Polso Watch

K220351 · Chronisense Medical, Ltd. · DQA · Nov 18, 2022 · Cardiovascular

Device Facts

• Record ID: K220351
• Device Name: Polso Watch
• Applicant: Chronisense Medical, Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

Device Story

Wrist-worn device; uses PPG sensors facing radial artery and dorsal wrist to measure SpO2, pulse rate, and respiration rate. Operates in non-motion conditions; user-initiated spot-checking. Data displayed on device screen; transmitted via Bluetooth Low Energy (BLE) to companion Android mobile app. App stores up to 3 months of data for remote clinician review. Benefits include non-invasive physiological monitoring in home settings. Physician reviews data during clinic visits or via remote communication. Powered by rechargeable lithium-polymer battery.

Clinical Evidence

Two clinical studies conducted. SpO2/Pulse Rate study: 10 healthy adults (plus 2 additional subjects with Fitzpatrick scores IV/VI) compared against arterial blood CO-Oximetry gold standard. Respiration Rate study: 31 adult subjects with varied skin types/health conditions compared against clinician-scored End Tidal CO2 monitoring. Testing performed per ISO 80601-2-61 and FDA pulse oximeter guidance. Results demonstrate accuracy in non-motion conditions.

Technological Characteristics

Wrist-worn form factor; PPG sensing principle. AMOLED display. Rechargeable lithium-polymer battery. Connectivity: Bluetooth Low Energy (BLE) to Android mobile app. Biocompatibility per ISO 10993-1/5/10. Electrical safety/EMC per IEC 60601-1, 60601-1-2, 60601-1-11, 62133, ISO 80601-2-61. Software V&V per IEC 62304.

Indications for Use

Indicated for patients aged 18+ for spot-checking SpO2, pulse rate, and respiration rate in home environments during non-motion conditions. Not for diagnostic use, independent treatment guidance, or apnea monitoring.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Loop System / Spry Health, Inc. (K181352)

Reference Devices

• Masimo MightySat Rx Fingertip Pulse Oximeter (K181956)

Submission Summary (Full Text)

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November 18, 2022

Chronisense Medical, Ltd. % Allison Komiyama President, AcKRS Ram+ 2251 San Diego Ave. Ste B-257 San Diego, California 92110

Re: K220351

Trade/Device Name: Polso Watch Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: October 14, 2022 Received: October 31, 2022

Dear Allison Komiyama:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Divisiion Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220351

Device Name Polso™ Watch

Indications for Use (Describe)

The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions.

The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary K220351

#### DATE PREPARED

November 10, 2022

#### MANUFACTURER AND 510(k) OWNER

ChroniSense Medical, Ltd. 2 Hacarmel St., P.O.B. 399, Yokneam Illit, Israel 2066724 Telephone: Official Contact: Bridget A. Ross, CEO

#### REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., RAC Pierre Bounaud, Ph.D. RQM+ 2251 San Diego Ave., Ste B-257, San Diego, CA 92110 Telephone: [phone] Email: [e-mail], [e-mail]

#### DEVICE INFORMATION

| Proprietary Name/Trade Name: | Polso™ Watch |
|------------------------------|----------------------------------------------------------------------|
| Common Name: | Oximeter, breathing frequency monitor |
| Regulation Number: | 21 CFR 870.2700, 21 CFR 868.2375 |
| Class: | II |
| Product Code: | DQA, BZQ |
| Premarket Review: | Anesthesiology |
| Review Panel: | OHT1/ Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C) |

#### PREDICATE DEVICE IDENTIFICATION

The Polso™ Watch is substantially equivalent to the following predicates:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary<br>Predicate | Reference<br>Device |
|---------------|----------------------------------------------------------------------|----------------------|---------------------|
| K181352 | Loop System / Spry Health, Inc. | ✓ | |
| K181956 | Masimo MightySat Rx Fingertip Pulse<br>Oximeter / Masimo Corporation | | ✓ |

The predicate devices have not been subject to a design related recall.

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#### DEVICE DESCRIPTION

The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescriptionuse device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions.

The Polso™ Watch is worn on the wrist and features sensors that are located facing the radial artery and at the dorsal wrist, for measurement of physiological information. The Polso™ Watch screen displays measurements, battery status, Bluetooth connection status, and time of day. The Control Button allows navigation between different display screens. The Polso™ Watch is available in sizes S, M and L to cover wrist sizes from 5.5″ to 8.4″ circumference. The Polso™ Watch is powered by a rechargeable lithium-polymer battery.

The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.

