(70 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device, intended use, and performance studies do not mention any AI or ML capabilities.
No
The device is described as a "Wearable Health Monitoring System" intended for "monitoring" of various physiological parameters and providing "alarms". It is explicitly stated that it is "not intended for SpO2 monitoring in conditions of high motion or low perfusion" and "not a substitute for an ECG monitor." These statements clarify that its purpose is observational and alerting, not for direct treatment or intervention of a disease or condition, which is the definition of a therapeutic device.
Yes.
The device monitors several physiological parameters (pulse rate, oxygen saturation, temperature, movement, respiration rate, non-invasive blood pressure, lung function, spirometry, weight) to aid in patient monitoring, which is a diagnostic activity.
No
The device description explicitly states that the system consists of a "monitoring device (the wearable)" which is a hardware component worn on the upper arm, in addition to the software platform and user interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Current Wearable Health Monitoring System is described as a system that monitors physiological parameters directly from the patient's body (on the upper arm) using sensors. It measures things like pulse rate, oxygen saturation, temperature, movement, respiration rate, non-invasive blood pressure, lung function, spirometry, and weight.
- Lack of Sample Analysis: There is no mention of the device collecting or analyzing samples from the patient's body in a laboratory setting. The monitoring is done externally and continuously or intermittently.
Therefore, the device's function aligns with patient monitoring rather than in vitro diagnostic testing.
N/A
Intended Use / Indications 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 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.
Product codes
MSX, FLL, DQA, BZQ, DRG, BZG
Device Description
The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.
The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult patients (aged 18 years old and over)
Intended User / Care Setting
trained healthcare professionals in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All changes were verified and validated according to Current Health's internal design control process and in accordance with special controls for software systems. The testing demonstrated that the proposed modification performed according to its specification and has met the technological and performance criteria which has not changed from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
November 1, 2022
Current Health Ltd. % Shyama Ramjagsingh Regulatory Compliance Manager Current Health Ltd The Stamp Office, Level 3, 10 Waterloo Place Edinburgh, EH1 3EG United Kingdom
Re: K222550
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: October 4, 2022 Received: October 4, 2022
Dear Shyama Ramjagsingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K222550
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 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.
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
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4
Image /page/4/Picture/0 description: The image contains the logo for "current health". The logo consists of a blue abstract symbol on the left, resembling interconnected loops or a stylized infinity symbol. To the right of the symbol is the text "current health" in a sans-serif font, with each letter in lowercase and a dark gray or black color.
Special 510(k) Summary
Version: 1.0
Special 510(k) Summary
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
| Submitter Information: | |
|---|---|
| Name: | Current Health Ltd. |
| Address: | The Stamp Office |
| Level 3, 10 Waterloo Place | |
| Edinburgh | |
| EH1 3EG | |
| United Kingdom | |
| Establishment Registration Number: | 3015134004 |
| Owner/Operator Number: | 10059040 |
| Phone: | +44 (0) 131 285 8101 |
| Contact: | Shyama Ramjagsingh |
| Regulatory Compliance Manager | |
| E-mail: | shyama.ramjagsingh@currenthealth.com |
| Date of Summary: | 22-Aug-2022 |
Device Information:
Below summarises the Device Classification information regarding the Current Health System.
| Device Name | Current Health System |
|---|---|
| Common Name: | Remote Patient Monitor |
| Trade Name: | Current Wearable Health Monitoring System |
| Product Code(s): | MSX; FLL; DQA; BZQ; DRG; BZG (see below) |
Primary Product Code
| Regulation
| Number (21 CFR) | Device | Product Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 870.2300 | System, Network and | |||
| Communication, | ||||
| Physiological Monitors | Class II | MSX | Cardiovascular |
Secondary Product Codes
| Regulation
| Number (21 CFR) | Device | Device Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 880.2910 | Thermometer, | |||
| Electronic, Clinical | Class II | FLL | General Hospital |
5
Special 510(k) Summary
Version: 1.0
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
|---|---|---|---|---|
| 868.2375 | Monitor, | |||
| Breathing | ||||
| Frequency | Class II | BZQ | Anaesthesiology | |
| 870.2910 | Transmitters and | |||
| Receivers, Physiological | ||||
| Signal, Radiofrequency | Class II | DRG | Cardiovascular | |
| 686.1840 | Spirometer, Diagnostic | Class II | BZG | Anaesthesiology |
Substantial Equivalence
| Manufacturer | Trade Name | Regulation & Product Code | 510(k) Number |
|---|---|---|---|
| Current Health Ltd | Current Wearable Health Monitoring System | MSX; FLL; DQA; BZQ; DRG; BZG | K191272 |
Submission Description
This Special 510(k) covers a modification to the implementation of the alarm functionality only on the software platform of the Current Health System, as cleared in 510(k) K191272. This was presented in the Q-Submission, Q212340.
