The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

Device Description

The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs: Red: with a wavelength of 660 nm ± 10 nm, Infrared: with a wavelength of 940 nm ± 20 nm. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary for the circul™ pro Ring:

Acceptance Criteria and Device Performance

The primary performance metrics for this device are oxygen saturation (SpO2) and pulse rate (PR) accuracy. The acceptance criteria are largely derived from the ISO 80601-2-61:2017 standard for pulse oximeters, as well as the device's intended use and comparison with predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (from ISO 80601-2-61:2017 or internal protocol)	Reported Device Performance
SpO2 Accuracy (ARMS)	$\le$ 3.5% (SpO2 within 70% - 100% range)	1.85% (within the range of < 3%)
PR Accuracy (Range)	$\pm$ 2% or $\pm$ 2 bpm, whichever is greater (30 bpm – 240 bpm)	Mean Bias: -0.33 bpm; 95% CI: [-0.59, -0.07] bpm (all within $\pm$ 2 bpm)
Overall Device Safety	No breaking of connecting parts, no loose parts, normal operation, no inability to return to normal when rebooting.	Met (None of the results exceeded evaluation range; no adverse reactions)
Operational Stability	Able to match machine, good contact during use, no abnormal interruption due to machine malfunction.	Met (None of the results exceeded evaluation range; no adverse reactions)
Device Defects	No failures or defects causing injury during trial.	Met (None of the results exceeded evaluation range; no adverse reactions)
Adverse Events	No probe overheating, no allergic reactions, no other adverse events.	Met (No adverse reactions occurred during the trial)
Biocompatibility	Pass ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation/sensitization).	Successfully met requirements for skin-contacting components.

Study Details

The study was a clinical validation performed to support the substantial equivalence claim for the circul™ pro Ring.

Sample Size and Data Provenance:
- Test Set Sample Size: A total of 12 subjects were enrolled in the clinical study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It describes the study as being performed "per clause 201.12.1 of ISO 80601-2-61:2017," which is an international standard. The study was conducted as a prospective clinical validation, as subjects were enrolled and measured specifically for this purpose. The document mentions four of the twelve subjects (33.3%) had dark pigmentation, indicating consideration for diverse skin tones as per pulse oximetry guidelines.
Number of Experts and Qualifications for Ground Truth:
- The ground truth for SpO2 measurements was established by comparing the device readings with arterial saturation values recorded by a "Blood Oxygen, Electrolyte, and Metabolite Analyzer." This is a gold-standard method for direct arterial blood gas analysis.
- The ground truth for pulse rate was established by comparison with a "control patient monitor (IntelliVue Patient Monitor MX500/MX550)."
- The document does not specify the number or explicit qualifications of human experts (e.g., clinicians, laboratory technicians) involved in operating these reference devices or interpreting their output for the purpose of establishing ground truth, as the ground truth itself is derived from direct physiological measurements from a reference device.
Adjudication Method for the Test Set:
- None in the context of human expert adjudication. The "ground truth" for SpO2 and PR was established by comparison with direct measurements from validated reference medical devices (Blood Oxygen, Electrolyte, and Metabolite Analyzer for SpO2; IntelliVue Patient Monitor for PR). Safety endpoints (device defects, adverse events) would have been observed and recorded by study personnel.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This study focuses on the standalone performance of the device against established reference measurements, not on its assistance to human readers or the effect on human reader performance.
Standalone Performance:
- Yes, a standalone performance study (algorithm only, without human-in-the-loop performance) was performed. The study directly compared the device's measurements (SpO2 and PR) against the gold-standard reference devices.
Type of Ground Truth Used:
- The ground truth used was physiological reference measurements (arterial blood gas analysis for SpO2, and a validated patient monitor for PR). This is generally considered a highly reliable and objective form of ground truth for physiological parameters.
Sample Size for the Training Set:
- The document does not specify a separate training set sample size or how it was established. Given this is a 510(k) submission for a physical device (pulse oximeter) rather than a complex AI algorithm, the "training" would primarily refer to the device's internal calibration and algorithm development, which might involve laboratory testing and data collection during the R&D phase, rather than a distinct "training set" in the machine learning sense. The provided performance data relates to the validation of the finalized product.
How Ground Truth for Training Set Was Established:
- As no explicit training set is mentioned in the filing for the purpose of this validation study, the method for establishing ground truth for any internal development/training data is not detailed in this document. It is implied that the device's algorithms were developed to meet the accuracy requirements of the ISO 80601-2-61 standard, which typically relies on established calibration methods and reference measurements.

