Current Health System

K231506 · Current Health , Ltd. · MSX · Aug 24, 2023 · Cardiovascular

Device Facts

• Record ID: K231506
• Device Name: Current Health System
• Applicant: Current Health , Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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.

Device Story

Remote patient monitoring system; wearable device worn on upper arm; software platform with web/mobile interface. Inputs: physiologic vital sign data (pulse rate, SpO2, temperature, movement, respiration rate, NIBP, lung function, weight). Operation: wearable continuously monitors/transmits encrypted data to secure server; software platform processes data to generate visual/audible multi-parameter alarms and notifications for clinical care teams. Used in hospitals, skilled nursing facilities, or home by trained healthcare professionals. Output: vital signs data and alarms presented on mobile/web dashboard. Benefits: enables remote physiologic monitoring of patients aged 14+; facilitates timely clinical intervention via alarm notifications.

Clinical Evidence

Bench testing only; no clinical or animal data included.

Technological Characteristics

Wearable monitor worn on upper arm with strap. Reusable. Non-sterile. Connectivity: secure server transmission to mobile/web interface. Software-based alarm system. Identical to predicate K222550.

Indications for Use

Indicated for patients aged 14 years and older in professional healthcare facilities or home settings. Not for high-acuity environments (ICU/OR) or acutely ill cardiac patients prone to life-threatening arrhythmias. Not for SpO2 monitoring during high motion or low perfusion.

Regulatory Classification

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.

Predicate Devices

• Current Wearable Health Monitoring System (K222550)

Reference Devices

• Infinity Acute Care System (IACS) Monitoring Solution (K113798)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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<br>Level 3, 10 Waterloo Place<br>Edinburgh<br>EH1 3EG<br>United Kingdom |
| Establishment Registration Number: | 3015134004 |
| Owner/Operator Number: | 10059040 |
| Phone: | [phone] |
| Contact: | Giovanni Maggi<br>Regulatory Affairs Manager |
| E-mail: | [e-mail] |
| 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<br>Number (21 CFR) | Device | Product Class | Product Code | Classification Panel |
|-------------------------------|-----------------------------------------------------------------|---------------|--------------|----------------------|
| 870.2300 | System, Network and<br>Communication,<br>Physiological Monitors | Class II | MSX | Cardiovascular |

Secondary Product Codes

| Regulation<br>Number (21 CFR) | Device | Device Class | Product Code | Classification Panel |
|-------------------------------|--------------------------------------|--------------|--------------|----------------------|
| 880.2910 | Thermometer,<br>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,<br>Breathing<br>Frequency | Class II | BZQ | Anaesthesiology |
| 870.2910 | Transmitters and<br>Receivers, Physiological<br>Signal, Radiofrequency | Class II | DRG | Cardiovascular |
| 686.1840 | Spirometer, Diagnostic | Class II | BZG | Anaesthesiology |

Substantial Equivalence

| Manufacturer | Trade Name | Regulation & Product<br>Code | 510(k) Number |
|--------------------|----------------------------------------------|---------------------------------|---------------|
| Current Health Ltd | Current Wearable Health<br>Monitoring System | MSX; FLL; DQA; BZQ;<br>DRG; BZG | K222550 |

