Pulse Oximeter

K191403 · Nonin Medical, Inc. · DQA · Dec 20, 2019 · Cardiovascular

Device Facts

• Record ID: K191403
• Device Name: Pulse Oximeter
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick, under non-motion conditions. For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

Device Story

Small, portable, reusable finger pulse oximeter; measures arterial hemoglobin saturation (%SpO2), pulse rate, and respiration rate. Inputs: red and infrared light absorption through perfused tissue. Operation: light passes through digit; device calculates parameters; displays values on integrated color LCD. Used in hospitals, clinics, long-term care, and home settings; operated by clinicians or patients for spot-checks. Provides visual pulse signal and poor pulse quality indicators. Output assists healthcare providers in assessing patient oxygenation and respiratory status; facilitates non-invasive monitoring without high-acuity requirements.

Clinical Evidence

Clinical testing included a respiratory rate accuracy study (n=30) comparing device output to capnography, and SpO2 accuracy testing (70-100% SaO2 range) on healthy subjects compared to co-oximetry. SpO2 accuracy measured via root-mean-squared (ARMS) values. Results demonstrated performance compliance with ISO 80601-2-61 and equivalency to predicate devices.

Technological Characteristics

Materials: Polycarbonate/Polyester enclosure, TPE finger pads. Sensing: Red (660nm) and IR (910nm) light absorption. Power: 3V DC (2x AAA batteries). Connectivity: Bluetooth 4.0. Form factor: Portable finger-clip. Software: Embedded firmware. Safety: Type BF, IP32 ingress protection. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1.

Indications for Use

Indicated for adult and pediatric patients (well or poorly perfused) for spot-check measurement of %SpO2 and pulse rate. Indicated for adult patients (well perfused) for spot-check measurement of respiration rate. Requires digit thickness 0.3–1.0 inch. Use restricted to non-motion conditions; not for high-acuity environments (ICU/OR).

Regulatory Classification

Identification

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

Predicate Devices

• Nonin Model 3230 Bluetooth Smart Pulse oximeter (K131021)

Reference Devices

• Nellcor Bedside Respiratory Patient Monitoring System (PM1000N) (K141518)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. Walter Holbein Manager, RA/CA 13700 1st Avenue North Plymouth, Minnesota 55441

Re: K191403

Trade/Device Name: Nonin Onyx 3, Model 9591 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 20, 2019 Received: November 25, 2019

## Dear Walter Holbein:

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 ([e-mail]) or phone [phone] 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) K191403

Device Name Nonin Onyx 3, Model 9591

#### Indications for Use (Describe)

The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.

For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.

For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

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

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# 1. 510(k) Summary: K191403

| Submitter: | Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Walter Holbein<br>RA/CA Manager |
| Phone: | 763-577-5504 |
| Fax: | 763-553-7807 |
| Date Prepared: | 20 May, 2019 |
| Trade Name: | Onyx® 3 Model 9591 Finger Pulse Oximeter |
| Common Name: | Finger Pulse Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Nonin Model 3230 Bluetooth® Smart Pulse oximeter cleared by the<br>FDA under K131021 on 9/11/2013, and |
| Reference Device: | Nellcor™ Bedside Respiratory Patient Monitoring System<br>(PM1000N) cleared by the FDA under K141518 on 3/5/2015. |

## Device Description

The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

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| Intended Use: | Model 9591 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small,<br>lightweight, portable and reusable spot-check device indicated for<br>use in measuring and displaying functional oxygen saturation of |
| | arterial hemoglobin (%SpO2) and pulse rate of patients who are well<br>or poorly perfused. The Respiration Rate parameter provides a non-<br>invasive measurement of respiration rate, in breaths per minute. |
| | For %SpO2, and pulse rate, the 9591 is intended for use in hospitals,<br>clinics, long-term care facilities, skilled nursing facilities, and home<br>healthcare services. It is intended for adult and pediatric patients |
| | who are well or poorly perfused, with digits that are between 0.3 -<br>1.0 inch (0.8 - 2.5 cm) thick, under non-motion conditions. |
| | For Respiration rate, the 9591 is intended for use in hospitals, |
| | clinics, long-term care facilities, skilled nursing facilities, and home |
| | healthcare services. It is intended for adult who are well perfused, |
| | with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick, |
| | under non-motion conditions. It is not intended for use in high-<br>acuity environments, such as ICU or operating rooms where<br>continuous monitoring is expected. |
| Testing: | Nonin's Model 9591 Finger Pulse Oximeter has successfully<br>undergone both laboratory and clinical hypoxia accuracy testing in<br>order to ensure that it has appropriate performance, functional<br>features to fully comply with ISO 80601-2-61:2011 and is<br>substantially equivalent to the predicate devices. |
| Functional and<br>Safety Testing: | The results of the testing demonstrate equivalency with the predicate<br>devices and compliance to recognized standards. Table 1<br>summarizes test results for the proposed devices, which met the<br>relevant requirements of the applicable recognized standards. |

