DURAMAX REUSABLE OXIMETRY SENSOR

K070408 · Nellcor Puritan Bennett, Inc. · DQA · May 25, 2007 · Cardiovascular

Device Facts

• Record ID: K070408
• Device Name: DURAMAX REUSABLE OXIMETRY SENSOR
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The DuraMax® reusable digit sensor is intended for use with patients weighing 40 kg or more when noninvasive arterial oxygen saturation and pulse rate monitoring are required.

Device Story

DuraMax is a reusable digit pulse oximetry sensor for patients ≥40 kg. Device consists of internal optical components and flexible circuit encapsulated in synthetic, latex-free rubber overmold. Sensor plug contains memory chip storing sensor-specific data (e.g., model, calibration) for oximeter compatibility. Device connects to Nellcor and other monitors using R-Cal or OxiMAX (DigiCal) technology. Operates by transmitting light through tissue to measure arterial oxygen saturation and pulse rate. Used in clinical settings by healthcare providers to monitor patient oxygenation status; output displayed on compatible oximeter monitor to assist in clinical decision-making and patient management.

Clinical Evidence

Human oxygenation evaluations conducted to confirm accuracy and precision specifications. Bench testing performed for conformance with ISO 9919:2005 requirements.

Technological Characteristics

Reusable digit sensor; synthetic, latex-free rubber overmold; internal optical components and flexible circuit. Memory chip in plug for sensor identification/calibration. Compatible with Nellcor R-Cal or OxiMAX (DigiCal) technology. Designed to meet ISO 9919:2005 safety and performance standards.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation and pulse rate monitoring in patients weighing 40 kg or more.

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 Puritan Bennett, Inc., OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors (K012891)

Submission Summary (Full Text)

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Ko 70408

tyco

Healthcare

Nellcor Puritan Bennett MAY 25 2007

4280 Hacienda Drive Pleasanton, CA 94588-2719

Tele: 925 463-4300 Fax: [phone]

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| Submitted by: | Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James Bonds Senior Director Regulatory Affairs [phone] Fax [phone] |
| Date Summary Prepared: | February 9, 2007 |
| Trade Name: | DuraMax® Reusable Oximetry Sensor |
| Common/Usual Name: | Oxygen Sensor |
| Classification Name: | Oximeter (DQA) per 21 CFR §870.2700 |
| Substantially Equivalent Devices: | Nellcor Puritan Bennett, Inc., OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors, K012891 |

510(k) Summary

### DEVICE DESCRIPTION

The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.

The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.

The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.

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## INTENDED USE

The DuraMax® reusable digit sensor is intended for use with patients weighing 40 kg or more when noninvasive arterial oxygen saturation and pulse rate monitoring are required.

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

The Nellcor DuraMax sensor has the same technological characteristics as the Nellcor DS-100A reusable sensor. The sensor uses the same optical components as the DS-100A. The differences relate to dimensions, one-piece external design, materials of construction, and labeling.

#### DETERMINATION OF SUBSTANTIAL SUPPORT TESTS PERFORMED TO EQUIVALENCE

Human and bench tests were performed to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.

The DuraMax sensor has been designed and tested for conformance with the applicable requirements of ISO 9919:2005, "Medical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use". When properly connected to an oximeter that is also compliant with this standard, the resulting system will comply with the standard.

### CONCLUSIONS

The technological characteristics of the DuraMax sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2007

Mr. James Bonds Senior Director Regulatory Affairs Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K070408

Trade/Device Name: Nellcor® DuraMax® Reusable Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 30, 2007 Received: May 1, 2007

Dear Mr. Bonds

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 Eederal Register.

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### Page 2 - Mr. Bonds

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 and installents 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,

Sylvite Y. Michieu Ous.

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 (if known): __

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.J. K070468

ാന of Anesthesiology, General Hospital, ്

ಿ(k) Number:_

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