The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

· For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings.

· For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings.

· For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/ or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

Device Description

The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is a small handheld wireless device intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2) of adult, pediatric and neonate patients. It is intended for professional use only, in healthcare facilities, mobile and EMS environments. The system is not provided sterile and is not a reprocessed single-use device. The H500 System consists of three components which are the display, the signal processor and associated sensors. It is intended to be used with specific parts, accessories and compatible sensors which are outlined in Table 1 below.

AI/ML Overview

The Nonin Medical CO-Pilot Model H500 Multi-Sensing Oximetry System is intended for non-invasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). The device underwent comprehensive testing to establish its accuracy and substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on the root-mean-squared (Arms) value, calculated per ISO 80601-2-61, for each physiological parameter. While the specific numerical acceptance criteria (e.g., maximum allowable Arms value) are not explicitly stated in the provided text, the document indicates that the device "meets all testing acceptance criteria." The described performance is the result of applying the stated methods and the device passing these criteria.

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance (as stated by "Pass")
COHb Accuracy	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.
MetHb Accuracy	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.
SpO2 Accuracy (No motion)	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.
SpO2 Accuracy (in presence of COHb and MetHb)	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.
rSO2 Accuracy (8004CA/8204CA sensors)	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.
rSO2 Accuracy (8004CB/8004CB-NA sensors)	(Implicitly an Arms value within a specified range per ISO 80601-2-61)	Data calculated using root-mean-squared (Arms value) for all subjects and reported as meeting requirements.

2. Sample Size Used for the Test Set and Data Provenance

COHb, MetHb, SpO2 (no motion), SpO2 (with COHb and MetHb):
- Sample Size: "healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
- Data Provenance: Prospective, conducted at an "independent research laboratory." The country of origin is not specified but it's an FDA submission, implying a US-based or internationally recognized standard for testing.
rSO2 (8004CA/8204CA sensors):
- Sample Size: "healthy, non-smoking, light- to dark-skinned subjects that were 18 years of age and older." The exact number of subjects is not specified, but the testing was "for all subjects."
- Data Provenance: Prospective, conducted during "induced hypoxia studies." The location is not specified, but implicitly an independent research laboratory.
rSO2 (8004CB/8004CB-NA sensors):
- Sample Size: "sick, male and female, pediatric patients ranging in age from 4 days to 10 years with light- to dark-skin." The exact number of subjects is not specified, but the testing was "for all subjects."
- Data Provenance: Prospective, conducted in "cardiac catheterization laboratories." The location is not specified but implicitly an independent research laboratory.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for all clinical accuracy testing was established using laboratory CO-oximetry for COHb, MetHb, and SpO2, and arterial/venous blood gas analysis for rSO2. This method relies on validated laboratory equipment rather than human expert consensus. Therefore, the concept of "number of experts" is not directly applicable in the same way it would be for image interpretation tasks. However, the operation and interpretation of these laboratory gold standard devices would have been performed by qualified laboratory personnel. Specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable as the ground truth was established by objective laboratory measurements (CO-oximetry and blood gas analysis), not via human expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the measurement accuracy of the device itself against established reference methods, not on how human readers' performance might improve with or without AI assistance from this specific device. The device is a multi-sensing oximetry system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC reader study to assess human-AI symbiosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical accuracy testing described for COHb, MetHb, SpO2, and rSO2 are standalone performance studies. The device's measurements were directly compared against the "gold standard" laboratory methods (CO-oximetry and blood gas analysis) to determine its accuracy without human interpretation influencing the measurement outcome. The device itself is an algorithm-driven measurement system.

7. The Type of Ground Truth Used

For %COHb, %MetHb, %SpO2, and %SpO2 in presence of COHb and MetHb: The ground truth was objective laboratory measurements from arterial blood samples as assessed by CO-oximetry.
For %rSO2: The ground truth was objective laboratory measurements from venous and arterial blood samples as assessed by blood gas analysis, modeling blood in the brain as 70% venous and 30% arterial.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. This suggests the device's underlying signal processing algorithms were developed and validated independently or through proprietary methods not detailed in this 510(k) summary. The clinical accuracy studies described are test set evaluations for regulatory submission.

9. How the Ground Truth for the Training Set Was Established

Information on how the ground truth for any potential training set was established is not provided in this document.

