(212 days)
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.
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.
The Corsano CardioWatch 287-2 System's acceptance criteria and studies are detailed below, primarily focusing on Pulse Rate, SpO2, Respiration Rate, and Skin Temperature.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Feature | Acceptance Criteria (Proposed Device) | Reported Device Performance (Proposed Device) | Predicate Device Performance | Comment in Document |
|---|---|---|---|---|
| Pulse Rate Measurement Range | 25 BPM to 250 BPM | 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. |
| Pulse Rate Accuracy | 3 BPM ARMS | 3 BPM ARMS | 3 BPM ARMS | Identical, both comply with ISO 80601-2-61. |
| SpO2 Measurement Range | 70% to 100% | 70% to 100% | 70% to 100% | Identical |
| SpO2 Measurement Resolution | 1% | 1% | 1% | Identical |
| SpO2 Accuracy | <2 % Arms for Range 70-100% | <2 % Arms for Range 70-100% | +/- 2 Digits | Identical, both comply with ISO 80601-2-61 as well as with FDA Guidance for Pulse Oximeters (2013). |
| RR Measurement Range | 4-60 RPM | 4-60 RPM | 6-60 RPM | Similar range; no impact safety & effectiveness as validation has been made through bench & clinical testing. |
| RR Measurement Resolution | 1 brpm | 1 brpm | 1 brpm | Identical |
| RR Accuracy | +/- 3 RPM ARMS | +/- 3 RPM ARMS | +/- 3 RPM | Identical |
| Skin Temperature Measurement Range | 34.0°C to 42.0°C (93.2°F to 107.6°F) | 34.0°C to 42.0°C (93.2°F to 107.6°F) | -20.0°C to 50.0°C (-4°F to 122°F) | Difference in range claims; no impact on safety & effectiveness as validation has been made through bench testing in accordance with IEC80601-2-56. Value provided by predicated device corresponds to the thermistor specifications. |
| Skin Temperature Accuracy | +/- 0.3°C (0.54°F) | +/- 0.3°C (0.54°F) | +/- 0.1°C (0.18°F) | Difference; no comparison is possible as the predicate device provides the performance of the thermistor sensor & not the wearable device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "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." And also that 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)."
However, the specific sample sizes used for these clinical studies (test set) are not provided in the given text.
The data provenance (country of origin, retrospective or prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the Respiratory Rate Validation Testing, the ground truth was established using a "blinded clinician." The number of these clinicians (experts) is not specified, nor are their specific qualifications (e.g., years of experience).
For Pulse Oximetry (SpO2) and Pulse Rate, the ground truth would typically come from a co-oximeter and ECG, respectively, as per the mentioned standards. The document does not explicitly state the number or qualifications of experts involved in analyzing this data beyond the implied standard procedures.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set, beyond stating that a "blinded clinician" was used for respiratory rate validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance is present in the provided text. The device is a patient monitoring system, not explicitly an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
The performance data presented in the table and the mention of "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]" and "Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System" indicates that standalone performance (algorithm only) was assessed for the device's measurements. The performance metrics listed (e.g., Accuracy for PR, SpO2, RR, Skin Temperature) are characteristics of the device's standalone measurement capabilities.
7. Type of Ground Truth Used
- Respiratory Rate: "gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram)." This indicates a combination of expert assessment and a validated medical device.
- Pulse Rate (PR) and Oxygen Saturation (SpO2): The document references compliance with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters (2013). These standards typically involve comparison against reference devices like an arterial blood gas co-oximeter for SpO2 and an ECG for PR, established under controlled desaturation studies or stable vital sign conditions. While not explicitly stated as "pathology" or "outcomes data," this method relies on highly accurate, established medical measurement techniques.
- Skin Temperature: Bench testing in accordance with IEC80601-2-56. This implies comparison against a calibrated reference temperature measurement.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set. This suggests that if machine learning models were used, the details of their training data are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
Since the document does not specify a training set or its sample size, it also does not detail how the ground truth for any potential training set was established.
