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 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.

AI/ML Overview

Let's break down the information provided about the K021089 submission for the OxiMAX MAX-FAST Adhesive Forehead Sensor.

Based on the provided document, this 510(k) submission is not about proving a new device meets acceptance criteria through a new effectiveness study. Instead, it's a resubmission for a labeling change to an already cleared device. The original device (OxiMAX MAX-FAST adhesive forehead sensor) was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891) and was labeled for adults. This K021089 submission updates the labeling to add pediatric use (≥ 10 kg).

The document explicitly states:

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

Therefore, the information you're asking for regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies related to meeting new acceptance criteria is not present in this specific K021089 document. This filing refers back to the original K012891 for device performance.

To answer your request thoroughly, I would need the K012891 submission document, which would contain the original performance study details that led to its clearance.

However, I can extract the information that is implicitly available or directly stated based on the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a labeling update, no new acceptance criteria or reported device performance studies are presented in K021089. The device's performance for adults would have been established in the predicate K012891 submission. For the pediatric expansion, the FDA typically assesses if the existing performance data and technological characteristics are sufficient to support the expanded indication without new testing, or if bridging data is required. The lack of new study data in this submission implies the FDA found the existing data (likely from K012891) sufficient for the pediatric expansion (≥10kg).

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/Not provided in this document as no new performance study was conducted.
Data Provenance: Not applicable/Not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided in this document as no new performance study was conducted.

4. Adjudication method for the test set

Not applicable/Not provided in this document as no new performance study was conducted.

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 oxygen sensor, not an AI-assisted diagnostic tool requiring MRMC studies.

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

Not applicable. This device is an oxygen sensor, not an algorithm.

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

Not applicable/Not provided in this document as no new performance study was conducted. For pulse oximeters, the typical ground truth involves co-oximetry (blood gas analysis) for SaO2 measurements.

8. The sample size for the training set

Not applicable/Not provided in this document as no new performance study was conducted. This device is hardware; any "training" would have been for the original algorithm development in K012891, not a new study here.

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

Not applicable/Not provided in this document as no new performance study was conducted.

Summary of K021089 specific to your questions:

The K021089 submission is a regulatory update to expand the indications for use of an already cleared device (OxiMAX MAX-FAST Adhesive Forehead Sensor) to include pediatric patients (≥10 kg). No new performance data, studies, or acceptance criteria are presented in this document. The substantial equivalence determination relies on the existing performance data from the predicate device (K012891) and the fact that no design modifications were made.

Summary

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K021089

4280 Hacienda Drive Pleasanton, CA 94588

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

JUN 1. 9 2002

tyco

Healthcare

Nellcor

510(k) Summary

Submitted by:	Nellcor Puritan Bennett Incorporated(A business unit of Mallinckrodt Inc.,a division of Tyco Healthcare Group LP)4280 Hacienda DrivePleasanton, CA 94588
Company Contact:	Gina ToSenior Regulatory Affairs Project Manager(925) 463-4427(925) 463-4020 - 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 (includingconnector) (74DSA) (per 21 CFR §870.2900)
Substantially EquivalentDevices:	Nellcor Puritan Bennett, IncorporatedOxiMAX Pulse Oximetry System with N-595 PulseOximeter and OxiMAX Sensors510(k) #K012891

DEVICE DESCRIPTION

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

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INTENDED USE

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

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).