MODEL 3100 WRISTOX PULSE OXIMETER

K030668 · Nonin Medical, Inc. · DQA · Oct 17, 2003 · Cardiovascular

Device Facts

• Record ID: K030668
• Device Name: MODEL 3100 WRISTOX PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 17, 2003
• 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. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute, and sleep study environments

Device Story

Wrist-worn pulse oximeter; uses electro-optical sensor to noninvasively measure SpO2 and pulse rate. Device displays real-time data and stores up to 33 hours of patient information. Operated by clinicians or patients in hospitals, clinics, or sleep study environments. Stored data is downloadable via nonproprietary communication protocol to external data management systems (e.g., nVISION software). Provides objective physiological data to assist healthcare providers in monitoring patient oxygenation and pulse status; facilitates clinical decision-making through data collection and recording.

Clinical Evidence

Functional and safety testing performed, including both bench and clinical testing, to demonstrate appropriate functional characteristics and substantial equivalence to the predicate device.

Technological Characteristics

Wrist-worn pulse oximeter; electro-optical sensor; noninvasive measurement of SpO2 and pulse rate; 33-hour data storage capacity; nonproprietary communication protocol for data download.

Indications for Use

Indicated for adult and pediatric patients requiring measurement, display, and storage of functional oxygen saturation (SpO2) and pulse rate. Suitable for use in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.

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 2500 PalmSat Hand Held Pulse Oximeter (K002690)

Submission Summary (Full Text)

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## OCT 1 7 2003

## Summary and Certification

## 510 Summary, K030668 A

| Submitter: | Nonin Medical Inc. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John R. Dalpee<br>Director, Regulatory Affairs<br>Nonin Medical Inc.<br>2605 Fernbrook Lane N.<br>Plymouth, MN 55447-4755 |
| Date Prepared: | 150October, 2003 |
| Trade Name: | WristOx TM Pulse Oximeter, Model 3100 |
| Classification Name<br>And Number: | Class II, 21 CFR Part 870.2700, Oximeter |
| Product Code: | DQA |
| Predicate Device: | Model 2500 PalmSat® Hand Held Pulse Oximeter<br>(K002690) |

Device Description: The Nonin Model 3100 WristOx is a small, wrist worn pulse oximeter. It uses an electro-optical sensor to noninvasively measure, display and store functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. The WristOx stores up to 33 hours of SpO2 and pulse rate data. Stored patient data may be downloaded to any data management software system using the nonproprictary communication protocol . Nonin's data management software system (nVISION™) is available as an accessory, but is not required to use the memory feature.

Indications for Use: The Nonin Model 3100 WristOx™ Pulse Oximeter is a small, wrist-worn device indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spotchecking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute and sleep study environments.

The Nonin Model 3100 WristOx has undergone Functional and Safety Testing: both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device.

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Conclusion: The Nonin Model 3100 WristOx is substantially equivalent to the Model 2500 PalmSat Hand Held Pulse Oximeter (K002690), which employs a similar memory function. This conclusion is based on the fact that the subject device is substantially equivalent to the predicate device in terms of principals of operation, function, and indications for use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2003

Mr. John R. Dalpee Director of Regulatory Affairs Nonin Medical Inc. 2605 Fernbrook Lane North Plymouth, MN 55447-4755

Re: K030668

> Trade/Device Name: WristOx Pulse Oximeter, Model 3100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 29, 2003 Received: July 30, 2003

Dear Mr. Dalpee:

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 vour 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 - Mr. John R. Dalpee

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/dsma/dsmamain.html.

Sincerely yours.

Patricia Cucentoffer

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

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## Indications For Use

510(k) number Device Name;

K030668 WristOx Model 3100

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. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute, and sleep study environments

Concurrence of CDRH, Office of Device Evaluation

Signature

Wision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KO30668 510(k) Number: _