FINGER PULSE OXIMETER, MODEL 9560

K081285 · Nonin Medical, Inc. · DQA · Jun 5, 2008 · Cardiovascular

Device Facts

• Record ID: K081285
• Device Name: FINGER PULSE OXIMETER, MODEL 9560
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Onyx II® Model 9560 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 on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.

Device Story

Onyx II Model 9560 is a portable, finger-clip pulse oximeter; measures SpO2 and pulse rate via red/IR light absorption in perfused tissue. Device contains LEDs and photodetector; microprocessor calculates saturation/pulse from pulsatile blood flow. Features tricolor LED display for pulse quality (green/yellow/red). Powered by 2 AAA batteries; activated by finger insertion. Includes embedded Bluetooth 2.0 module for wireless data transmission to telemedicine or health collection systems. Used for spot-checking; provides clinicians with numerical data to assess patient oxygenation status. Benefits include portable, non-invasive monitoring of perfusion status.

Clinical Evidence

Supported by bench and human testing. No specific clinical trial metrics (e.g., sensitivity/specificity) provided in the summary document.

Technological Characteristics

Finger-clip form factor; LED/photodetector sensing; 2 AAA alkaline battery power. Embedded Bluetooth 2.0 module (STLC2500C transceiver, LPC2138FHN64/01 ARM7 microcontroller).

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult and pediatric patients with well or poor perfusion. Finger thickness 0.8-2.5 cm (excluding thumb).

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's Onyx II® Model 9550 Finger Pulse Oximeter (K053130)
• Model 4100 Patient Oximeter Module (K043359)

Submission Summary (Full Text)

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K081285

## 510(k) Summary

Submitter: Contact Person:

Date Prepared:

Trade Name:

Classification Name: and Number:

Product Code:

Predicate Device(s):

## Device Description:

Nonin Medical, Inc.

JUN - 5 2008

Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 1st Ave. N. Plymouth, MN 55441-5443

May 2, 2008

Onyx II® Model 9560 Finger Pulse Oximeter

Class II, 21 CFR 870.2700

DQA

The predicate devices are Nonin's Onyx II® Model 9550 Finger Pulse Oximeter, K053130, cleared on January 11, 2006 and Model 4100 Patient Oximeter Module, K043359, cleared on January 7, 2005.

The Model 9560 is a small, lightweight, portable finger pulse oximeter with Bluetooth® communication which can be integrated into a telemedicine system or other health data collection system through the wireless connection. The device 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. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.

Light emitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a

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good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation.

The Model 9560 uses 2 "AAA" disposable alkaline batteries for power, which shall provide 600 spot-checks. The 9560 requires no routine calibration or maintenance other than replacement of the alkaline batteries.

Technical Summary of the Bluetooth Module

- � Bluetooth 2.0 is is an embedded module communicating over the Serial Port.
- . lt utilizes a STLC2500C HCl Bluetooth transceiver and a LPC2138FHN64/01 ARM7 microcontroller running the t.Blue Bluetooth Stack.
- . The module has on-board connectors that allow it to communicate to an oximeter device microcontroller either via hardware or software asynchronous serial communication interface.
- . The module is designed to automatically switch the output transmit power between Bluetooth Class 1 (16 dBm) and Bluetooth Class 2 (4 dBm), conserving battery life and reducing unnecessary RF emissions.

The Nonin® Onyx II® Model 9560 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 spotchecking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 -- 2.5 cm) thick. The index finger is the recommended site.

Nonin's Model 9560 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence.

Nonin's Model 9560 Finger Pulse Oximeter is substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation. Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices.

## Indications for Use:

Functional and Safety Testing:

Conclusion:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2008

Ms. Lori M. Roth Clinical Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443

Re: K081285

Trade/Device Name: Nonin Medical, Inc. Onyx II® Model 9560 Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 5, 2008 Received: May 6, 2008

Dear Ms. Roth:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Roth

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Syville Y. Michie, M.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k)<br>Number<br>(if known) | |
|--------------------------------|-----------------------------------------|
| Device Name | Nonin Medical, Inc. Onyx II® Model 9560 |

Indications for Use

The Nonin® Onyx II® Model 9560 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 on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.

Prescription Use × (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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|---------------------|-------|
| (Division Sign-Off) | |

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K081285 |
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Nonin Medical Inc.

Model 9560 Special 510(k): Device Modification

Confidential