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 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.

AI/ML Overview

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the Current Health System, focusing on an age range extension. While it mentions the device's intended use and compares it to a predicate device, it explicitly states that "no animal or clinical performance data is included" (Page 11) and that "The performance of the modification is identical to the predicate and previously cleared device in terms of technical specification and safety." (Page 11).

Therefore, there is no study described that proves the device meets specific acceptance criteria through performance data, sample sizes, expert involvement, or ground truth establishment. The submission relies on the existing clearance of the predicate device for its performance claims.

Summary

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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.

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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

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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 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 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.

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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 OfficeLevel 3, 10 Waterloo PlaceEdinburghEH1 3EGUnited Kingdom
Establishment Registration Number:	3015134004
Owner/Operator Number:	10059040
Phone:	+44 (0) 131 285 8101
Contact:	Giovanni MaggiRegulatory 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

RegulationNumber (21 CFR)	Device	Product Class	Product Code	Classification Panel
870.2300	System, Network andCommunication,Physiological Monitors	Class II	MSX	Cardiovascular

Secondary Product Codes

RegulationNumber (21 CFR)	Device	Device Class	Product Code	Classification Panel
880.2910	Thermometer,Electronic, Clinical	Class II	FLL	General Hospital

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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,BreathingFrequency	Class II	BZQ	Anaesthesiology
870.2910	Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	Class II	DRG	Cardiovascular
686.1840	Spirometer, Diagnostic	Class II	BZG	Anaesthesiology

Substantial Equivalence

Manufacturer	Trade Name	Regulation & ProductCode	510(k) Number
Current Health Ltd	Current Wearable HealthMonitoring System	MSX; FLL; DQA; BZQ;DRG; BZG	K222550

Referenced Device

Manufacturer	Trade Name	Regulation & ProductCode	510(k) Number
Draeger	Infinity Acute Care SystemMonitoring 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 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

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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.

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 WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
Device Name	Current Health MonitoringSystem	Current HealthMonitoring System	Infinity Acute CareSystem MonitoringSolution (IACS)	Equivalent
Characteristic	Current Health WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
Manufacturer	Current Health Ltd	Current Health Ltd	Draeger	Equivalent
DeviceClassification	II	II	II	Equivalent
PrimaryProduct Code	MSX	MSX	MHX	Equivalent
SecondaryProduct Code	FLL; DQA; BZQ; DRG	FLL; DQA; BZQ; DRG	BZQ; CCK; DQA,DRT; DSK; DXN;FLL; FLS; MLD; MSX	Equivalent
TargetPopulation	14 years and above	Adult	Adult, Paediatricand Neonatal	Substantiallyequivalent
Indications forUse	The Current WearableHealth Monitoring System isintended for reusablebedside, mobile and centralmulti-parameter,physiologic monitoring ofpatients aged 14 years oldand above in professionalhealthcare facilities, such ashospitals or skilled nursingfacilities, such as hospitalsor skilled nursing facilities,or their own home. It isintended for monitoring ofpatients by trainedhealthcare professionals.The Current WearableHealth Monitoring System isintended to provide visualand audible physiologicmulti-parameter alarms.The Current WearableHealth Monitoring System isintended for temperaturemonitoring wheremonitoring temperature atthe upper arm is clinicallyindicated.The Current WearableHealth Monitoring System isintended for continuousmonitoring of the followingparameters:● Pulse rate	The Current WearableHealth MonitoringSystem is intended forreusable bedside,mobile and centralmulti-parameter,physiologic patientmonitoring of adultpatients inprofessionalhealthcare facilities,such as hospitals orskilled nursingfacilities, or their ownhome. It is intendedfor monitoring ofpatients by trainedhealthcareprofessionals.The Current WearableHealth MonitoringSystem is intended toprovide visual andaudible physiologicmulti-parameteralarms. The CurrentWearable HealthMonitoring System isintended fortemperaturemonitoring wheremonitoringtemperature at theupper arm is clinicallyindicated.	The IACSMonitoring Solutionis a combination oftwo devices; InfinityM540 patientmonitor withInfinity M500docking stationintegrated with theInfinity C500Medical Cockpit oroptional C700(larger screen size)Medical Cockpit andrespective software.The IACS isintended for multi-parameter,physiologic patientmonitoring of adult,pediatric andneonatal patients inenvironmentswhere patient careis provided bytrained healthcareprofess sionals. TheIACS obtains thephysiologic, multi-parameter datafrom theconnection to theM540 monitor andoptional medicaldevices and	SubstantiallyEquivalent

