The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).

Device Description

The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.

The OxiMax NeoMAX sensor contains 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. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.

AI/ML Overview

The provided text describes the OxiMax NeoMAX Adhesive Forehead Reflectance Oximetry Sensor, but it does not contain a table of acceptance criteria or detailed results from a study proving the device meets specific criteria. The document states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but it does not present these specifications or the results in detail.

Therefore, many of the requested items cannot be answered directly from the provided text.

Here is what can be extracted based on the input:

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

Acceptance Criteria: Not explicitly stated in the provided text. The text mentions "accuracy and precision specifications" were confirmed, but the specific values for these specifications are not given.
Reported Device Performance: Not explicitly stated in the provided text. The document indicates that testing was performed and concluded that "The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." However, the actual performance metrics (e.g., accuracy, bias, standard deviation of SaO2 readings) are not provided.

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

Sample Size for Test Set: Not specified. The document only states "Human oxygenation evaluations were conducted."
Data Provenance: Not specified (e.g., country of origin, 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)

Not applicable/Not specified. This device is an oximeter sensor, and ground truth for oxygen saturation measurements is typically established through arterial blood gas analysis, not expert consensus on images. The document does not describe how ground truth was established.

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

Not applicable/Not specified. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., images), which is not the primary form of evaluation for an oximeter sensor.

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

Not applicable. This device is an oximeter sensor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This device is a sensor. Its "performance" inherently refers to its ability to accurately measure oxygen saturation and pulse rate. The evaluation would be of the sensor's direct measurement capabilities, which is analogous to a standalone performance evaluation in the context of a medical device's fundamental function. The document states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a direct measurement efficacy study.

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

Not explicitly stated, but for oxygen saturation measurements, the common gold standard (ground truth) is arterial blood gas analysis. It is highly probable this method was used, though not specified in the text.

8. The sample size for the training set

Not applicable/Not specified. This device is a sensor; it does not involve a "training set" in the context of machine learning algorithms.

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

Not applicable. This device does not involve a training set.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device and mentions that human and bench tests were performed to confirm accuracy and precision. However, it lacks the detailed quantitative data, sample sizes, and ground truth methodologies that would be necessary to fully answer many of the questions regarding acceptance criteria and study particulars.

Summary

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K05/27/

4280 Haclenda Drive

Tele: 925 463-4000 Fax: 925 463-4020

Pleasanton, CA 94588

tyco

Healthcare

Nellcor

510(k) Summary

JAN 1 0 2006

Submitted by:	Nellcor Puritan Bennett, Inc.4280 Hacienda DrivePleasanton. CA 94588
Company Contact:	James Patrick Garvey II, RRTRegulatory Affairs Manager(925) 463-4479(925) 463-4020 - FAX
Date Summary Prepared:	May 4, 2005
Trade Name:	OxiMax NeoMAX Adhesive Forehead ReflectanceOximetry Sensor
Common/Usual Name:	Oxygen Sensor
Classification Name:	Oximeter (DQA) per 21 CFR §870.2700
Substantially EquivalentDevices:	• Nellcor Puritan Bennett, Inc.. OxiMax Pulse OximetSystem with N-595 Pulse Oximeter and OxiMaxSensors, K012891• Nellcor Puritan Bennett, Inc., OxiMax MAX-FASTAdhesive Forehead Sensor, K021089

DEVICE DESCRIPTION

The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.

INTENDED USE

The Nellcor® OxiMax® adhesive forehead reflectance sensor, model NeoMAX, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).

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

The OxiMax NeoMAX sensor has the same technological characteristics as the OxiMax MAX-FAST. The differences relate to dimensions. lighter adhesive on the patient contact surface, and labeling.

TESTS PERFORMED TO SUPPORT DETERMINATION OF SUBSTANTIAL 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.

CONCLUSIONS

The technological characteristics of the OxiMax NeoMAX 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN I 0 2006

Mr. James P. Garvey Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K051271

Trade/Device Name: OxiMax NeoMax Adhesive Forehead Reflectance Regulation Number: 21 CFR 870.2700 Regulation Name: Oximcter Regulatory Class: II Product Code: DQA Dated: December 22, 2005 Received: December 23, 2005

Dear Mr. Garvey:

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 - Mr. Garvey

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), 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte if. Michin Omd.

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

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

ﻟﺴ Prescription Use (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)

Suette y. Michael Ond

Henry General Hospital,
Rehabilitation Services

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).