ONYX II FINGER PULSE OXIMETER, MODEL 9550

K053130 · Nonin Medical, Inc. · DQA · Jan 11, 2006 · Cardiovascular

Device Facts

• Record ID: K053130
• Device Name: ONYX II FINGER PULSE OXIMETER, MODEL 9550
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Onyx® II Model 9550 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

Portable finger pulse oximeter; measures SpO2 and pulse rate via red/infrared light absorption in perfused tissue. Sensor contains LEDs and photodetector; microprocessor calculates saturation and pulse. Device activates upon finger insertion. Tricolor LED display provides visual pulse quality feedback (green/yellow/red). Used for spot-checking in clinical or home settings by clinicians or patients. Output allows immediate assessment of patient oxygenation status, aiding clinical decision-making regarding patient perfusion and respiratory health.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable finger-clip form factor; LED/photodetector sensing; battery-powered; microprocessor-based signal processing; tricolor LED visual indicator for signal quality.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult and pediatric patients with well or poor perfusion. Applicable to fingers (excluding thumb) 0.3-1.0 inch thick.

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

• Onyx® II Model 9550 Finger Pulse Oximeter (K051107)

Submission Summary (Full Text)

{0}------------------------------------------------

## JAN 1 1 2006

# SECTION 2. SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

| Submitter: | Nonin Medical, Inc. | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Lori M. Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Avenue North<br>Plymouth, MN 55441-5443 | |
| Date Prepared: | November 4, 2005 | |
| Trade Name: | Onyx® II Model 9550 Finger Pulse Oximeter | |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | 74 DQA | |
| Predicate Device(s): | Nonin's Onyx® II Model 9550 is substantially equivalent<br>to the Onyx® II Model 9550 Finger Pulse Oximeter<br>manufactured by Nonin Medical, Inc. that was cleared by<br>the FDA under K051107 on 06/01/05. | |
| Device Description: | The Onyx® II Model 9550 is a small, lightweight, portable,<br>finger pulse oximeter that displays numerical values for<br>functional oxygen saturation of arterial hemoglobin (SpO2)<br>and pulse rate by measuring the absorption of red and<br>infrared (IR) light passing through perfused tissue.<br>Changes in the absorption caused by the pulsation of blood<br>in the vascular bed are used to determine oxygen saturation<br>and pulse rate. | |
| | Light omitting diodes (LEDs) are contained within the<br>sensor along with the photo detector, which is on the<br>opposite side of the probe from the LEDs. The SpO2 and<br>heart rate are displayed on the LED digital displays<br>contained within the finger clip sensor. A tricolor LED<br>display provides a visual indication of the pulse quality<br>signal, while blinking at the corresponding pulse rate. This<br>display changes colors to alert you to changes in pulse<br>quality that may affect the readings: green indicates a good<br>pulse quality signal, yellow indicates a marginal pulse<br>quality, and red indicates as inadequate pulse signal. All | |
| | associated electronics and the microprocessor are within<br>the sensor, which is activated by inserting a patient's<br>finger. This allows the power to be applied to all the<br>internal circuitry upon activation. The device is intended<br>for spot-checking adult and pediatric patients who are well<br>or poorly perfused. | |
| Intended Use: | The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter<br>is a small, lightweight, portable device indicated for use in<br>measuring and displaying functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate of patients who<br>are well or poorly perfused. It is intended for spot-<br>checking of adult and pediatric patients on fingers (other<br>than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm)<br>thick. The index finger is the recommended site. | |
| Functional and<br>Safety Testing: | Nonin's Model 9550 Finger Pulse Oximeter has<br>successfully undergone bench testing in order to<br>demonstrate that it has appropriate functional features and<br>is substantially equivalent to the predicate device. | |
| Conclusion: | Nonin's Model 9550 is substantially equivalent to the<br>Model 9550 Finger Pulse Oximeter manufactured by Nonin<br>Medical, Inc. and cleared by the FDA under K051107 on<br>06/01/05. | |

4

{1}------------------------------------------------

:

:

.

5

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its head and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2006

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

Re: K053130

Trade/Device Name: Onyx® II Model 9550 Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 4, 2005 Received: November 8, 2005

Dear Ms. Roth:

We have reviewed your Scction 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.

{3}------------------------------------------------

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 mean that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Fet of mrly 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 and noting (2) est forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) I mis feter wifi ation. The FDA finding of substantial equivalence of your device to a premainter lettreations on 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), n 93st contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You onnived, "This was al 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,

Ches

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

{4}------------------------------------------------

## Indications for Use Statement

510(K) Number: (If known)

Device Name:

### Onyx® II Model 9550 Finger Pulse Oximeter

#### Indications for Use:

The Nonin® Onyx® II Model 9550 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 | X |
|-----------------------------|----------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | AND/OR 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)

| (Division S | General Hospital, |
|---------------|-------------------|
| Division of | services |
| Infection Co. | K053130 |
| 510(k) Numbe | |

. . .

}