The LNOP x Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infam, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The LNOP x and LNOP X Oximely Sellsols are indicated for the ventinated by an SpO2 sensor) for use with ault, oxygen saturation of areflal nemogroum (3002) and motion and for patients who are well or pediative, intaint, and neonally darking overling over, and home environments. poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The LNOPx and LNOP x Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNOP x and LNOP x disposable sensors are similar in construction to the predicate devices except that the SPO2 COM sensors are cable based while the LNOP sensors including the LNOP x sensors are flex circuit based. The emitter and detector are connected to the flex circuit. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masmo's LNOP series of disposable sensors. Two sizes of disposable LNOPy sensors are available for use with infant and neonatal patients. Two sizes of disposable LNOP x sensors are available for use with adult and pediatric patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material The patient contacting materials in the LNOP x disposable sensors are the same that is used in Masimo's SPO2.COM sensor line. The LNOP x disposable sensors are supplied non-sterile for single patient use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (SpO2)
Adult	< 2% Apys in the range of 70%-100% SaO2
Pediatric	< 2% Apys in the range of 70%-100% SaO2
Infant	< 2% Apys in the range of 70%-100% SaO2
Neonatal	< 3% Apys in the range of 70%-100% SaO2
Biocompatibility	Non-toxic, non-irritating, and non-sensitizing
Environmental Testing	All tests passed (electrical, mechanical, environmental)

Note: The document only explicitly states accuracy for SpO2. While biocompatibility and environmental testing were performed and passed, specific quantitative acceptance criteria for these were not provided in the summary. The "less than 2% Apys" and "less than 3% Apys" values likely represent the accuracy specifications (e.g., RMS error or similar statistical measure) used by the manufacturer as acceptance criteria for their devices.

Study Information:

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

Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" but does not quantify how many unique subjects were included in the clinical studies. It also states the studies were done for "adults, pediatrics and infants and for neonates," implying different cohorts, but again, no numbers are given.
Data Provenance: The study was conducted clinically with human subjects. The country of origin is not specified but generally, such studies are conducted within the country of the submitting company or in regions with comparable regulatory standards. It was a prospective study, as subjects were "subjected to a progressive induced hypoxia."

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth method involved a "CO-Oximeter," which is an instrument, not human experts. Human oversight of the CO-Oximeter operation would be assumed, but their qualifications are not detailed.

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

Adjudication Method: Not applicable. The ground truth was established by an objective instrument (CO-Oximeter) measuring arterial blood samples, not by human expert consensus or adjudication of subjective data.

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:

MRMC Study: No, an MRMC study was not done. This device is an oximetry sensor, which is a measurement device, not an AI diagnostic tool that assists human readers in interpreting images or other data.

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

Standalone Performance: Yes, the clinical testing describes the "accuracy of the LNOP x Oximetry Sensors" against direct arterial blood gas measurements, which is a standalone performance assessment of the sensor's accuracy in measuring SpO2. The device functions independently to provide a physiological measurement.

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

Ground Truth Type: Objective measurement from a CO-Oximeter analysis of arterial blood samples. This is considered a highly accurate, direct physiological measurement.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This document describes a medical device (sensor) that performs physical measurements, not an AI/ML algorithm that requires a training set. The "design change" refers to hardware and material changes, not algorithmic learning.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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SEP 2 0 2004 510(k) SUMMARY

K042346

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "40 Parker Irvine, CA 92618". The phone number is "949-297-7000" and the fax number is "949-297-7001".

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	August 27, 2004
Trade Name	LNOPv and LNOP x Oximetry Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	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 and Cables510(k) Number - K031330SPO2.COM A, I, P, N, RSI Pulse Oximeter Sensors510(k) Number - K033298

Device Description

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510(k) SUMMARY

Predicate Devices

LNCS Sensor Line	Masimo Predicate LNOP Sensors- in K031330, K033298
LNOP Adtx - Adult Disposable Sensor	LNOP-Adt, SPO2.COM A
LNOP Pdtx - Pediatric DisposableSensor	LNOP-Pdt, SPO2.COM P
LNOPv In - Infant Disposable Sensor	LNOP-Neo, SPO2.COM I
LNOP Ne - Neonatal Disposable Sensor	LNOP-Neo, SPO2.COM N

Intended Use

The I.NOP x Oximetry Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infam, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Technology Comparison

The I.NOP and L.NOP x Oximetry Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The LNOP v and LNOP x Oximetry Sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeters. The LNOP x Oximetry Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the I.NOP x Oximetry Sensors is equivalent to those of the predicate devices.

Performance Testing

Biocompatibility

All the patient contacting materials used in the LNOP x Oximetry Sensors are the same materials that are used in Masimo's SPO2. COM series of sensors. Test results demonstrated that the materials were non-toxic, nonirritating, and non sensitizing.

Environmental Testing

Applicable environmetal testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. clectrical, mechanical and environmental were performed and all tests passed

Clinical Testing

Clinical studies were performed using the LNOP x Oximetry Sensors on healthy adult volunteer subjects during motion and no motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the LNOP x Oximetry Sensors resulted in an accuracy of less than 2% Spon a Ris in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% Apys for neonates.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Cronin Vice President, President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618

Re: K042346

Trade/Device Name: LNOPv and LNOP x Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 27, 2004 Received: August 30, 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.

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Page 2 - Mr. Cronin

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 (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

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Indications for Use

510(k) Number (if known):

LNOPv and LNOP x Oximetry Sensors Device Name:

Indications For Use:

The LNOP x Oximetry Sensors are indicated for the continuous nonitoring of functional The LNOP x and LNOP X Oximely Sellsols are indicated for the ventinated by an SpO2 sensor) for use with ault, oxygen saturation of areflal nemogroum (3002) and motion and for patients who are well or pediative, intaint, and neonally darking overling over, and home environments.
poorly perfused in hospital-type facilities, mobile, and home environments.

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

Over-The-Counter Use __ (Per 21 CFR 807 Subpart C) 000 €

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Uu rihom

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number	K042346

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).