#### INDICATIONS FOR USE

The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

ChroniSense Medical, Ltd. believes that the Polso™ Watch is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has the same intended use as the device cleared in K181352. Both devices are intended to measure pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR) in non-moving adult patients in home environments. The intended population for the subject device includes transitional adolescents, aged 18 to 21. For the intended use of the device, the inclusion of this pediatric population does not raise new questions of safety or effectiveness and is validated by two clinical studies.

The subject device has a similar design as the device cleared in K181352. Both devices have a 'watch' form factor that is worn on the wrist, with measurements displayed on the wearable

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device and transmitted to another location (mobile app, web interface) for additional monitoring. Both devices have internal rechargeable batteries.

The subject device uses similar technology for measurements as the device cleared in K181352. Both devices have PPG sensors to gather data from peripheral arteries.

The main technological differences of the subject device, as compared to the predicate device cleared in K181352, are:

- . Sampling frequency. The subject device is intended for spot-checking under non-motion conditions, meaning the user determines when to check for measurements. By contrast, the predicate device is designed for nearly continuous measuring and recording of physiological data when the patient is not in motion. The difference in sampling frequency does not raise new questions of safety or effectiveness.
- . SpO2 accuracy. The subject device display range is 70% to 100% and accuracy is 2% Arms while the predicate device has the same display range, but accuracy is 3% Arms. This difference is within the values of the predicate device and is therefore considered equivalent.
- RR range. The subject device has a RR range of 5-45 BPM while the predicate device has a RR range of 4-40 RPM. This technical difference has undergone testing to ensure the subject device is as safe and effective as the predicate device.
- Data communication. Both devices transmit measurements wirelessly to either a mobile device (subject device) or a web server (predicate). The subject device uses Bluetooth low energy (BLE) methodology while the predicate uses a cellular connection. This technical difference has undergone testing to ensure the subject device is as safe and effective as the predicate device.
- Data communication to physician. The predicate device automatically transmits collected data to a remote server for review by a physician, while the subject device stores data on the Watch and the mobile application. Review of the data by the physician is done during clinic visits or data is communicated remotely to the physician by the patient. This technical difference has undergone human factor testing to ensure the subject device is as safe and effective as the predicate device. In addition, the reference device cleared in K181956 uses similar spot-checking technology in a home use environment. Collected data is stored on the reference device. Bluetooth communication to a mobile app is an optional feature for data transfer and review by a physician.

The Polso™ Watch is substantially equivalent to the predicate devices based on the information summarized in the following table:

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# P:::lso

| | Subject Device | Predicate Device | Reference Device |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ChroniSense Medical Ltd | Spry Health, Inc. | Masimo Corporation |
| | Polso™ Watch | Loop System | Masimo MightySat Rx<br>Fingertip Pulse Oximeter |
| | K220351 | K181352 | K181956 |
| Indications for<br>Use | The Polso™ Watch is a wrist-<br>worn device indicated for use<br>in measuring and displaying<br>functional oxygen saturation<br>of arterial hemoglobin<br>(%SpO2), pulse rate, and<br>respiration rate. The Polso™<br>Watch is a prescription-use<br>device intended for spot-<br>checking measurements of<br>patients aged 18 years and<br>older in the home use<br>environment in non-motion<br>conditions.<br>The device is not intended to<br>be used for diagnostic<br>applications nor is it intended<br>to independently guide<br>treatment decisions. The<br>device is not an apnea<br>monitor. Physiological<br>parameters will later be<br>provided for remote review<br>by a clinician. | The Loop System is intended<br>for adult patients in the home<br>environment for passive, non-<br>invasive, intermittent data<br>collection of physiological<br>parameters that will later be<br>transmitted to a web server<br>for remote review by a<br>clinician.<br>The Loop System measures<br>and records:<br>• arterial oxygen<br>saturation (SpO2)<br>• heart rate (HR)<br>• respiration rate (RR)<br>All of these measurements<br>are made when no motion is<br>detected by the System. The<br>Loop System device does not<br>provide physiological alarms | The Masimo MightySat Rx<br>Fingertip Pulse Oximeter is<br>intended for hospitals,<br>hospital-type facilities, home<br>environments, and transport.<br>The Masimo MightySat Rx<br>Fingertip Pulse Oximeter is<br>indicated for the noninvasive<br>spot checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR) for adult and<br>pediatric patients during both<br>no motion and motion<br>conditions, and for patients<br>who are well or poorly<br>perfused.<br>The Masimo MightySat Rx<br>Fingertip Pulse Oximeter is<br>indicated for the noninvasive<br>spot checking of respiration<br>rate (RRp) for adult patients. |
| Product Codes<br>/ Regulation<br>Number | DQA / 21 CFR 870.2700<br>BZQ / 21 CFR 868.2375 | DQA / 21 CFR 870.2700<br>BZQ / 21 CFR 868.2375 | DQA / 21 CFR 870.2700<br>BZQ / 21 CFR 868.2375 |
| Rx/OTC | Rx | Rx | Rx |
| Intended users | Adults (aged 18 and older) | Adults | Adults/pediatric (SpO2, pulse<br>rate)<br>Adults (respiration rate) |
| Intended use<br>environments | Home environment | Home environment | Hospitals, hospital-type<br>facilities,<br>home environments, and<br>transport |
| Technological Characteristics | | | |
| Device | • Polso™ Watch | • Loop band | • Fingertip device |
| Components | • Polso™ App | • Spry server | • Battery |
| | • Polso™ Watch Charger<br>Stand with micro USB cable<br>and power adapter | • Charging station | • Carrying case |
| | | | |
| Anatomical site<br>of<br>measurements | Wrist | Wrist | Finger |
| Sampling<br>frequency | Spot-checking in non-motion<br>conditions | Intermittent data collection<br>when patient is not in motion | Spot-checking in non-motion<br>and motion conditions |
| SpO2<br>measurement<br>method | Photoplethysmography | Photoplethysmography | Photoplethysmography |
| SpO2 display<br>range | 70% to 100% | 70% to 100% | 70% to 100% (no motion) |
| SpO2 Accuracy | 2% Arms | 3% Arms | 2% Arms (no motion) |
| Pulse rate /<br>heart rate<br>measurement<br>method | Photoplethysmography | Photoplethysmography | Photoplethysmography |
| Pulse rate /<br>heart rate<br>display range | 25-250 beats per minute<br>(BPM) | 25-250 BPM | 25-240 BPM |
| Pulse rate /<br>heart rate<br>accuracy | 3 BPM Arms | 3 BPM Arms | 3 BPM Arms |
| RR<br>measurement<br>method | Photoplethysmography | Photoplethysmography | Photoplethysmography |
| RR display<br>range | 5-45 breaths per minute<br>(BPM) | 4-40 respirations per minute<br>(RPM) | 4-70 respirations per minute<br>(RPM) |
| RR accuracy | 3 BPM Arms | 3 RPM Arms | 3 RPM Arms |
| Display | AMOLED color display | LED color display | OLED color display |
| Power source | Internal rechargeable battery | Internal rechargeable<br>batteries | Two 1.5V AAA batteries |
| Data<br>communication | Wireless (Bluetooth BLE<br>pairing) with Android mobile<br>device | Wireless (cellular connection)<br>via charging station to Spry<br>Server | Optional wireless (Bluetooth<br>LE) |

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### SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety and performance based on current industry standards:

- . Biocompatibility testing per ISO 10993-1, 10993-5, 10993-10
- . Software V&V per IEC 62304
- Electrical Safety and Electromagnetic Compatibility testing per IEC 60601-1, IEC 60601-1-. 2, IEC 60601-1-11, IEC 62133, ISO 80601-2-61
- . Compliance to CFR 47 Part 15 Subpart C for BLE transmission
- . Bench performance testing for RR range and accuracy

The results of these tests indicate that the Polso™ Watch is substantially equivalent to the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for Polso. The logo is purple and features the word "Polso" in a sans-serif font. The "o" in "Polso" is replaced by a circle of dots, with some of the dots being a lighter blue color. The logo is simple and modern.

#### SUMMARY OF CLINICAL TESTING

Two clinical studies were conducted to demonstrate the performance of the Polso™ Watch. Evaluation included participants with a range of demographics including a mix of gender, skin tone (Fitzpatrick scale I-VI), age, and BMI (based on height and weight).

- SpO2 and Pulse Rate Validation Study. The objective of this study was to validate the SpO2 accuracy and the pulse rate accuracy of the Polso™ Watch pulse oximeter during non-motion conditions in 10 healthy adult subjects with a range of skin types (2 having a Fitzpatrick score of V or VI). The accuracy of the Polso™ Watch was compared to the gold standard, arterial blood samples assessed by SaO2 CO-Oximetry. Per FDA's request, data on two additional subjects with Fitzpatrick scores of IV and VI were provided to demonstrate the device works on the intended population.
- Respiration Rate Validation Study. The objective of this study was to validate the . respiration rate accuracy of the Polso™ Watch pulse oximeter during non-motion conditions in 31 adult subjects with a range of skin types and health conditions. The accuracy of the Polso™ Watch was compared to manual, clinician-scored End Tidal Carbon Dioxide monitoring as the gold standard.

This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, and FDA's Guidance Pulse Oximeters - Premarket Notifications Submissions.

#### CONCLUSION

Based on the testing performed, including biocompatibility, software V&V, EMC and electrical safety, wireless transmission testing, bench performance testing, and clinical testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Polso™ Watch are assessed to be substantially equivalent to the predicate device.