(70 days)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults.
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmas e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with specific devices for monitoring of blood pressure and weight.
The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP) and weight (WEIGHT).
In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.q. an office or within the hospital or could be with the patient in their own home.
The provided document is a 510(k) summary for the Current Wearable Health Monitoring System. It details the device's intended use, classification, and comparison to predicate devices, along with non-clinical and software testing. However, it explicitly states:
- No animal studies were conducted.
- No clinical studies were conducted.
Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance. The document primarily focuses on non-clinical performance (bench testing) and software verification/validation to demonstrate substantial equivalence to previously cleared predicate devices.
Given this, I cannot provide acceptance criteria and reported device performance from a clinical study, nor details on sample sizes, ground truth establishment, or expert adjudication as these elements are typically part of clinical studies, which were not performed for this submission according to the document.
The document does, however, list several non-clinical tests performed and their results, which all "Passed." These implicitly serve as the acceptance criteria for those specific tests.
Here is a table summarizing the acceptance criteria (implied by the test description) and reported performance from the non-clinical tests:
1. Table of Non-Clinical Acceptance Criteria and Reported Device Performance
| Test Name | Implied Acceptance Criteria (from Test Description) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Meet applicable standards for electrical safety (IEC 60601-1). | Passed |
| EMC | Meet applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2). | Passed |
| QI Charger Testing | Device can be charged using the QI Charger. | Passed |
| Environment Testing | Operate within and withstand specified storage and operating temperature ranges. | Passed |
| Alarm Testing | Meet applicable standards for basic safety and essential performance for alarm systems (IEC 60601-1-8); Alarm Function Verification Tests for each parameter function are successful. | Passed |
| Pulse Rate Testing Validation of accuracy | Accuracy of pulse rate monitoring in accordance with ISO 80601-2-61 and FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. | Passed |
| Battery Testing | Demonstrate specified battery life in various operating modes and time to full charge. | Passed |
| PDU Buffering Time Testing | Observe a maximum PDU buffering time consistent with or better than theoretical maximum. | Passed |
| Usability Testing | Compliance with IEC 62366 - Medical devices - Application of usability engineering to medical devices and IEC 60601-1-11. | Passed |
| Device Ship/Transport Testing | Device, enclosed in selected shipping container, meets ASTM D4169 specifications. | Passed |
| Biocompatibility Testing | Compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance. | Passed |
| SpO2 Testing Validation of accuracy | Accuracy and communication of SpO2 functions within the Current Health system as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff. | Passed |
| Respiratory Rate Testing | Accuracy of measurement of respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures. | Passed |
| Temperature Measurement Accuracy | Accuracy of the temperature measurement in compliance with ISO 80601-2-56. | Passed |
| Wireless Radio Communication (Wireless Coexistence Testing) | Device can communicate via wireless radio in its intended environment. | Passed |
| System Verification and Validation Testing | Software and firmware of the Current Health System are verified; integration and interoperability of peripheral devices for blood pressure and weight are tested. | Passed |
Since no clinical studies were performed, the following information is not available from the provided document:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a monitoring device and not an AI-assisted diagnostic tool for human readers, and no comparative effectiveness studies were conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The non-clinical tests assess the device's technical performance, which can be seen as "standalone" algorithm/device performance. However, human interpretation of the displayed data is inherent to the intended use.
- The type of ground truth used: For the non-clinical tests, the "ground truth" was typically established by recognized standards, reference devices, or defined test protocols. For example, for pulse rate and SpO2, the ground truth would be from a reference oximeter or validated physiological simulator. For temperature, it would be a reference thermometer.
- The sample size for the training set: Not applicable, as no machine learning training data is mentioned.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2019
Current Health Ltd. Edwin Lindsay OA/RA Manager Playfair House. 12A Broughton Street Lane Edinburgh, EH1 3LY Gb
Re: K190073
Trade/Device Name: Current Wearable Health Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, DQA, FLL, BZQ, DRG Dated: January 11, 2019 Received: January 16, 2019
Dear Edwin Lindsay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190073
Device Name
Current Wearable Health Monitoring System
Indications for Use (Describe)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults.
