The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Device Description

The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.

In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.

AI/ML Overview

The provided 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not include specific acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific numerical thresholds in a clinical or analytical study.

Here's an analysis of the available information against your requested points:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the 510(k) summary. The document states that "The following testing of the uSpO2 Pulse Oximetry Cable was performed... to demonstrate substantial equivalence of the modified device to the cleared device," but it does not specify what performance criteria (e.g., accuracy, bias, precision for SpO2 or PR) were used or what the specific test results were.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The summary lists types of testing conducted (e.g., Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System, System Compatibility), but none of these descriptions include details about sample sizes for a test set or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Given that the listed tests are primarily engineering and system compatibility tests, it is unlikely that "experts" in the sense of clinical specialists establishing ground truth were involved in these specific tests as described. Clinical performance testing (if performed) for SpO2 devices typically involves arterial blood gas analysis, which is an objective measurement rather than an expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed in the listed tests.

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

This information is not provided. MRMC studies are not relevant for a pulse oximetry cable, which is a sensor and cable connecting to a host system, not an AI-powered diagnostic tool requiring human interpretation.

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

The device itself (the uSpO2 Pulse Oximetry Cable) operates as a standalone component connecting to a host system. The summary implies that "System Compatibility Testing (GE ApexPro Telemetry System)" would assess the cable's performance in conjunction with the host, which is a form of integrated system performance. However, there's no "algorithm only" performance study in the sense of an independent software assessment described. The Masimo SET® technology is inherent to the oximetry process, and its performance characteristics would have been established during the original clearance of Masimo SET® products (e.g., K040259, the predicate device). This submission focuses on the cable's compatibility and functional equivalence when integrated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided for the studies listed. For pulse oximeters, the typical ground truth for SpO2 accuracy is arterial blood gas analysis, which is an objective physiological measurement. However, this specific 510(k) emphasizes testing related to the cable's functionality and compatibility, not a de novo clinical accuracy study of the oximetry technology itself.

8. The sample size for the training set

This information is not provided. Training sets are generally associated with machine learning or AI algorithms. This submission is for a medical device (a cable for a pulse oximeter) and does not involve AI/ML technology that would have a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable as there is no mention of a training set or AI/ML algorithm in this 510(k) submission.

Summary of Device Performance as Reported:

The 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not provide specific performance data or numerical acceptance criteria. Instead, it concludes:

"The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance."

This statement implies that the device meets performance requirements by being equivalent to a previously cleared device (K040259 - Masimo SET® IntelliVue Pulse Oximeter Module), which itself would have had its performance validated. The tests conducted (Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System Testing, System Compatibility Testing with GE ApexPro Telemetry System) are primarily aimed at demonstrating that the new cable does not introduce new risks or alter the established performance characteristics of the Masimo SET technology when integrated with the specified host system.

Summary

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510(k) Summary	K121914	SEP 7 2012
Submitter:	Masimo Corporation40 ParkerIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Contact:	David ColletteSr. Manager, Regulatory Affairs
Date Summary Prepared:	September 6, 2012
Trade Name:	Masimo SET® uSpO2™ Pulse Oximetry Cable
Regulation Name:	Pulse Oximeter
Classification Regulation:	21 CFR 870.2700Class II
Product Code:	DQA
Existing Device:	K040259 - Masimo SET® IntelliVue Pulse Oximeter Module

Device Description

Indications for Use

The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET uSpO2 Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

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Predicate Device Comparison

Characteristic	Masimo SET® IntelliVuePulse Oximeter ModuleK040259	Masimo SET® uSpO2™ PulseOximetry CableK121912
Host system	Philips IntelliVue	GE ApexPro TelemetrySystem
Physical configuration	Plug-in moduleDirect connect to hostsystem.	Plug-in module with in-linecable to connect to hostsystem.
Pulse oximetry technology	Masimo SET Technology	Masimo SET Technology
Communication protocol	IntelliVue host-systemspecific	GE ApexPro host-systemspecific
Compatible sensors andcables	Masimo LNOP and LNCSoximetry sensorsMasimo LNC patient cables	Masimo LNCS oximetrysensorsMasimo LNOP oximetrysensors (with adapter)(patient cables not required)

Summary of Testing

The following testing of the uSpO2 Pulse Oximetry Cable was performed in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence of the modified device to the cleared device:

. Design Review Process
Risk Analysis per ISO 14971 .
Software Verification and Validation per FDA Guidance Documents .
Electromagnetic Compatibility per IEC 60601-1-2 t
. Electrical Safety Testing per IEC 60601-1
Environmental Testing (Operating Temperature, Humidity, Fluid Ingress) .
. Component and System Testing
System Compatibility Testing (GE ApexPro Telemetry System) .

Conclusion

The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance.

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

SEP 7 2012

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

Re: K121914

Trade/Device Name: Masimo Set® uSpO2™ Pulse Oximetry Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 8, 2012 Received: August 9, 2012

Dear Mr. Collette:

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. 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 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. Collette

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/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 Division 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,

for

B. Sheth

B. Sheth m.D.

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

Enclosure

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Section 4. Indications for Use

Indications for Use

510(k) Number: K12|914

Device Name: Masimo SET® uSpO2™ Pulse Oximetry Cable

Indications for Use:

The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2" Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

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)

L. Schultk

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

510(k) Number: K121914

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).