The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking 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 hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) have been cleared under K090662 for use with Masimo SET and Masimo SET -compatible pulse oximeter monitors as well as Nellcor and Nellcor compatible pulse oximeter monitors. This submission presents data demonstrating that the DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. Two additional M-LNCS sensors with M-15 connectors are included in this notification.

AI/ML Overview

The provided text describes a 510(k) submission for Masimo SET® Reusable Soft Oximetry Sensors. However, it explicitly states that "There are no changes to the design of the device cleared in K090662. Specifically, the principles of operation performance and materials of the device remain unchanged from the existing Masimo SET Reusable Soft Oximetry Sensors."

This indicates that the current submission (K113596) is for demonstrating compatibility of the existing device with Philips FAST SpO2 Technology, rather than presenting new performance data for the device itself. Therefore, the document does not contain specific acceptance criteria or a dedicated study proving performance against new criteria for this particular submission. Instead, it refers to prior performance data.

Given this, I cannot extract the detailed information requested in the prompt based on the provided text, as the focus is on demonstrating equivalence rather than a new performance study.

However, I can extract the information that is implicitly available or explicitly stated regarding the nature of the submission and the validation that was performed to support the substantial equivalence claim.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance (Implicit, as this is mainly an equivalence claim):

Acceptance Criteria Category	Target/Method	Reported Device Performance (Implicitly refers to prior clearance K090662)
SpO2 Accuracy (for Philips FAST SpO2)	Equivalent to performance data submitted for previously cleared Masimo sensors.	"results demonstrate that the SpO2... accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors."
Pulse Rate Accuracy (for Philips FAST SpO2)	Equivalent to performance data submitted for previously cleared Masimo sensors.	"results demonstrate that the... pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors."
Compatibility with Philips FAST SpO2	Demonstrate mechanical and electrical compatibility leading to functional equivalence.	"The DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology."

Study Details:

The provided text does not contain the specific details about the original design validation study (K090662) that would provide explicit numbers for the acceptance criteria, sample sizes, ground truth establishment, etc. This submission (K113596) is a supplemental filing based on prior clearance.

However, based on the information provided for K113596:

2. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated for this submission's validation. The text mentions "Bench and clinical testing," but no numbers are provided for participants or data points.
- Data Provenance: Not specified. likely internal to Masimo or a contracted lab. The type of testing ("Bench and clinical") suggests a combination of lab and human subject data, though no specifics are given.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified in this document, as this submission primarily focuses on demonstrating compatibility with a new monitor technology rather than re-evaluating core device performance. The original K090662 submission would contain such details if they were needed for that clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No. This device is a pulse oximetry sensor, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- While the device itself operates "standalone" in its measurement function, the "standalone" assessment usually refers to performance of a diagnostic algorithm without human input. This submission primarily relates to hardware compatibility. The "Bench and clinical testing" implicitly involves the device operating in a standalone capacity to measure SpO2 and pulse rate. No explicit standalone algorithm performance report as typically seen in AI/CAD submissions is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified in this document. For pulse oximeters, the typical "ground truth" for SpO2 accuracy studies is co-oximetry (blood gas analysis) from arterial blood samples. The original K090662 submission would likely detail this.
8. The sample size for the training set:
- Not applicable. This is a hardware sensor, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a hardware sensor, not a machine learning model.

Summary of what can be determined from the provided text:

This 510(k) submission (K113596) is for Masimo SET® Reusable Soft Oximetry Sensors to demonstrate "substantial equivalence" when used with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. The core device design and performance principles remain unchanged from a previously cleared device (K090662).

The key "study" or validation performed for K113596 found that "Bench and clinical testing... demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors" when used with Philips FAST SpO2 Technology. The "acceptance criteria" for this submission was effectively demonstrating equivalence to the previously established performance. No specific quantitative criteria or detailed study results are provided within this document.

Summary

{0}------------------------------------------------

1113596 510(k) Summary

Submitter:	Masimo Corporation40 ParkerIrvine, CA 92618(949) 297-7000Fax: (949) 297-7592
Company Contact:	David ColletteSenior Manager, Regulatory Affairs
Date Prepared:	January 25, 2012
Trade Name:	Masimo SET® Reusable Soft Oximetry Sensors
Regulation Number:	21 CFR 870.2700
Regulation Name:	Pulse Oximeter (Oximetry Sensors)
Regulatory Class:	Class II
Product Code	DQA
Cleared Device:	K090662 – Masimo SET Reusable Soft Oximetry Sensors

Device Description

Indications for Use

{1}------------------------------------------------

Comparative Analysis

There are no changes to the design of the device cleared in K090662. Specifically, the principles of operation performance and materials of the device remain unchanged from the existing Masimo SET Reusable Soft Oximetry Sensors.

Validation Testing

Bench and clinical testing of the Masimo SET Reusable Soft Oximetry Sensors was performed using monitors incorporating Philips FAST SpO2 Technology and the results demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors.

Conclusion

Data presented in this submission demonstrate that, when used with pulse oximetry monitors incorporating the Philips FAST Technology, the Masimo SET Reusable Soft Oximetry Sensors are substantially equivalent to the cleared device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

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

Mr. David Collette Senior Manager, Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

FEB 2 4 2012

Re: K113596

Trade/Device Name: Masimo SET® Reusable Soft Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 25, 2012 Received: January 26, 2012

Dear Mr. Collette:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaller by 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de vices mat nat i SAct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment . For (10) ............................................................................................................................... approval application (11th 1). . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirents for unnual regionant misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (1 Mrs), it may be sucject to adame Federal Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Feather regains concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Collette

Please be advised that FDA's issuance of a substantial equivalence determination does not r rease be actived that 12 a determination that your device complies with other requirements moun mat 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the receively 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 (reporting of meated: as not total 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), 11 you acon o sportion w.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.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 Compilation" (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/MedicalDevices/Safety/ReportaProblem/default.htm 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 I ou nike of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number: K.113596

Device Name: Masimo SET® Reusable Soft Oximetry Sensors

Indications for Use:

The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive The Mashino SET Kedsable Soft Sensons are installed of arterial hemoglobin (SpOz)
monitoring and spot-checking of functional oxygen saturation of artections during monioring and spor-checking of functional only goss with adult and pediatric patients during and pulse fale (fileasured by an SpO2 sensor) for ass or well or poorly perfused in hospitals, hospitaltype facilities, mobile, and home environments.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K113596
----------------	---------

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).