K Number
K052829
Device Name
WRISTOX MODEL 3100 PULSE OXIMETER
Date Cleared
2005-11-10

(36 days)

Product Code
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
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.
More Information

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)

K033307

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.

1

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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.

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) 276-0120. 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 NameNonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter
Indications
for UseThe 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