(36 days)
No
The description focuses on standard pulse oximetry technology and data storage, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a pulse oximeter used for measuring, displaying, and storing functional oxygen saturation and pulse rate. It is a diagnostic device that provides information, rather than a device that directly treats or prevents a disease or condition.
Yes
The device measures, displays, and stores 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 used for diagnosis, treatment, or prevention of disease.
No
The device description clearly states it is a "small wrist-worn pulse oximeter" with an "electro-optical sensor," indicating it is a hardware device with integrated software, not a software-only device.
No, 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 Model 3100 WristOx® Pulse Oximeter measures oxygen saturation and pulse rate by using an electro-optical sensor placed on the finger. This is a non-invasive measurement taken directly from the patient's body, not from a sample taken from the body.
Therefore, based on the provided information, the device is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nonin® Model 3100 WristOx® Pulse Oximeter is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
Product codes
74 DQA, DQA
Device Description
The Nonin Model 3100 WristOx® is a small wrist-worn pulse oximeter. It has an electro-optical sensor that determines the light absorption of functional arterial hemoglobin. It is used to spot check patients, or it can be used to provide continuous data collection and recording of patients in situations where alarms are not required. The device turns on automatically when the sensor is placed on the finger and turns off when the finger is removed. It may be used with Nonin's 8000AA-WO articulated finger clip sensor or the 8000J-WO flex sensor. The WristOx is also memory capable in conjunction with nVision® data management software (K033307). It is capable of storing up to 33 hours of SpO2 and pulse rate data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 3100 WristOx® Pulse Oximeter has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device.
Nonin's Model 3100 WristOx® Pulse Oximeter is identical in everyway to the predicate device not with standing the changes specified in the labeling. This conclusion is based upon the fact that the Model 3100 WristOx® Pulse Oximeter is substantially equivalent to the predicate device in terms of functional design and principles of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Model 3100 WristOx® (K030668)
Reference Device(s)
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
NOV 1 0 2005
NOV 16 2005
510(k) Summary K052829
Submitter: | Nonin Medical, Inc. |
---|---|
Contact Person: | Lori Roth |
Clinical/Regulatory Specialist | |
Nonin Medical, Inc. | |
13700 1st Ave. North | |
Plymouth, MN 55441-5443 | |
Date Prepared: | October 3, 2005 |
Trade Name: | Model 3100 WristOx® Pulse Oximeter |
Classification Name: | |
and Number: | Class II, 21 CFR 870.2700 |
Product Code: | 74 DQA |
Predicate Device(s): | Model 3100 WristOx® is substantially equivalent to |
the Model 3100 WristOx® (K030668), which is also | |
manufactured by Nonin Medical. | |
Device Description: | The Nonin Model 3100 WristOx® is a small wrist- |
worn pulse oximeter. It has an electro-optical sensor | |
that determines the light absorption of functional | |
arterial hemoglobin. It is used to spot check patients, | |
or it can be used to provide continuous data collection | |
and recording of patients in situations where alarms | |
are not required. The device turns on automatically | |
when the sensor is placed on the finger and turns off | |
when the finger is removed. It may be used with | |
Nonin's 8000AA-WO articulated finger clip sensor or | |
the 8000J-WO flex sensor. The WristOx is also | |
memory capable in conjunction with nVision® data | |
management software (K033307). It is capable of | |
storing up to 33 hours of SpO2 and pulse rate data. | |
Intended Use: | The Nonin® Model 3100 WristOx® Pulse Oximeter is |
a small wrist-worn device indicated for use in | |
measuring, displaying, and storing functional oxygen | |
saturation of arterial hemoglobin (SpO2) and pulse | |
rate of adult and pediatric patients. It is intended for | |
spot-checking and / or data collection and recording | |
of patients during both no motion and motion | |
conditions, and for patients who are well or poorly | |
perfused. | |
Functional and | |
Safety Testing: | Nonin's Model 3100 WristOx® Pulse Oximeter has |
successfully undergone both bench and clinical | |
testing in order to demonstrate that it has appropriate | |
functional characteristics and is substantially | |
equivalent to the predicate device. | |
Conclusion: | Nonin's Model 3100 WristOx® Pulse Oximeter is |
identical in everyway to the predicate device not with | |
standing the changes specified in the labeling. | |
This conclusion is based upon the fact that the Model | |
3100 WristOx® Pulse Oximeter is substantially | |
equivalent to the predicate device in terms of | |
functional design and principles of operation. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with three parallel lines extending from its head, resembling feathers or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 154 Avenue North Plymouth, Minnesota 55441-5443
Re: K052829
Trade/Device Name: Model 3100 WristOx® Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 1, 2005 Received: October 13, 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 yours,
Chiu-Lin Liu, 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
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Indications for Use Statement
| 510(k)
Number
(if known) | |
---|---|
Device Name | Nonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter |
Indications | |
for Use | The Nonin® Model 3100 WristOx® Pulse Oximeter is a small |
wrist-worn device indicated for use in measuring, displaying, and | |
storing functional oxygen saturation of arterial hemoglobin | |
(SpO2) and pulse rate of adult and pediatric patients. It is | |
intended for spot-checking and / or data collection and recording | |
of patients during both no motion and motion conditions, and for | |
patients who are well or poorly perfused. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
Quir, Siliom
on San-Qif) of Anesthesiology, General Hospital, otion Control, Dental Devices
Number: K552 829