Summary

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Nonin Medical, Inc. Brent Geiger Vice President Quality, Regulatory,Clinical Affairs 13700 1st Avenue North Plymouth, Minnesota 55441

Re: K192900

Trade/Device Name: Nonin Medical CO-Pilot Model H500 Multi-Sensing Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, MUD Dated: May 21, 2020 Received: May 26, 2020

Dear Brent Geiger:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

Todd Courtney Assistant Director DHT1C: Division of ENT, 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) K192900

Device Name

Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System

Indications for Use (Describe)

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)

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K192900 510(k) Summary – H500 Multi-Sensing Oximetry System

Submitter:Phone:Fax:	Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443763 553 9968763 553 7807
Contact Person:	Brent Geiger, MS, RACVice President Quality, Regulatory and Clinical Affairs
Date Prepared:Trade Names:	January 31st, 2020CO-Pilot™ Model H500 Multi-Sensing Oximetry System
Common Name:Classification Name:Regulation Number:Product Code, Panel:	OximeterOximeterClass II, 21 CFR 870.2700 (Oximeter)DQA, AnesthesiologyMUD, Cardiovascular

Predicate Devices

Primary Predicate Device - Nonin's SenSmart X-100 Universal Oximetry System (refer to clearance K132402) is the primary predicate and is a modular system that is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoqlobin (%SpO2) and pulse rate or cerebral or somatic hemoqlobin oxygen saturation (%rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories and subacute environments. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (%SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Reference Predicate Devices - Nonin's X-100C/Multi-Sensing Oximetry Systems (refer to clearances K160231 and K172625) are additional reference predicate devices for this submission and are indicated for noninvasive spot-checking and/or continuous monitoring of carboxyhemoglobin (%COHb), methemoglobin (%MetHb), functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of adult and pediatric patients. The systems are indicated for use by trained personnel in clinical and nonclinical settings, including Emergency Medical Service (EMS), hospitals, medical facilities, mobile environments, and home healthcare environments.

Indications for Use

The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninyasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemodlobin saturation (%COHb), methemodlobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring . during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings.
. For %rSO2, the H500 System is intended for spot-checking and/or measuring dinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings.

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For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

Device Description

Parts and Accessories	Compatible Sensors
	Sensor Model	510(k)	Description
• H500-PS – Power Supply,25W and cable	8100A Series	K160865	Reusable, Finger Clip Pulse Oximeter Sensor
• D-HH – H500 SystemDisplay			8100AA: Measures SpO2 and pulse rate of adultand pediatric patients (> 30 kg / 66 lb) who arewell or poorly perfused, during both motion andnon-motion conditions.
• SP-BLE – SignalProcessor for use with theH500 System			8100AP: Measures SpO2 and pulse rate ofpediatric patients (8 – 60 kg / 18 – 132 lb) whoare well or poorly perfused, during both motionand non-motion conditions
• X-100SL – SignalProcessor Sensor Lock, 2-pack
• H500CC – Carrying case
• INT-100 IntermediateCable for use with 8204CAonly.	8100S Series	K132402	Reusable, Soft Pulse Oximeter Sensor
• INT-200 IntermediateCable for use with SpO2-only sensors			8100SL: Measures SpO2 and pulse rate of adultand pediatric patients who are well or poorlyperfused, during both motion and non-motionconditions, with digit height (thickness) of 12.5 –25.5 mm (0.5 – 1.0 in.).
			8100SM: Measures SpO2 and pulse rate ofadult and pediatric patients who are well orpoorly perfused, during both motion and non-motion conditions, with digit height (thickness) of10 – 19 mm (0.4 – 0.75 in.).
			8100SS: Measures SpO2 and pulse rate of adultand pediatric patients who are well or poorlyperfused, during both motion and non-motionconditions, with digit height (thickness) of 7.5 –12.5 mm (0.3 – 0.5 in.).
	6100C Series	K160865	Single-Patient Use, Disposable Pulse OximeterSensors
			6100CA: Measures SpO2 and pulse rate of adultpatients (> 30 kg / 66 lb) who are well or poorlyperfused, during both motion and non-motionconditions.
			6100CP: Measures SpO2 and pulse rate ofpediatric patients (> 10 kg / 22 lb) who are well

