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

The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:

Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg
Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

Device Description

The Masimo 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

Here's a summary of the acceptance criteria and study information for the Masimo series of oximetry sensors, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported accuracy (Arms) for different sensors and patient populations. The document states a target range of 70% to 100% SaO2 for these accuracy figures.

Device/Sensor Type	Patient Population	Acceptance Criteria (Accuracy Arms)	Reported Device Performance (Accuracy Arms) over 70%-100% SaO2 Range
NR7 Sensor	Adults	Not explicitly stated (implied)	± 2%
LNOP-Ear Sensor	Adults	Not explicitly stated (implied)	± 3.5%
LNOP-YI Sensor	Adults & Pediatrics	Not explicitly stated (implied)	± 2% for adults and pediatrics
LNOP-YI Sensor	Neonates	Not explicitly stated (implied)	± 3% for neonates

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

Sample Size: Not explicitly stated beyond "adult volunteers."
Data Provenance: The study was conducted on "adult volunteers." No specific country of origin is mentioned, but the company is based in Irvine, CA, USA, suggesting the study was likely conducted in the US. The study appears to be prospective, as it involved performance testing on volunteers.

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

Not applicable. The ground truth was established through direct measurement (arterial blood samples), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established through direct measurement (arterial blood samples).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device measures physiological parameters.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, a standalone performance study was done. The "Performance Data and Conclusions" section describes the device's accuracy by comparing its readings to arterial blood samples, which is a standalone evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used was arterial blood sampled. This refers to direct measurement of oxygen saturation from arterial blood.

8. Sample Size for the Training Set

Not applicable. The document describes a performance validation study, not the development or training of a machine learning algorithm.

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

Not applicable as there is no mention of a training set for a machine learning algorithm.

Summary

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K012992

0061

OCT - 3 2001

510(k) SUMMARY

Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo features the company name in a bold, sans-serif font with a stylized "M". Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The telephone number is 949-250-9688, and the fax number is 949-250-9686.

Submitted by:	Masimo Corporation 2852 Kelvin Ave Irvine, CA 92614-5826 (714) 250-9688 FAX (714) 250-9686
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	September 5, 2001
Trade Names	LNOP-Ear Sensor, LNOP-YI Sensor, NR7 Sensor
Common Names	Pulse Oximetery Sensors SpO2 Ear Sensor
Classification Names	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 series of Sensors and Cables 510(k) Number - K000126 Nellcor DURA-Y Oxygen Transducer, Ear Clip - 510(k) Number - K944760

Description

Intended use

Indications For Use:

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

Single use oximetry sensor intended for adults and pediatrics greater than 10 kg
Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg

Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

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510(k) SUMMARY

Comparison to Predicate Devices:

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

Performance Data and Conclusions:

Performance testing was conducted on adult volunteers. The additional series of sensors were compared to arterial blood sampled r continet tooling was oneated or. Accuracy (Arms) for the NR7 was ± 2%, for the LNOP-Ear ± 3.5%, and for the LNOP-YI and your a nediatrics ± 2% and ± 3% for neonates over the range of 70% to 100% SaO2.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

OCT = 3 2001

Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614-5826

Re: K012992

Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors (LNOP-Ear Sensor, LNOP-YI Sensor, NR7 Sensor) Regulation Number: 870.2700, 870.2710 Regulation Name: Oximeter, Ear Oximeter Regulatory Class: II (two) Product Code: 74 DQA, 74 DPZ Dated: September 5, 2001 Received: September 6, 2001

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

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Page 2 - Mr. James J. Cronin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Oala Tullh

lillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KO12992 510(k) Number (if known):

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

Indications For Use:

The following additional Masimo Sensors are indicated for the continuous noninvasive function of arterial hemoglobin (SpO2) and pulse rate:

Single use oximetry sensor intended for adults and pediatrics greater than 10 kg Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than 1 kg

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dale Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012992

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

0060

(Optional Format 1-2-96)

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).