PULSE OXIMETER

K140785 · Nonin Medical, Inc. · DQA · Jul 7, 2014 · Cardiovascular

Device Facts

• Record ID: K140785
• Device Name: PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portable 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. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.

Device Story

Model 3231 is a portable, finger-worn pulse oximeter for spot-checking SpO2 and pulse rate. Device uses red and infrared LEDs and a photodetector to measure light absorption through perfused tissue; internal microcontroller processes signals to calculate SpO2 and pulse rate. Output is displayed on an integrated color LCD, which also provides visual pulse quality indication. Device is activated automatically upon placement on a patient's digit. Powered via USB 2.0 connection, which also serves as a serial communication interface. Intended for use by clinicians or patients in various settings for non-invasive monitoring. Provides immediate physiological data to assist in clinical assessment of patient oxygenation and heart rate.

Clinical Evidence

Bench testing only. Performance verified through laboratory testing including software verification, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per ISO 80601-2-61. Usability, mechanical durability, and ingress protection also validated. No clinical trial data required due to identical measurement technology as predicate.

Technological Characteristics

Finger-worn pulse oximeter; red/IR LED sensing; LCD display. Powered via USB 2.0. Connectivity: USB 2.0 serial. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (oximeter performance). Software: Identical to predicate Model 3230.

Indications for Use

Indicated for spot-checking functional oxygen saturation (%SpO2) and pulse rate in adult and pediatric patients with digit thickness 0.8-2.5 cm, including those who are well or poorly perfused.

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

• Model 3230 Finger Pulse oximeter (K131021)

Submission Summary (Full Text)

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JUL 07 2014

## 2. 510(k) Summary

| Submitter: | Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | 763-553-9968<br>763-553-7807 |
| Contact Person: | Brodie Pedersen<br>Senior Regulatory Engineer |
| Date Prepared: | June 19, 2014 |
| Trade Name: | Model 3231 |
| Classification Name<br>and Number: | Pulse Oximeter<br>Class II, 21 CFR 870.2700 |
| Product Code: | DQA |
| Predicate Device(s): | Nonin's Model 3231 finger pulse oximeter is substantially equivalent to the<br>Model 3230 Finger Pulse oximeter cleared by the FDA under K131021 on<br>9/11/2013. |
| Indications for Use: | Model 3231<br>The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portable<br>device indicated for use in measuring and displaying functional oxygen<br>saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are<br>well or poorly perfused. It is intended for spot-checking of adult and pediatric<br>patients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick. |
| Device Description: | Model 3231 Pulse oximeter is a small, lightweight, portable, digit pulse oximeter<br>that displays numerical values for functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate by measuring the absorption of red and<br>infrared (IR) light passing through perfused tissue. Changes in the absorption<br>caused by the pulsation of blood in the vascular bed are used to determine<br>oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained<br>within the device along with the photo detector, which is on the opposite side<br>of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD<br>display contained within the device. A color LCD provides a visual indication of<br>the pulse signal, while blinking at the corresponding pulse rate. The display will<br>indicate if there is poor pulse quality that may affect the readings. All associated<br>electronics and the microcontroller are within the sensor, which is activated by |

13700 1st Aveitue North, Plymouth, MN 55441-5443 USA / Phone [phone].356.8874 / Fax [phone] / www.nonin.com

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K140785

Image /page/1/Picture/1 description: The image shows the logo for Nonin Medical. The logo consists of a geometric shape on the left, followed by the word "NONIN" in bold, sans-serif font. Below the word "NONIN" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.

placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

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The modification of the Model 3230 to the Model 3231, include the removal of Bluetooth LE 4.0 and the addition USB 2.0 for serial communication. This modification includes moving from batteries to the USB 2.0 to power the Model 3231. The oximeter circuitry, software and electro optical elements of the Model 3231 are identical to the Model 3230. There are no technological characteristic changes to the device that affect the measurement or display of SpO2 or pulse rate to the user.

## Technological Characteristics Comparison:

| Characteristic | Identical/<br>Different | Model 3230 | Model 3231 |
|-------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE | Identical except<br>Model Number | The Nonin® Model 3230<br>Finger Pulse Oximeter is a<br>small, lightweight, portable<br>device indicated for use in<br>measuring and displaying<br>functional oxygen<br>saturation of arterial<br>hemoglobin (%SpO2) and<br>pulse rate of patients who<br>are well or poorly perfused.<br>It is intended for spot-<br>checking of adult and<br>pediatric patients with digits<br>between 0.8 - 2.5 cm (0.3 -<br>1.0 inch) thick. | The Nonin® Model 3231<br>Finger Pulse Oximeter is a<br>small, lightweight, portable<br>device indicated for use in<br>measuring and displaying<br>functional oxygen<br>saturation of arterial .<br>hemoglobin (%SpO2) and<br>pulse rate of patients who<br>are well or poorly perfused.<br>It is intended for spot-<br>checking of adult and<br>pediatric patients with digits<br>between 0.8 - 2.5 cm (0.3 -<br>1.0 inch) thick. |
| SYSTEM CONFIGURATIONS | | | |
| Parts and Accessories | | | |
| Power input | Different | LR03 AAA batteries(2) | USB 2.0 |
| Operator's instructions | Identical | Paper | Paper |
| OVERALL SPECIFICATIONS | | | |
| SpO2 Range | Identical | 0% to 100% SpO2 | 0% to 100% SpO2 |
| Pulse Rate Range | Identical | 18-321 BPM | 18-321 BPM |
| Accuracy | | | |
| Decades | Identical | Decade Oxygen<br>Saturation (Arms)<br>70-80% ±2<br>80 - 90% ±2<br>90 - 100% ±2<br>70-100% ±2 | Decade Oxygen<br>Saturation (Arms)<br>70-80% ±2<br>80 – 90% ±2<br>90 - 100% ±2<br>70 - 100% ±2 |