Referenced Device

| Manufacturer | Trade Name | Regulation & Product<br>Code | 510(k) Number |
|--------------|----------------------------------------------------------|-------------------------------------------------------------|---------------|
| Draeger | Infinity Acute Care System<br>Monitoring Solution (IACS) | MHX; BZQ; CCK; DQA,<br>DRT; DSK; DXN; FLL; FLS;<br>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<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Device Name | Current Health Monitoring<br>System | Current Health<br>Monitoring System | Infinity Acute Care<br>System Monitoring<br>Solution (IACS) | Equivalent |
| Characteristic | Current Health Wearable<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
| Manufacturer | Current Health Ltd | Current Health Ltd | Draeger | Equivalent |
| Device<br>Classification | II | II | II | Equivalent |
| Primary<br>Product Code | MSX | MSX | MHX | Equivalent |
| Secondary<br>Product Code | FLL; DQA; BZQ; DRG | FLL; DQA; BZQ; DRG | BZQ; CCK; DQA,<br>DRT; DSK; DXN;<br>FLL; FLS; MLD; MSX | Equivalent |
| Target<br>Population | 14 years and above | Adult | Adult, Paediatric<br>and Neonatal | Substantially<br>equivalent |
| Indications for<br>Use | The Current Wearable<br>Health Monitoring System is<br>intended for reusable<br>bedside, mobile and central<br>multi-parameter,<br>physiologic monitoring of<br>patients aged 14 years old<br>and above in professional<br>healthcare facilities, such as<br>hospitals or skilled nursing<br>facilities, such as hospitals<br>or skilled nursing facilities,<br>or their own home. It is<br>intended for monitoring of<br>patients by trained<br>healthcare professionals.<br>The Current Wearable<br>Health Monitoring System is<br>intended to provide visual<br>and audible physiologic<br>multi-parameter alarms.<br>The Current Wearable<br>Health Monitoring System is<br>intended for temperature<br>monitoring where<br>monitoring temperature at<br>the upper arm is clinically<br>indicated.<br>The Current Wearable<br>Health Monitoring System is<br>intended for continuous<br>monitoring of the following<br>parameters:<br>● Pulse rate<br> | The Current Wearable<br>Health Monitoring<br>System is intended for<br>reusable bedside,<br>mobile and central<br>multi-parameter,<br>physiologic patient<br>monitoring of adult<br>patients in<br>professional<br>healthcare facilities,<br>such as hospitals or<br>skilled nursing<br>facilities, or their own<br>home. It is intended<br>for monitoring of<br>patients by trained<br>healthcare<br>professionals.<br>The Current Wearable<br>Health Monitoring<br>System is intended to<br>provide visual and<br>audible physiologic<br>multi-parameter<br>alarms. The Current<br>Wearable Health<br>Monitoring System is<br>intended for<br>temperature<br>monitoring where<br>monitoring<br>temperature at the<br>upper arm is clinically<br>indicated. | The IACS<br>Monitoring Solution<br>is a combination of<br>two devices; Infinity<br>M540 patient<br>monitor with<br>Infinity M500<br>docking station<br>integrated with the<br>Infinity C500<br>Medical Cockpit or<br>optional C700<br>(larger screen size)<br>Medical Cockpit and<br>respective software.<br>The IACS is<br>intended for multi-<br>parameter,<br>physiologic patient<br>monitoring of adult,<br>pediatric and<br>neonatal patients in<br>environments<br>where patient care<br>is provided by<br>trained healthcare<br>profess sionals. The<br>IACS obtains the<br>physiologic, multi-<br>parameter data<br>from the<br>connection to the<br>M540 monitor and<br>optional medical<br>devices and | Substantially<br>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<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | Oxygen saturation Temperature Movement The Current Wearable<br>Health Monitoring System is<br>intended for intermittent or<br>spot-check monitoring of<br>the following parameters of: Respiration rate Non-invasive blood<br>pressure Lung function &<br>spirometry Weight The Current Wearable<br>Health Monitoring System is<br>not intended for use in high-<br>acuity environments, such<br>as ICU or operating rooms.<br>The Current Wearable<br>Health Monitoring System is<br>not intended for use on<br>acutely ill cardiac patients<br>with the potential to<br>develop life-threatening<br>arrhythmias e.g., very fast<br>atrial fibrillation. For these<br>patients, they should be<br>monitored using a device<br>with continuous ECG. The<br>Current Wearable Health<br>Monitoring System is not a<br>substitute for an ECG<br>monitor.<br>The Current Wearable<br>Health Monitoring System is<br>not intended for SpO2<br>monitoring in conditions of<br>high motion or low<br>perfusion. | The Current Wearable<br>Health Monitoring<br>System is intended for<br>continuous<br>monitoring of the<br>following parameters<br>in adults:<br>Pulse rate Oxygen<br>saturation Temperature Movement The Current Wearable<br>Health Monitoring<br>System is intended for<br>intermittent or spot-<br>check monitoring of<br>the following<br>parameters in adults,<br>of: Respiration<br>rate Non-invasive<br>blood<br>pressure Lung<br>function &<br>spirometry Weight in<br>adults The Current Wearable<br>Health Monitoring<br>System is not<br>intended for use in<br>high-acuity<br>environments, such as<br>ICU or operating<br>rooms.<br>The Current Wearable<br>Health Monitoring<br>System is not<br>intended for use on<br>acutely ill cardiac<br>patients with the<br>potential to develop<br>life-threatening<br>arrhythmias e.g., very | displays. The<br>transfer of this data<br>is accomplished by<br>the Infinity<br>network.<br>The Infinity M540 is<br>intended for the<br>monitoring of multi-<br>parameter,<br>physiological<br>patient information<br>obtained from<br>connected<br>hardware in<br>environments<br>where patient care<br>is provided by<br>trained healthcare<br>professional. The<br>M540 is intended to<br>monitor one patient<br>at a time. | |

