OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

K033973 · Nellcor Puritan Bennett, Inc. · NLF · Dec 13, 2004 · Cardiovascular

Device Facts

• Record ID: K033973
• Device Name: OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: NLF · Cardiovascular
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

Device Story

Reprocessed pulse oximetry sensors; input consists of light signals transmitted through patient tissue; device contains two LEDs (light sources) and one photodiode (detector) within adhesive envelope; OxiMax models include memory chip for sensor data, signal evaluation, and model identification; connects to Nellcor-licensed pulse oximetry monitors; monitors process optical signals to calculate SpO2 and pulse rate; used by clinicians or patients in hospitals, transport, or home; output displayed on monitor to assist clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Optical sensor with two LEDs and one photodiode; laminated adhesive envelope; OxiMax models include integrated memory chip; connects to pulse oximetry monitors; non-sterile (reprocessed).

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2 and pulse rate in neonatal, pediatric, and adult patients, including those with motion or poor perfusion, in clinical and home settings.

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-395 Pulse Oximeter (K993637)
• OxiMax Pulse Oximetry System with N-595 Pulse Oximeter (K012891)

Submission Summary (Full Text)

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K033973

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Healthcare

DEC 1 3 2004

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925 463-4000 Fax: [phone]

Nellcor

# 510(k) Summary

| Submitted by: | Nellcor Puritan Bennett, Inc.<br>4280 Hacienda Drive<br>Pleasanton, CA 94588 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Luanne Ng<br>Regulatory Affairs Manager<br>[phone]<br>[phone] -- FAX |
| Date Summary Prepared: | December 18, 2003 |
| Trade Name: | 1. Reprocessed Oxisensor II Sensor<br>2. Reprocessed OxiMax Sensor |
| Common/Usual Name: | Oximetry Sensor |
| Classification Name: | Oximeter, NLF per 21 CFR §870.2700 |
| Substantially Equivalent<br>Devices: | Sensors cleared with:<br>Nellcor N-395 Pulse Oximeter, K993637 and<br>OxiMax Pulse Oximetry System with N-595 Pulse<br>Oximeter, K012891 |

### DEVICE DESCRIPTION

The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter.

The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model.

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### INDICATIONS FOR USE

The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES

The technological characteristics of the subject devices and the predicate devices are identical. The predicate devices and the Reprocessed Oxisensor II and the OxiMax Sensors contain a photodetector that senses the signal strength of two wavelengths of light, which vary with the amount of light transmitted through the tissue. The Reprocessed Oxisensor II and OxiMax Sensors meet the same performance requirements as the predicate devices.

#### CONCLUSIONS

The technological characteristics of the Reprocessed Oxisensor II and OxiMax Sensors and the results of bench tests and laboratory tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices. The technological characteristics of the Reprocessed Oxisensor IIs and the OxiMax Sensors are identical in all aspects to those of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Ms. Luanne Ng Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719

Re: K033973

Trade/Device Name: Reprocessed Oxisensor II and OxiMax Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: October 8, 2004 Received: October 12, 2004

Dear Ms. Ng:

This letter corrects our substantially equivalent letter of December 13, 2004.

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 (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 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. Ng

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 continue 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,

Chin-Lin, 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

Enclosure

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| Nellcor Oxisensor II |
|----------------------|
| D-20 |
| D-25L |
| D-25 |
| N-25 |
| I-20 |
| Nellcor OxiMax |
| MAX-A |
| MAX-AL |
| MAX-I |
| MAX-P |
| MAX-N |

List of Models: Nellcor Reprocessed Oxisensor II and OxiMax Sensors

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