The LNCS Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation I he LNCS Sellsons and Cables are multided for and continued by an SpO2 sensor) for use with adult, pediatric, infant, and of arterial nemogroum (op(0)) and pare (motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

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

The LNCS DC-I/DC-IP reusable sensors are essentially identical to Masimo LNOP-DC-I/DC-IP sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the LNCS DC-I/DC-IP and LNOP-DC-I/DC-IP sensors. The patient contacting materials in the LNCS DC-I/DC-IP and LNOP-DC-IP sensors are the same. The LNCS DC-I/DC-IP sensors are supplied non-sterile.

The LNCS TC-I and TF-I reusable sensors are essentially identical to Masimo LNOP-Ear and TF-I sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The same emitter (with Red wavelength of 653/659 nm and Infrared wavelength of 880 nm respectively) and detector are used in both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile.

The LNCS disposable sensors are similar in construction to the predicate devices except that the LNCS sensors are cable based while the LNOP sensors are flex circuit based. The emitter and detector are connected to the cable assembly. 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 Masimo's LNOP series of disposable sensors. Four sizes of disposable LNCS sensors are available for use with adult, pediatric, infant and neonatal 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 LNCS disposable sensors are the same that is used in Masimo's LNOP sensor line. The LNCS disposable sensors are supplied non-sterile for single patient use.

The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary indicates that the accuracy of the LNCS oximetry sensors is equivalent to the predicate devices. The summary explicitly states:

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of less than 2% SpO2 ARMs in the range of 70%-100% SaO2	"[Clinical testing of the SPO2.COM Disposable and Reusable sensors resulted in an accuracy of less than 2% SpO2 ARMs in the range of 70%-100% SaO2 for adults, pediatrics and infants."
Accuracy of less than 3% SpO2 ARMs for neonates	"and less than 3% ARMs for neonates."

Note: The document states that the "LNCS oximetry sensors are substantially equivalent...and performance to predicate sensors" and that "The accuracy of the LNCS oximetry sensors is equivalent to those of the predicate devices." The specific accuracy values presented in the "Clinical Testing" section are attributed to "SPO2.COM Disposable and Reusable sensors." While these are listed as predicate devices in the 510(k) (K033298), the document implies that the LNCS sensors achieve equivalent performance to these predicate devices, thus meeting these implied acceptance criteria.

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

Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" and "adults, pediatrics and infants and neonates" were included. However, the exact number of subjects or data points is not provided.
Data Provenance: The study was conducted on "healthy adult volunteer subjects" and involved "induced hypoxia." This indicates a prospective clinical study. The country of origin of the data is not specified.

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

Number of Experts: Not applicable in this context. The ground truth for SpO2 measurements is not established by human experts in the typical sense of image or diagnostic interpretation.
Qualifications of Experts: Not applicable. The ground truth relied on a CO-Oximeter to measure arterial hemoglobin oxygen from arterial blood samples.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from a CO-Oximeter, not through human interpretation requiring adjudication.

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 oximeter sensor, not an AI-powered diagnostic tool that assists human readers.

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

Standalone Performance: Yes, the clinical testing describes the standalone performance of the oximetry sensors against a reference standard (CO-Oximeter). The device itself is the 'algorithm' in this context, directly measuring and reporting SpO2.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used was arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, gold-standard measurement for blood oxygen saturation.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a medical device (sensor) and its performance, not a machine learning model that would typically have a distinct training set. The device's design and parameters are established through engineering and previous device iterations rather than a "training set" in the AI sense.

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

Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device where a training set with established ground truth would be relevant in the same way. The device's operating principles are based on established physiological and photometric principles.

Summary

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JUL 2 9 2004

510(k) SUMMARY

K041815

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo is the company's address, which is 40 Parker, Irvine, CA 92618, and their phone number, which is 949-297-7000.

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:	July 2, 2004
Trade Name	LNCS Oximetry Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)Cable, Transducer and Electrode (74DSA) (870.2900)Oximeter, Ear (74DPZ) (870.2710)
Substantially Equivalent Devices:	Masimo SET® Radical Pulse Oximeter with SatShare™ and LNOP®scries of Sensors and Cables510(k) Number - K031330Masimo SET Intellivue Pulse Oximeter Module510(k) Number - K040259SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors510(k) Number - K033298

Device Description

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510(k) SUMMARY

both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile.

The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

LNCS Sensor Line	Masimo Predicate LNOP Sensors- in K031330, K040259
LNCS DC-I/DC-IP - Reusable Adult/PediatricSensors	LNOP-DC-I/DC-IP
LNCS Adt - Adult Disposable Sensor	LNOP-Adt
LNCS Pdt - Pediatric DisposableSensor	LNOP- Pdt
LNCS Inf - Infant Disposable Sensor	LNOP-Neo
LNCS Neo - Neonatal Disposable Sensor	LNOP-Neo
LNCS NeoPt - Neonatal Disposable Sensor	LNOP NeoPt
LNC 10 - Patient Cable	PC Patient Cable
LNC to PC	N/A
LNC to Intellivue	MP12
LNCS TC-I- Reusable Ear Sensor	LNOP Ear
LNCS TF-I - Reusable Transflectance Sensor	LNOP-TF-I

Predicate Devices

Intended Use

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

Technology Comparison

The LNCS 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 LNCS oximetry sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SE i` compatible pulse oximeters. The LNCS oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

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The accuracy of the LNCS oximetry sensors is equivalent to those of the predicate devices.

Performance Testing

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510(k) SUMMARY

Biocompatibility

All the patient contacting materials used in the LNCS sensors are the same materials that are used in Masimo's LNOP series of sensors. Test results demonstrated that the materials were non-toxic, non-irritating, and non sensitizing.

Environmental Testing

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

Clinical Testing

Clinical studies were performed using the LNCS Disposable and Reusable 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 SPO2.COM Disposable and Reusable sensors resulted in an accuracy of less than 2% SpO2 ARMs in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% ARMs for neonates.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2004

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

Re: K041815

Trade/Device Name: LNCS Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 2, 2004 Received: July 6, 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 I lease to act read a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the receiver 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 and ifsuing (21 es read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet resist 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) remarket notification. The FDA finding of substantial equivalence of your device to a premaired foredicate 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), 11 you donto 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,

Carls

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):

LNCS Sensors and Cables Device Name:

Indications For Use:

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

Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Dff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041813

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).