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

The LNOP Blue Sensors are indicated for the continuous nonitoring of fifictional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions in hospital-type facilities, mobile, and home environments.

Device Description

The LNOP Blue Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors. The LNOP Blue sensor is substantially equivalent to Masimo's LNOP Inf-L sensor except it is designed for use on patients with congenital cyanotic cardiac lesions.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the LNOP Blue Oximetry Sensors, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria (Target Accuracy)	Reported Device Performance (Achieved Accuracy)
N/A (implied by predicate, but not explicitly stated as a target)	Less than 4% SpO2 ARMS in the 60%-80% SaO2 range
N/A (implied by predicate, but not explicitly stated as a target)	Less than 3% SpO2 ARMS in the 80%-100% SaO2 range

Note: The 510(k) summary doesn't explicitly state the acceptance criteria as a pre-defined numerical target for accuracy. Instead, it reports the achieved accuracy, implying that these results were deemed acceptable for substantial equivalence, likely benchmarked against predicate devices and clinical expectations for this patient population.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of patients. It refers to "pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions."
- Data Provenance: The study was "Clinical studies... performed using the LNOP Blue Disposable oximetry sensors with Masimo SET Radical Pulse Oximeters." This indicates a prospective clinical study, typically conducted in a hospital setting. The country of origin is not specified, but given the FDA submission, it's generally assumed to be carried out under U.S. clinical trial standards, or internationally recognized standards acceptable to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth was established by a device, not human experts.
Adjudication method for the test set:
- Not applicable. The ground truth was established by objective device measurements, not expert consensus requiring adjudication.
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:
- Not applicable. This device is an oximetry sensor, not an AI-assisted diagnostic tool requiring human reader studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was conducted. The "Clinical testing of the LNOP Disposable sensors resulted in an accuracy of less than 4% SpO2 ARMs in the range of 60%-80% SaO2 and less than 3% SpO2 ARMS in the range of 80%-100%." This reflects the device's performance in measuring SpO2 values directly against a reference standard.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Objective physiological measurement. The ground truth was "the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is considered a gold standard for blood oxygen saturation measurement.
The sample size for the training set:
- Not applicable/Not specified. This device is a physiological sensor, not a machine learning algorithm that requires a training set in the typical sense. Its design and performance are based on established physiological principles and engineering.
How the ground truth for the training set was established:
- Not applicable. As noted above, training sets and associated ground truths in the context of machine learning are not relevant to this type of device.

Summary

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510(k) SUMMARY

K051439

JUL 1 5 2005

Image /page/0/Picture/3 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "40 Parker Irvine, CA 92618". The image also includes the phone number 949-297-7000 and fax number 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:	May 23, 2005
Trade Name	LNOP Blue Oximetry Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)
Substantially Equivalent Devices:	Masimo SET® Rad 57 Pulse CO-Oximeter510(k) Number - K042536.

Device Description

Intended Use

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510(k) SUMMARY

Technology Comparison

The LNOP Blue oximetry sensors are 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 Blue oximetry sensors are designed, configured, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximetry sensors are constructed of similar materials and components as used in the predicate devices.

Performance Testing

Biocompatibility

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

Clinical Testing

Clinical studies were performed using the LNOP Blue Disposable oximetry sensors with Masimo SET Radical Pulse Oximeters on pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions 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 Disposable sensors resulted in an accuracy of less than 4% SpO2 ARMs in the range of 60%-80% SaO2 and less than 3% SpO2 ARMS in the range of 80%-100% for pediatrics, infants and neonates on patients with congenital cyanotic lesions.

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Public Health Service

JUL 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051439

Trade/Device Name: LNOP Blue Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximetry Sensor Regulatory Class: II Product Code: DQA Dated: May 31, 2005 Received: June 02, 2005

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 (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,

Sujite J. Michie, M.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):

LNOP Blue Device Name:

Indications For Use:

Prescription Use _ X (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)

Ain Sshom

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number:_

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).