(258 days)
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or algorithms that learn from data. The performance studies focus on standard clinical accuracy metrics and comparisons to predicate devices.
No
The device is described as an oximetry system intended for noninvasive measuring of various oxygen and hemoglobin saturation levels. Its function is diagnostic/monitoring, not therapeutic.
Yes.
The device measures various physiological parameters like oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin, and regional oxygen saturation, which are used to assess a patient's condition. While it states it's not for sole use in clinical decision-making, the act of measuring these parameters for assessment constitutes a diagnostic function.
No
The device description explicitly states the system consists of three components: the display, the signal processor, and associated sensors. This indicates the device includes hardware components beyond just software.
Based on the provided text, the Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The H500 System measures physiological parameters directly from the patient's body using non-invasive sensors (%SpO2, pulse rate, %COHb, %MetHb, %rSO2). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes measuring these parameters directly on patients.
- Device Description: The description reinforces that it's a handheld wireless device with sensors applied to the patient.
Therefore, the H500 System falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA, MUD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, infant, and neonate patients.
Intended User / Care Setting
Professional healthcare facilities, mobile, and EMS settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
SpO2 accuracy testing 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 70 – 100%. Accuracy data was calculated using the rootmean-squared (Arms value) for all subjects, per ISO 80601-2-61.
SpO2 in Presence of COHb and MetHb accuracy testing 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.
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
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.
| 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.
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."
3
Image /page/3/Picture/1 description: The image shows the logo for NONIN. The logo consists of two overlapping orange squares on the left side of the image. To the right of the squares is the word "NONIN" in blue, with each letter being capitalized.
K192900 510(k) Summary – H500 Multi-Sensing Oximetry System
| Submitter:
Phone:
Fax: | Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443
763 553 9968
763 553 7807 |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brent Geiger, MS, RAC
Vice President Quality, Regulatory and Clinical Affairs |
| Date Prepared:
Trade Names: | January 31st, 2020
CO-Pilot™ Model H500 Multi-Sensing Oximetry System |
| Common Name:
Classification Name:
Regulation Number:
Product Code, Panel: | Oximeter
Oximeter
Class II, 21 CFR 870.2700 (Oximeter)
DQA, Anesthesiology
MUD, 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.
4
Image /page/4/Picture/1 description: The image contains the logo for Nonin. The logo consists of two overlapping orange squares on the left, followed by the word "NONIN" in blue. The letters are bold and sans-serif.
- 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.
| 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 System | |||
| Display | 8100AA: Measures SpO2 and pulse rate of adult | ||
| and pediatric patients (> 30 kg / 66 lb) who are | |||
| well or poorly perfused, during both motion and | |||
| non-motion conditions. | |||
| • SP-BLE – Signal | |||
| Processor for use with the | |||
| H500 System | 8100AP: Measures SpO2 and pulse rate of | ||
| pediatric patients (8 – 60 kg / 18 – 132 lb) who | |||
| are well or poorly perfused, during both motion | |||
| and non-motion conditions | |||
| • X-100SL – Signal | |||
| Processor Sensor Lock, 2- | |||
| pack | |||
| • H500CC – Carrying case | |||
| • INT-100 Intermediate | |||
| Cable for use with 8204CA | |||
| only. | 8100S Series | K132402 | Reusable, Soft Pulse Oximeter Sensor |
| • INT-200 Intermediate | |||
| Cable for use with SpO2- | |||
| only sensors | 8100SL: Measures SpO2 and pulse rate of adult | ||
| and pediatric patients who are well or poorly | |||
| perfused, during both motion and non-motion | |||
| conditions, with digit height (thickness) of 12.5 – | |||
| 25.5 mm (0.5 – 1.0 in.). | |||
| 8100SM: Measures SpO2 and pulse rate of | |||
| adult and pediatric patients who are well or | |||
| poorly perfused, during both motion and non- | |||
| motion conditions, with digit height (thickness) of | |||
| 10 – 19 mm (0.4 – 0.75 in.). | |||
| 8100SS: Measures SpO2 and pulse rate of adult | |||
| and pediatric patients who are well or poorly | |||
| perfused, during both motion and non-motion | |||
| conditions, with digit height (thickness) of 7.5 – | |||
| 12.5 mm (0.3 – 0.5 in.). | |||
| 6100C Series | K160865 | Single-Patient Use, Disposable Pulse Oximeter | |
| Sensors | |||
| 6100CA: Measures SpO2 and pulse rate of adult | |||
| patients (> 30 kg / 66 lb) who are well or poorly | |||
| perfused, during both motion and non-motion | |||
| conditions. | |||
| 6100CP: Measures SpO2 and pulse rate of | |||
| pediatric patients (> 10 kg / 22 lb) who are well |
5
Image /page/5/Picture/1 description: The image contains the logo for Nonin. The logo consists of two overlapping orange squares on the left side of the image. To the right of the squares is the company name "NONIN" in blue, with each letter being capitalized.
| 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 ( 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
6
Image /page/6/Picture/1 description: The image shows the logo for Nonin. The logo consists of two overlapping orange squares on the left, followed by the word "NONIN" in blue. The letters are in a sans-serif font and are slightly rounded.