{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}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
510(k) Summary
GENERAL INFORMATION 1
| Submitter and 510(k) Owner | |
|---|---|
| Name | Corsano Health B.V. |
| Address : | Wilhelmina Van Pruisenweg 35's-Gravenhage2595 ANNetherlands |
| 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 | ||||
|---|---|---|---|---|
| ClassificationRegulation | Classification Name | DeviceClass | ProductCode | Classification Panel |
| 21 CFR 870.2300 | System, Network andCommunication, PhysiologicalMonitors | Class II | MSX | Cardiovascular |
| Secondary Product Codes | ||||
|---|---|---|---|---|
| ClassificationRegulation | Classification Name | DeviceClass | ProductCode | ClassificationPanel |
| 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 | ||||
|---|---|---|---|---|
| ClassificationRegulation | Classification Name | DeviceClass | ProductCode | ClassificationPanel |
| 21 CFR 870.2910 | Clinical Electronic Thermometer | Class II | FLL | General Hospital |
| 21 CFR 870.2910 | Radiofrequency physiologicalsignal transmitter & receiver | Class II | DRG | Cardiovascular |
| 21 CFR 870.1130 | Non-invasive Blood PressureMonitor | 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 HealthMonitoring System | Comment |
|---|---|---|---|
| DeviceManufacturer | Corsano Health B.V. | Current Health Ltd | - |
| DeviceClassification | II | II | Identical |
| 510(k)Number | N/A | K210133 | - |
| PrimaryProduct Code | MSX | MSX | Identical |
| SecondaryProduct Code | DQA | DQA | Identical |
| BZQ | BZQ | Identical | |
| FLL | FLL | Identical (Clinical ElectronicThermometer) both for wearablesensor & third-party device | |
| DRG | DRG | Identical (Radiofrequencyphysiological signal transmitter &receiver) | |
| BZG | BZG | Identical (Spirometer - third-partydevice) | |
| DXN | - | Both devices use the NIPB (third-party device), however thePredicate device has notincluded the Product Code. | |
| Features | Proposed Device:CardioWatch 287-2 System | Predicate Device:Current Wearable HealthMonitoring System | Comment |
| FRI | - | Both devices use the Scales(third-party device), however thePredicate device has notincluded the Product Code. | |
| DeviceClassificationName | System, Network andCommunication,Physiological Monitors | System, Network andCommunication,Physiological Monitors | Identical |
| Intended Use/Indication for Use | The CardioWatch 287-2System is intended forreusable bedside, mobileand central multi-parameter, physiologicpatient monitoring of adultpatients in professionalhealthcare facilities, suchas hospitals or skillednursing facilities, or theirown home. It is intended formonitoring of non-acutely illpatients by trainedhealthcare professionals.The CardioWatch 287-2System is intended toprovide visual and audiblephysiologic multi-parameteralarms.The CardioWatch 287-2System is intended formonitoring of skintemperature at wrist of thepatient or axillarytemperature withconnected thermometerdevice.The CardioWatch 287-2System is intended forcontinuous monitoring ofthe following physiologicalindices in adults (over22years old):• Pulse rate• Oxygen saturation• Temperature | The Current WearableHealth Monitoring Systemis intended for reusablebedside, mobile and centralmulti-parameter,physiologic patientmonitoring of adult patientsin professional healthcarefacilities, such as hospitalsor skilled nursing facilities, ortheir own home. It isintended for monitoring ofpatients by trainedhealthcare professionals.The Current WearableHealth Monitoring Systemis intended to providevisual and audiblephysiologic multi-parameteralarms.The Current WearableHealth Monitoring Systemis intended for temperaturemonitoring wheremonitoring temperature atthe upper arm is clinicallyindicated.The Current WearableHealth Monitoring Systemis intended for continuousmonitoring of the followingparameters in adults:• Pulse rate• Oxygen saturation• Temperature• Movement | Identical both devices can beconsidered similar in terms ofintended use (measurements,transmission, data visualization,alarms and third party devices) inthe same healthcareenvironments and the sameintended patients. |
| Features | Proposed Device:CardioWatch 287-2 System | Predicate Device:Current Wearable HealthMonitoring System | Comment |
| The CardioWatch 287-2System is intended forintermittent monitoring withthe CardioWatch Braceletof the followingphysiological indices inadults (over 22years old):• Respiration rate. | The Current WearableHealth Monitoring Systemis intended for intermittentor spot-check monitoring, inadults, of:• Respiration rate• Non-invasive bloodpressure• Lung function &spirometry• Weight | ||