{9}------------------------------------------------

Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

| Characteristic | Current Health Wearable<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
|-----------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | | fast atrial fibrillation.<br>For these patients,<br>they should be<br>monitored using a<br>device with<br>continuous ECG. The<br>Current Wearable<br>Health Monitoring<br>System is not a<br>substitute for an ECG<br>monitor.<br>The Current Wearable<br>Health Monitoring<br>System is not<br>intended for SpO2<br>monitoring in<br>conditions of high<br>motion or low<br>perfusion. | | |
| Intended<br>user/Location | Professional healthcare<br>facilities & home<br>environments | Professional<br>healthcare facilities<br>& home<br>environments | Professional<br>healthcare<br>facilities | Equivalent |
| Site of<br>application | Wearable monitor upper<br>arm with a strap | Wearable monitor<br>upper arm with a<br>strap | Wearable monitor | Equivalent |
| Wearable<br>physiological<br>monitoring | Pulse rate; Oxygen<br>saturation; Temperature;<br>Respiration Rate;<br>Movement | Pulse rate; Oxygen<br>saturation;<br>Temperature;<br>Respiration Rate;<br>Movement | Heart rate;<br>Arrhythmia<br>(adult and<br>pediatric only);<br>12-lead analysis;<br>ST segment<br>analysis<br>including TruST®<br>(adult and<br>pediatric only);<br>12-lead ST<br>segment analysis<br>(adult and<br>pediatric only);<br>Apnea;<br>Respiration rate;<br>Invasive<br>pressure; Non-<br>invasive | Equivalent |

{10}------------------------------------------------

| ) current health |
|------------------|
| |

Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

| Characteristic | Current Health Wearable<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | | | Temperature;<br>Cardiac output;<br>Arterial oxygen<br>saturation (SpO<br>2); Pulse rate;<br>Perfusion Index<br>(PI); Total<br>hemoglobin<br>(SpHb) - adult<br>and pediatric<br>only; Total<br>oxygen content<br>(SpCO) - adult<br>and pediatric<br>only;<br>Methemoglobin<br>saturation<br>(SpMet); Pleth<br>variability index<br>(PVI);<br>Mainstream<br>etCO2 | |
| Instructions of<br>use | Instructions for use<br>included that includes<br>graphical instructions, text<br>and relevant warnings and<br>cautions | Instructions for use<br>included that<br>includes graphical<br>instructions, text and<br>relevant warnings<br>and cautions | Instructions for use<br>included that<br>includes graphical<br>instructions, text<br>and relevant<br>warnings and<br>cautions | Equivalent |
| Sterile | No | No | No | Equivalent |
| Re-usable | Yes | Yes | Yes | Equivalent |
| Generation of<br>Alarms | The alarm system inputs<br>data from the patient facts<br>database (data from the<br>wearable, existing<br>integrated devices and<br>from a broader range of<br>patient observations) to<br>generate appropriate<br>alarms, notifications and<br>quantified notes to the<br>clinical care team | The alarm system<br>inputs data from<br>the patient facts<br>database (data<br>from the wearable,<br>existing<br>integrated devices<br>and from a<br>broader range of<br>patient<br>observations) to<br>generate<br>appropriate alarms,<br>notifications | Arrhythmia<br>detector and alarm<br>(including ST-<br>segment<br>measurement and<br>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<br>Monitoring System with<br>Modification | Current Health<br>Wearable<br>Monitoring System<br>K222550<br>(Primary Predicate) | Draeger IACS<br>K113798<br>(Referenced<br>Device) | Equivalence<br>with Primary<br>Predicate |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------|
| | | and quantified notes<br>to the clinical<br>care team | | |
| Display of<br>Alarms on User<br>Interface | Alarms are presented<br>through visual and audible<br>notifications on the web<br>dashboard and mobile<br>apps | Alarms are<br>presented through<br>visual and audible<br>notifications on the<br>web dashboard and<br>mobile apps | Alarms are<br>presented through<br>user interface<br>displayable at<br>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.