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		or poorly perfused, during both motion and non-motion conditions.
		6100CI: Measures SpO2 and pulse rate of infant patients (> 2 kg / 4 lb) who are well or poorly perfused, during both motion and non-motion conditions.
		6100CN: Measures SpO2 and pulse rate of neonate patients (< 2 kg / 4 lb) and adult patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
8100Q2	K160865	Reusable Ear Clip Pulse Oximeter Sensor
		Measures SpO2 and pulse rate of adult and pediatric patients (>40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions.
8004CA	K132402	Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor
		Measures rSO2 of adult and pediatric patients weighing ≥ 88 pounds (40 kilograms).
8004CB	K132402	Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor
		Measures rSO2 of neonate, infant, and pediatric patients weighing ≤ 88 pounds (40 kilograms).
8004CB-NA	K132402	Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor
		Measures rSO2 of neonate, infant, and pediatric patients weighing ≤ 88 pounds (40 kilograms).
8204CA	K151305	Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor
		Measures rSO2 of adult and pediatric patients weighing ≥ 88 pounds (40 kilograms).
8330AA	K172625	Multi-Sensing Reusable Finger Clip Sensor
		Measures SpO2, COHb, MetHb and pulse rate of adult and pediatric patients (> 66 lbs/30 kg).

Table 1: H500 Parts, Accessories and Compatible Sensors

The H500 system is compatible and intended to be used only with Nonin-branded oximeter sensors. Such sensors are manufactured to meet the accuracy specifications for Nonin oximeters and using other manufacturers' sensors can result in improper oximeter performance. Sensor application sites are as specified in the respective instructions for use.

The main function of the H500 System software is to acquire signal data for oximetry measurements and translate that data into pulse rate, %SpO2, %COHb, %MetHb, and/or %rSO2 data for the display device. The H500 system utilizes software separated into three distinct modules: display software, signal processor software and Bluetooth Low-Energy (BLE) radio software modules control and monitor interdependent system operations, generate errors, monitor and report on patient measurements, and provide the operator with a user interface. The software communicates oximetry data using the standard wireless BLE technology and determines when to turn the device on and off based on the user input to the display device. The H500 is not an alarm system and is not intended to be used for monitoring with patient alarms. Required software documentation deliverables and applicable software

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testing have been completed in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

System Performance Testing

The H500 Multi-Sensing Oximetry System and its associated sensors are supported by safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices were tested with the H500 system. A summary of such testing is as follows:

Wireless Coexistence Testing

Wireless Coexistence testing has been conducted following the ANSI C63.27:2017 procedure for cochannel and adjacent channel interference including overstress per Annex F.6. The Tier 1 (most rigorous) band-specific guidance per Annex A, Sub-clause A.2.2 for Bluetooth Low Energy was also followed.

Functional and Safety Testing - The results of the testing demonstrate equivalency with the predicate devices and compliance to recognized standards. Table 2 summarizes test results for the proposed devices, which met the relevant requirements of the applicable recognized standards.

Test	Reference	Result
Electrical Safety	IEC 60601-1	Pass
Temperature and Humidity	IEC 60601-1EN 1789	Pass
Atmospheric Pressure (Altitude)	IEC 60601-1	Pass
Electromagnetic Immunity andEmissions	IEC 60601-1-2	Pass
Performance	ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 60601-1-12IEC 62304ANSI/AAMI EC13ISO 14155	Pass
Ingress Protection	ISO 80601-2-61	Pass
Diaphoretic related ingress	Internal performancecharacterization	Pass
Mechanical Durability	IEC 60601-1ISO 80601-2-61ISTA 2AASTM D-4169	Pass
Biocompatibility	ISO 10993-1	Pass

Table 2 - Summary of Functional and Safety Testing

Clinical Accuracy Testing

COHb

COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older. The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by CO-oximetry. The accuracy of the sensors in comparison to the COoximeter samples measured over the COHb range of 0-15% with 95 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61. Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.

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MetHb

MetHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older. The measured methemoqlobin value (%MetHb) of the sensors was compared to simultaneous arterial blood samples as assessed by CO-oximetry. The accuracy of the sensors in comparison to the COoximeter samples measured over the MetHb range of 0 – 15% with 95 – 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61. Medical Electrical Equipments for basic safety and essential performance of pulse oximeter equipment.

SpO2

During no-motion conditions at an independent research laboratory, SpO2 accuracy testing was conducted during induced hypoxia studies on healthy, male and female, non-smoking, light- to darkskinned subjects that were 18 years of age and older. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70 – 100%. Accuracy data was calculated using the rootmean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.