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmas e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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For Current Wearable Health Monitoring System
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
Current Health Ltd
Submitter's Address:
Playfair House, 12A Broughton Street Lane Edinburgh EH1 3LY
Telephone: +44 (0) 131 560 1137
Establishment Registration Number:
Still to be established
Contact Person:
Edwin Lindsay
Telephone +44 (0) 7917134922
Date Prepared:
11th January 2019
Note: snap40 Ltd has recently changed their name to Current Health Ltd.
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For Current Wearable Health Monitoring System
Below summaries the Device Classification Information regarding the Current Wearable Health Monitoring System:
Primary Product Code:
| RegulationNumber | Device | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 870.2300 | System, Network andCommunication,Physiological Monitors | Class 2 | MSX | Cardiovascular |
Secondary Product Codes:
| RegulationNumber | Device | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 880.2910 | Thermometer, Electronic,Clinical | Class 2 | FLL | GeneralHospital |
| 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular |
| 868.2375 | Monitor, BreathingFrequency | Class 2 | BZQ | Anesthesiology |
| 870.2910 | Transmitters andReceivers, PhysiologicalSignal, Radiofrequency | Class 2 | DRG | Cardiovascular |
Device Trade Name:
Current Wearable Health Monitoring System
Device Common Name:
Current Wearable Health Monitoring System
Intended/ Indications Use:
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- Pulse rate
- . Oxygen saturation
- Temperature
- Movement ●
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For Current Wearable Health Monitoring System
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults.
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.q. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
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For Current Wearable Health Monitoring System
Summary of Substantial Equivalence:
The following predicate devices have been that the Current Wearable Heath Monitoring System can claim equivalence with and these are detailed below
General Comparison
| Property | Proposed DeviceCurrent Wearable HealthMonitoring System | Primary Predicatesnap40 Wearable VitalSigns Monitoring System | Secondary Predicate:VitalConnect Platform | Secondary Predicate:IACS | Comment |
|---|---|---|---|---|---|
| CommonName | System, Network andCommunication,Physiological Monitors | System, Network andCommunication,Physiological Monitors | Transmitters andReceivers, PhysiologicalSignal, Radiofrequency | Monitor, Physiological,Patient (With ArrhytmiaDetection or Alarms) | N/A |
| DeviceManufacturer | Current Health Ltd | Current Health Ltd | Philips | Draeger | N/A |
| DeviceClassification | II | II | II | II | N/A |
| 510(k)Number | N/A | K182543 | K141167 | K113798 | N/A |
| PrimaryProduct Code | MSX | MSX | DRG | MHX | N/A |
| SecondaryProduct Code | FLL DQA BZQ DRG | FLL DQA BZQ DRG | DSI MHX | MSX, DRT, DQA, BZQ,FLL, DSK, FLS, MLD,DXN, CCK | N/A |
| TargetPopulation | Adult | Adult | Adult | Adult, Paediatric andNeonatal | The proposed device andpredicates are identical |
| Environment | Professional HealthcareFacilities & home | Hospital | Professional HealthcareFacilities & Home | Hospital | The proposed device andsecondary predicate are identical |
| Property | Proposed DeviceCurrent Wearable HealthMonitoring System | Primary Predicatesnap40 Wearable VitalSigns Monitoring System | Secondary Predicate:VitalConnect Platform | Secondary Predicate:IACS | Comment |
| Intended Use/Indication forUse | The Current WearableHealth MonitoringSystem is intended forreusable bedside, mobileand central multi-parameter, physiologicpatient monitoring ofadult patients inprofessional healthcarefacilities, such ashospitals or skillednursing facilities, or theirown home. It is intendedfor monitoring of patientsby trained healthcareprofessionals. | snap40 is intended forreusable bedside,mobile and centralmulti-parameter,physiologic patientmonitoring of adultpatients inenvironments wherepatient care isprovided by trainedhealthcareprofessionals.snap40 is intended toprovide visual andaudible physiologicmulti-parameteralarms.Snap40 is intended fortemperaturemonitoring wheremonitoringtemperature at theupper arm is clinicallyindicated.Snap40 is intended forcontinuousmonitoring of thefollowing parametersin adults:Pulse rateOxygen