(30 days)
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.
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.
This document describes the acceptance criteria and study used to demonstrate the performance of the Nonin Medical, Inc. Onyx® II Model 9550 Finger Pulse Oximeter.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria with specific thresholds for accuracy or precision of SpO2 and pulse rate measurements. However, it indicates that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The conclusion states that the device "is substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation," implying that its performance meets comparable levels to the predicate device, the Model 9500 Onyx® Finger Pulse Oximeter (K001085).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to accuracy specifications for SpO2 | Human oxygenation evaluations confirmed conformance to accuracy specifications. |
| Conformance to precision specifications for SpO2 | Human oxygenation evaluations confirmed conformance to precision specifications. |
| Conformance to accuracy specifications for Pulse Rate | Human oxygenation evaluations confirmed conformance to accuracy specifications. |
| Conformance to precision specifications for Pulse Rate | Human oxygenation evaluations confirmed conformance to precision specifications. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of human subjects or data points used in the "human oxygenation evaluations."
- Data Provenance: The document does not explicitly state the country of origin. It indicates "human testing to support the determination of substantial equivalence." Given the submitter (Nonin Medical, Inc.) is based in Plymouth, MN, USA, it is highly probable the data was collected in the USA. The study was prospective, as it involved human oxygenation evaluations specifically conducted to confirm conformance to specifications for this new device.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is a pulse oximeter which directly measures physiological parameters (SpO2 and pulse rate). Ground truth for such devices is typically established through a reference method, not expert consensus on interpretations. The ground truth for oxygen saturation would likely be based on an arterial blood gas analyzer.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study is based on direct physiological measurements against a reference standard, not interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone diagnostic tool, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "human oxygenation evaluations" were conducted to assess the performance of the device itself (algorithm only) in measuring SpO2 and pulse rate against reference standards. The document explicitly states, "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."
7. Type of Ground Truth Used
The ground truth for the "human oxygenation evaluations" was almost certainly a reference method for blood oxygen saturation and pulse rate measurement, such as direct arterial blood gas analysis for oxygen saturation and an ECG or manual pulse check for pulse rate. The term "human oxygenation evaluations" strongly implies a comparison against a more invasive and accurate reference standard.
8. Sample Size for the Training Set
Not applicable. Pulse oximeters are typically developed based on established physiological principles and algorithms, not through machine learning models requiring a "training set" in the common AI sense. The algorithms are built upon physics of light absorption and blood pulsation.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the machine learning context for this type of device. The underlying principles and algorithms are based on established physiological and engineering principles.
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JUN 1 - 2005
K 051107
Attachment 7
510(k) Summary
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Lori M. RothClinical/Regulatory SpecialistNonin 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® FingerPulse Oximeter, K001085, cleared on May 1, 2000. |
| Device Description: | The Model 9550 Onyx® II is a small, lightweight,portable, finger pulse oximeter that displays numericalvalues for functional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate by measuring theabsorption of red and infrared (IR) light passingthrough perfused tissue. Changes in the absorptioncaused by the pulsation of blood in the vascular bedare used to determine oxygen saturation and pulserate.Light omitting diodes (LEDs) are contained within thesensor along with the photo detector, which is on theopposite side of the probe from the LEDs. The SpO2and heart rate are displayed on the LED digitaldisplays contained within the finger clip sensor. Atricolor LED display provides a visual indication of thepulse quality signal, while blinking at thecorresponding pulse rate. This display changescolors to alert you to changes in pulse quality that |
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| may affect the readings: green indicates a good pulsequality signal, yellow indicates a marginal pulsequality, and red indicates as inadequate pulse signal.All associated electronics and the microprocessor arewithin the sensor, which is activated by inserting apatient's finger. This allows the power to be appliedto all the internal circuitry upon activation. The deviceis intended for spot-checking adult and pediatricpatients who are well or poorly perfused. | |
|---|---|
| Indications for Use: | The Nonin® Onyx® II Model 9550 Finger PulseOximeter is a small, lightweight, portable deviceindicated for use in measuring and displayingfunctional 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 recommendedsite. |
| Functional andSafety Testing: | Nonin's Onyx® II Model 9550 Finger Pulse Oximeterhas successfully undergone both bench and humantesting to support the determination of substantialequivalence. Human oxygenation evaluations wereconducted to confirm conformance to accuracy andprecision specifications. |
| Conclusion: | Nonin's Onyx® II Model 9550 Finger Pulse Oximeteris substantially equivalent to the predicate devices interms of accuracy, functional design and principles ofoperation. Performance test results do not raise newquestions of safety and effectiveness when compareto the legally marketed devices. |
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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 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.
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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 (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
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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
§ 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).