This Special 510(k) presents a modified alarm system which does not change the alarm system operates for the user - specifically, there no changes to how alarms are presented to the healthcare professionals. The modification enables it to fully utilise a broader range of patient observation data to generate appropriate alarms, notifications, and quantified notes for the clinical care team. It also enhances the reliability, auditability, and scalability of the independent alarm system.
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. In addition, there are no changes to the wearable hardware component, as cleared in 510(k) K210133. Well-established methods have been used to evaluate the change and the date to be reviewed is provided 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 adult patients (aged 18 years old and over), 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.
6
Version: 1.0
Special 510(k) Summary
Intended/ Indications for Use
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multiparameter, 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 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 in adults:
- . Pulse rate
- Oxygen saturation
- Temperature
- Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of the following parameters in adults, 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, K191272, the Current Health Wearable Monitoring System and a comparison of the key characteristics is summarised in Table 1.
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health Wearable
Monitoring System K191272
(Predicate) | Equivalence |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Device Name | Current Health Monitoring System | Current Health Monitoring System | Equivalent |
| Manufacturer | Current Health Ltd | Current Health Ltd | Equivalent |
| Device Classification | II | II | Equivalent |
| Primary Product Code | MSX | MSX | Equivalent |
| Secondary Product
Code | FLL; DQA; BZQ; DRG | FLL; DQA; BZQ; DRG | Equivalent |
| Indications for Use | The Current Wearable Health
Monitoring System is intended for
reusable bedside, mobile and central | The Current Wearable Health
Monitoring System is intended for
reusable bedside, mobile and central | Equivalent |
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health Wearable
Monitoring System K191272
(Predicate) | Equivalent |
| | 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 intended for intermittent or spot-check monitoring of the following parameters in adults, of: Respiration rate Non-invasive blood pressure Lung function & spirometry Weight in adults The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g., very 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. | 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 intended for intermittent or spot-check monitoring of the following parameters in adults, of: Respiration rate Non-invasive blood pressure Lung function & spirometry Weight in adults The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g., very 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. | |
| Characteristic | Current Health Wearable
Monitoring System with
Modification | Current Health Wearable
Monitoring System K191272
(Predicate) | Equivalence |
| SpO2 monitoring in conditions of high
motion or low perfusion. | SpO2 monitoring in conditions of high
motion or low perfusion. | | |
| Intended user/Location | Professional healthcare facilities &
home environments | Professional healthcare facilities &
home environments | Equivalent |
| Site of application | Upper arm with a strap | Upper arm with a strap | Equivalent |
| Wearable physiological
monitoring | Pulse rate; Oxygen saturation;
Temperature; Respiration Rate;
Movement | Pulse rate; Oxygen saturation;
Temperature; Respiration Rate;
Movement | Equivalent |
| Instructions of use | Instructions for use included that
includes graphical instructions, text
and relevant warnings and cautions | Instructions for use included that
includes graphical instructions, text
and relevant warnings and cautions | Equivalent |
| Sterile | No | No | Equivalent |
| Re-usable | Yes | Yes | Equivalent |
| Generation of Alarms | The alarm system inputs data from
the patient facts database (data
from the wearable, existing
integrated devices and from a
broader range of patient
observations) to generate
appropriate alarms, notifications
and quantified notes to the clinical
care team | The alarm system inputs data from
the patient facts database (data
from the wearable and existing
integrated devices) to generate
appropriate alarms and notifications
to the clinical care team. | Substantially Equivalent |
| Display of Alarms on
User Interface | Alarms are presented through visual
and audible notifications on the web
dashboard and mobile apps | Alarms are presented through visual
and audible notifications on the web
dashboard and mobile apps | Equivalent |
7
current health
Special 510(k) Submission
Special 510(k) Ref: K222550
Version: 1.0
Special 510(k) Summary
8
current health
Special 510(k) Submission
Special 510(k) Ref: K222550
Special 510(k) Summary
Version: 1.0
Table 1: Comparison of characteristics between the Modified System and the Predicate System.
Technological Characteristics
The proposed modification to the alarm system 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. The proposed modification enables the alarm system to utilise a broader range of patient observation data to generate alarms to the clinical care team. Equivalence between both systems have been shown through performance testing performed.
Summary of Non-Clinical Tests (Performance data)
The performance of the alarm system modification is identical to the previously cleared device in terms of technical specification and safety. The primary difference is the modified system allows a wider range of patient observation data to generate alarms and it enhances the reliability, and scalability of the alarm system.
All changes were verified and validated according to Current Health's internal design control process and in accordance with special controls for software systems. The testing demonstrated that the proposed modification performed according to its specification and has met the technological and performance criteria which has not changed from the predicate device.
9
Special 510(k) Summary
Version: 1.0
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 alarm system, 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 for its intended use.