(212 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is described as a monitoring system that measures physiological indices. Its intended use is for monitoring and providing alarms, not for treating a condition, which is a characteristic of a therapeutic device.
No
The device is intended for monitoring physiological parameters and providing alarms, not for diagnosing specific medical conditions or diseases.
No
The device description explicitly states the system consists of a "monitoring bracelet device worn on the wrist" in addition to software components (web platform and mobile app). This bracelet is a hardware component that collects physiological data.
Based on the provided information, the CardioWatch 287-2 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioWatch 287-2 System's Intended Use: The intended use of the CardioWatch 287-2 System is to monitor physiological parameters directly from the patient's body (pulse rate, oxygen saturation, temperature, movement, respiration rate, blood pressure, lung function, weight). It does not involve the analysis of specimens taken from the body.
- Device Description: The device description confirms that it monitors vital signs data directly from the patient via a wearable bracelet and integrated third-party devices.
Therefore, the CardioWatch 287-2 System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CardioWatch 287-2 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 their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.
The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.
The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.
The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):
- Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):
· Respiration rate.
The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:
- · Non-invasive blood pressure
- · Lung function & spirometry
• Weight
The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.
The CardioWatch 287-2 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 CardioWatch 287-2 system is not a substitute for an ECG monitor.
The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.
Product codes (comma separated list FDA assigned to the subject device)
MSX, DQA, BZG, BZQ, FLL, DRG, DXN, FRI
Device Description
The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.
Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.
The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).
The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.
The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist (for skin temperature, pulse rate, oxygen saturation, respiration rate, movement)
Axillary (for temperature with connected thermometer device)
Indicated Patient Age Range
Adults (over 22 years old)
Intended User / Care Setting
Trained healthcare professionals.
Professional healthcare facilities, such as hospitals 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)
Clinical Studies:
Clinical studies were carried out to support compliance to IEC IEC 80601-2-61 and FDA Guidance on Pulse Oximeters - Premarket Notification Submissions (510(k)s], March 2013. The Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System in the intended patient population using the gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Pulse Rate Accuracy: 3 BPM ARMS
- SpO2 Accuracy:
§ 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 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2024
Corsano Health B.V. Peter Stas CEO - Head of Firm Wilhelmina van Pruisenweg 35 2595AN 's-Gravenhage The Netherlands
Re: K232548
Trade/Device Name: Corsano CardioWatch 287-2 System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX, DQA, BZG, BZQ, FLL, DRG, DXN, FRI Dated: February 16, 2024 Received: February 20, 2024
Dear Peter Stas:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 W. Shih -S
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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232548
Device Name Corsano CardioWatch 287-2 System
Indications for Use (Describe)
The CardioWatch 287-2 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 their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.
The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.
The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.
The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):
- Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):
· Respiration rate.
The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:
- · Non-invasive blood pressure
- · Lung function & spirometry
• Weight
The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.
The CardioWatch 287-2 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 CardioWatch 287-2 system is not a substitute for an ECG monitor.
The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion. Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summary
GENERAL INFORMATION 1
| Submitter and 510(k) Owner | |
|---|---|
| Name | Corsano Health B.V. |
| Address : | Wilhelmina Van Pruisenweg 35 |
| 's-Gravenhage | |
| 2595 AN | |
| Netherlands | |
| Official Correspondent | Mr Peter STAS, CEO – Head of firm |
| Phone | +41793102442 |
| Email : | pcstas@corsano.com |
| Date of Summary : | 22nd March 2024 |
| Device Information | |
|---|---|
| Trade/Proprietary Name | Corsano CardioWatch 287-2 System |
| Common/Usual Name | Patient Remote Monitoring System |
| Medical Specialty | Cardiovascular |
| Regulation | 870.2300 |
| Class: | II |
| Classification Name: | System, Network and Communication, Physiological Monitors |
| Product Codes: | MSX, DQA, BZG, FLL, DRG, DXN, FRI |
| Primary Product Code | ||||
|---|---|---|---|---|
| Classification | ||||
| Regulation | Classification Name | Device | ||
| Class | Product | |||
| Code | Classification Panel | |||
| 21 CFR 870.2300 | System, Network and | |||
| Communication, Physiological | ||||
| Monitors | Class II | MSX | Cardiovascular |
| Secondary Product Codes | ||||
|---|---|---|---|---|
| Classification | ||||
| Regulation | Classification Name | Device | ||
| Class | Product | |||
| Code | Classification | |||
| Panel | ||||
| 21 CFR 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
| 21 CFR 868.1840 | Spirometer | Class II | BZG | Anesthesiology |
| 21 CFR 868.2375 | Breathing Frequency Monitor | Class II | BZQ | Anesthesiology |
6
Image /page/6/Picture/1 description: The image shows the word "Corsano" in a teal color, followed by a teal-colored plus sign inside of a circle. The word is written in a sans-serif font and is the main focus of the image. The plus sign is located to the right of the word and is slightly smaller in size.
