OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR

K021089 · Nellcor Puritan Bennett, Inc. · DQA · Jun 19, 2002 · Cardiovascular

Device Facts

• Record ID: K021089
• Device Name: OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.

Device Story

The OxiMAX MAX-FAST is a disposable adhesive forehead reflectance sensor; used for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. It is intended for adult and pediatric patients (≥ 10 kg), including those mechanically ventilated or in a supine position. The sensor contains an integrated memory chip that stores sensor-specific information required for oximeter operation. It is designed for single-patient use and can be worn for up to two days, with a maximum of four site changes or inspections. The device functions as part of the OxiMAX Pulse Oximetry System; it transmits physiological data to the oximeter for processing and display. Healthcare providers use the output to monitor patient oxygenation status and pulse rate, facilitating clinical decision-making regarding respiratory support and patient stability.

Clinical Evidence

No clinical data provided; the submission relies on the substantial equivalence of the device design to the previously cleared predicate (K012891) and the addition of pediatric labeling.

Technological Characteristics

Disposable adhesive forehead reflectance sensor; includes an integrated memory chip for sensor identification/calibration data. Designed for continuous monitoring; compatible with OxiMAX Pulse Oximetry System. No design modifications from predicate.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation and pulse rate monitoring in adult and pediatric patients weighing ≥ 10 kg.

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

• OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors (K012891)

Submission Summary (Full Text)

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K021089

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925 463-4000 Fax: [phone]

# JUN 1. 9 2002

tyco

Healthcare

Nellcor

## 510(k) Summary

| Submitted by: | Nellcor Puritan Bennett Incorporated<br>(A business unit of Mallinckrodt Inc.,<br>a division of Tyco Healthcare Group LP)<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: | April 3, 2002 |
| Trade Name: | OxiMAX MAX-FAST Adhesive Forehead Sensor |
| Common/Usual Name: | Oxygen Sensor |
| Classification Name: | Patient Transducer and Electrode Cable (including<br>connector) (74DSA) (per 21 CFR §870.2900) |
| Substantially Equivalent<br>Devices: | Nellcor Puritan Bennett, Incorporated<br>OxiMAX Pulse Oximetry System with N-595 Pulse<br>Oximeter and OxiMAX Sensors<br>510(k) #K012891 |

#### DEVICE DESCRIPTION

The OxiMAX MAX-FAST Adhesive Forehead Sensor is a disposable adhesive sensor for the forehead. MAX-FAST may be used on mechanically ventilated patients and on patients in supine position. MAX-FAST may be used continuously up to two days with appropriate site inspections, and will allow a maximum of four site changes and/or inspections with the removal of adhesive layers.

The OxiMAX MAX-FAST sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation.

The OxiMAX MAX-FAST adhesive forehead sensor was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891). This forehead sensor was labeled for adults. The labeling has been updated to add pediatric use.

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#### INTENDED USE

The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE LEGALLY MARKETED (UNMODIFIED) DEVICE

No design modifications have been made to the OxiMAX MAX-FAST adhesive forehead sensor. Only labeling has been revised.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·

JUN 1 9 2002

Nellcor Puritan Bennett, Inc. c/o Ms. Gina To 4280 Hacienda Drive Pleasanton, CA 94588

Re: K021089

OxiMAX MAX-FAST Adhesive Forehead Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: April 3, 2002 Received: April 4, 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.

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Page 2 - Ms. Gina To

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 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Donna Rea Tillman, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO21089

OxiMAX MAX-FAST Adhesive Forehead Sensor Device Name:

#### Indications For Use:

The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021089

(Optional Format 3-10-98)