The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are fully compatible reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The DBI/P Sensors are also fully compatible for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-oximeter monitors. Additionally, the DBI Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Masimo SET Reusable Soft Oximetry Sensors, based on the provided text:

Acceptance Criteria and Device Performance

Feature	Acceptance Criteria (Masimo SET & Rainbow SET Technology)	Reported Device Performance (with Masimo SET & Rainbow SET Technology)	Acceptance Criteria (Nellcor & Nellcor Compatible Technology)	Reported Device Performance (with Nellcor & Nellcor Compatible Technology)
Accuracy – SpO₂ During No Motion Conditions
Adults, Pediatrics: 70% - 100%	± 2%	± 2%	± 2%	± 2%
Adults, Pediatrics: 0% - 69%	Unspecified	Unspecified	Unspecified	Unspecified
Accuracy – SpO₂ Low Perfusion
Adults, Pediatrics: 70% - 100%	± 2%	± 2%	N/A	N/A
Adults, Pediatrics: 0% - 69%	Unspecified	Unspecified	N/A	N/A
Accuracy – Pulse Rate During No Motion Conditions
Adults, Pediatrics: 25 - 240 bpm	± 3 bpm	± 3 bpm	± 3 bpm	± 3 bpm
Accuracy – Pulse Rate Low Perfusion
Adults, Pediatrics: 25 - 240 bpm	± 3 bpm	± 3 bpm	N/A	N/A

Note: The document explicitly states that "The DBI/P Sensor performance is equivalent to those of the LNCS Oximetry Sensor." The reported device performance in the table above is directly taken from the "SENSOR SPECIFICATIONS" provided in the 510(k) summary, which outlines the expected performance and thus serves as the acceptance criteria that the device is stated to meet.

Study Details:

Sample size used for the test set and the data provenance:
- The provided document does not specify the sample size for the clinical testing.
- The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical Testing" as one of the quality assurance measures.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The provided document does not contain any information regarding the number of experts or their qualifications used to establish ground truth. For pulse oximeters, the reference standard (ground truth) is typically established by laboratory co-oximeters measuring arterial blood gas samples.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The provided document does not specify any adjudication method.
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:
- No, a MRMC comparative effectiveness study was not done. This device is a pulse oximeter which directly measures physiological parameters and does not involve human interpretation or AI assistance in the way a diagnostic imaging device might.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance was done. The performance specifications listed in the table directly represent the standalone accuracy of the device. Pulse oximeters are designed to provide direct measurements without human-in-the-loop interaction for the core SpO2 and pulse rate readings. The term "algorithm only" isn't directly applicable in the same way as machine learning models, but the specifications are for the device's inherent measurement capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- While not explicitly stated in this summary, the standard practice for pulse oximeters involves using laboratory co-oximetry of arterial blood gas samples as the gold standard (ground truth) for oxygen saturation, and often an ECG for heart rate or specific reference pulse oximeters for pulse rate accuracy.
The sample size for the training set:
- This document describes a medical device, not a machine learning algorithm in the typical sense of a "training set." Therefore, the concept of a "training set" with a specified sample size in the context of machine learning does not apply here. The device's design and parameters are established through engineering and physiological principles, not through a data-driven training process.
How the ground truth for the training set was established:
- As explained above, the concept of a "training set" for a device like a pulse oximeter does not apply. The device is designed based on known physiological principles and validated through clinical testing against established reference methods.

Summary

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AUG 10 2009

510(k) SUMMARY

K09 0662

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	March 9, 2009
Trade Name	Masimo SET Reusable Soft 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 LNCS Oximetry Sensors , 510(k) No. K051212

Device Description

Predicate Device

The predicate devices used in this filing are the Masimo LNCS Oximetry Sensors (K051212).

Intended Use

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510(k) SUMMARY

Technology

and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s

The DBVP Sensors are substantially equivalent in design, principles of operation, materials, and performance to predicate device LNCS Oximetry Sensors. The DBI/P Sensor performance is equivalent to those of the LNCS Oximetry Sensor.

The specifications for the DBI/P Sensors for adults (> 30 kg) and pediatrics (10-50 kg) are the following:

FEATURES	SENSOR SPECIFICATIONS:with Masimo SET and MasimoRainbow SET Technology	SENSOR SPECIFICATIONS:with Nellcor and NellcorCompatible Technology
Accuracy – SpO2During No MotionConditions	Adults, Pediatrics: 70% - 100% $\pm$ 2%Adults, Pediatrics: 0% - 69%unspecified	Adults, Pediatrics: 70% - 100% $\pm$ 2%Adults, Pediatrics: 0% - 69%unspecified
Accuracy – SpO2Low Perfusion	Adults, Pediatrics: 70% - 100% $\pm$ 2%Adults, Pediatrics: 0% - 69%unspecified	N/A
Accuracy – Pulse RateDuring No MotionConditions	Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm	Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm
Accuracy – Pulse RateLow Perfusion	Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm	N/A

Test Summary

The DBI/P Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the DBI/P Sensors:

Risk Analysis ●
Design Reviews .
Biocompatibility Testing .
Performance Testing .
Safety Testing .
Environmental Testing
Clinical Testing

Conclusions

The information in this 510(k) submission demonstrates that the Masimo SET® Reusable Soft Oximetry Sensors are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

AUG 10 2009

Re: K090662

Trade/Device Name: Masimo SET Reusable Soft Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 29, 2009 Received: August 4, 2009

Dear Ms. Thomlinson:

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 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- Ms. Thomlinson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

far

Susan Runner, D.D.S., M.A. Acting Division 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):

Masimo SET Reusable Soft Sensors Device Name:

Indications For Use:

The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatic patients during no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

L. Arletta

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

-10(k) Number. 4 090662

Prescription Use (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Masimo 510(k) Trad-3/9/09 DBI & DBIP Sensors Page 10 of 262

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).