Summary

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August 29, 2023

BodiMetrics, LLC % Michael Nilo President & Prinicipal Consultant Nilo Medical Consulting Group, LLC 3491 Denny Street Pittsburgh, Pennsylvania 15201

Re: K221361

Trade/Device Name: circul™ pro Ring Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 11, 2023 Received: August 14, 2023

Dear Michael Nilo:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Bradley Q. Quinn -S

Bradley Quinn Assistant 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

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Indications for Use

D-2

510(k) Number (if known) K221361

Device Name circul™ pro Ring

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	「 Over-The-Counter Use (21 CFR 801 Subpart C)

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This 510(k) Summary was prepared in accordance with 21 CFR 807.92

Date Prepared 1.

December 2022

Submitter 2.

Applicant:	BodiMetrics, LLC1601 N. Sepulveda Blvd, Suite 839Manhattan Beach, CA 90266
Official Contact:	Mark GoettlingCEO, CFO, and Co-FounderPhone: (818) 268-6828Email: mgoettling@bodimetrics.com
ApplicationCorrespondent:	Michael NiloPresident and Principal Consultant, Nilo Medical Consulting GroupPhone: (717) 421-4396Email: michael.nilo@nilomedicalconsulting.com

3. Proposed Device Information

Trade Name:	circul TM pro Ring
Common Name:	Oximeter
Device Classification:	Name: OximeterRegulation No.: 21 CFR 870.2700Product Code: DQAClass: II

4. Predicate Device Information

Trade Name:	Belun Ring BLR-100X
510(k) Number:	K211407
Common Name:	Oximeter
Device Classification:	Name: OximeterRegulation No.: 21 CFR 870.2700Product Code: DQAClass: II

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Trade Name:	Oxiband (Checkme) O2 Pulse Oximeter
510(k) Number:	K191088
Common Name:	Oximeter
Device Classification:	Name: OximeterRegulation No.: 21 CFR 870.2700Product Code: DQAClass: II

Reference Device Information ട്.

6. Device Description

Red: with a wavelength of 660 nm ± 10 nm
Infrared: with a wavelength of 940 nm ± 20 nm ●

The wavelength beyond this range has a certain impact on the accuracy of the measurement results. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.

7. Indications for Use

The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

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Comparison of Technical Characteristics with the Predicate Device 8.