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current health

Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

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) { current health

Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

Characteristic	Current Health WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
	Oxygen saturation Temperature Movement The Current WearableHealth Monitoring System isintended for intermittent orspot-check monitoring ofthe following parameters of: Respiration rate Non-invasive bloodpressure Lung function &spirometry Weight The Current WearableHealth Monitoring System isnot intended for use in high-acuity environments, suchas ICU or operating rooms.The Current WearableHealth Monitoring System isnot intended for use onacutely ill cardiac patientswith the potential todevelop life-threateningarrhythmias e.g., very fastatrial fibrillation. For thesepatients, they should bemonitored using a devicewith continuous ECG. TheCurrent Wearable HealthMonitoring System is not asubstitute for an ECGmonitor.The Current WearableHealth Monitoring System isnot intended for SpO2monitoring in conditions ofhigh motion or lowperfusion.	The Current WearableHealth MonitoringSystem is intended forcontinuousmonitoring of thefollowing parametersin adults:Pulse rate Oxygensaturation Temperature Movement The Current WearableHealth MonitoringSystem is intended forintermittent or spot-check monitoring ofthe followingparameters in adults,of: Respirationrate Non-invasivebloodpressure Lungfunction &spirometry Weight inadults The Current WearableHealth MonitoringSystem is notintended for use inhigh-acuityenvironments, such asICU or operatingrooms.The Current WearableHealth MonitoringSystem is notintended for use onacutely ill cardiacpatients with thepotential to developlife-threateningarrhythmias e.g., very	displays. Thetransfer of this datais accomplished bythe Infinitynetwork.The Infinity M540 isintended for themonitoring of multi-parameter,physiologicalpatient informationobtained fromconnectedhardware inenvironmentswhere patient careis provided bytrained healthcareprofessional. TheM540 is intended tomonitor one patientat a time.

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Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

Characteristic	Current Health WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
		fast atrial fibrillation.For these patients,they should bemonitored using adevice withcontinuous ECG. TheCurrent WearableHealth MonitoringSystem is not asubstitute for an ECGmonitor.The Current WearableHealth MonitoringSystem is notintended for SpO2monitoring inconditions of highmotion or lowperfusion.
Intendeduser/Location	Professional healthcarefacilities & homeenvironments	Professionalhealthcare facilities& homeenvironments	Professionalhealthcarefacilities	Equivalent
Site ofapplication	Wearable monitor upperarm with a strap	Wearable monitorupper arm with astrap	Wearable monitor	Equivalent
Wearablephysiologicalmonitoring	Pulse rate; Oxygensaturation; Temperature;Respiration Rate;Movement	Pulse rate; Oxygensaturation;Temperature;Respiration Rate;Movement	Heart rate;Arrhythmia(adult andpediatric only);12-lead analysis;ST segmentanalysisincluding TruST®(adult andpediatric only);12-lead STsegment analysis(adult andpediatric only);Apnea;Respiration rate;Invasivepressure; Non-invasive	Equivalent

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) current health

Special 510(k) Ref: K231506

Section 05 – Special 510(k) Summary

Characteristic	Current Health WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
			Temperature;Cardiac output;Arterial oxygensaturation (SpO2); Pulse rate;Perfusion Index(PI); Totalhemoglobin(SpHb) - adultand pediatriconly; Totaloxygen content(SpCO) - adultand pediatriconly;Methemoglobinsaturation(SpMet); Plethvariability index(PVI);MainstreametCO2
Instructions ofuse	Instructions for useincluded that includesgraphical instructions, textand relevant warnings andcautions	Instructions for useincluded thatincludes graphicalinstructions, text andrelevant warningsand cautions	Instructions for useincluded thatincludes graphicalinstructions, textand relevantwarnings andcautions	Equivalent
Sterile	No	No	No	Equivalent
Re-usable	Yes	Yes	Yes	Equivalent
Generation ofAlarms	The alarm system inputsdata from the patient factsdatabase (data from thewearable, existingintegrated devices andfrom a broader range ofpatient observations) togenerate appropriatealarms, notifications andquantified notes to theclinical care team	The alarm systeminputs data fromthe patient factsdatabase (datafrom the wearable,existingintegrated devicesand from abroader range ofpatientobservations) togenerateappropriate alarms,notifications	Arrhythmiadetector and alarm(including ST-segmentmeasurement andalarm)	Equivalent

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Image: Current Health logo	current health
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Special 510(k) Ref: K231506

Section 05 - Special 510(k) Summary

Version: 1.0

Characteristic	Current Health WearableMonitoring System withModification	Current HealthWearableMonitoring SystemK222550(Primary Predicate)	Draeger IACSK113798(ReferencedDevice)	Equivalencewith PrimaryPredicate
		and quantified notesto the clinicalcare team
Display ofAlarms on UserInterface	Alarms are presentedthrough visual and audiblenotifications on the webdashboard and mobileapps	Alarms arepresented throughvisual and audiblenotifications on theweb dashboard andmobile apps	Alarms arepresented throughuser interfacedisplayable atbedside	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.

Regulation Number and Section

§ 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).