MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES by MASIMO CORP.

The Masimo SET® (Quartz 2500 Pulse Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation or arterial hernoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET "Quartz 2500 Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and home environments.

The Masimo LNOP® Series of Sensors are indicated for the Masimo SETYQuartz 2500 Pulse Oximeter and the following:

A single use oximetry sensor intended for adults and pediatrics greater than 30kg.

A single use oximetry sensor intended for pediati.cs and small adults greater than 10 kg and less than 50 kg;

A single use oximetry sensor intended for neonates with good skin integrity less than 10kg;

A single use oximetry sensor intended for neonates with integrity less than 1kg; and

A reusable oximetry sensor intended for adults and pediatrics greater than 30kg.

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET /Quartz 2500 Pulse Oximeter.

Device Description

The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is a portable stand alone device, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LED's to determine the functional oxygen saturation of arterial hemoglobin (SpO>) and pulse rate and provide for the connection to the connecting cable.

The Masimo SET®/Quartz 2500 Pulse Oximeter is available in one configuration as a portable stand alone pulse oximeter that is 10cm high, 27.5cm wide, 25cm deep and weighs 4 kg. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of 5.5 hours and a charge time of 4.5 hours to 80% capacity.

The PC series of connecting cables connects the monitor to the oximetry sensors and transfers LED drive power and the calibration drive to the oximetry sensors from the monitor and the monitor receives the detector signal from the oximetry sensor.

The PC series of connecting cables is available in one configuration and three lengths, 4 feet, 8 feet and 12 feet.

The LNOP® series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.

The LNOP® series of oximetry sensors is available in five configurations:

a single use oximetry sensor intended for adults and pediatrics greater than 30 kg; ●
a single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and . less than 50 kg:
. a single use oximetry sensor intended for neonates with good skin integrity less than 10kg;
a single use oximetry sensor intended for neonates with integrity less than 1kg; and .
. a reusable oximetry sensor intended for adults and pediatrics greater than 30kg.

AI/ML Overview

The provided text is a 510(k) summary for the Masimo SET®/Quartz 2500 Pulse Oximeter, asserting its substantial equivalence to a previously marketed device, the Masimo SET® 2000 Pulse Oximeter. While it mentions "rigorous testing" and compliance with standards, it does not contain the detailed study information needed to fully answer your request. Specifically, it lacks explicit acceptance criteria, performance metrics, sample sizes, ground truth establishment methods, or information on comparative effectiveness studies, multi-reader multi-case studies, or standalone algorithm performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the specific studies. The document focuses on regulatory equivalence and design specifications rather than detailed clinical validation study results.

Here's a breakdown of what can be extracted from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that the device was "validated through rigorous testing that, in part, support the compliance... to the above mentioned standards." However, it does not specify the acceptance criteria used for these tests (e.g., accuracy +/- X% SpO2) or the specific performance results achieved against those criteria.

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

Not available in the provided document. The document does not describe a clinical test set, its sample size, or the provenance of any data used for testing.

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

Not applicable/Not available. Since no details of a clinical test set are provided, there is no information about experts or ground truth establishment for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not available. No information on an adjudication method is provided as no test set details are given.

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

Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, an MRMC study as described would not be relevant. The document does not mention any studies involving human readers or AI assistance.

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

Partially addressed, but details are lacking. The device is a standalone pulse oximeter, inferring that its performance is reported as algorithm-only, measuring SpO2 and pulse rate. However, the document does not present the specific standalone performance metrics (e.g., bias, accuracy, precision) that would result from such testing. It broadly states the device was "validated through rigorous testing."

7. The Type of Ground Truth Used

Not available in the provided document for specific performance studies. For pulse oximetry, the typical "gold standard" for SpO2 accuracy studies is arterial blood gas (co-oximetry). While it's implied that such methods would have been used in "rigorous testing," the document does not explicitly state how ground truth was established for the validation.

8. The Sample Size for the Training Set

Not available in the provided document. No information about a training set for algorithm development is provided.

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

Not available in the provided document. No information about a training set or its ground truth establishment is provided.