Sp02 in Presence of COHb and MetHb

During no-motion conditions at an independent research laboratory, SpO2 accuracy testing in the presence of COHb and MetHb was conducted during induced hypoxia studies on healthy, male and female, non-smoking, light- to dark-skinned subjects that were 18 years of age and older. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 80 – 100%, range 0 – 15% COHb and SpO2 range of 80 – 100%, range 0 – 15% MetHb. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.

rSO2

rSO2 accuracy testing using 8004CA/8204CA sensors was conducted during induced hypoxia studies on healthy, non-smoking, light- to dark-skinned subjects that were 18 years of age and older. The measured regional hemoglobin saturation value (rSO2) of the sensors was compared to arterial/venous hemoglobin oxygen (SavO2) value, determined from venous and arterial blood samples. The model used for blood in the brain was 70% venous and 30% arterial, which is applicable under normocapnic conditions. The venous blood was drawn from the right jugular bulb. The accuracy of the sensors in comparison to the blood gas analyzer samples measured over the rSO2 range of 45 - 100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61. Medical Electrical Equipment—Particular requirements for basic safety and essential performance of pulse oximeter equipment.

rSO2 accuracy testing using 8004CB/8004CB-NA sensors was conducted in cardiac catheterization laboratories on sick, male and female, pediatric patients ranging in age from 4 days to 10 years with lightto dark-skin. The measured regional hemoglobin saturation value (rSO2) of the sensors is compared to arterial/venous hemoglobin oxygen (SavO2) value, determined from venous and arterial blood samples. The model used for blood in the brain was 70% venous and 30% arterial. The venous blood was drawn from the right jugular bulb. The accuracy of the sensors in comparison to the blood gas analyzer samples measured over the rSO2 range of 45 – 95%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment—Particular requirements for basic safety and essential performance of pulse oximeter equipment.

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Testing Conclusion

The subiect H500 Multi-Sensing Oximetry System meets all testing acceptance criteria. Based on test results, and comparison to the legally marketed predicates, the H500 Multi-Sensing Oximetry System performance is substantially equivalent to the predicate devices for its intended use.

Summary of Substantial Equivalence

The subject and predicate devices are all designed, developed and manufactured by Nonin Medical, Inc. All share the same intended use in that thev are intended to be used to noninvasively measure physiological parameters including %SpO2, pulse rate, %COHb, %MetHb, and %rSO2 and similar indications for use including use environment and intended patient populations. The systems all share the same measurement technology, principles of operation, safety specifications, sensor application sites, critical sensor optics technology and level of ingress protection. There are no changes in the optics performance specifications, optics wavelengths, and signal processing algorithms between the subject and predicates. The systems all use the same compatible sensor accessories and share the same specified environmental use conditions. The accuracy specifications are the same among the subject and predicates for their respective parameters. The subject H500 system uses the same SenSmart oximetry signal processing as the X-100C systems. As such, there is no accuracy difference between the predicate devices and the CO-Pilot H500 systems. The subject and predicate devices primarily differ in that the H500 System is small, handheld and wireless while the predicate systems are larger, wired and tabletop designs. Please refer to Table 3 for predicate device comparison table.