| The CardioWatch 287-2System is intended forintermittent or spot-checkmonitoring, in adults, of:• Non-invasive bloodpressure• Lung function &spirometry• Weight | The Current WearableHealth Monitoring Systemis not intended for use inhigh-acuity environments,such as ICU or operatingrooms. | ||
| The CardioWatch 287-2System is not intended foruse in high-acuityenvironments, such as ICUor operating rooms. | The Current WearableHealth Monitoring Systemis not intended for use onacutely ill cardiac patientswith the potential todevelop life threateningarrhythmias e.g. very fastatrial fibrillation. For thesepatients, they should bemonitored using a devicewith continuous ECG. TheCurrent Wearable HealthMonitoring System is not asubstitute for an ECGmonitor. | ||
| The CardioWatch 287-2System is not intended foruse on acutely ill cardiacpatients with the potentialto develop life threateningarrhythmias e.g. very fastatrial fibrillation. For thesepatients, they should bemonitored using a devicewith continuous ECG. TheCardioWatch 287-2 systemis not a substitute for anECG monitor. | The Current WearableHealth Monitoring Systemis not intended for SpO2monitoring in conditions ofhigh motion or lowperfusion. | ||
| The CardioWatch 287-2System is not intended forSpO2 monitoring inconditions of high motion orlow 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.IdenticalIdentical |
| 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 HealthMonitoring System | Comment |
| Red LED | 660nm | 660nm | Identical wavelength |
| IR LED | 880nm | 930nm | Similar wavelength, in that thenon-significant difference of50nm has no impact on thesafety, and the effectiveness hasbeen demonstrated in the Bench& Clinical Testing. |
| ConnectedExternal Third-Party Devices | Non-invasive bloodpressure monitorWeight scaleThermometerSpirometer | Non-invasive bloodpressure monitorWeight scaleThermometerSpirometer | Identical |
| Alarms overview | Visible and audible alertsfor PR, SpO2, AxillaryTemperature outside limits. | Visible and audible alertsfor PR, SpO2, Temperatureoutside limits. | Identical |
| User Interfaces | |||
| HCP | Mobile device application,and cloud software platform | Mobile device and centralstation | Identical |
| Patient | Mobile device application | Mobile device application | Identical |
| WearableSensors | PPG,Accelerometer,Thermopile | PPG,Accelerometer,Thermopile | Identical |
| Energy Source | Battery | Battery | Identical |
| Battery Type | RechargeableLithium-Ion | RechargeableLithium-Ion | Identical |
| WirelessCommunicationMeans | Yes | Yes | Identical |
| OTC/PrescriptionUse | Prescription Use | Prescription Use | Identical |
| Environment | Professional HealthcareFacilities and Home | Professional HealthcareFacilities and Home | Identical |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Performance Features :
| PerformanceFeatures | Proposed Device:CardioWatch 287-2System | Predicate Device:Current Wearable HealthMonitoring System | Comment |
|---|---|---|---|
| Pulse RateMeasurementRange | 25 BPM to 250 BPM | 30 BPM to 240 BPM | Similar range; no impact safety &effectiveness as validation hasbeen made through bench &clinical testing. |
| PerformanceFeatures | Proposed Device:CardioWatch 287-2System | Predicate Device:Current Wearable HealthMonitoring System | Comment |
| Pulse RateAccuracy | 3 BPM ARMS | 3 BPM ARMS | Identical, both comply with ISO80601-2-61. |
| SpO2 MeasurementRange | 70% to 100% | 70% to 100% | Identical |
| SpO2 MeasurementResolution | 1% | 1% | Identical |
| SpO2 Accuracy | <2 % Arms for Range 70-100% | +/- 2 Digits | Identical, both comply with ISO80601-2-61 as well as with FDAGuidance for Pulse Oximeters(2013). |
| RR MeasurementRange | 4-60 RPM | 6-60 RPM | Similar range; no impact safety &effectiveness as validation hasbeen made through bench &clinical testing. |
| RR MeasurementResolution | 1 brpm | 1 brpm | Identical |
| RR Accuracy | +/- 3 RPM ARMS | +/- 3 RPM | Identical |
| Skin TemperatureMeasurementRange | 34.0°C to 42.0°C(93.2°F to 107.6°F) | -20.0°C to 50.0°C(-4°F to 122°F) | Difference in range claims ; noimpact on safety & effectivenessas validation has been madethrough bench testing inaccordance with IEC80601-2-56Value provided by predicateddevice corresponds to thethermistor specifications. |
| Skin TemperatureMeasurementResolution | 0.1°C | 0.1°C | Identical |
| Skin TemperatureAccuracy | +/- 0.3°C (0.54°F) | +/- 0.1°C (0.18°F) | Difference; no comparison ispossible as the predicate deviceprovides the performance of thethermistor sensor & not thewearable device. |
{13}------------------------------------------------
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image contains the word "Corsano" in a teal color, followed by a teal circle with a white plus sign inside. The plus sign is centered within the circle. The font of the word "Corsano" is sans-serif and appears to be a logo or brand name.
