The Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use.

Device Description

Nellcor OxiMax Pulse Oximetry Sensors, models MAX-AL, MAX-AL, MAX-P, MAX-I and MAX-FAST are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor pulse oximeter. Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

These OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation including sensor model, Advanced Signal Evaluation, and data set revision. The memory chip is also cable of storing including in-sensor data when connected to an OxiMax-capable monitor, and lot code.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nellcor OxiMax Pulse Oximetry Sensors, based on the provided text:

Nellcor OxiMax Pulse Oximetry Sensors: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Not explicitly stated in terms of specific numerical thresholds (e.g., +/- X%). The document indicates that "clinical tests were performed to support accuracy specifications for SpO2 performance." However, the specific quantitative acceptance criteria and the resulting performance values (e.g., bias, precision, ARMS values) are not detailed within this summary.
Pulse Rate Accuracy	Not explicitly stated in terms of specific numerical thresholds. The device is designed for monitoring pulse rate, and accuracy would be a key performance metric, but the specific criteria and performance aren't provided in this summary.
No Motion Conditions	The device is intended "for use with neonatal, pediatric, and adult patients during both no motion conditions." While this is an intended use, the specific performance criteria (e.g., minimum accuracy under no motion) and the quantitative results are not detailed.
Well or Poorly Perfused Patients	The device is intended "for patients who are either well or poorly perfused." Similar to no motion, this is an intended use, but the specific performance criteria (e.g., minimum accuracy under different perfusion states) and the quantitative results are not detailed.
Compatibility	The sensors are stated to be "compatible with the N-595, other Nellcor oximeters and instruments containing Nellcor oximetry, or with instruments licensed to use Nellcor sensors (Nellcor-compatible instruments)." This implies acceptance criteria related to successful communication and data exchange, which is implicitly met by the described functionality.
Data Storage (In-Sensor)	The memory chip is "capable of storing including in-sensor data... allowing patient history, namely SpO2 and pulse rate alarm events, to travel with the patient, and enabling quick patient assessment upon transfer to a new point of care." This implies functional acceptance criteria for data storage and retrieval.

Important Note: The provided text is a 510(k) summary, which often provides a high-level overview. Detailed performance data and specific acceptance criteria (e.g., ARMS values for SpO2 accuracy) are typically found in the full 510(k) submission, not always in the public summary. The summary confirms that studies were performed to support accuracy specifications, but doesn't report the specific numerical values of these specifications or the device's performance against them.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. The document mentions "Clinical tests were performed" and "Clinical studies were conducted" but does not specify the number of subjects or data points in the test set.
Data Provenance: Not explicitly stated. The document confirms that clinical studies were conducted, implying human subject data collection, but does not specify the country of origin or whether it was retrospective or prospective. Given the context of a 510(k) submission for new sensors, it is highly probable these were prospective clinical studies conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the device's readings to arterial blood gas (ABG) measurements or co-oximetry, not usually by human expert consensus on the device's output itself. Therefore, the concept of "experts establishing ground truth for the test set" in the context of reader evaluation isn't directly applicable here. The experts involved would more likely be the clinicians performing the ABG measurements or managing the study, and their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods (like 2+1 or 3+1) are typically used when multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. For pulse oximetry, the direct comparison to ABG/co-oximetry as a reference standard eliminates the need for such adjudication of the device's output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done as described in the provided text. MRMC studies are designed to assess the impact of an AI algorithm on human reader performance, usually in diagnostic tasks involving interpretation of visual data. Pulse oximetry is a direct measurement device; its performance is evaluated against a reference standard (like ABG), not by how it assists human readers in interpreting its output.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The entire premise of pulse oximetry testing for regulatory approval is to establish the accuracy of the device's (algorithm's) measurements of SpO2 and pulse rate against a
reference standard (typically arterial blood gas/co-oximetry). The statement "Clinical tests were performed to support accuracy specifications for SpO2 performance" directly refers to evaluating the device's intrinsic measurement capabilities. The device processes electrical information "by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude," indicating a standalone algorithmic evaluation.

