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.

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.

AI/ML Overview

Nellcor® DuraMax® Reusable Oximetry Sensor

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly state quantitative acceptance criteria in a table format. However, it indicates adherence to the ISO 9919:2005 standard and states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The implicit acceptance criterion, therefore, is conformance to the accuracy and precision specifications outlined in ISO 9919:2005 for pulse oximeters. The submission concludes that the device meets these requirements.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance with ISO 9919:2005 for accuracy and precision specifications for pulse oximeters	"Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications."
No new questions of safety or effectiveness compared to predicate device	"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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission states that "Human... tests were performed to support the determination of substantial equivalence" and that "Human oxygenation evaluations were conducted." However, the document does not specify:

The exact sample size used for the human test set.
The country of origin of the data.
Whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the submission. The submission mentions "Human oxygenation evaluations," which implies direct physiological measurements rather than expert review of data. In the context of pulse oximetry, the "ground truth" for oxygen saturation is typically established through co-oximetry measurements of arterial blood samples. Expert review for ground truth establishment is not typically the primary method for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the submission. Given that the ground truth for oxygen saturation is usually established by direct or highly accurate indirect physiological measurements (e.g., co-oximetry), a multi-reader adjudication method would not be applicable in the traditional sense for the device's primary function.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The DuraMax® sensor is an oximetry sensor, not an AI-powered diagnostic device that assists human readers in case interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a passive sensor that provides data (oxygen saturation and pulse rate) to an oximeter; it does not contain a standalone "algorithm" in the sense of an AI-driven component. The "Advanced Signal Evaluation" and "Intention and data set revision" are mentioned as information carried by the sensor's memory chip, indicating internal processing logic for signal quality, but this is part of the integrated system and not a standalone algorithm evaluated independently for diagnostic performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For oxygen saturation measurements, the ground truth is typically established using arterial co-oximetry, where arterial blood samples are analyzed to determine actual oxygen saturation (SaO2). The submission states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," which strongly implies comparison against a gold standard for oxygen saturation, most commonly co-oximetry.

8. The sample size for the training set

The submission does not mention a distinct "training set" for the device, as it is a hardware sensor rather than a machine learning model that requires training. The development and verification process for such a device would involve design, bench testing, and human testing for performance validation.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable. The ground truth for performance validation (the human oxygenation evaluations) would have been established through methods like co-oximetry as described in point 7.

Summary

{0}------------------------------------------------

Ko 70408

tyco

Healthcare

Nellcor Puritan Bennett MAY 25 2007

4280 Hacienda Drive Pleasanton, CA 94588-2719

Tele: 925 463-4300 Fax: 925 463-4020

Page 1 of 2

Submitted by:	Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588
Company Contact:	James Bonds Senior Director Regulatory Affairs (925) 463-4371 Fax (925) 463-4020
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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

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.

{3}------------------------------------------------

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------

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:_

Page 1 of 1

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).