13700 1st Avenue North, Plymouth, MN 55441-5443 USA

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Phone [phone].356.8874 /

Fax [phone]

www.nonin.com

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Image /page/2/Picture/1 description: The image shows the logo for Nonin Medical. The logo consists of a geometric shape on the left, followed by the word "NONIN" in bold, sans-serif font. Below the word "NONIN" is the word "MEDICAL" in a smaller, sans-serif font.

| C<br>C | <br>A 42 " | |
|------------|------------|--|
| PORTO<br>0 | 014 | |

| Characteristic | Identical/<br>Different | Model 3230 | Model 3231 |
|----------------------------|-------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| SpO2 | Identical | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Low Perfusion SpO2 | Identical | ±2 digits (± 1 Arms) | ±2 digits (± 1 Arms) |
| Pulse Rate | Identical | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits |
| Low Perfusion Pulse Rate | Identical | 40 to 240 BPM ±3 digits | 40 to 240 BPM ±3 digits |
| Displays | | | |
| 7-Segment 3-Digit Displays | Identical | Multi-pixel 3-Digit Displays | Multi-pixel 3-Digit Displays |
| Pulse Strength | Identical | LCD, readings or dashes give<br>two levels of pulse quality<br>indication | LCD, readings or dashes give<br>two levels of pulse quality<br>indication |
| Connectivity | Different | Bluetooth SMART | USB 2.0 |
| Package | Identical | Box | Box |

## Testing:

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Nonin's Model 3231 Pulse Oximeter is supported by predicate laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance and functional features to fully comply with recognized standards and guidance documents and is substantially equivalent to the predicate device except these features specific to the modifications.

13700 1st Avenue North, Plymouth, MN 55441-5443 USA

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K140785

Image /page/3/Picture/1 description: The image shows the logo for Nonin Medical. The logo consists of the word "NONIN" in bold, black letters, with a stylized square design to the left of the word. Below the word "NONIN" is the word "MEDICAL" in a smaller, italicized font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

Functional and Safety Testing:

Laboratory testing included: software verification, safety testing for electrical, mechanical, biocompatibility analysis, ingress protection, electromagnetic compatibility, device performance, usability evaluation, certification and mechanical durability have been performed to demonstrate equivalency with the predicates. As shown in the table below the device met the relevant requirements of the applicable recognized standards and guidance.

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| Test | Reference | Result |
|-------------------------------------------|------------------------------------------------|--------|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1<br>IEC 60601-1-11 | Pass |
| Cleaning | IEC 60601-1 | Pass |
| Electromagnetic Immunity and<br>Emissions | IEC 60601-1-2 | Pass |
| USB 2.0 certification | USB 2.0 | Pass |
| Performance | ISO 80601-2-61<br>IEC 60601-1<br>IEC 60601-1-6 | Pass |
| Ingress Protection | ISO 80601-2-61<br>IEC 60601-1-11 | Pass |
| Mechanical Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1<br>IEC 60601-1-6 | Pass |
| Usability | IEC 60601-1-6<br>IEC 60601-1-11 | Pass |

Conclusion:

Nonin's Model 3231 is substantially equivalent to the Model 3230 Bluetooth® Smart Pulse oximeter cleared by the FDA under K131021 on 9/11/2013, · manufactured by Nonin Medical, Inc. The concurrent shared design elements and positive results of testing, lead.to the conclusion that the indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

13700 1st Avenue North, Plymouth, MN 55441-5443 USA

Phone [phone].356.8874

Fax [phone]

www.nonin.com

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2014

Nonin Medical, Inc. Mr. Brodie Pedersen Senior Regulatory Engineer 13700 1st Ave. North Plymouth, MN 55441-5443

Re: K140785

Trade/Device Name: Nonin Model 3231 Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 22, 2014 Received: April 23, 2014

Dear Mr. Pedersen:

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. 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.

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MarySTBmer-S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 1. Indications for Use Statement

510(K) Number:

Device Name:

Nonin Medical, Inc. Model 3231

Indications for Use:

Model 3231

The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portable 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. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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13700 1st Avenue North, Plymouth, MN 55441-5443 USA / Phone [phone].356.8874 / Fax [phone] www.nonin.com