PERFORMANCE TESTING 5
Corsano CardioWatch 287-2 System has been designed and developed according to a robust hardware & software development process and was rigorously verified and validated and complies with the following standards/guidance through testing and/or analysis:
Recognised standards :
- IEC 60601-1:2005/A2:2020 ●
- IEC 60601-1-2:2014/A1:2020 ●
- . IEC 60601-1-8:2006, AMD1:2012, AMD2:2020 :
- IEC 60601-1-11:2015/A1:2020
- ISO 80601-2-56:2017/AMD11:2018 ●
- ISO 80601-2-61:2018 ●
- ISO 14971:2019 + A11:2021 ●
- IEC 62304:2006+AMD1:2015 ●
- IEC 62366-1:2015 + AC:2015 + A1:2020 ●
- ISO 10993-1:2018 ●
- ISO 10993-5:2009 ●
- ISO 10993-10:2010
- ISO 10993-10:2021 .
- ISO 20417:2021
- ISO 15223-1:2021 ●
- . ASTM D4169-16
FDA Guidance :
- Pulse Oximeters Premarket Notification Submissions [510(k)s] ; March 4, 2013 ●
- Use of International Standard ISO 10993-1, "Biological evaluation of medical . devices - Part 1: Evaluation and testing within a risk management process" ; Sept 4, 2020
- Applying Human Factors and Usability Engineering to Medical Devices; Feb 3, 2016
- Content of Premarket Submissions for Device Software Functions; June 14, 2023
- Policy for Device Software Functions and Mobile Medical Applications; Sept 28, ● 2022
- Multiple Function Device Products: Policy and Considerations, July 29, 2020 ●
- . Off-The-Shelf Software Use in Medical Devices, August 11, 2023
- Off-the-shelf software use in medical devices, 27 Sep 2019.
- General principles of software validation ; January 11, 2002.
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Oct 2, 2014
- Postmarket Management of Cybersecurity in Medical Devices: Dec 28, 2016 .
{15}------------------------------------------------
- Cybersecurity in Medical Devices: Quality System Considerations and Content of . Premarket Submissions (Draft Guidance) ; April 8, 2022
- . Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software; Jan 2005
- Design Considerations and Pre-market Submission Recommendations for . Interoperable Medical Devices; September 6, 2017
- Electromagnetic Compatibility (EMC) of Medical Devices; June 6, 2022 ●
- Radio Frequency Wireless Technology in Medical Devices: Aug 14, 2013 ●
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and ● Labeling; March 17, 2015
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
Clinical Studies
No clinical studies were conducted as part of the submission to prove substantial equivalence.
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).
6 Conclusion
Based on the information presented in this substantial equivalence comparison, the Corsano CardioWatch 287-2 System can be considered substantially equivalent to the already cleared Current Wearable Health Monitoring in terms of safety, performance, functionality and indications for use and can thus be considered as safe and as effective as the cleared Predicate Device (K210133).
§ 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).