Summary of Device and Regulatory Status from the Provided Text:

Device Name: Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories
Classification: Class II - 21CFR870.2700 - 74 DQA (Oximeter)
Indication for Use: Continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients during no-motion conditions and for well or poorly perfused patients in various environments.
Predicate Device: Masimo SET® 2000 Pulse Oximeter and Accessories
Substantial Equivalence: Approved based on design concepts, technologies, materials, and compliance with various standards (CSA C22.2 #601, IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, ISO 9919:1992, EN 865:1997, UL 2601-1).
Validation: "Validated through rigorous testing" and "software...fully specified and validated by Masimo and Quartz." (Details of this validation are not included).

Summary

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K99355-5

NOV 1 9 1999

Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo. The logo is a stylized, bold typeface with a small circle above the 'i'. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686.

18 October 1999

510(k) Summary of Safety and Effectiveness Information for the Masimo Subject:s SET®/Ouartz 2500 Pulse Oximeter Accessories Proprietary: Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories Common: Oximeter Classification: Oximeter Class II - 21CFR870.2700 - 74 DQA

The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.

The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is substantially equivalent to the following currently marketed device(s):

Masimo SET® 2000 Pulse Oximeter and Accessories .
The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is a portable stand alone device, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The PC series of connecting cables is available in one configuration and three lengths, 4 feet, 8 feet and 12 feet.

Page 1 of 2

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The LNOP® series of oximetry sensors is available in five configurations:

a single use oximetry sensor intended for adults and pediatrics greater than 30 kg; ●
a single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and . less than 50 kg:
. a single use oximetry sensor intended for neonates with good skin integrity less than 10kg;
a single use oximetry sensor intended for neonates with integrity less than 1kg; and .
. a reusable oximetry sensor intended for adults and pediatrics greater than 30kg.

The Masimo SET®/Quartz 2500 Pulse Oximeter is designed to comply with the following standards:

1. CSA C22.2 #601
1. IEC 601-1, Part 1 and Amendments 1 and 2
1. IEC 601-1-1, Part 1
1. IEC 601-1-2, Part 1
1. IEC 601-1-4, Part 1
1. ISO 9919: 1992
1. EN 865: 1997
1. UL 2601-1

The Masimo SET® 2000 Pulse Oximeter and the Masimo SET®/Quartz 2500 Pulse Oximeter are substantially equivalent in design concepts, technologies and materials. The Masimo SET®/Quartz 2500 Pulse Oximeter was validated through rigorous testing that, in part, support the compliance of the Masimo SET®/Quartz 2500 Pulse Oximeter to the above mentioned standards. Additionally, the software for the Masimo SET®/Quartz 2500 Pulse Oximeter was developed following a robust software development process and was fully specified and validated by Masimo and Quartz.

The Masimo SET®/Quartz 2500 Pulse Oximeter and Accessories is the next generation in the Masimo Pulse Oximeter family of products.

Page 2 of 2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

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

K993555 Re: Masimo SET®/Quartz 2500 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: October 18, 1999 Received: October 20, 1999

Dear Mr. Cronin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James J. Cronin

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Chale ( Ho

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7142509686

Indications for Use

510(k) Number (if known): K993555

Device Name:

Masimo SET®/Quartz 2500 Pulse Oximeter

Indications for Use:

The Masimo LNOP® Series of Sensors are indicated for the Masimo SETYQuartz 2500 Pulse Oximeter and the following:

A single use oximetry sensor intended for adults and pediatrics greater than 30kg.

A single use oximetry sensor intended for pediati.cs and small adults greater than 10 kg and less than 50 kg;

A single use oximetry sensor intended for neonates with good skin integrity less than 10kg;

A single use oximetry sensor intended for neonates with integrity less than 1kg; and

A reusable oximetry sensor intended for adults and pediatrics greater than 30kg.

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET /Quartz 2500 Pulse Oximeter.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chas Ads for JXH

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number:

Prescription Use (Per 21CFR801.109)

Over-The-Counter Use OR

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).