(227 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring and data transmission.
No.
The device is a monitoring system intended to collect and present physiological data, not to treat or cure any condition.
No
Explanation: The document states that the device is intended for "physiologic patient monitoring" and for "continuous monitoring of the following parameters...". While monitoring provides data that can be used for diagnosis, the device itself is described as a monitoring system, not one that provides a diagnosis. It collects data on vital signs but does not interpret that data to identify a disease or condition. The "intended use" section specifically states it's for "multi-parameter, physiologic patient monitoring" and for providing "visual and audible physiologic multi-parameter alarms," which are functions of monitoring rather than diagnosing.
No
The device description explicitly states the system consists of a "single monitoring device (the wearable)" in addition to the software platform and user interface. The performance studies also include testing related to the hardware components like electrical safety, EMC, and biocompatibility of the wearable.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Function: The Current Wearable Health Monitoring System is a wearable device that directly monitors physiological parameters from the patient's body (pulse rate, oxygen saturation, temperature, movement, respiration rate, blood pressure, lung function, weight). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes monitoring of patients in vivo (within the body) for various physiological signs.
Therefore, the device falls under the category of a patient monitoring system, not an In Vitro Diagnostic.
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 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 Health Monitoring System is a remote patient monitoring system that consists of a single monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), 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, spirometry, lung function, and weight.
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.
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 and lung function, 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. 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.
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
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.
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. 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.
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
Substantial equivalence is based on an assessment of non-clinical performance data and no animal or clinical performance data is included.
Non-Clinical Tests (Performance data):
Electrical Safety: The Current Health Gen 2 was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1)
Electromagnetic compatibility: The current Health Gen 2 was tested to confirm it meets the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2)
Pulse Rate Testing: Validation of the accuracy of pulse rate monitoring – the Current Health Gen 2 was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters – Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007
SpO2 Testing: Validation of the accuracy of SpO2 monitoring – Ensure the accuracy and communication of the SpO2 functions of the Current Health Gen 2 wearable as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013
Respiratory Rate Testing: Ensure accuracy of the Current Health Gen 2 measurement of respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures
Temperature Measurement Accuracy: The Current Health Gen 2 was tested to confirm the Temperature Measurement Accuracy of the system in compliance with ISO 80601-2-56
Device Ship/Transport Testing: Ensure device, enclosed in the selected shipping container, meets ASTM D7386 specifications.
Biocompatibility Testing: Testing and analysis of the Current Health Gen 2 has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance
System Verification and Validation Testing: The system verification testing was performed to verify the software and firmware of the Current Health Gen 2. This included testing of integration and interoperability of the peripheral devices for blood pressure and weight.
Software Verification and Validation Testing: Software verification 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 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.
Key Metrics
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). 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.
September 3, 2021
Current Health Phil Bromley VP/OA/RA Playfair House, 6 Broughton Street Lane Edinburgh, EH 1 3LY United Kingdom
Re: K210133
Trade/Device Name: Current Health Monitoring System Gen 2 (G2) 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 18, 2021 Received: June 4, 2021
Dear Phil Bromley:
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
1
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 (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 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,
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)
Device Name
Current Health Monitoring System Gen 2
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
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4
Version: 2
510(k) Summary
K210133 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
| Submitters Information: | |
|---|---|
| Name: | Current Health Ltd. |
| Address: | Playfair House |
| 6A Boughton Street Lane | |
| Edinburgh | |
| EH1 3LY | |
| United Kingdom | |
| Establishment Registration Number: | 3015134004 |
| Owner/Operator Number: | 10059040 |
| Phone: | +44 (0) 131 285 8101 |
| Contact: | Phil Bromley |
| VP of QA/RA | |
| E-mail: | phil.bromley@currenthealth.com |
| Date of Summary: | 26-Apr-21 |
Device Information:
Below summarises the Device Classification information regarding the Current Wearable Health Monitoring System, Gen 2, Device.
| Device Proprietary Name | Second Generation (G2) Wearable |
|---|---|
| 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 |
|---|---|---|---|---|
| ------------------------------- | -------- | -------------- | -------------- | ---------------------- |
5
Version: 2
510(k) Summary
| 880.2910 | Thermometer,
Electronic, Clinical | Class II | FLL | General Hospital |
|----------|------------------------------------------------------------------------|----------|-----|------------------|
| 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 |
Device Description
This 510(k) for the introduction of the Second Generation (Gen 2) wearable is component of the Current Wearable Health Monitoring System. There is no substantial change to the healthcare professional monitoring applications (mobile apps and web-dashboard) and data infrastructure (secure server) with this 510(k) submission.
General Description
The Current Wearable Health Monitoring System is a remote patient monitoring system that consists of a single monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), 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, spirometry, lung function, and weight.
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.
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 and lung function, 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. 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.
Intended/ Indications for Use
The Current Wearable Health Monitoring System is intended for reusable mobile and central multiparameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as
6
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 in adults
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.