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| Test | Reference | Result |
|-------------------------------------------|--------------------------------------------------------------------------------------------|--------|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity and<br>Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61<br>IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-1-11<br>IEC 62304<br>ISO 14155 | Pass |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance<br>characterization | Pass |
| Mechanical Durability | IEC 60601-1<br>ISO 80601-2-61 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |

#### Table 1

#### Clinical Testing: Respiratory Rate Accuracy Verification Clinical (QATR10912)

Respiratory rate accuracy testing was a comparative single-center, randomized study. The respiratory rate output of the Onyx 3 fingertip oximeter was compared to Capnography based respiratory rate. This was a minimal risk study using a non-significant risk device. A total of 30 subjects were enrolled in the study. Up to 3 subjects were enrolled per day. Subject participation lasted up to 2 hours. Demographic and anthropometric data (date of birth, gender, ethnicity, race, height, weight, skin tone and finger dimensions) were collected for all subjects. Accuracy data was calculated using both mean error and root mean square error (RMSE).

### SpO2 Accuracy Testing

SpO2 accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured oxygen saturation value (SpO2) of the device was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy of the device in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in motion and non-motion conditions. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.

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# Summary of Substantial Equivalence:

The Model 9591 Onyx® 3 Finger Pulse Oximeter has the following similarities to its respective predicate Nonin device:

- Similar SpO2 and Pulse Rate ranges ●
- . Identical SpO2 and Low Perfusion SpO2 accuracy specifications
- Identical critical optics technology
- Perform equivalently to the similar specifications

The following lists the differences and the rationale for those differences between the proposed device and the predicate devices:

- Indications for Use: the proposed and predicate Nonin devices have identical Indications for Use and identical patient population, with the exception of the respiratory rate feature in the proposed device. The Nellcor device is a tabletop device with the additions of an alarm feature and expanded patient population, which Nonin is not seeking claims for.
- Respiratory Rate: the Nonin predicate device does not have the respiratory rate feature. The Nonin proposed device and the Nellcor predicate have similar respiratory rate ranges.
- SpO2 accuracy with Motion: Nonin is not seeking motion claims similar to the predicate Nellcor device.
- Pulse accuracy with Motion: Nonin is not seeking motion claims similar to the predicate Nellcor device.
- Enclosure Ingress Protection: the proposed and predicate ● Nonin devices are identical and offer more ingress protection than the Nellcor device.
- Battery Input: the proposed and predicate Nonin devices are identical. The Nellcor device is a tabletop-type device with a rechargeable battery (Li-Ion battery). The Nonin devices do not use rechargeable batteries.

