The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The Nellcor Portable SpO2 Patient Monitoring System is a modification of the OxiMax NPB-40 and N-600X Pulse Oximetry Systems. It is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology, and the oximetry sensor cable. The monitor displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor Portable Sp02 Patient Monitoring System is powered by four AA batteries.

AI/ML Overview

This document is a 510(k) summary for the Nellcor Portable SpO2 Patient Monitoring System (K141542). It claims substantial equivalence to two predicate devices: OxiMAX NPB-40 Pulse Oximeter (K051352) and N-600X Pulse Oximeter (K123581).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for the Nellcor Portable SpO2 Patient Monitoring System itself. Instead, it relies on the established performance of its predicate devices and states that its performance is equivalent.

However, it does mention adherence to standards, which imply certain performance expectations:

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Oximetry performance verification in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff"	Verified by non-clinical testing.
Compliance with ISO 80601-2-61:2011	Test reports available.
Compliance with IEC 60601-1:2005	Test reports available.
Human Factors Summative Usability validation	Validation performed.
Pulse rate accuracy in the range of 20-250 beats per minute during motion	Verified using a functional tester and simulated motion.
SpO2 and Pulse Rate performance across neonatal, pediatric, and adult patients during both no motion and motion, well-perfused and poorly-perfused conditions	Stated to be the same as the N-600X pulse oximeter, established in K060576 and K123581.

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

The document leverages clinical data from the predicate devices (K060576 and K123581). Since these studies are not detailed within this document, the specific sample sizes for their test sets and data provenance (e.g., country of origin, retrospective/prospective) are not directly provided in this K141542 summary.

The current device (K141542) underwent non-clinical/bench testing. For the pulse rate accuracy test during motion, it refers to using a "functional tester" and "simulated motion," which implies a test set of situations/scenarios rather than human subjects. The details of this test set are not specified (e.g., number of different motion patterns, duration).

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

This information is not provided in the K141542 summary. As the device relies on clinical data from predicate devices, details about how ground truth was established in those earlier studies (K060576 and K123581) would be necessary for a full answer. For the non-clinical testing of K141542, ground truth would likely be based on calibrated equipment for measurements like pulse rate.

4. Adjudication Method for the Test Set:

This information is not provided in the K141542 summary.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and presents them to a user. It is not an AI-assisted diagnostic imaging or interpretation tool where human readers would improve with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance discussed is inherently "standalone" in the sense that it refers to the device's ability to accurately measure SpO2 and pulse rate. The "oximetry performance verification" and "pulse rate accuracy during motion" tests evaluate the device's technical capabilities directly, without requiring human interpretation as part of the core measurement process.

7. The Type of Ground Truth Used:

For the clinical data referenced from K060576 and K123581, the ground truth for SpO2 measurements in pulse oximetry studies typically involves arterial blood gas analysis (co-oximetry) as the gold standard for measuring actual arterial oxygen saturation. For pulse rate, an ECG often serves as the reference.

For the non-clinical testing of K141542, particularly for pulse rate accuracy during motion, the "functional tester" would likely have a precisely controlled and known output for pulse rate, serving as the instrument-based ground truth.

8. The Sample Size for the Training Set:

This document is for a medical device (pulse oximeter) that performs direct physiological measurements, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would refer to its design, engineering, and calibration processes. Therefore, the concept of a "training set sample size" as typically understood for AI is not applicable.

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

As mentioned above, the concept of a "training set" as it applies to AI/ML is not relevant for this specific device. The device's performance is based on its underlying technology and algorithms, which are developed and validated against established physiological principles and measurement standards.

Summary

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

October 2, 2014

Covidien Ms. Mia Ware Senior Regulatory Affairs Product Specialist 6135 Gunbarrel Ave. Boulder, CO 80301

Re: K141542

Trade/Device Name: Nellcor Portable SpO2 Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 28, 2014 Received: September 4, 2014

Dear Ms. Ware:

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 - Ms. Ware

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K141542

Device Name

NellcorTM Portable SpO2 Patient Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY

Applicant Name and Address:	Covidien LP.6135 Gunbarrel AveBoulder, CO 80301Phone: (303) 305-2750Fax: (303) 305-2212
Establishment Registration Number:	2936999
Device Name(s):	Nellcor™ Portable SpO2 Patient Monitoring System
Classification:	Class II
Classification Name:	Oximeter (74DQA) (per 21 CFR §870.2700)
Product Code:	DQA
Date Prepared:	06/09/2014
510(k) Contact Person and Phone Number:	Mia M. WareSr. Regulatory Affairs SpecialistCovidien - Respiratory and Monitoring Solutions6135 Gunbarrel Ave.Boulder, CO 80301Phone: (303)305-2750Fax: (303) 305-2212
Name and Address of Manufacturing Site(s)
Establishment Registration Number:	30003591740
Registered Establishment Name:	Mediana Co. LTD
Address:	Wonju Medical Industry Park,1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea

Predicate Devices:

The predicate device(s) to which the Nellcor™ Portable SpO2 Patient Monitoring System is claiming substantial equivalence are as follows:

Trade Name:	OxiMAX NPB-40 Pulse Oximeter	N-600X Pulse Oximeter
510(k) Number:	K051352 (cleared on 8/11/05)	K123581 (cleared on 05/09/2013)
Applicant:	Nellcor Puritan Bennett, Incorporated4280 Hacienda DrivePleasanton, CA 94588-8604	Covidien LP6135 Gunbarrel AveBoulder, CO 80301

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Purpose of this 510(k):

This 510(k) submission is to obtain market clearance for the Nellcor Portable Sp02 Patient Monitoring System, a line extension of the Nellcor pulse oximeters with OxiMAX technology.

General Description:

Proposed Nellcor Portable SpO2 Patient Monitoring System Indications for Use:

The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Summary of Technical Characteristics

The Nellcor Portable Sp02 Patient Monitoring System is a line extension of the Nell-1 family of pulse oximeters. It is technologically identical to the predicate devices. It has the same oximetry PCBA and software as N-600X and has the same hand-held portable form factor and performs within the same specifications as the NPB-40. The clinical performance when used with adult, pediatric and neonatal patients is the same as in the N-600X pulse oximeter and was established with that oximeter in K060576 and K123581. The Nellcor Portable SpO2 Patient Monitoring System is intended to be used with the same Nellcor Sp02 sensors that are commercially available and used with the predicate devices. Based on the results of the non-clinical validation studies, Covidien has established that the Nellcor Portable SpO2 Patient Monitoring System is substantially equivalent to the predicate devices.

Non-clinical/bench-testing data

The performance testing section of this submission includes verification and validation reports for pulse oximetry performance in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff". Non-clinical testing in this submission includes, but is not limited to, ISO 80601-2-61:2011 and IEC 60601-1:2005 test reports, Oximetry performance verification, Human Factors Summative Usability validation, and testing incorporating simulated motion performed to validate the pulse rate accuracy of in the range of 20 -250 beats per minute during motion using a functional tester.

Discussion of clinical data

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Clinical data submitted in K060576, and K123581 is applicable to the Nellcor Portable SpO2 Patient Monitoring System. Because there are no changes to the performance, technology, and intended use of the device, the clinical data submitted as part of the premarket notifications for the predicate devices also applies to the Nellcor Portable SpO2 Patient Monitoring System.

Conclusions

The technological characteristics of the Nellcor Portable SpO2 Patient Monitoring System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.

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).