NELLCOR N-200 PULSE OXIMETER, MODEL N-200

K022819 · Nellcor Puritan Bennett, Inc. · DQA · Sep 24, 2002 · Cardiovascular

Device Facts

• Record ID: K022819
• Device Name: NELLCOR N-200 PULSE OXIMETER, MODEL N-200
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.

Device Story

Nellcor N-200 Pulse Oximeter provides continuous, non-invasive monitoring of oxygen saturation, pulse rate, and pulse amplitude. Device utilizes C-Lock ECG synchronization technology to reduce motion artifact during signal processing. Compatible with Nellcor reusable and disposable sensors. Used in clinical settings for patient monitoring; operated by healthcare professionals. Output displayed visually with audible/visual alarms. Labeling modification adds performance specifications for motion and low perfusion conditions when using C-Lock.

Clinical Evidence

Clinical evaluation performed to support updated labeling specifications for motion and low perfusion performance. Testing conducted in accordance with 21 CFR Parts 812, 50, and 56. No design changes were made; clinical data confirms performance claims under specified conditions.

Technological Characteristics

Pulse oximeter utilizing optical sensing and C-Lock ECG synchronization for motion artifact reduction. Compatible with Nellcor reusable and disposable sensors. No hardware or design modifications; labeling update only.

Indications for Use

Indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude in patients requiring such monitoring. Prescription use only.

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

• Nellcor N-200 Pulse Oximeter (K863784)

Submission Summary (Full Text)

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SEP 2 4 2002

KQ2819

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925 463-4000 Fax: [phone]

# tyco Healthcare

Nellcor

510(k) Summary

| Submitted by: | Nellcor Puritan Bennett, Incorporated<br>4280 Hacienda Drive<br>Pleasanton, CA 94588 |
|---------------------------------------|------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To<br>Senior Regulatory Affairs Project Manager<br>[phone]<br>[phone] - FAX |
| Date Summary Prepared: | August 22, 2002 |
| Trade Name: | Nellcor N-200 Pulse Oximeter |
| Common/Usual Name: | Pulse Oximeter |
| Classification Name: | Oximeter (74DQA) per 21 CFR §870.2700 |
| Legally Marketed (Unmodified) Device: | Nellcor N-200 Pulse Oximeter, 510(k) #K863784 |

## Device Description

The Nellcor N-200 Pulse Oximeter provides continuous non-invasive measurement and display of pulse rate and oxygen saturation values with visual and audible alarms, and features C-Lock, Nellcor's patented ECG Synchronization technology which reduces motion artifact. The N-200 Pulse Oximeter functions with all Nellcor reusable and disposable oximeter sensors.

This Special 510(k) covers the labeling modification of Nellcor N-200 Pulse Oximeter that was cleared under 510(k) #K863784. The modification involves revising the N-200 labeling to add performance specifications for motion and low perfusion when the N-200 is used with C-Lock ECG synchronization. Results from clinical evaluation are provided to support the labeling change. No device modifications have been made to the N-200. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.

## Intended Use

The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.

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## Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device

No design modifications have been made to the N-200 Pulse Oximeter. Only labeling has been revised.

## Tests Performed to Support Determination of Substantial Equivalence

Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.

## Conclusions

The technological characteristics of the N-200 Pulse Oximeter and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed (unmodified) device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or movement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2002

Ms. Gina To Senior Regulatory Affairs Project Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K022819

Trade/Device Name: N-200 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 22, 2002 Received: August 26, 2002

Dear Ms. To:

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.

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.

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### Page 2 -- Ms. To

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runne

Timothy A. Ulatowski 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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| 510(k) Number (if known): | K022519 |
|---------------------------|----------------------|
| Device Name: | N-200 Pulse Oximeter |

#### Indications For Use:

The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K022819