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 60601-1 | |
| EN 1789 | Pass | |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity and | ||
| Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61 | |
| IEC 60601-1 | ||
| IEC 60601-1-6 | ||
| IEC 60601-1-12 | ||
| IEC 62304 | ||
| ANSI/AAMI EC13 | ||
| ISO 14155 | Pass | |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance | |
| characterization | Pass | |
| Mechanical Durability | IEC 60601-1 | |
| ISO 80601-2-61 | ||
| ISTA 2A | ||
| ASTM 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.
7
Image /page/7/Picture/1 description: The image contains the logo for NONIN. The logo consists of two overlapping orange squares on the left side of the image. To the right of the squares is the company name, NONIN, in blue font.
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.
8
Image /page/8/Picture/0 description: The image shows the logo for NONIN. The logo consists of two overlapping orange squares that are rotated 45 degrees. To the right of the squares is the word "NONIN" in blue, with each letter being capitalized.
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 | |||
|---|---|---|---|
| Important | |||
| Parameters | Subject Device | ||
| CO-Pilot TM Model H500 Multi- | |||
| Sensing Oximetry System | Primary Predicate Device | ||
| X-100 System (K132402) | Reference Predicate Devices | ||
| X-100C/Multi-Sensing | |||
| Oximetry System (K160231 | |||
| and K172625) | |||
| Intended Use | Same | ||
| All systems are intended to be used to noninvasively measure physiological parameters including | |||
| functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin | |||
| saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin | |||
| oxygen saturation (%rSO2) | |||
| Product Code | DQA/MUD | DQA/MUD | DQA |
| FDA Regulation | Same | ||
| 870.2700 | |||
| Indications for | |||
| Use | 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. | The X-100 system is a modular system | ||
| and is indicated for use in | |||
| simultaneously measuring, displaying, | |||
| monitoring, and recording up to six (6) | |||
| channels of functional oxygen saturation | |||
| of arterial hemoglobin (%SpO2) and | |||
| pulse rate or cerebral or somatic | |||
| hemoglobin 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, sub-acute | |||
| environments, and Emergency Medical | |||
| Services (EMS), including patient | |||
| transport. The X-100 SenSmart system | |||
| may be used for spot-checking and | |||
| continuous monitoring with patient | |||
| alarms. The SenSmart pulse oxlmetry | |||
| (SpO2) functionality Is suitable for use | |||
| In both motion and non-motion | |||
| conditions, Including patients who are | |||
| well or poorly perfused. | The X-100C/Multi-Sensing Oximetry | ||
| system is indicated for noninvasive | |||
| measuring of functional oxygen | |||
| saturation of arterial hemoglobin | |||
| (%SpO2), carboxyhemoglobin | |||
| saturation (%COHb), methemoglobin | |||
| saturation (%MetHb), and pulse rate of | |||
| adult and pediatric patients (>66 lbs / 30 | |||
| kg) using the Model 8300AA/8330AA | |||
| sensor. The measurements may be | |||
| multiple spot-checks to observe change | |||
| and/or continuous monitoring. The | |||
| systems are indicated for use by trained | |||
| personnel in clinical and non-clinical | |||
| settings, including Emergency Medical | |||
| Service (EMS), hospitals, medical | |||
| facilities, and mobile environments. 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. | |||
| Use | |||
| Environment | Professional healthcare facilities, | ||
| mobile, and EMS settings | Hospitals, long-term care, | ||
| medical facilities, sleep | |||
| laboratories, sub-acute | |||
| environments, and EMS | |||
| settings | Hospitals, medical facilities, | ||
| mobile environments and EMS | |||
| settings | |||
| Compatible | |||
| Sensor | |||
| Accessories | Same | ||
| 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. | |||
| Compatible | |||
| Sensor | |||
| Application | |||
| Sites | Same | ||
| As specified in the respective sensor instructions for use | |||
| Handheld or | |||
| Tabletop? | Handheld | Tabletop | Tabletop |
| Wireless? | Yes | No | No |
| Includes Patient | |||
| Alarms? | No | Yes | Yes |
| Principles of | |||
| Operation | Same | ||
| Non-invasive oximetry using light-based measurement sharing the same measurement technology | |||
| including optics specifications and signal processing algorithms. | |||
| Range of SpO2 | Same | ||
| 0-100% | |||
| Range of Pulse | |||
| Rate | |||
| (beats per | |||
| minute) | 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% |
| Safety | |||
| Specifications | Same | ||
| IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 80601-2-61 | |||
| Specified | |||
| Environmental | |||
| Use Conditions | Same | ||
| All systems share the same specified operating temperature (5-40°C), storage/transport | |||
| temperature and humidity (-30 to 70°C, up to 93%), operating humidity (15-93%) and operating | |||
| altitude (0-4000m) | |||
| Enclosure | |||
| Degree of | |||
| Ingress | |||
| Protection | Same | ||
| IP33 | |||
| Provided | |||
| Sterile? | Same | ||
| No |
9
Image /page/9/Picture/0 description: The image contains the word "NONIN" in blue font. To the left of the word is a logo consisting of two overlapping orange squares that are rotated 45 degrees. The word "NONIN" is written in all capital letters and is a sans-serif font. The first two letters are a darker shade of blue than the last three letters.
10
Image /page/10/Picture/0 description: The image contains the logo for NONIN. The logo consists of two orange squares that are overlapping each other on the left side of the image. To the right of the squares, the word "NONIN" is written in blue, block letters.
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.