(30 days)
Not Found
No
The description details standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, not for treating any condition.
Yes
The device measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. While it's indicated for spot-checking, these measurements provide information that assists in diagnosis and patient management.
No
The device description clearly details hardware components such as LEDs, a photo detector, associated electronics, a microprocessor, and a finger clip sensor, all of which are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter measures oxygen saturation and pulse rate by shining light through the finger and detecting the absorption. This is a non-invasive measurement performed directly on the patient's body.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient.
Therefore, the device's function and method of operation clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The Model 9550 Onyx® II is a small, lightweight, portable, finger 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. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light omitting 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 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 device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonin's Onyx® II Model 9550 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Model 9500 Onyx® Finger Pulse Oximeter, K001085
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 1 - 2005
K 051107
Attachment 7
510(k) Summary
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Lori M. Roth |
| Clinical/Regulatory Specialist | |
| Nonin Medical, Inc. | |
| 13700 1st Ave. N. | |
| Plymouth, MN 55441-5443 | |
| Date Prepared: | April 28, 2005 |
| Trade Name: | Model 9550 Onyx® II Finger Pulse Oximeter |
| Classification Name: | |
| and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | The predicate device is the Model 9500 Onyx® Finger |
| Pulse Oximeter, K001085, cleared on May 1, 2000. | |
| Device Description: | The Model 9550 Onyx® II is a small, lightweight, |
| portable, finger 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. Changes in the absorption | |
| caused by the pulsation of blood in the vascular bed | |
| are used to determine oxygen saturation and pulse | |
| rate. | |
| Light omitting 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 |
1
| may affect the readings: green indicates a 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 device
is intended for spot-checking adult and pediatric
| patients who are well or poorly perfused. | |
|---|---|
| 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. 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. | |
| Functional and | |
| Safety Testing: | Nonin's Onyx® II Model 9550 Finger Pulse Oximeter |
| has successfully undergone both bench and human | |
| testing to support the determination of substantial | |
| equivalence. Human oxygenation evaluations were | |
| conducted to confirm conformance to accuracy and | |
| precision specifications. | |
| Conclusion: | Nonin's Onyx® II Model 9550 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 compare | |
| to the legally marketed devices. |
:
.
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2005
Ms. Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 15 Avenue North Plymouth, Minnesota 55441-5443
Re: K051107
Trade/Device Name: Onyx® II Model 9550 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 28, 2005 Received: May 2, 2005
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.
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 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.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
4
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | K051107 |
|---|---|
| Device Name | Nonin Medical, Inc. Onyx® II Model 9550 |
| 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. 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. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Q.R.
("Ivision Sign-Off) Division of Anesthesiology, General Hospital. Intection Control, Dental Devices
310(k) Number: K051107
Model 9550 Special 510 (K): Device Modification