Substantial Equivalence
The candidate device is substantially equivalent to the predicate, K191272, the Current Health Wearable Monitoring System (Gen 1) and a comparison of the key characteristics is summarised in Table 1.
| Characteristic | Current Health Gen 2 Wearable
(Candidate) | Current Health Wearable
Monitoring System K191272
(Predicate( | Equivalence |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name | Current Health Gen 2 | Current Health Monitoring System | n/a |
| Manufacturer | Current Health Ltd | Current Health Ltd | n/a |
| 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
multi-parameter, physiologic patient
monitoring of adult patients in
professional healthcare facilities, such
as hospitals or skilled nursing facilities, | 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, | Equivalent |
| Characteristic | Current Health Gen 2 Wearable
(Candidate) | Current Health Wearable
Monitoring System K191272
(Predicate) | Equivalence |
| | or their own home. It is intended for
monitoring of patients by trained
healthcare professionals. | 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 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: | The Current Wearable Health
Monitoring System is intended for
continuous monitoring of the following
parameters in adults: | |
| | • 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
of the following parameters in adults,
of: | 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 | • 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 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
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. | The Current Wearable Health
Monitoring System is not intended for
SpO2 monitoring in conditions of high
motion or low perfusion. | |
| Characteristic | Current Health Gen 2 Wearable
(Candidate) | Current Health Wearable
Monitoring System K191272
(Predicate( | Equivalence |
| 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 |
| Materials | Plastic case and ISO 10993-1:2018
compliant | Plastic case and ISO 10993-1:2018
compliant | Equivalent |
| Standards Applied | IEC 60601-1; IEC 60601-1-2; IEC
62304; IEC 80601-2-61; IEC 80601-
2-56 | IEC 60601-1; IEC 60601-1-2; IEC
62304; IEC 80601-2-61; IEC 80601-
2-56 | Equivalent |
7
current health
510(k) Submissions - Gen 2
Version: 2
510(k) Summary
8
rrent health
510(k) Submissions - Gen 2
Version: 2
510(k) Summary
Table 1: Comparison of characteristics between Gen 2 and Gen 1 Wearable Devices
Technological Characteristics
The Gen 2 wearable device has identical indications for use, operating principles, performance, and technical specification as the predicate device, the Current Health Wearable Monitoring system (Gen 1) wearable.
The PPG sensor in the Gen 2 wearable device is identical to the sensor used in the Gen 1 wearable for equivalent sensing of oxygen saturation and pulse rate and it is used in the same way. The Gen 2 wearable has different analogue front-end electronics and sampling rate to the Gen 1 wearable however this has been demonstrated to be equivalent through the performance testing presented in this 510(k). Temperature sensing in Gen 2 uses a different thermocouple which has been demonstrated to have equivalent performance to the Gen 1 temperature sensor in terms of accuracy and tolerance. Reparatory rate for Gen 2 is measured using the same technical method with different motion sensors and these have been demonstrated to have equivalent performance during performance testing.
Summary of Non-Clinical Tests (Performance data)
The performance of the Gen 2 wearable is identical to the predicate device in terms of technical specification and safety. The primary differences are that the Gen 2 is smaller than the Gen 1 with the ability to charge the device on-arm while in use.
Verification and validation activities established the safety and performance of the Gen 2 based on the following tests, which were all passed:
Electrical Safety: The Current Health Gen 2 was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1)
Electromagnetic compatibility: The current Health Gen 2 was tested to confirm it meets the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2)
9
Version: 2
510(k) Summary
Pulse Rate Testing: Validation of the accuracy of pulse rate monitoring – the Current Health Gen 2 was tested to confirm the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters – Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007
SpO2 Testing: Validation of the accuracy of SpO2 monitoring – Ensure the accuracy and communication of the SpO2 functions of the Current Health Gen 2 wearable as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013
Respiratory Rate Testing: Ensure accuracy of the Current Health Gen 2 measurement of respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures
Temperature Measurement Accuracy: The Current Health Gen 2 was tested to confirm the Temperature Measurement Accuracy of the system in compliance with ISO 80601-2-56
Device Ship/Transport Testing: Ensure device, enclosed in the selected shipping container, meets ASTM D7386 specifications.
Biocompatibility Testing: Testing and analysis of the Current Health Gen 2 has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance
System Verification and Validation Testing: The system verification testing was performed to verify the software and firmware of the Current Health Gen 2. This included testing of integration and interoperability of the peripheral devices for blood pressure and weight.
Software Verification and Validation Testing: Software verification 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 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.
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
The Gen 2 wearable device has identical indications for use, operating principles, performance, and technical specification as the Current Health Wearable Monitoring system (Gen 1) wearable.
Based on the information presented in this 510(k) premarket notification, the Current Health Second Generation (Gen 2) wearable device is substantially equivalent to the predicate device (Current Health Wearable Monitoring System (Gen 1)) in terms of safety, performance, functionality and indications for use and is as safe and effective for its intended use.