| Secondary Product Codes | ||||
|---|---|---|---|---|
| Classification | ||||
| Regulation | Classification Name | Device | ||
| Class | Product | |||
| Code | Classification | |||
| Panel | ||||
| 21 CFR 870.2910 | Clinical Electronic Thermometer | Class II | FLL | General Hospital |
| 21 CFR 870.2910 | Radiofrequency physiological | |||
| signal transmitter & receiver | Class II | DRG | Cardiovascular | |
| 21 CFR 870.1130 | Non-invasive Blood Pressure | |||
| Monitor | Class II | DXN | Cardiovascular | |
| 21 CFR 880.2700 | Stand-on Weight Scale | Class I | FRI | General Hospital |
| Predicate Device | |
|---|---|
| Trade/Proprietary Name | Current Wearable Health Monitoring System |
| Common/Usual Name | Remote Patient Monitor |
| Medical Specialty | Cardiovascular |
| Regulation | 870.2300 |
| Class: | II |
| Classification Name: | System, Network and Communication, Physiological Monitors |
| Product Codes: | MSX, FLL, DQA, BZQ, DRG, BZG |
2 Device Description
The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.
Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.
The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).
The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.
The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
7
The healthcare professional can securely access the patient physiological signs remotely via the Corsano mobile application HCP Mode or via a browser web-interface which are also intended to provide visual and audible physiologic multi-parameter alarms.
3 Intended Use / Indications for Use
The CardioWatch 287-2 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 non-acutely ill patients by trained healthcare professionals.
The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.
The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of the patient or axillary temperature with connected thermometer device.
The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):
- · Pulse rate
- Oxygen saturation
- · Temperature
- Movement
The CardioWatch 287-2 System is intended for intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):
-
Respiration rate. ●
The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of: -
· Non-invasive blood pressure
-
· Lung function & spirometry
-
Weight
The CardioWatch 287-2 System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The CardioWatch 287-2 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 CardioWatch 287-2 system is not a substitute for an ECG monitor.
The CardioWatch 287-2 System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
8
Substantial Equivalence ব
The Corsano CardioWatch 287-2 System has an intended use statement identical to the predicate device with the exception of several word changes specific to the CardioWatch 287-2 System, both the devices also share same conditions of use in terms measurement technology, measurements, transmission, data visualization and alarms whilst using third party devices, as well as in the same healthcare environments and the same intended patients.
Technological characteristics
Corsano CardioWatch 287-2 System share the same technological characteristics as the predicate device, providing patient physiological parameters measurements using PPG technology on wearable sensors, transmit and provide data visualization and alarms (visual & audible) to HCP's.
Both systems provide the possibility of using validated third-party devices that provide additional physiological parameters & data visualization to HCP's.
| Features | Proposed Device:
CardioWatch 287-2 System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Corsano Health B.V. | Current Health Ltd | - |
| Device
Classification | II | II | Identical |
| 510(k)
Number | N/A | K210133 | - |
| Primary
Product Code | MSX | MSX | Identical |
| Secondary
Product Code | DQA | DQA | Identical |
| | BZQ | BZQ | Identical |
| | FLL | FLL | Identical (Clinical Electronic
Thermometer) both for wearable
sensor & third-party device |
| | DRG | DRG | Identical (Radiofrequency
physiological signal transmitter &
receiver) |
| | BZG | BZG | Identical (Spirometer - third-party
device) |
| | DXN | - | Both devices use the NIPB (third-
party device), however the
Predicate device has not
included the Product Code. |
| Features | Proposed Device:
CardioWatch 287-2 System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
| | FRI | - | Both devices use the Scales
(third-party device), however the
Predicate device has not
included the Product Code. |
| Device
Classification
Name | System, Network and
Communication,
Physiological Monitors | System, Network and
Communication,
Physiological Monitors | Identical |
| Intended Use/
Indication for Use | The CardioWatch 287-2
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 non-acutely ill
patients by trained
healthcare professionals.
The CardioWatch 287-2
System is intended to
provide visual and audible
physiologic multi-parameter
alarms.
The CardioWatch 287-2
System is intended for
monitoring of skin
temperature at wrist of the
patient or axillary
temperature with
connected thermometer
device.