saturationTemperatureMovementsnap40 is intended forintermittent or spot-check monitoring ofrespiration rate inadults. | The VitalConnectPlatform is a wirelessremote monitoringsystem intended for useby healthcareprofessionals forcontinuous collection ofphysiological data inhome and healthcaresettings. This includesheart rate,electrocardiography(EGG), heart ratevariability (R-R interval),respiratory rate, skintemperature, activity(including step count),and posture (bodyposition relative togravity including fall).Data is transmittedwirelessly to a centrallocation where it isstored for analysis. TheVital Connect Platformcan be configured byAuthorized Persons tonotify healthcareprofessionals whenphysiological data fallsoutside selectedparameters.The device is intendedfor use on general carepatients who are 18 yearsof age or older as ageneral patient monitor,to provide physiologicalinformation. The datafrom the VitalConnectPlatform is intended foruse by healthcare | The IACS is intendedfor multi-parameter,physiologic patientmonitoring of adult,pediatric and neonatalpatients inenvironments wherepatient care isprovided by trainedhealthcareprofessionals.The IACS obtains thephysiologic, multi-parameter data fromthe connection to theM540 monitor andoptional medicaldevices and displays.The transfer of thisdata is accomplishedby the Infinitynetwork.The Infinity M540 isintended for themonitoring of multi-parameter,physiological patientinformation obtainedfrom connectedhardware inenvironments wherepatient care isprovided by trainedhealthcareprofessional. TheM540 is intended tomonitor one patient ata time.The M540 monitorsthe followingparameters. | The intended use and indications for use ofthe proposed device and the predicates arethe same except that the primary predicateis only intended for use in the hospital.The intended use and indications for use ofthe proposed device and the secondarypredicate, the Vital Connect, are the same inthat they both offer multi-parameterphysiologic monitoring in healthcare settingand in the home.The intended use and indications for useof the proposed device and thesecondary predicate, the Draeger IACS,are the same in that they both monitorblood pressure non-invasively. |
| Property | Proposed DeviceCurrent Wearable HealthMonitoring System | Primary Predicatesnap40 Wearable VitalSigns Monitoring System | Secondary Predicate:VitalConnect Platform | Secondary Predicate:IACS | Comment |
| The Current WearableHealth MonitoringSystem is intended forintermittent or spot-check monitoring ofrespiration rate, non-invasive blood pressureand weight in adults. | Snap40 is notintended for use inhigh-acuityenvironments, suchas ICU or operatingrooms or for use inthe home | professionals as an aidto diagnosis andtreatment. It is notintended for use oncritical care patients. | · Heart rate· Arrhythmia (adultand pediatric only)· 12-lead analysis· ST segmentanalysis includingTruST® (adult andpediatric only)· 12-lead ST segmentanalysis (adult andpediatric only)· Apnea· Respiration rate· Invasive pressure· Non-invasivepressure· Temperature· Cardiac output(only available whenthe M540 is docked inan IACSconfiguration)· Arterial oxygensaturation (SpO 2)· Pulse rate· Perfusion Index(P1)· Total hemoglobin(SpHb) - adult andpediatric only· Total oxygencontent (SpCO) - adultand pediatric only· Methemoglobinsaturation (SpMet)· Pleth variabilityindex (PVI)· Mainstream etCO2 | ||
| The Current WearableHealth MonitoringSystem is not intendedfor use in high-acuityenvironments, such asICU or operating rooms. | snap40 is notintended for use onacutely ill cardiacpatients with thepotential to developlife threateningarrhythmias e.g. veryfast atrial fibrillation.For these patients,they should bemonitored using adevice withcontinuous ECG.Snap40 is not asubstitute for an ECGmonitor. | ||||
| The Current WearableHealth MonitoringSystem is not intendedfor use on acutely illcardiac patients with thepotential to develop lifethreatening arrhythmiase.g. very fast atrialfibrillation. For thesepatients, they should bemonitored using a devicewith continuous ECG.The Current WearableHealth MonitoringSystem is not asubstitute for an ECGmonitor. | Snap40 is notintended for SpO2monitoring inconditions of highmotion or lowperfusion |
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For Current Wearable Health Monitoring System
Page 5 of 10
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For Current Wearable Health Monitoring System
Any technical differences have been justifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.