Comparison Element	Subject Devicecircul pro Ring	Predicate DeviceBelun Ring BLR 100X	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
Basic Elements
Product Name	Pulse Oximeter	Pulse Oximeter	Pulse Oximeter	Identical
Manufacturer	Hangzhou MegasensTechnology Company,Ltd.	Belun TechnologyCompany Ltd.	Shenzen ViatomTechnology Co., Ltd.	N/A
FDA 510(k) DocumentNumber	K221361	K211407	K191088	N/A
Regulation Number	870.2700	870.2700	870.2700	Identical
Classification	II	II	II	Identical
Classification Name	Oximeter	Oximeter	Oximeter	Identical
Product Code	DQA	DQA	DQA	Identical
Comparison Element	Subject Device	Predicate Device	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
	circulTM pro Ring	Belun Ring BLR 100X
Intended Use	The circulTM pro Ring is awireless, non-invasive, andstand-alone pulse oximeterintended to be used forspot-check and/orcontinuous data collectionof oxygen saturation ofarterial hemoglobin (SpO2)and pulse rate (PR) throughthe index in adult patients.It can be used in hospitalsand home environments forup to twelve hours in non-motion and well perfusedconditions. It is notintended for single-use andout-of-hospital transportuse and does not havealarms.	Belun Ring BLR-100X is awireless, non-invasive andstand-alone pulse oximeterintended to be used forcontinuous data collectionand recording of oxygensaturation of arterialhemoglobin (SpO2) and thepulse rate of adult patientsthrough index finger inhospital and homeenvironment for up to tenhours, during no motionand motion conditions, andfor patients who are well orpoorly perfused. It is notintended for single-use andout-of-hospital transportuse and does not havealarms.	The Oxiband PulseOximeter is a wrist pulseoximeter indicated for usein measuring, displaying,storing and transmittingfunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate for adult patients.It is intended for spot-checkand/or continuous datacollection, and notcontinuous monitoring. Itcan be used in sleep labs,long-term care, hospitalsand home use.	Substantially EquivalentBoth the subject and predicate device share theindication for collection of oxygen saturation orarterial hemoglobin (SpO2) and pulse rate (PR)through the index finger and are therefore consideredsubstantially equivalent.The subject device's indication statement reflects itsfunctionality, in that the subject device is not intendedfor motion conditions. Use of the subject device forup to twelve hours is supported by testing whichdemonstrated safe and effective performance underthese conditions. Also, the performance of the subjectdevice was not evaluated in poorly perfused subjectsand the indication reflects this. The subject device isused for spot-check or continuous data collection, andnot continuous monitoring whereas the predicatedevice is indicated for continuous data collection. Thesubject device shares the same indication as thelegally marketed reference device for use conditionsand is therefore considered substantially equivalent.Although the subject device proposes a longerperformance window and does not seek indication formotion or poorly perfused conditions relative to thepredicate device, the differences in the proposedindication does not raise different questions of safetyor effectiveness as the performance of the subjectdevice is adequately supported by test data.
Technology
Technology Type	Reflective Light	Reflective Light	Reflective Light	Identical
Intended Application Site	Finger	Finger	Finger	Identical
Comparison Element	Subject Devicecircul pro Ring	Predicate DeviceBelun Ring BLR 100X	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
Measurement Wavelength
Red	$660 nm \pm 10 nm$	$658 nm \pm 2 nm$	Not Reported	Substantially Equivalent
Infrared	$940 nm \pm 20 nm$	$886 nm \pm 6 nm$	Not Reported	Although the measurement wavelengths of the subjectand predicate device differ slightly, the ability of thesubject device to perform accurate measurements wasconfirmed by meeting the requirements ISO 80601-2-61 as well as a clinical validation which includeddarkly pigmented subjects. Therefore, the minordifferences between the measurement wavelength ofthe subject and predicate devices do not raise differentquestions of safety or effectiveness.
Performance
Interface	Bluetooth (BLE 4.1)	• USB• Bluetooth	Bluetooth	Substantially Equivalent
User Interface	Via mobile application	Via host program interface	Not reported	Substantially EquivalentThe user interface of the subject and predicate deviceare similar, and the ability of the subject device toperform and report accurate measurements wasconfirmed by meeting the requirements ISO 80601-2-61 as well as a clinical validation. Therefore, theminor differences between the subject and predicatedevice interfaces do not raise different questions ofsafety or effectiveness.
