The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospital-type facilties, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Adult Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Device Description

The subject device is the Nellcor™ Bedside Respiratory Patient Monitoring System (oximeter) which contains the Nellcor™ Respiration Rate Parameter (RR Version 2.0 Application device). The oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and respiratory rate by use of one of compatible Nellcor OxiMax oxygen transducers (sensors). The oximeter displays digital values of SpO2 and pulse and respiratory rate. The oximeter device features the same technological characteristics as the predicate, which is the exact same system featuring a system software upgrade.

The oximeter features the optional Nellcor™ Respiration Rate (RR) Software Application for use on the finished oximeter device. Covidien is submitting this traditional 510(k) submission as the result of a design change to the RR software device residing on the oximeter. The design change to the RR Software Application involves a modification to the principles of operation of the RR software algorithm.

The RR software application is intended for continuous non-invasive monitoring of respiration rate in adult patients, and it is calculated by an RR algorithm residing on the monitor which derives patient respiratory rate in breaths per minute based upon oximetry photoplethysmography data that is received from the oximetry sensor on the patient. The software parameter was cleared by the FDA through traditional 510(k) premarket notification (K111933) as the Nellcor Respiration Rate Software, Version 1.0 on March 15, 2012. Version 2.0 (V2.0) of the Respiration Rate (RR) software is an upgraded design of the original cleared software.

AI/ML Overview

This document describes the regulatory submission for the Nellcor™ Bedside Respiratory Patient Monitoring System, specifically focusing on the Nellcor™ Respiration Rate (RR) Software Version 2.0. The device is a pulse oximeter that non-invasively monitors arterial oxygen saturation (SpO2), pulse rate, and respiration rate.

Here's a breakdown of the requested information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Respiration Rate (RR) Measurement Range	For adults: a specified range of respiration rates	4 to 40 breaths per minute
Respiration Rate (RR) Accuracy	For adults: within ±1 breath per minute	±1 breath per minute (over a range of 4-40 breaths/minute based on non-clinical testing, and 4-32 breaths/minute based on clinical validation)
Pulse Oximetry Performance	Adherence to FDA Guidance ("Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff") and ISO 80601-2-61:2011 and IEC 60601-1:2005 standards, including simulated motion testing for pulse rate accuracy (20-250 bpm).	Verification and validation reports confirm adherence. Simulated motion testing validated pulse rate accuracy across 20-250 bpm.
Human Factors	Summative Usability Validation	Human Factors Summative Usability validation completed.
Safety and Environmental	The appropriate safety and environmental specifications	Testing conducted to ensure specifications were met.

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

Non-clinical Testing (Simulated Motion Data for Respiration Rate): The document states this data was "collected from monitored patients on the general care floor which represents the intended populations and includes extreme boundaries of patient characteristics and artifact."
- Sample Size: Not explicitly stated as a number but described qualitatively (patients on general care floor).
- Data Provenance: Retrospective, derived from monitored patients on a general care floor. The country of origin is not specified.
Clinical Validation Studies (for Respiration Rate Software):
- Sample Size: Not explicitly stated as a number, but conducted on "healthy adult volunteers and on subjects from the hospital general care floor."
- Data Provenance: Prospective, as these were conducted as part of the clinical validation. The country of origin is not specified.

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

This information is not provided in the document. The document refers to "ground truth" implicitly through expert-defined standards (e.g., ±1 breath per minute accuracy) and clinical assessment, but does not detail how the true respiration rates or SpO2 values for the test sets were established by experts, nor their specific qualifications.

4. Adjudication Method

The document does not explicitly mention an adjudication method for establishing ground truth in either the non-clinical or clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the standalone performance of the device.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm and device. The document describes several tests:

Non-clinical performance data summary: This includes verification and validation reports for pulse oximetry, ISO and IEC test reports, Human Factors Summative Usability validation, and simulated motion testing for both pulse rate and respiration rate accuracy. This demonstrates the algorithm's performance under various simulated conditions.
Clinical Summary: Clinical validation studies were conducted on healthy adult volunteers and hospital subjects to assess the accuracy of the Respiration Rate Software algorithm. The results demonstrated the algorithm's ability to calculate respiration rate within a stated accuracy.

7. Type of Ground Truth Used

For Pulse Oximetry: Implied to be established against reference methods as per FDA Guidance, ISO, and IEC standards, which typically involve co-oximetry for SpO2 and ECG for heart rate.
For Respiration Rate: For the non-clinical simulated motion data, the ground truth was based on measurements under controlled conditions simulating motion, low pulse rate, low perfusion, and low respiratory variations. For the clinical validation studies, the ground truth for respiration rate would typically be established by a reference method such as capnography or direct observation by trained personnel, though this is not explicitly stated. The document refers to "the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of +1 breath per minute over a range of 4-32 breaths per minute" implying a comparative measurement to a gold standard.

