WRISTOX MODEL 3100 PULSE OXIMETER

K052829 · Nonin Medical, Inc. · DQA · Nov 10, 2005 · Cardiovascular

Device Facts

• Record ID: K052829
• Device Name: WRISTOX MODEL 3100 PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 Story

Wrist-worn pulse oximeter; utilizes electro-optical sensor to measure light absorption of functional arterial hemoglobin. Provides continuous data collection/recording or spot-check measurements of SpO2 and pulse rate. Operates automatically upon finger sensor placement; powers off upon removal. Compatible with 8000AA-WO articulated finger clip or 8000J-WO flex sensors. Stores up to 33 hours of data; integrates with nVision® data management software for analysis. Used in clinical or home settings; operated by clinicians or patients. Output allows healthcare providers to monitor patient oxygenation status and pulse rate, facilitating clinical decision-making regarding respiratory or cardiovascular health.

Clinical Evidence

Bench and clinical testing performed to demonstrate functional characteristics and substantial equivalence to the predicate device. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Wrist-worn pulse oximeter; electro-optical sensing principle. Compatible with articulated finger clip or flex sensors. Memory capacity for 33 hours of data. Connectivity via nVision® data management software. Software-based data storage and processing.

Indications for Use

Indicated for adult and pediatric patients requiring measurement, display, and storage of SpO2 and pulse rate. Suitable for patients who are well or poorly perfused, under both motion and no-motion conditions.

Regulatory Classification

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.

Predicate Devices

• Model 3100 WristOx® (K030668)

Reference Devices

• nVision® data management software (K033307)

Submission Summary (Full Text)

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NOV 1 0 2005

NOV 16 2005

510(k) Summary K052829

| Submitter: | Nonin Medical, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lori Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
| Date Prepared: | October 3, 2005 |
| Trade Name: | Model 3100 WristOx® Pulse Oximeter |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | Model 3100 WristOx® is substantially equivalent to<br>the Model 3100 WristOx® (K030668), which is also<br>manufactured by Nonin Medical. |
| Device Description: | The Nonin Model 3100 WristOx® is a small wrist-<br>worn pulse oximeter. It has an electro-optical sensor<br>that determines the light absorption of functional<br>arterial hemoglobin. It is used to spot check patients,<br>or it can be used to provide continuous data collection<br>and recording of patients in situations where alarms<br>are not required. The device turns on automatically<br>when the sensor is placed on the finger and turns off<br>when the finger is removed. It may be used with<br>Nonin's 8000AA-WO articulated finger clip sensor or<br>the 8000J-WO flex sensor. The WristOx is also<br>memory capable in conjunction with nVision® data<br>management software (K033307). It is capable of<br>storing up to 33 hours of SpO2 and pulse rate data. |
| Intended Use: | The Nonin® Model 3100 WristOx® Pulse Oximeter is<br>a small wrist-worn device indicated for use in<br>measuring, displaying, and storing functional oxygen<br>saturation of arterial hemoglobin (SpO2) and pulse<br>rate of adult and pediatric patients. It is intended for<br>spot-checking and / or data collection and recording |
| | of patients during both no motion and motion<br>conditions, and for patients who are well or poorly<br>perfused. |
| Functional and<br>Safety Testing: | Nonin's Model 3100 WristOx® Pulse Oximeter has<br>successfully undergone both bench and clinical<br>testing in order to demonstrate that it has appropriate<br>functional characteristics and is substantially<br>equivalent to the predicate device. |
| Conclusion: | Nonin's Model 3100 WristOx® Pulse Oximeter is<br>identical in everyway to the predicate device not with<br>standing the changes specified in the labeling. |
| | This conclusion is based upon the fact that the Model<br>3100 WristOx® Pulse Oximeter is substantially<br>equivalent to the predicate device in terms of<br>functional design and principles of operation. |

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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 [phone]. 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 [phone] or [phone] 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)<br>Number<br>(if known) | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Nonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter |
| Indications<br>for Use | The Nonin® Model 3100 WristOx® Pulse Oximeter is a small<br>wrist-worn device indicated for use in measuring, displaying, and<br>storing functional oxygen saturation of arterial hemoglobin<br>(SpO2) and pulse rate of adult and pediatric patients. It is<br>intended for spot-checking and / or data collection and recording<br>of patients during both no motion and motion conditions, and for<br>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