(203 days)
The Nonin® Onyx Vantage 9590 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 digits, including the thumb and toes, that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The device's intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.
Onyx Vantage 9590 is a small, lightweight, portable, digit 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 emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LED display contained within the device. A tricolor LED provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to indicate the pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates an inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking of adult and pediatric patients who are well or poorly perfused on digits, including the thumb and toes.
The provided document is a 510(k) summary for the Nonin Onyx Vantage 9590 Finger Pulse Oximeter. It describes the device and states that it underwent "laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance, functional features to fully comply with ISO 9919:2005 and is substantially equivalent to the predicate device." However, the document does not provide specific acceptance criteria or detailed results of these tests. It only makes a general statement of compliance.
Therefore, much of the requested information cannot be extracted from this document.
Here's what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with ISO 9919:2005 (for performance and functional features) | Nonin's Onyx Vantage 9590 has successfully undergone both laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance, functional features to fully comply with ISO 9919:2005. |
| Substantial equivalence to predicate device (Nonin Model 9550 Onyx II) | The results of testing lead to the conclusion that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness. |
| Accuracy in measuring SpO2 and pulse rate in well or poorly perfused patients. | (General statement of successful testing, but no specific accuracy metrics or ranges provided) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided document.
- Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). It only mentions "laboratory and clinical hypoxia accuracy testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided document.
4. Adjudication method for the test set
- Not specified in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a pulse oximeter, not an AI-based diagnostic tool that assists human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone measurement device (an algorithm-only performance is its primary function). The document states it underwent "laboratory and clinical hypoxia accuracy testing," which would evaluate its standalone performance. However, specific performance metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For oxygen saturation and pulse rate measurements, the "ground truth" in clinical hypoxia accuracy testing typically refers to a co-oximeter (which provides direct arterial oxygen saturation, SaO2) and/or an ECG for pulse rate, often measured from arterial blood samples in a controlled setting. The document only mentions "clinical hypoxia accuracy testing" but does not explicitly state the method for establishing ground truth.
8. The sample size for the training set
- This device is not described as being based on machine learning or AI that requires a "training set" in the conventional sense. Its function is based on established optical principles for measuring pulsing blood volume. Therefore, this concept is not applicable here, and no training set size is mentioned.
9. How the ground truth for the training set was established
- As above, the concept of a training set is not applicable to this device as described.
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GINONIN
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510(k) Summary
CILIT
APR 1 9 2012
112 843 :W
.
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Brodie PedersenSenior Regulatory EngineerNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
| Phone: | 763-553-9968 |
| Fax: | 763-553-7807 |
| Date Prepared: | September 28, 2011 |
| Trade Name: | Onyx® Vantage 9590 |
| Classification Nameand Number: | Class II, 21 CFR 870.2700 |
| Product Code: | DQA |
| Predicate Device(s): | Nonin's Onyx Vantage 9590 finger pulse oximeter is substantiallyequivalent to the Nonin Model 9550 Onyx II finger pulse oximetercleared by the FDA in K053130 on 1/11/2006. |
| Indications for Use: | Onyx Vantage 9590The Nonin® Onyx Vantage 9590 Finger Pulse Oximeter is a small,lightweight, portable device indicated for use in measuring anddisplaying functional oxygen saturation of arterial hemoglobin(%SpO2) and pulse rate of patients who are well or poorlyperfused. It is intended for spot-checking of adult and pediatricpatients on digits, including the thumb and toes, that are between0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The device's intended useenvironments include hospitals, clinics, long-term care facilities,skilled nursing facilities, emergency medical services, and homehealthcare services. |
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GNONIN
Device Description:
Onyx Vantage 9590 is a small, lightweight, portable, digit 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 emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LED display contained within the device. A tricolor LED provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to indicate the pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates an inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking of adult and pediatric patients who are well or poorly perfused on digits, including the thumb and toes.
Functional and Safety Testing:
Conclusion:
Nonin's Onyx Vantage 9590 Finger Pulse Oximeter has successfully undergone both laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance, functional features to fully comply with ISO 9919:2005 and is substantially equivalent to the predicate device.
Nonin's Onyx Vantage 9590 is substantially equivalent to the Model 9550 Onyx II Finger Pulse Oximeter manufactured by Nonin Medical, Inc. and cleared by the FDA under K053130 on 1/11/2006.
The results of testing lead to the conclusion that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Mr. Brodie Pedersen Senior Regulatory Engineer Nonin Medical, Inc. 13700 156 Avenue North Plymouth, Minnesota 55441
Re: K112843 Trade/Device Name: Onyx® Vantage 9590 Regulation Number: 21 CFR 870.2700 . Regulation Name: Oximeter Regulatory Class: Il Product Code: DQA Dated: April 13, 2012 Received: April 16, 2012
Dear Mr. Pedersen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
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Page 2 – Mr. Pedersen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Ginomir.
Indications for Use Statement
510(K) Number:
Device Name:
Nonin Medical, Inc. Onyx Vantage 9590
Indications for Use:
Onyx Vantage 9590
The Nonin® Onyx Vantage 9590 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 digits, including the thumb and toes, that are between 0.3 ~ 1.0 inch (0.8 ~ 2.5 cm) thick. The device's intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.
Prescription Use __ AND/OR (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: | K112843 |
|---|---|
| ---------------- | --------- |
§ 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).