Who is the manufacturer of Wearable Device, Wearable Package?

Current Health , Ltd. filed the 510(k) submission for Wearable Device, Wearable Package (K191272).

What is the FDA product code for Wearable Device, Wearable Package?

MSX. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Wearable Device, Wearable Package?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Wearable Device, Wearable Package?

Current Wearable Health Monitoring System (K190073); Spirobank G (K072979); VivaLnk Fever Scout (K181013).

Who can help prepare an FDA 510(k) submission like Wearable Device, Wearable Package?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wearable Device, Wearable Package

K191272 · Current Health , Ltd. · MSX · Jul 12, 2019 · Cardiovascular

Device Facts

Record ID	K191272
Device Name	Wearable Device, Wearable Package
Applicant	Current Health , Ltd.
Product Code	MSX · Cardiovascular
Decision Date	Jul 12, 2019
Decision	SESE
Submission Type	Traditional
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 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 The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, 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

Wearable upper-arm device monitors physiologic parameters; integrates with peripheral devices for blood pressure, spirometry, and weight. Inputs include pulse rate, SpO2, temperature, and movement data. System includes a software platform with alarming capabilities and a user interface for mobile and central station display. Used in professional healthcare facilities or home settings by trained healthcare professionals. Patients may apply the device and manage charging in home environments. Data is transmitted to remote or on-site healthcare professionals for clinical review. Output provides visual and audible alarms to alert providers to patient status changes, supporting clinical decision-making. Benefits include continuous or intermittent monitoring of vital signs outside high-acuity settings.

Clinical Evidence

No clinical studies were conducted. Evidence is based on bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm system safety (IEC 60601-1-8), pulse rate and SpO2 accuracy (ISO 80601-2-61), temperature accuracy (ISO 80601-2-56), usability (IEC 62366), and biocompatibility (ISO 10993-1).

Technological Characteristics

Wearable upper-arm monitor with optional axillary sensor. Connectivity via wireless radio. Biocompatible materials per ISO 10993-1. Standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), ISO 80601-2-61 (SpO2/Pulse), ISO 80601-2-56 (Temperature), ASTM D4169 (shipping).

Indications for Use

Indicated for adult patients in professional healthcare facilities or home settings for continuous monitoring of pulse rate, SpO2, temperature, and movement, and intermittent/spot-check monitoring of respiration rate, blood pressure, lung function/spirometry, and weight. 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 (K190073)
Spirobank G (K072979)
VivaLnk Fever Scout (K181013)

Related Devices

K190073 — Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub · Current Health , Ltd. · Mar 27, 2019
K210133 — Current Health Monitoring System Gen 2 (G2) · Current Health · Sep 3, 2021
K222550 — Current Health System · Current Health , Ltd. · Nov 1, 2022
K231506 — Current Health System · Current Health , Ltd. · Aug 24, 2023
K182543 — Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package · Snap40, Ltd. · Nov 14, 2018