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| Category | Identical/Similar/<br>Different<br>(rationale) | Predicate: Model 3230<br>(K131021, cleared 9/11/15) | Predicate: Nellcor™ Bedside<br>Respiratory Patient Monitoring<br>System<br>(K141518, cleared 3/5/15) | Proposed: Model 9591 | | | | | |
|----------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------|--|-----------|--|
| | | Indications for Use | | | | | | | |
| Indications for use and<br>Intended Use from<br>Labeling | Different | The Model 3230 Finger Pulse<br>oximeter is a small, lightweight<br>portable device indicated for use<br>in measuring and displaying<br>functional oxygen saturation of<br>arterial hemoglobin (%SpO2) and<br>pulse rate of patients who are well<br>or poorly perfused. It is intended<br>for spot checking of adult and<br>pediatric patients on digits<br>between 0.3-1.0 inch (0.8-2.5<br>cm) thick. | The Nellcor™ Bedside<br>Respiratory Patient Monitoring<br>System is a portable pulse<br>oximeter intended for prescription<br>use only as a continuous non-<br>invasive monitor of arterial<br>oxygen saturation (SpO₂) and<br>pulse rate of adult, pediatric, and<br>neonatal patients during both no<br>motion and motion conditions,<br>and for patients who are well or<br>poorly perfused. The monitoring<br>system is intended for use in<br>hospitals, hospital-type facilities,<br>and during intra-hospital<br>transport. The OxiMax SPD™<br>Alert (SPD) feature is intended<br>only for facility-use care of<br>adults to detect patterns of<br>desaturation indicative of<br>repetitive reductions in<br>airflow through the upper airway<br>and into the lungs. | The Nonin® Model 9591 Finger<br>Pulse Oximeter is a small,<br>lightweight, portable spot-check<br>device indicated for use in<br>measuring and displaying<br>functional oxygen saturation of<br>arterial hemoglobin (%SpO2) and<br>pulse rate of patients who are well<br>or poorly perfused. The<br>Respiration Rate parameter<br>provides a non-invasive<br>measurement of respiration rate,<br>in breaths per minute. For %<br>SpO2, pulse rate, and respiration<br>rate the 9591 is intended for use<br>in professional healthcare and<br>home healthcare settings in adult<br>and pediatric patients who are<br>well or poorly perfused, with<br>digits that are between 0.3-1.0<br>inch (0.8-2.5 cm) thick. | | | | | |
| SpO₂ Range | Similar | 0% to 100% SpO₂ | 1% to 100% SpO₂ | 0% to 100% SpO₂ | | | | | |
| Pulse Rate Range | Similar | 18-321 BPM | 20 to 250 BPM | 18-321 BPM | | | | | |
| Respiration Rate | Different | NA | 4 to 40 breaths/minute | 3 to 44 breaths/minute | | | | | |
| | | SpO₂ Accuracy | | | | | | | |
| Adult /Pediatric SpO₂ | Identical | $\pm$ 2 digits ( $\pm$ 1 Arms) | 70 to 100% $\pm$ 2 digits | $\pm$ 2 digits ( $\pm$ 1 Arms) | | | | | |
| Low Perfusion SpO₂ | Identical | $\pm$ 2 digits ( $\pm$ 1 Arms) | 70 to 100% $\pm$ 2 digits | $\pm$ 2 digits ( $\pm$ 1 Arms) | | | | | |
| Adult /Pediatric SpO₂<br>with Motion | Different | NA | 70 to 100% $\pm$ 3 digits | NA | | | | | |
| | | Pulse Rate Accuracy | | | | | | | |
| Adult and Pediatric<br>Pulse Rate | Identical | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | | | | | |
| Low Perfusion Pulse<br>Rate | Similar | 40 to 240 BPM $\pm$ 3 digits | 20 to 250 BPM $\pm$ 3 digits | 40 to 240 BPM $\pm$ 3 digits | | | | | |
| Adult/Pediatric Pulse<br>Rate with Motion | Different | NA | 48 to 127 BPM $\pm$ 5 digits | NA | | | | | |
| | | Device Specifications | | | | | | | |
| Measurement<br>Wavelength | Identical | 660 and 910 nanometers | 660 and 900 nanometers | 660 and 910 nanometers | | | | | |
| Operating Altitude | Similar | Up to 13,123 feet | -1,000 ft. to 15,000 ft. | Up to 13,123 feet | | | | | |
| Operating Temperature<br>Storage/Transportation<br>Temperature | Similar | -5° to +40°C | 5° to +40°C | -5° to +40°C | | | | | |
| Operating Humidity | Similar | -40° to +70°C | -20° to +70°C | -40° to +70°C | | | | | |
| Storage/Transportation<br>Humidity | Similar | 10 - 95% non-condensing | 15 - 95% non-condensing | 10 - 95% non-condensing | | | | | |
| Power Requirements | Similar | 3 volts DC | 7.2 volts DC | 3 volts DC | | | | | |
| Battery Life<br>(Operating) | Similar | 2200 Spot Checks | 6 hours | 2000 Spot checks 25 hours<br>continuous | | | | | |
| Battery Life (Storage) | Different | 1 month, with batteries installed | 4 months | 1 month, with batteries installed | | | | | |
| Electrical - Type and<br>Degree of Protection | Identical | Type BF Internally powered | Type BF Internally powered | Type BF Internally powered | | | | | |
| Enclosure - Degree of<br>Ingress Protection | Different | IP32 | IPX1 | IP32 | | | | | |
| Modes of Operation | Similar | Spot-check | Continuous | Spot-check | | | | | |
| Battery Input | Different | Two 1.5 volt AAA-size batteries | 30 VAC maximum | Two 1.5 volt AAA-size batteries | | | | | |
| 7-Segment 3-Digit<br>Displays | Identical | Multi-pixel 3-Digit Displays<br>(color LCD) | Not specified | Multi-pixel 3-Digit Displays<br>(color LCD) | | | | | |
| Pulse Strength Indicator | | Identical | | Color LCD | | Not specified | | Color LCD | |
| Sensor Fault Indicator | Identical | Poor signal symbol followed by dashes | Not specified…