Battery	3.7 V Lithium Battery	3.7 V Lithium Battery	Lithium RechargeableBattery	Substantially Equivalent
Power SupplyRequirement	5 V DC (minimum)	3.1 V - 4.2 V DC	Not reported	Substantially EquivalentThe differences in power supply requirements do notraise different questions of safety or effectiveness.
Comparison Element	Subject Devicecircul pro Ring	Predicate DeviceBelun Ring BLR 100X	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
SpO2 MeasurementRange	70% - 100%	70% - 100%	Not reported	Substantially EquivalentThe SpO2 measurement range of the subject device issimilar to the SpO2 measurement range of thepredicate and reference devices. The SpO2measurement of the subject device meets therequirements of the ISO 80601-2-61.
SpO2 Accuracy	$\pm$ 3.5% (SpO2 within 70% -100% range)	$\pm$ 2.7%	70% - 100%: $\pm$ 2%(Arms:1.88)70%-80%: $\pm$ 3%80%-90%: $\pm$ 2%90%-100%: $\pm$ 2%0%-69%: not defined	Substantially EquivalentThe SpO2 measurement accuracy of the subjectdevice is similar to the SpO2 measurement accuracyof the predicate and reference devices. The SpO2measurement of the subject device meets therequirements of the ISO 80601-2-61, so the differencedoes not affect the safety and effectiveness of thesubject device.
PR Measurement Range	30 bpm – 240 bpm	30 bpm – 250 bpm	30 bpm – 250 bpm	Substantially EquivalentThe PR measurement range of the subject device issimilar to the PR measurement range of the predicateand reference devices. The PR measurement of thesubject device meets the requirements of the ISO80601-2-61, so the difference does not affect thesafety and effectiveness of the subject device.
PR Accuracy	$\pm$ 2% or $\pm$ 2 bpm,whichever is greater	$\pm$ 2.5bpm or $\pm$ 2%, which islarger	$\pm$ 2bpm or $\pm$ 2%, whicheveris greater	Substantially EquivalentThe PR measurement accuracy of the subject deviceis within the range of the predicate and referencedevices. The PR measurement accuracy of the subjectdevice meets the requirements of ISO 80601-2-61, soany minor differences do not raise new questions ofsafety or effectiveness.
Atmospheric Pressure	70 kPa - 106 kPa	70 kPa - 106 kPa	70 kPa – 106 kPa	Identical
Comparison Element	Subject Devicecircul pro Ring	Predicate DeviceBelun Ring BLR 100X	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
Operating Temperature	5°C - 40°C	10°C - 38°C	5°C - 40°C	Substantially EquivalentThe operating temperature of the subject device isidentical to the reference device, which is a widerrange than the predicate device. The subject devicemet the requirements of IEC 60601-1, IEC 60601-1-11, and ISO 80601-2-61. The difference in operatingtemperature between the subject and predicate devicedoes not raise new questions of safety oreffectiveness.
Relative Humidity	30% - 80%(non-condensing)	≤ 75%	10% - 95%	Substantially EquivalentThe relative humidity of the subject device fallswithin the range of the reference device. The subjectdevice met the requirements of IEC 60601-1, IEC60601-1-11, and ISO 80601-2-61. The difference inrelative humidity between the subject and predicatedevice does not raise new questions of safety oreffectiveness.
Storage Environment	-10°C - 50°C Temperature15% - 95% RelativeHumidity (non-condensing)70 kPa - 106 kPaAtmospheric Pressure	-10°C - 60°C Temperature10% - 95% RelativeHumidity50 kPa - 106 kPaAtmospheric Pressure	-25°C - 70°C	Substantially EquivalentThe storage environment conditions of the subjectdevice fall within the range of the subject andreference devices and are expressed in the devicelabeling.The subject device met the requirements of IEC60601-1, IEC 60601-1-11, and ISO 80601-2-61. Thedifference in storage conditions between the subjectand predicate device does not raise new questions ofsafety or effectiveness.
IP Classification	IP65	IP22	Not Reported	Substantially EquivalentThe subject device met the requirements of ISO80601-2-61. The difference in ingress protectionbetween the subject and predicate device does notraise new questions of safety or effectiveness.
Normal Service Life	3 Years	3 Years	Not Reported	Identical
Comparison Element	Subject Devicecircul pro Ring	Predicate DeviceBelun Ring BLR 100X	Reference DeviceOxiband (Checkme) O2Pulse Oximeter	Comments
Contacting Materials	Stainless Steel, PC	TPE, PC	Not Reported	Substantially EquivalentThe subject device met the requirements of ISO10993 testing for skin-contacting materials.Therefore, the difference in contacting materials doesnot raise new questions of safety or effectiveness.

