The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments.

The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The Masino series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Accuracy (Arms) for SpO2	± 2.0% SpO2

Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated, but the performance testing was conducted on "adult volunteers."
- Data Provenance: The data was collected prospectively from "adult volunteers." The country of origin is not specified but implicitly the US, given the submission to the FDA.
Number of Experts and Qualifications for Ground Truth:
- No information provided regarding experts. The ground truth was established by comparing the device's measurements to arterial blood samples analyzed on a laboratory CO-Oximeter, which is a recognized gold standard for oxygen saturation in medical contexts.
Adjudication Method for the Test Set:
- Not applicable as the ground truth was derived from a laboratory instrument (CO-Oximeter) rather than human adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This study is about a medical device's accuracy in measuring physiological parameters, not about human readers' performance with or without AI assistance.
Standalone Performance (Algorithm only):
- Yes. The study assessed the standalone performance of the LNOP-TF-I sensor by directly comparing its readings to a laboratory CO-Oximeter.
Type of Ground Truth Used:
- The ground truth was established using arterial blood samples analyzed on a laboratory CO-Oximeter. This is considered a highly accurate, objective gold standard for measuring oxygen saturation.
Sample Size for the Training Set:
- Not applicable. This device is a sensor for a pulse oximeter, and the performance testing described is for its accuracy in measurement, not for a trainable algorithm.
How Ground Truth for the Training Set was Established:
- Not applicable, as there is no mention of a training set for an algorithm in this context. The device's function is purely measurement-based, not based on machine learning.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the company's address, which is 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. The text "K032551" is written diagonally above the logo.

510(k) SUMMARY

FEB 1 9 2004

Submitted by:	Masimo Corporation2852 Kelvin AveIrvine, CA 92614-5826(714) 250-9688FAX (714) 250-9686
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	October 2, 2003
Trade Names	LNOP-TF-I Reusable Transflectance Sensor
Common Names	Pulse Oximetery Sensors
Classification Names	Oximeter (74DQA) (870.2700)Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices	Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors andCables 510(k) Number - K000126Nellcor Oximax Max-Fast Adhesive Forchcad Sensor - 510(k) Number - K021089

Description

Intended use

Indications For Use:

The additional Masimo series of sensors are indicated for the following:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments.

Comparison to Predicate Devices:

The additional Masimo series of sensors all use the same theory and principle of operation as the predicate devices.

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

510(k) SUMMARY

Performance Data and Conclusions:

Performance testing was conducted on adult volunteers. The additional sensor was compared to arterial blood samples analyzed on a laboratory CO-Oximeter. Accuracy (Arms) for the LNOP-TF-I sensor is ± 2.0% SpO2.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized stripes or lines, which are meant to represent the concept of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Mr. James Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Ave. Irvine, CA 92614-5826

Re: K032551

Trade/Device Name: Masimo LNOP TF-1 Reusable Transflectance Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Codc: 74 DQA Dated: February 4, 2004 Received: February 5, 2004

Dear Mr. Cronin:

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.

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

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

Page 2 - Mr. James Cronin

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 (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,

Chiu Lin, Ph.D.

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): K032551

Device Name: Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors and Cables

Indications For Use:

The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate:

Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 807 Subpart C) 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ion o: Anesthesiologi Infection Control, Denta

510(k) Number: K032551

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).