868.2375 | Monitor, | |||
| Breathing | ||||
| Frequency | Class II | BZQ | Anaesthesiology | |
| 870.2910 | Transmitters and | |||
| Receivers, Physiological | ||||
| Signal, Radiofrequency | Class II | DRG | Cardiovascular | |
| 686.1840 | Spirometer, Diagnostic | Class II | BZG | Anaesthesiology |
Substantial Equivalence
| Manufacturer | Trade Name | Regulation & Product
Code | 510(k) Number |
|--------------------|----------------------------------------------|---------------------------------|---------------|
| Current Health Ltd | Current Wearable Health
Monitoring System | MSX; FLL; DQA; BZQ;
DRG; BZG | K222550 |
Referenced Device
| Manufacturer | Trade Name | Regulation & Product
Code | 510(k) Number |
|--------------|----------------------------------------------------------|-------------------------------------------------------------|---------------|
| Draeger | Infinity Acute Care System
Monitoring Solution (IACS) | MHX; BZQ; CCK; DQA,
DRT; DSK; DXN; FLL; FLS;
MLD; MSX | K113798 |
Submission Description
This Special 510(k) covers an extension of the age range to 14 years old and above patients on the software platform and G2 wearable of the Current Health System. This was also presented in the Q-Submission, Q212340.
There are no significant changes presented to the other software components previously cleared in K191272 – specifically, there is no change to the display of data from the wearable or how alarms are presented/notified to the healthcare professional. There are no changes to the wearable hardware component, as cleared in 510(k) K210133. There are no changes to the alarms system, as cleared in 510(k) K222550. Well-established methods have been used to evaluate the change and the data to be reviewed is provided in a summary in this submission.
Well-established methods have been used to evaluate the change and the date to be reviewed in a summary in this submission.
Device Description
General Description
The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.
The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is
6
urrent health
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
Version: 1.0
intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
Intended / Indications for Use
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multiparameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, such as hospitals 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 multiparameter 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:
- . Pulse rate
- Oxygen saturation
- Temperature
- Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of the following parameters of:
- . Respiration rate
- Non-invasive blood pressure
- Lung function & spirometry .
- Weight
The Current Wearable Health Monitoring System is not 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.
Comparison with the Predicate and Previously Cleared Device
The candidate device is substantially equivalent to the predicate, K222550, the Current Health Wearable Monitoring System and a comparison of the key characteristics is summarised in Table 1.
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Device Name | Current Health Monitoring
System | Current Health
Monitoring System | Infinity Acute Care
System Monitoring
Solution (IACS) | Equivalent |
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
| Manufacturer | Current Health Ltd | Current Health Ltd | Draeger | Equivalent |
| Device
Classification | II | II | II | Equivalent |
| Primary
Product Code | MSX | MSX | MHX | Equivalent |
| Secondary
Product Code | FLL; DQA; BZQ; DRG | FLL; DQA; BZQ; DRG | BZQ; CCK; DQA,
DRT; DSK; DXN;
FLL; FLS; MLD; MSX | Equivalent |
| Target
Population | 14 years and above | Adult | Adult, Paediatric
and Neonatal | Substantially
equivalent |
| Indications for
Use | The Current Wearable
Health Monitoring System is
intended for reusable
bedside, mobile and central
multi-parameter,
physiologic monitoring of
patients aged 14 years old
and above in professional
healthcare facilities, such as
hospitals or skilled nursing
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:
● Pulse rate
| 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 IACS
Monitoring Solution
is a combination of
two devices; Infinity
M540 patient
monitor with
Infinity M500
docking station
integrated with the
Infinity C500
Medical Cockpit or
optional C700
(larger screen size)
Medical Cockpit and
respective software.