8. Sample Size for the Training Set

The document does not specify a separate sample size for a training set. The submission focuses on validating the performance of an upgraded algorithm (Version 2.0) against established criteria and its predicate. It is likely that development and initial tuning of the algorithm occurred on separate datasets, but these are not detailed in this regulatory summary.

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

As no training set is explicitly discussed, information on how its ground truth was established is not provided. The document details acceptance criteria and performance against those criteria, but not the developmental process of the algorithm in terms of training data and ground truth creation.

Summary

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

March 5, 2015

Covidien Jamie Thomas Senior Regulatory Affairs Specialist 6135 Gunbarrel Ave. Boulder, CO 80301

Re: K141518

Trade/Device Name: Nellcor™ Bedside Respiratory Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, BZQ Dated: January 30, 2015 Received: February 2, 2015

Dear Ms. Thomas,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tejashri Purohit-Sheth, M.D.

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

Enclosure

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Indications for Use

510(k) Number (if known) K141518

Device Name

Nellcor™ Bedside Respiratory Patient Monitoring System

Indications for Use (Describe)

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

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

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510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, provided is the 510(k) summary for the Nellcor™ Bedside Respiratory Patient Monitoring System.

SUBMITTER INFORMATION:

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Contact:	Jamie ThomasSr. Regulatory Affairs Specialist
Phone:	303-305-2315
Fax:	303-305-2212
Date of Preparation:	June 6, 2014

Device Name:

Trade Name(s):	Nellcor ™ Bedside Respiratory Patient Monitoring System
Common/Usual Name:	Pulse Oximeter
Classification Names:	Class II, Anesthesiology
CFR Reference:	21 CFR 870.2700
Product Code:	DQA, BZQ

PREDICATE DEVICES:

Covidien Nellcor™ BedsideRespiratory Patient MonitoringSystem	K121806
Covidien Nellcor™ BedsideRespiratory Patient MonitoringSystem	K123581
Covidien Nellcor™ BedsideRespiratory Patient MonitoringSystem	K130320

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospitaltype facilities, and during intra-hosport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Adult Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in hospitals and hospitals and hospital type facilities.

TECHNOLOGICAL CHARACTERISTICS SUMMARY & SUBSTANTIAL EQUIVALENCE STATEMENT:

The subject device, is the Nellcor™ Bedside Respiratory Patient Monitoring System (oximeter) which contains the Nellcor™ Respiration Rate Software Version 2.0 Application (RR software device), has the same intended use (Adults), general design (continuous, non-invasive indication of respiration rate) and fundamental scientific technology (indicator of central ventilatory drive) as the predicate device Nellcor™ Bedside Respiratory Patient Monitoring System K130320, K123581 and K121806.

The Respiration Rate Software uses photoplethysmography to calculate respiration rate, both of which are indicators of central ventilator drive. The respiration rate measurement range for the Respiration Rate Software is 4-40 breaths/minute, and is indicated for adults only. Both the subject and predicate devices have an accuracy of +1 breaths/minute for the adult population.

PERFORMANCE DATA SUMMARY:

Non-clinical performance data summary

The appropriate safety, environmental, performance and functional testing was conducted to ensure that the specifications of the Nellcor Respiration Rate Software and Nellcor™ Adult Respiratory Sensor were met.

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". Nonclinical 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, testing incorporating simulated motion performed to validate pulse rate accuracy across the operating

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range of 20 to 250 beats per minute, and testing incorporating simulated motion performed to validate respiration rate accuracy across the operating range of 4 to 40 breaths per minute.

The simulated motion data used to assess respiration rate performance was collected from monitored patients on the general care floor which represents the intended populations and includes extreme boundaries of patient characteristics and artifact. Specifically, this simulation assesses respiration rate accuracy in the presence of motion artifact under conditions of low pulse rate (5th percentile) and low perfusion (5th percentile) and low respiratory variations for all of frequency, amplitude and baseline modulations (all 10th percentile) and validates the respiration rate accuracy across the range of 4 to 40 breaths per minute.

The results of this testing demonstrate that the Nellcor™ Bedside Respiratory Patient Monitoring System has a respiration rate measurement range of 4 to 40 breaths per minute with an accuracy of +1 breath per minute, and is substantially equivalent to the predicate device with respect to Respiration Rate (for adults).

Clinical Summary

Clinical validation studies on healthy adult volunteers and on subjects from the hospital general care floor were conducted to assess the accuracy of the Respiration Rate Software algorithm. The studies demonstrated the accuracy of the Respiration Rate Software algorithm was as good as the predicate. The studies demonstrated the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of +1 breath per minute over a range of 4-32 breaths per minute and is shown to be substantially equivalent to the predicate device.

No device related adverse events were observed during the clinical studies.

Conclusions

The information provided in this 510(k) demonstrates the Nellcor™ Bedside Respiratory Patient Monitoring System is substantially equivalent to the predicate devices with respect to performance.

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).