Table 3: Predicate Device Comparison Table
ImportantParameters	Subject DeviceCO-Pilot TM Model H500 Multi-Sensing Oximetry System	Primary Predicate DeviceX-100 System (K132402)	Reference Predicate DevicesX-100C/Multi-SensingOximetry System (K160231and K172625)
Intended Use	SameAll systems are intended to be used to noninvasively measure physiological parameters includingfunctional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobinsaturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobinoxygen saturation (%rSO2)
Product Code	DQA/MUD	DQA/MUD	DQA
FDA Regulation		Same870.2700
Indications forUse	The Nonin Medical CO-Pilot™ ModelH500 Multi-Sensing Oximetry System isintended for noninvasive measuring offunctional oxygen saturation of arterialhemoglobin (%SpO2), pulse rate,carboxyhemoglobin saturation (%COHb)methemoglobin saturation (%MetHb),and cerebral or somatic hemoglobinoxygen saturation (%rSO2). This deviceis not meant for sole use in clinicaldecision making; it must be used inconjunction with additional methods ofassessing clinical signs and symptoms.• For %SpO2 and pulse rate, the H500System is intended for spot-checkingand/or measuring during clinicianassessment of adult, pediatric, infant,and neonate patients who are well orpoorly perfused, during both motion andnon-motion conditions in professionalhealthcare facilities, mobile, and EMSsettings.• For %rSO2, the H500 System isintended for spot-checking and/ormeasuring during clinician assessment ofadult, pediatric, infant, and neonatepatients in professional healthcarefacilities, mobile, and EMS settings.• For %COHb and %MetHb, the H500System is intended for spot-checking,multiple spot-checks to observe change,and/or measuring during clinicianassessment of adult and pediatricpatients in professional healthcarefacilities, mobile, and EMS settings.	The X-100 system is a modular systemand is indicated for use insimultaneously measuring, displaying,monitoring, and recording up to six (6)channels of functional oxygen saturationof arterial hemoglobin (%SpO2) andpulse rate or cerebral or somatichemoglobin oxygen saturation (%rSO2)of blood underneath the sensor. Patientpopulations include adult, pediatric,infant, and neonate through the use ofSenSmart compatible sensors.The SenSmart system is intended foruse in hospitals, long-term care, medicalfacilities, sleep laboratories, sub-acuteenvironments, and Emergency MedicalServices (EMS), including patienttransport. The X-100 SenSmart systemmay be used for spot-checking andcontinuous monitoring with patientalarms. The SenSmart pulse oxlmetry(SpO2) functionality Is suitable for useIn both motion and non-motionconditions, Including patients who arewell or poorly perfused.	The X-100C/Multi-Sensing Oximetrysystem is indicated for noninvasivemeasuring of functional oxygensaturation of arterial hemoglobin(%SpO2), carboxyhemoglobinsaturation (%COHb), methemoglobinsaturation (%MetHb), and pulse rate ofadult and pediatric patients (>66 lbs / 30kg) using the Model 8300AA/8330AAsensor. The measurements may bemultiple spot-checks to observe changeand/or continuous monitoring. Thesystems are indicated for use by trainedpersonnel in clinical and non-clinicalsettings, including Emergency MedicalService (EMS), hospitals, medicalfacilities, and mobile environments. Thisdevice is not meant for sole use inclinical decision making; it must be usedin conjunction with additional methodsof assessing clinical signs andsymptoms.
UseEnvironment	Professional healthcare facilities,mobile, and EMS settings	Hospitals, long-term care,medical facilities, sleeplaboratories, sub-acuteenvironments, and EMSsettings	Hospitals, medical facilities,mobile environments and EMSsettings
CompatibleSensorAccessories	SameCompatible and intended to be used only with Nonin-branded oximeter sensors. Such sensors aremanufactured to meet the accuracy specifications for Nonin oximeters and using othermanufacturers' sensors can result in improper oximeter performance.
CompatibleSensorApplicationSites	SameAs specified in the respective sensor instructions for use
Handheld orTabletop?	Handheld	Tabletop	Tabletop
Wireless?	Yes	No	No
Includes PatientAlarms?	No	Yes	Yes
Principles ofOperation	SameNon-invasive oximetry using light-based measurement sharing the same measurement technologyincluding optics specifications and signal processing algorithms.
Range of SpO2	Same0-100%
Range of PulseRate(beats perminute)	18-321 bpm	18-300 bpm	18-321 bpm
Range of rSO2	0-100%	0-100%	N/A
Range of COHb	0-99%	N/A	0-99%
Range of MetHb	0-99.9%	N/A	0-99.9%
SafetySpecifications	SameIEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 80601-2-61
SpecifiedEnvironmentalUse Conditions	SameAll systems share the same specified operating temperature (5-40°C), storage/transporttemperature and humidity (-30 to 70°C, up to 93%), operating humidity (15-93%) and operatingaltitude (0-4000m)
EnclosureDegree ofIngressProtection	SameIP33
ProvidedSterile?	SameNo

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Conclusion

The subject and predicate devices have the same intended use, fundamental technology, and performance and share similar indications for use, including use environment and intended patient populations. They differ in size, handheld vs tabletop portability and patient alarms however such differences do not raise additional questions of safety and effectiveness. In conclusion, the subject and predicate devices are similar in all critical parameters that are essential for effectively measuring functional %SpO2, pulse rate, %COHb, %MetHb, and %rSO2 and any differences in technological or design characteristics do not raise different questions of safety and effectiveness and thus the devices are substantially equivalent.

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).