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 12, 2019 Current Health Ltd. Edwin Lindsay QA/RA Manager Playfair House 12A Broughton Street Lane Edinburgh, EH1 3LY United Kingdom Re: K191272 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, FLL, DQA, BZQ, DRG, BZG Dated: May 6, 2019 Received: May 13, 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. {1}------------------------------------------------ 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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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. for Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) 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, in adults, 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) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ 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: 3015134004 ## Contact Person: Edwin Lindsay Telephone +44 (0) 7917134922 ## Date Prepared: 6th May 2019 Note: snap40 Ltd has recently changed their name to Current Health Ltd. {5}------------------------------------------------ For Current Wearable Health Monitoring System ## Below summaries the Device Classification Information regarding the Current Wearable Health Monitoring System: ## Primary Product Code: | Regulation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|-----------------------------------------------------------------|-----------------|-----------------|-------------------------| | 870.2300 | System, Network and Communication, Physiological Monitors | Class 2 | MSX | Cardiovascular | ## Secondary Product Codes: | Requlation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|------------------------------------------------------------------------|-----------------|-----------------|-------------------------| | 880.2910 | Thermometer, Electronic, Clinical | Class 2 | FLL | General Hospital | | 870.2700 | Oximeter | Class 2 | DQA | Cardiovascular | | 868.2375 | Monitor, Breathing Frequency | Class 2 | BZQ | Anesthesiology | | 870.2910 | Transmitters and Receivers, Physiological Signal, Radiofrequency | Class 2 | DRG | Cardiovascular | | 868.1840 | Spirometer, Diagnostic | Class 2 | BZG | Anesthesiology | #### Device Trade Name: Current Wearable Health Monitoring System ## Device Common Name: Current Wearable Health Monitoring System #### Intended/ Indications Use: The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - . Pulse rate - Oxygen saturation ● - Temperature ● - Movement {6}------------------------------------------------ For Current Wearable Health Monitoring System The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, 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. {7}------------------------------------------------ For Current Wearable Health Monitoring System ## Summary of Substantial Equivalence: The following predicate devices have been that the Current Wearable Heath Monitoring System can claim equivalence with and these are detailed below ## General Comparison | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate Current Wearable Health Monitoring System | Secondary Predicate Spirobank G | Secondary Predicate VivaLnk Fever Scout | Comment | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | System, Network and Communication, Physiological Monitors | System, Network and Communication, Physiological Monitors | Spirometer, Diagnostic | Thermometer, Electronic, Clinical | N/A | | Device Manufactur er | Current Health Ltd | Current Health Ltd | M.I.R Medical International Research | VivaLnk Inc | N/A | | Device Classificati on | II | II | II | II | N/A | | 510(k) Number | N/A | K190073 | K072979 | K181013 | N/A | | Primary Product Code | MSX | MSX | BZG | FLL | N/A | | Secondary Product Code | FLL DQA BZQ DRG BZG | FLL DQA BZQ DRG BZG | N/A | N/A | N/A | | Target Population | Adult | Adult | Adult | Adult & Children | The proposed device and predicates are identical | | Environme nt | Professional Healthcare Facilities & Home | Professional Healthcare Facilities & Home | Professional Healthcare Facilities & Home | Professional Healthcare Facilities & Home | The proposed device and predicates are identical | | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate Current Wearable Health Monitoring System | Secondary Predicate Spirobank G | Secondary Predicate VivaLnk Fever Scout | Comment | | Intended Use/ Indication for Use | The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. 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 | 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 | The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting. | The wireless Fever Scout Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use and a non-invasive and single patient use in the home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older. | The intended use and indications for use of the proposed device and the primary predicate are identical in that they both offer multi-parameter physiologic monitoring in professional healthcare facilities and the home. The intended use and indications for use of the proposed device and the secondary predicate, the Spirobank G, are the same in that they both monitor lung function and spirometry. The intended use and indications for use of the proposed device and the secondary predicate, the VivaLnk Fever Scout, are the same in that they both monitor temperature. | | Property | Proposed Device Current Wearable Health Monitoring System in adults: | Primary Predicate Current Wearable Health Monitoring System in adults: | Secondary Predicate Spirobank G | Secondary Predicate VivaLnk Fever Scout | Comment | | | Pulse rate Oxygen saturation Temperature Movement | Pulse rate Oxygen saturation Temperature Movement | | | | | | The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring, in adults, of: | The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of respiration rate, non- invasive blood pressure and weight in adults. | | | | | | 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 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 Wee | | | | | | 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, | | | | | | Property | Proposed Device Current Wearable Health Monitoring System | Primary Predicate Current Wearable Health Monitoring System | Secondary Predicate Spirobank G | Secondary Predicate VivaLnk Fever Scout | Comment | | | monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. | Health Monitoring System is not a substitute for an ECG monitor. | | | | | | The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. | The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. | | | | {8}------------------------------------------------ ## Current Health Ltd. For Current Wearable Health Monitoring System {9}------------------------------------------------ For Current Wearable Health Monitoring System {10}------------------------------------------------ For Current Wearable Health Monitoring System There are no technical differences. {11}------------------------------------------------ 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 devices for monitoring of blood pressure, spirometry & lung function, 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), spirometry & lung function, and weight (WEIGHT). While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature. 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.g. an office or within the hospital or could be with the patient in their own home. ## Technological Characteristics: A comparative review of the Current Wearable Health Monitoring System with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device. ## Non-Clinical Tests (Performance/Physical Data): The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing: | Test Name | Test Description | Results | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Electrical Safety | The Current Health System was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1) | Passed | | EMC | The Current Health System was tested to confirm that it met the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1- 2) | Passed | | QI Charger Testing | The Current Health Wearable was tested to confirm the device could be charged using the QI Charger…