(64 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 measuring and displaying physiological parameters (SpO2 and pulse rate) for spot-checking purposes, but it does not describe any therapeutic function (e.g., treatment, mitigation, or prevention of disease).
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. This falls under the definition of a diagnostic device as it provides information for diagnosis.
No
The device description explicitly details hardware components such as LEDs, a photo detector, and internal circuitry within a finger clip sensor, indicating it is a physical medical device, not software-only.
Based on the provided text, the Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the device measures oxygen saturation and pulse rate by measuring the absorption of light passing through perfused tissue (a finger). This is a non-invasive measurement taken directly from the patient's body, not from a specimen taken from the body.
- Intended Use: The intended use describes measuring and displaying physiological parameters (SpO2 and pulse rate) of patients, not analyzing biological samples.
Therefore, the Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a non-invasive medical device used for monitoring physiological parameters, not an In Vitro Diagnostic device.
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 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.
Product codes
74 DQA
Device Description
The Onyx® II Model 9550 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)
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 Model 9550 Finger Pulse Oximeter has successfully undergone bench testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 1 2006
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | Nonin Medical, Inc. | |
|---|---|---|
| Contact Person: | Lori M. Roth | |
| Clinical/Regulatory Specialist | ||
| Nonin Medical, Inc. | ||
| 13700 1st Avenue North | ||
| Plymouth, MN 55441-5443 | ||
| Date Prepared: | November 4, 2005 | |
| Trade Name: | Onyx® II Model 9550 Finger Pulse Oximeter | |
| Classification Name: | ||
| and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | 74 DQA | |
| Predicate Device(s): | Nonin's Onyx® II Model 9550 is substantially equivalent | |
| to the Onyx® II Model 9550 Finger Pulse Oximeter | ||
| manufactured by Nonin Medical, Inc. that was cleared by | ||
| the FDA under K051107 on 06/01/05. | ||
| Device Description: | The Onyx® II Model 9550 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. | ||
| 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. | ||
| Functional and | ||
| Safety Testing: | Nonin's Model 9550 Finger Pulse Oximeter has | |
| successfully undergone bench testing in order to | ||
| demonstrate that it has appropriate functional features and | ||
| is substantially equivalent to the predicate device. | ||
| Conclusion: | Nonin's Model 9550 is substantially equivalent to the | |
| Model 9550 Finger Pulse Oximeter manufactured by Nonin | ||
| Medical, Inc. and cleared by the FDA under K051107 on | ||
| 06/01/05. |
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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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 |
. . .
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