7. Type of Ground Truth Used

The type of ground truth used is physiological reference data, specifically arterial blood oxygen saturation (SaO2) and heart rate measurements, likely obtained through arterial blood gas (ABG) analysis or co-oximetry. While not explicitly named, this is the universally accepted gold standard for determining the accuracy of pulse oximeters. The text states "Clinical tests were performed to support accuracy specifications for SpO2 performance," which implies comparison to a highly accurate and independent measure of arterial oxygen saturation.

8. Sample Size for the Training Set

This information is not provided in the given text. For pulse oximetry devices, "training set" doesn't apply in the same way it would for a machine learning model that learns from large datasets. Instead, the device's algorithm is developed and refined based on engineering principles, physiological models, and data collected during R&D. If the "data set revision" mentioned in the memory chip refers to an internal algorithm update, the data used for its development (not necessarily a distinct "training set" in the ML sense) is not specified. The summary focuses on the clinical validation of the device's performance.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided in the traditional sense of a "training set" for a machine learning model. The pulse oximetry algorithm relies on empirical relationships between light absorption and blood oxygenation. The ground truth for developing and refining such an algorithm would have been established through extensive physiological studies, often involving human subjects under controlled desaturation protocols, where arterial blood samples (co-oximetry) provide the reference standard. However, the summary does not detail the specific methods or data used during the initial algorithm development or "training." It focuses on the validation of the final device.

Summary

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NOW : 0 2005

tyco

Healthcare

Nellcor

4280 Hacienda Drive Pleasanton, CA 94588

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

510(k) Summary

Submitted by:	Nellcor Puritan Bennett, Inc.4280 Hacienda DrivePleasanton, CA 94588
Company Contact:	James Patrick Garvey II, RRT, RACRegulatory Affairs Manager(925) 463-4479 - Phone(925) 463-4020 - FAX
Date Summary Prepared:	July 5, 2005
Product Name:	Nellcor OxiMax Pulse Oximetry Sensors, modelsMAX-A, MAX-AL, MAX-N, MAX-P, MAX-I andMAX-FAST
Common Name:	Oxygen Sensor
Classification:	Patient Transducer and Electrode Cable (includingconnector) (74DQA) per 21CFR §870.2700
Legally Marketed(Unmodified) Device:	Nellcor OxiMax Pulse Oximetry Sensors, modelsMAX-A, MAX-AL, MAX-N, MAX-P, MAX-I andMAX-FAST (cleared via K012891, March 07, 2002 andK021089, June 19, 2002)

DEVICE DESCRIPTION

INTENDED USE

The OxiMax Pulse Oximetry System is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra-hospital transport, and home environments. These devices are for prescription use only.

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TECHNOLOGICAL CHARACTERISTICS

The OxiMax Pulse Oximetry System measures functional oxygen saturation non-invasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsatile blood flow. Red and infrared light-emitting diodes (LEDs) are utilized as light sources. A photodiode acting as a photo detector senses the signal strengths of the two wavelengths of light, which vary with the amount of light transmitted through the tissue. The pulse oximeter receives this electrical information from the sensor and processes the information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude.

Nellcor brand sensors containing OxiMax technology are compatible with the N-595, other Nellcor oximeters and instruments containing Nellcor oximetry, or with instruments licensed to use Nellcor sensors (Nellcor-compatible instruments). OxiMax Sensor Technology, including insensor data, allows OxiMax-cable oximeters to write data to and read data from OxiMax adhesive sensors allowing patient history, namely SpO2 and pulse rate alarm events, to travel with the patient, and enabling quick patient assessment upon transfer to a new point of care.

TESTS PERFORMED TO SUPPORT DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Clinical tests were performed to support accuracy specifications for SpO2 performance. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.

CONCLUSION

The device characteristics and results of clinical testing demonstrate that the revision to the labeling does not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2005

Mr. James Patrick Garvey Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719

Re: K052186

Trade/Device Name: Nellcor® OxiMax® Pulse Oximetry Sensors, Models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-1 and MAX-FAST Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 14, 2005 Received: October 17, 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

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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510(k) Number (if known):

OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, Device Name: MAX-N, MAX-P, MAX-I and MAX-FAST

Indications For Use:

Prescription Use: Yes (per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ques Sefrom

ision Sign-Off

Sign-Off)
ision of Anesthesiology, General Hospital,
fection Control, Dental Devices

Number: K052186

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).