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Performance Data 9.

Non-Clinical Testing

The proposed device was tested in accordance with both mandatory and voluntary standards, including:

. ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
. EN 60601-1:2006+A1:2013 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General ● requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2+A1: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

The results of bench testing for pulse oximetry accuracy showed an acceptable accuracy of ± 3.5% SpO2 within a range of 70% - 100%. No claims are made for SpO2 accuracy under conditions of motion or low perfusion. The results of bench testing for pulse rate accuracy showed an acceptable accuracy of ± 2% or ± 2 bpm (30 bpm – 240 bpm). No claims are made for Pulse Rate accuracy under conditions of motion or low perfusion.

Software validation was performed per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The management of cybersecurity is in compliance with the FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Biocompatibility testing successfully met the requirements for the skin-contacting components of the circul pro Ring per applicable standards:

ISO 10993-5:2009: Biological evaluation of medical devices Part 5: Tests for in ● vitro cytotoxicity
ISO 1099-3-10:2010: Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization

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Clinical Testing

A clinical study was performed per clause 201.12.1 of ISO 80601-2-61:2017, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The study enrolled a total of twelve subjects, four of which had dark pigmentation (33.3%). In the study, the subjects' blood oxygen saturation was measured using the circul pro Ring and the values were then compared with arterial saturation values recorded by a Blood Oxygen, Electrolyte, and Metabolite Analyzer.

The primary endpoint of the study was the accuracy of the circul pro pulse blood oxygen saturation measurements as compared to the SaO2 measurements of the control device. The measurement error of the circul pro Ring in the range of 70% - 100% should be ≤ 3.5%. The secondary endpoints of the study were:

. The accuracy of the pulse rate recorded by the circul pro Ring as compared to the heart rate measured by a control patient monitor (IntelliVue Patient Monitor MX500/MX550)
. The overall device safety, operational stability, device defects, and incidence of adverse events (complications)
- Overall device safety -
  - . Breaking of the connecting parts of the overall device system
  - Parts loose and falling off during use, resulting in abnormal . operation
  - Unable to return to normal when rebooting ●
  - Other (with a description provided) .
- I Operational stability
  - Unable to match the machine ●
  - Poor contact during use ●
  - Abnormal interruption occurring for reasons attributable to the ● machine during use
  - Other (with a description provided) .
- I Device defects
  - Device failures or defects (including the overall safety of the tested ● device, operational stability, and whether any failure of the tested device caused any injury to the subject) during the trial
- I Incidence of adverse events
  - Where a medical oximeter is placed, the probe overheated and the . skin showed an allergic reaction
  - Other (with a description provided) .

The Accuracy Root Mean Square (ARMS) of the blood oxygen saturation measured by the circul pro Ring was 1.85%, within the range of < 3%. The mean bias between the measured pulse rate and the heart rate measured by the control device was -0.33 bpm, and

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its 95% confidence interval was [-0.59, -0.07] bpm, all within the allowable error range of ± 2 bpm. None of the results exceeded the evaluation range to be satisfied, and no adverse reactions occurred during the trial. The results of the clinical study demonstrated that the measurement accuracy of the circul pro Ring for blood oxygen saturation and pulse rate met the protocol requirements, and that it is accurate and safe during use.

10. Conclusion

The proposed circul pro Ring has the same classification information, similar intended use, and similar technologies as the predicate device. According to non-clinical test results, the proposed device is substantially equivalent to the predicate and reference devices.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).