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For Current Wearable Health Monitoring System
Device Description:
The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with specific devices for monitoring of blood pressure and weight.
The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP) and weight (WEIGHT).
In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.q. an office or within the hospital or could be with the patient in their own home.
Technological Characteristics:
A comparative review of the Current Wearable Health Monitoring System with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device.
Non-Clinical Tests (Performance/Physical Data):
The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing:
| Test Name | Test Description | Results |
|---|---|---|
| Electrical Safety | The Current Health System was tested to confirmthat it met the applicable standards for electricalsafety (IEC 60601-1) | Passed |
| EMC | The Current Health System was tested to confirmthat it met the applicable standards forelectromagnetic compatibility (EMC) (IEC 60601-1-2) | Passed |
| QI Charger Testing | The Current Health Wearable was tested to confirmthe device could be charged using the QI Charger | Passed |
| Environment Testing | The Current Health System was tested to confirmthe storage and operating temperature ranges. | Passed |
| Test Name | Test Description | Results |
| Alarm Testing | The Current Health System was tested to confirmthat it met the applicable standards for basic safetyand essential performance for alarm systems (IEC60601-1-8)Alarm Function Verification Tests for eachparameter function were performed. | Passed |
| Pulse Rate TestingValidation of theaccuracy of pulse ratemonitoring | The Current Health System was tested to confirmthe accuracy of pulse rate monitoring of the systemin accordance with ISO 80601-2-61 and the FDAPulse Oximeters - Premarket NotificationSubmissions: Guidance for Industry and FDA Staff.2007 | Passed |
| Battery Testing | The Current Health Wearable Device Battery Lifetesting was performed to determine the battery lifeof the Wearable Device while operating in variousmodes as well as time to fully charge. | Passed |
| PDU Buffering TimeTesting | The Current Health system was tested to evaluatethe difference between the theoretical maximumPDU buffering time and the observed maximumPDU buffering time. | Passed |
| Usability Testing | The Current Health System was assessed withregards to usability for compliance with IEC 62366 -Medical devices - Application of usabilityengineering to medical devices and IEC 60601-1-11 | Passed |
| Device Ship/TransportTesting | Ensure device, enclosed in the selected shippingcontainer, meets ASTM D4169 specifications. | Passed |
| BiocompatibilityTesting | Testing and analysis of the Current Health Systemhas demonstrated compliance to ISO 10993-1:Biological evaluation of medical devices – Guidance | Passed |
| SpO2 TestingValidation of theaccuracy of SpO2monitoring | Ensure the accuracy and communication of theSpO2 functions within the Current Health system asper ISO80601-2-61 and the FDA SpO2 guidance;Pulse Oximeters-Premarket NotificationSubmissions Guidance for Industry and Food andDrug Staff, March 4, 2013 | Passed |
| Test Name | Test Description | Results |
| Respiratory RateTesting | Ensure accuracy of the Current Health systemmeasurement of respiration rate in comparison torespiration rate measured via end-tidal CO2 in avariety of postures | Passed |
| TemperatureMeasurementAccuracy | The Current Health System was tested to confirmthe Temperature Measurement Accuracy of thesystem in compliance with ISO 80601-2-56 | Passed |
| Wireless RadioCommunication(Wireless CoexistenceTesting) | The Current Health System was tested to ensuredevice can communicate via wireless radio in itsintended environment | Passed |
| System Verificationand Validation Testing | The system verification and validation testing wasperformed to verify the software and firmware of theCurrent Health System. This included testing ofintegration and interoperability of the peripheraldevices for blood pressure and weight. | Passed |
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For Current Wearable Health Monitoring System
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For Current Wearable Health Monitoring System
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
Clinical Studies
No clinical studies were conducted as part of submission to prove substantial equivalence.
Safety and Effectiveness/Conclusion:
Based on the information presented in these 510(k) premarket notifications the Current Wearable Health Monitoring System is considered substantially equivalent. The Current Wearable Health Monitoring System is as safe and effective as the currently marketed predicate devices.
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For Current Wearable Health Monitoring System
Based on testing and comparison with the predicate devices, the Current Wearable Health Monitoring System indicated no adverse indications or results. It is our determination that the Current Wearable Health Monitoring System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.
§ 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).