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
profess sionals. The
IACS obtains the
physiologic, multi-
parameter data
from the
connection to the
M540 monitor and
optional medical
devices and | Substantially
Equivalent |
7
current health
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
8
| ) { current health |
|---|
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | Oxygen saturation Temperature Movement The Current Wearable
Health Monitoring System is
intended for intermittent or
spot-check monitoring of
the following parameters 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. | 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 intended for
intermittent or spot-
check monitoring of
the following
parameters in adults,
of: Respiration
rate Non-invasive
blood
pressure Lung
function &
spirometry 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.g., very | 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. | |
9
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
|-----------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | | 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. | | |
| Intended
user/Location | Professional healthcare
facilities & home
environments | Professional
healthcare facilities
& home
environments | Professional
healthcare
facilities | Equivalent |
| Site of
application | Wearable monitor upper
arm with a strap | Wearable monitor
upper arm with a
strap | Wearable monitor | Equivalent |
| Wearable
physiological
monitoring | Pulse rate; Oxygen
saturation; Temperature;
Respiration Rate;
Movement | Pulse rate; Oxygen
saturation;
Temperature;
Respiration Rate;
Movement | 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 | Equivalent |
10
| ) current health |
|---|
Special 510(k) Ref: K231506
Section 05 – Special 510(k) Summary
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | | | Temperature;
Cardiac output;
Arterial oxygen
saturation (SpO
2); Pulse rate;
Perfusion Index
(PI); Total
hemoglobin
(SpHb) - adult
and pediatric
only; Total
oxygen content
(SpCO) - adult
and pediatric
only;
Methemoglobin
saturation
(SpMet); Pleth
variability index
(PVI);
Mainstream
etCO2 | |
| Instructions of
use | Instructions for use
included that includes
graphical instructions, text
and relevant warnings and
cautions | Instructions for use
included that
includes graphical
instructions, text and
relevant warnings
and cautions | Instructions for use
included that
includes graphical
instructions, text
and relevant
warnings and
cautions | Equivalent |
| Sterile | No | No | No | Equivalent |
| Re-usable | Yes | Yes | Yes | Equivalent |
| Generation of
Alarms | The alarm system inputs
data from the patient facts
database (data from the
wearable, existing
integrated devices and
from a broader range of
patient observations) to
generate appropriate
alarms, notifications and
quantified notes to the
clinical care team | The alarm system
inputs data from
the patient facts
database (data
from the wearable,
existing
integrated devices
and from a
broader range of
patient
observations) to
generate
appropriate alarms,
notifications | Arrhythmia
detector and alarm
(including ST-
segment
measurement and
alarm) | Equivalent |
11
| Image: Current Health logo | current health |
|---|---|
| ---------------------------- | ---------------- |
Special 510(k) Ref: K231506
Section 05 - Special 510(k) Summary
Version: 1.0
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health
Wearable
Monitoring System
K222550
(Primary Predicate) | Draeger IACS
K113798
(Referenced
Device) | Equivalence
with Primary
Predicate |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------|
| | | and quantified notes
to the clinical
care team | | |
| Display of
Alarms on User
Interface | Alarms are presented
through visual and audible
notifications on the web
dashboard and mobile
apps | Alarms are
presented through
visual and audible
notifications on the
web dashboard and
mobile apps | Alarms are
presented through
user interface
displayable at
bedside | Equivalent |
Table 1: Comparison of characteristics between the Modified System and the Predicate Systems.
Technological Characteristics
The proposed modification to extending the age range to 14 years old and above patients on the Current Health Wearable Monitoring System has identical indications for use, operating principles, performance, and technical specification as the predicate device, the Current Health Wearable Monitoring system.
Summary of Non-Clinical Tests (Performance data)
The performance of the modification is identical to the predicate and previously cleared device in terms of technical specification and safety.
Summary of Animal & Clinical Studies
Substantial equivalence is based on an assessment of non-clinical performance data and no animal or clinical performance data is included.
Conclusion
Based on the information presented in this Special 510(k) submission, the Current Health Wearable Monitoring System with the modified intended patient population, is substantially equivalent to the predicate device (Current Health Wearable Monitoring System) in terms of safety, performance, functionality, and indications for use and is as safe and effective as the predicate device for its intended use.