(30 days)
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.
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 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.
The provided text from K081285 describes a 510(k) submission for the Nonin Onyx II Model 9560 Finger Pulse Oximeter. While it states that the device "has successfully undergone both bench and human testing to support the determination of substantial equivalence," it does not provide explicit acceptance criteria or detailed study results and methodologies to definitively prove the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices based on accuracy, functional design, and operating principles.
However, based on the context of pulse oximeter submissions, we can infer typical acceptance criteria and study types. I will construct an answer assuming standard practices for pulse oximeter submissions, explaining where information is explicitly stated and where it is inferred.
Inferred Acceptance Criteria for Pulse Oximeters based on FDA Guidance:
For pulse oximeters, key performance metrics typically involve accuracy for oxygen saturation (SpO2) and pulse rate (PR).
- SpO2 Accuracy: Often, the accuracy requirement for SpO2 is expressed as the Root Mean Square (RMS) difference between the oximeter reading and a reference standard (e.g., arterial blood gas co-oximetry). A common range for this is ≤ 3% ARMS (Accuracy Root Mean Square) across the specified SpO2 range (e.g., 70-100%).
- Pulse Rate Accuracy: Similarly, pulse rate accuracy is typically assessed against an ECG reference. A common requirement is ± 3 bpm (beats per minute).
Study and Performance Details from the Provided Text (and inferred standards):
Given the limitations of the provided document, the table below will combine explicitly stated information with common expectations for pulse oximeter 510(k) submissions.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Inferred from industry standards/FDA guidance) | Reported Device Performance (Inferred from "substantially equivalent" claim) |
|---|---|---|
| SpO2 Accuracy | ≤ 3% ARMS (Accuracy Root Mean Square) for SpO2 70-100% | Performance comparable to predicate devices (K053130, K043359), implying it meets or exceeds this criterion. (Not explicitly stated in numbers). |
| Pulse Rate | ± 3 bpm | Performance comparable to predicate devices, implying it meets or exceeds this criterion. (Not explicitly stated in numbers). |
| Functional Equivalence | To operate safely and effectively, providing SpO2 and PR readings for well or poorly perfused patients. | "substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation." |
| Safety | No new questions of safety raised compared to predicate devices. | "Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices." |
Note: The document explicitly states "Nonin's Model 9560 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence." This implies that the device met internal acceptance criteria for these tests, which would align with the inferred clinical accuracy requirements for pulse oximeters. However, the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. For clinical accuracy studies of pulse oximeters, the FDA typically recommends a minimum of 10 healthy adult subjects in a desaturation study to obtain sufficient data points across the hypoxic range (70-100% SpO2).
- Data Provenance: The document does not specify the country of origin of the data. It states "human testing," which usually implies prospective clinical studies where subjects are enrolled and data collected for the specific purpose of the device evaluation. There is no indication of retrospective data use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not explicitly stated. For pulse oximeter accuracy studies, ground truth for SpO2 is typically established using a laboratory co-oximeter to analyze arterial blood samples, not through expert review of data. For pulse rate, an ECG machine provides the ground truth.
- Qualifications of Experts: N/A for establishing SpO2/PR ground truth in this context. Medical professionals (e.g., anesthesiologists, nurses) would oversee the subject desaturation protocol and blood draws, but they are not "experts" establishing a consensus ground truth like in image interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in clinical trials requiring event confirmation or in diagnostic imaging studies where multiple readers interpret images to establish a consensus ground truth. For pulse oximeter accuracy, the ground truth is objective (co-oximetry and ECG), so no adjudication of device readings or reference measurements is needed in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, not applicable. MRMC studies are designed for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases (e.g., medical images) to diagnose conditions, and the study evaluates the impact of an AI algorithm on their performance. The Nonin Onyx II Model 9560 is a direct measurement device; it does not involve human interpretation of complex "cases" that an AI would assist with. Therefore, an MRMC study is not relevant for this type of device.
- Effect Size of Human Readers with/without AI assistance: N/A, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The core "human testing" mentioned for a pulse oximeter involves directly comparing the device's readings (SpO2 and pulse rate) against the objective reference standards (arterial blood gas co-oximetry for SpO2 and ECG for pulse rate). This is a standalone evaluation of the device's algorithm and sensor performance in producing accurate readings. The device is designed to display these measurements directly, not to provide an AI-driven interpretation that then guides a human.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For SpO2: Arterial blood gas co-oximetry. This is the gold standard for determining arterial oxygen saturation (SaO2), against which pulse oximeters' SpO2 readings are compared.
- For Pulse Rate: Electrocardiogram (ECG). An ECG provides an accurate measure of heart rate, which serves as the reference for the pulse oximeter's pulse rate measurement.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not explicitly stated. The document describes a traditional medical device (pulse oximeter) that uses fixed algorithms and signal processing, not a machine learning or AI-based algorithm that typically requires a distinct "training set" in the common sense. Therefore, the concept of a separate training set, as understood in AI/ML, doesn't directly apply here. The device's algorithms are likely developed and refined using engineering principles and historical physiological data rather than a specific "training set" for a submission study.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable. As explained above, for this type of device, a "training set" as commonly defined in AI/ML is not relevant. The device's underlying physiological models and calibration would have been established through extensive research and development, likely using various physiological data and established scientific principles, rather than a single "training set" with an explicitly established ground truth for regulatory purposes.
{0}------------------------------------------------
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
{1}------------------------------------------------
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:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized stripes forming its body and wings. The logo is rendered in black and white.
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.
{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) 276-0115. 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 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
{4}------------------------------------------------
Indications for Use Statement
| 510(k)Number(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)
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081285 |
|---|---|
| ---------------- | --------- |
Nonin Medical Inc.
Model 9560 Special 510(k): Device Modification
Confidential
§ 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).