The CardioWatch 287-2
System is intended for
continuous monitoring of
the following physiological
indices in adults (over
22years old):
• Pulse rate
• Oxygen saturation
• Temperature | 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 | Identical both devices can be
considered similar in terms of
intended use (measurements,
transmission, data visualization,
alarms and third party devices) in
the same healthcare
environments and the same
intended patients. |
| Features | Proposed Device:
CardioWatch 287-2 System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
| | The CardioWatch 287-2
System is intended for
intermittent monitoring with
the CardioWatch Bracelet
of the following
physiological indices in
adults (over 22years old):
• Respiration rate. | The Current Wearable
Health Monitoring System
is intended for intermittent
or spot-check monitoring, in
adults, of:
• Respiration rate
• Non-invasive blood
pressure
• Lung function &
spirometry
• Weight | |
| | The CardioWatch 287-2
System is intended for
intermittent or spot-check
monitoring, in adults, of:
• 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 CardioWatch 287-2
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 CardioWatch 287-2
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
CardioWatch 287-2 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 CardioWatch 287-2
System is not intended for
SpO2 monitoring in
conditions of high motion or
low perfusion. | | |
| Features | Proposed Device: CardioWatch 287-2 System | Predicate Device: Current Wearable Health Monitoring System | Comment |
| Target Population | Adult (22yrs & older) | Adult (18yrs & older) | Similar ; both devices are intended for use on adults |
| Patient target category | Non acutely ill patients | Non acutely ill patients | Identical |
| Wearing location | Wrist | Upper arm | The difference in wearing location on the body does not raise new questions of safety or efficacy.
Both locations are valid clinical locations allowing for monitoring peripheral arteries. |
| Duration of Use | Upto 24 hours per day as required by the practician | Upto 24 hours per day as required by the practician | Identical |
| Sterile | Non-sterile | No-sterile | Identical |
| Mechanism of Action / Principle of Operation | The Corsano CardioWatch 287-2 System continuously monitors Pulse Rate (PR), oxygen saturation (SpO2), temperature (sTEMP) and Activity (STEPS) and intermittently the respiration rate (RESP) through sensors in the wrist bracelet.
The Corsano System monitors skin temperature (sTEMP) at wrist or axillary temperature (aTEMP) with connected thermometer.
The device has wireless communication capabilities.
Intermittent or spot-checking monitoring of blood pressure (BP), spirometry & lung function (SPIRO) and weight (WEIGHT) through third-party product integration. | The Current Health System continuously monitors pulse rate (PR), oxygen saturation (SpO2), skin temperature (TEMP) and movement (MOVEMENT) through sensors in a device designed to be worn around the upper arm.
The Current Health System monitors skin temperature (sTEMP) at upper arm or axillary temperature (aTEMP) with connected thermometer.
The device has wireless communication capabilities.
Intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function (SPIRO), and weight (WEIGHT) through third-party product integration. | Identical, both devices use their own wearable sensor to provide these measurements.
Identical, both devices use their own wearable sensor, in addition to providing measurement using with FDA cleared third-Party External device.
Identical
Identical |
| PPG Sensor Characteristics | | | |
| Green LED | 525nm | 530nm | Similar wavelength, in that the non-significant difference of 5nm has no impact on the safety, and the effectiveness has been demonstrated in the Bench & |
| Features | Proposed Device:
CardioWatch 287-2 System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
| Red LED | 660nm | 660nm | Identical wavelength |
| IR LED | 880nm | 930nm | Similar wavelength, in that the
non-significant difference of
50nm has no impact on the
safety, and the effectiveness has
been demonstrated in the Bench
& Clinical Testing. |
| Connected
External Third-
Party Devices | Non-invasive blood
pressure monitor
Weight scale
Thermometer
Spirometer | Non-invasive blood
pressure monitor
Weight scale
Thermometer
Spirometer | Identical |
| Alarms overview | Visible and audible alerts
for PR, SpO2, Axillary
Temperature outside limits. | Visible and audible alerts
for PR, SpO2, Temperature
outside limits. | Identical |
| User Interfaces | | | |
| HCP | Mobile device application,
and cloud software platform | Mobile device and central
station | Identical |
| Patient | Mobile device application | Mobile device application | Identical |
| Wearable
Sensors | PPG,
Accelerometer,
Thermopile | PPG,
Accelerometer,
Thermopile | Identical |
| Energy Source | Battery | Battery | Identical |
| Battery Type | Rechargeable
Lithium-Ion | Rechargeable
Lithium-Ion | Identical |
| Wireless
Communication
Means | Yes | Yes | Identical |
| OTC/Prescription
Use | Prescription Use | Prescription Use | Identical |
| Environment | Professional Healthcare
Facilities and Home | Professional Healthcare
Facilities and Home | Identical |
9
10
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Performance Features :
| Performance
Features | Proposed Device:
CardioWatch 287-2
System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
|-----------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Rate
Measurement
Range | 25 BPM to 250 BPM | 30 BPM to 240 BPM | Similar range; no impact safety &
effectiveness as validation has
been made through bench &
clinical testing. |
| Performance
Features | Proposed Device:
CardioWatch 287-2
System | Predicate Device:
Current Wearable Health
Monitoring System | Comment |
| Pulse Rate
Accuracy | 3 BPM ARMS | 3 BPM ARMS | Identical, both comply with ISO
80601-2-61. |
| SpO2 Measurement
Range | 70% to 100% | 70% to 100% | Identical |
| SpO2 Measurement
Resolution | 1% | 1% | Identical |
| SpO2 Accuracy |