The Nellcor OxiMax SoftCare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg.

The Nellcor OxiMax SoftCare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg.

The OxiMax SoftCare Sensors are indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required.

Device Description

The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-adhesive Sensors. These sensors have a noon and soft and soft as a more is eliminated.

These sensors contain 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 SoftCare sensors are compatible with OxiMAX monitors.

AI/ML Overview

The provided text is a 510(k) summary for the Nellcor OxiMax SoftCare Sensors. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the typical format for a medical device's performance study.

Based on the information provided, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., accuracy, precision values, specific thresholds for SpO2 or pulse rate) during these evaluations. This is common for 510(k) summaries which often refer to conformance to established standards or predicate device performance without detailing the exact numbers.

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

Sample Size for Test Set: Not specified. The document only mentions "Human oxygenation evaluations."
Data Provenance: Not specified, but likely from a clinical setting, given "human oxygenation evaluations." It does not clarify if it was retrospective or prospective.

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

This information is not provided. For oxygen saturation sensors, ground truth for human oxygenation evaluations is typically established by arterial blood gas analysis performed by trained medical professionals, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This is not applicable to this device. The OxiMax SoftCare Sensors are an oxygen sensor (hardware) designed for continuous noninvasive arterial oxygen saturation and pulse rate monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is not applicable in the context of device performance as typically understood for AI/software devices. The device itself is a sensor that outputs data, not an algorithm that interprets complex inputs for diagnosis. Its performance is measured by its accuracy and precision in measuring SpO2 and pulse rate. The document states "human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a standalone performance assessment against a clinical reference standard.

7. The Type of Ground Truth Used:

For "human oxygenation evaluations," the most common ground truth for pulse oximeters is arterial blood gas (ABG) analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for SpO2 accuracy.

8. The Sample Size for the Training Set:

This information is not provided. The device is a physical sensor, and while it contains a "memory chip carrying information about the sensor" and uses "Advanced Signal Evaluation," the document doesn't discuss a "training set" in the context of a machine learning algorithm. If there are internal calibration or signal processing algorithms, the training data for those are not described.

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

This information is not provided and likely not applicable in the context of device training as understood for AI systems. Any internal calibration data or signal processing optimization would have associated ground truth, but this is not detailed.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gina To Senior Regulatory Affairs Project Manager Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K030930

Trade/Device Name: OxiMax SoftCare Sensor Models SC-A, SC-PR, SC-NEO, SC-N Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 24, 2003 Received: March 25, 2003

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.

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

Page 2 - Ms. 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 " promatics nothleated." The 127 I midnig of backanial of 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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely yours,

Susan Ruasr

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page of

510(k) Number (if known): KO30 930

Nellcor® OxiMax™ SoftCare™ Sensors 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)

G.H. Watson

eneral Hospital.

510(k) Number: K030930

Prescription Use V

Over-The-Counter Use

Optional Format (1-2-96)

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

K030930

4280 Hacienda Drive Pleasanton, CA 94588

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

tuco

Healthcare

Nellcor

510(k) Summary

Submitted by:

Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588

Company Contact:

Gina To Senior Regulatory Affairs Project Manager (925) 463-4427 (925) 463-4020 - FAX

March 24, 2003 Date Summary Prepared:

Trade Name:

Common/Usual Name:

Oxygen Sensor

Oximeter (DQA) per 21 CFR §870.2700 Classification Name:

Nellcor Puritan Bennett, Inc., OxiMax Pulse Oximetry Legally Marketed System with N-595 Pulse Oximeter and OxiMax Sensors, (Unmodified) Device: K012891

OxiMax™ SoftCare™ Sensors

DEVICE DESCRIPTION

The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-adhesive The Oxiviax SoftCare Schools are Sterne, Intell 1900, estem as a means of attachment. Sensors. These sensors have a noon and soft and soft as a more is eliminated.

INTENDED USE

The OxiMax SoftCare Sensors are indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required.

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

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

The OxiMax SoftCare Sensors have the same technological characteristics as the OxiMax MAX-N. The differences relate to patient contact surface, attachment means, electro-optical specifications, and labeling. The dimensions of the MAX-N have been modified to result in four distinct SoftCare sensors, to provide different sized sensors and graphics for various patient weight ranges within the adult and neonatal populations.

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 SoftCare Sensors and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.

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).