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 and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, 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 Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Device Description

The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range of compatible Nellcor OxiMax oxygen transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.

AI/ML Overview

The provided 510(k) summary for the Covidien Nellcor Bedside Respiratory Patient Monitoring System primarily establishes substantial equivalence to predicate devices and focuses on the integration of existing respiration rate software. It does not present a new study with specific acceptance criteria and detailed performance data for this device.

Instead, the summary states:

"The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert."
"performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission."
"Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission."

Therefore, the detailed acceptance criteria and study information you requested would reside within the referenced predicate device submissions (K060576, K083325, and K111933), not in this document. This submission relies on the previously established performance of its components.

However, I can extract the information provided about the overall performance testing and what was confirmed by this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission does not present new, specific acceptance criteria for a novel study, but rather refers to predicate devices, the table below reflects the general scope of verification mentioned. Specific quantitative acceptance criteria and reported numerical performance values for parameters like SpO2 accuracy, pulse rate accuracy, and respiration rate accuracy are not provided in this document but would be found in the predicate 510(k)s.

Acceptance Criterion (Type of Test)	Reported Device Performance (as stated in this submission)
Saturation (SpO2) Accuracy	Unchanged from K060576 and K083325 predicate devices.
Pulse Rate Accuracy	Unchanged from K060576 and K083325 predicate devices.
SPD (OxiMax SPD Alert) Performance	Unchanged from K083325 predicate device. Validated for detection of patterns indicative of repetitive reductions in airflow.
Respiration Rate Accuracy	Unchanged from K111933 predicate device.
Mechanical System Features Verification	Met specified requirements.
Software System Features Verification	Met specified requirements.
Operating Range Verification	Met specified requirements.
20-point COPs Accuracy (Bench Test)	All verification and validation activities met product requirements.
Low Perfusion Pulse Rate and Saturation Accuracy (Bench Test)	All verification and validation activities met product requirements.
Usability / Human Factors	Formative and Summative studies demonstrated adequate assurance of safety and performance for patient and operator.

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

This document describes "Bench Testing" and "Usability / Human Factors" studies.

Bench Testing: No sample sizes are specified for 20-point COPs or Low Perfusion tests in this document. The data provenance is implied to be laboratory/bench testing.
Usability / Human Factors: No sample size is specified. The study was "simulated operating environments."
Clinical Performance (SpO2, Pulse Rate, Respiration Rate): No new test set sample sizes or data provenance are stated for these parameters, as the submission relies on the data from predicate devices K060576, K083325, and K111933.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the current document, as it refers to predicate device data for clinical performance. For the usability studies, the "users" involved are noted, but their qualifications are not specified nor is there mention of experts establishing a ground truth in the context of human factors.

4. Adjudication Method

This information is not provided in the current document.

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

This information is not provided, and given the nature of the device (a monitoring system for physiological parameters), an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant in the traditional sense. The AI (algorithm) here is for parameter calculation, not diagnostic image interpretation.

6. Standalone Performance Study

The submission states that "integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate." This implies that the performance data for the algorithm (standalone) for respiration rate was established in the K111933 submission and is referenced here as unchanged. Similarly, SpO2 and pulse rate algorithms would have standalone performance established in K060576 and K083325.
This document describes "Bench Testing" which included "20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests," which are forms of standalone performance evaluation against a known standard.

7. Type of Ground Truth Used

For SpO2 and Pulse Rate: Historically, pulse oximeter accuracy studies (like those in K060576, K083325) use arterial blood gas (ABG) analysis as the gold standard for oxygen saturation (SaO2), along with ECG-derived heart rate for pulse rate.
For Respiration Rate: The K111933 submission would have detailed the ground truth for respiration rate, which typically involves manual counting by experts from capnography, impedance pneumography, or direct observation/audio recording.
For Bench Testing: Controlled laboratory standards and reference measurements are used as ground truth (e.g., precise oxygen mixtures for CO-oximetry, simulated pulse signals).

8. Sample Size for the Training Set

This information is not provided in the current document, as the core algorithms and their training (if any neural networks were involved, which is not explicitly stated but implied by "software algorithm") were developed prior to this submission and are referenced via predicate devices.

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

This information is not provided in the current document, for the same reasons as point 8.

Summary

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K 121806 510(k) Summary

Date summary prepared: 31-Aug-2012

510(k) Submitter/Holder

Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301

Contact

Elizabeth Malo Sr. Regulatory Affairs Specialist Office 303.305.2763 Mobile 720.539.9634 Fax: 303-305-2212 Email: elizabeth.malo@covidien.com

Name of Device

Trade Name:	Bedside Respiratory Patient Monitoring System
Catalog Numbers:	GR101704, GR101704-RR
Common Name:	Pulse oximeter
Classification Name:	oximeter (21 CFR § 870.2700, class II, DQA)
	monitor, breathing frequency (21 CFR § 868.2375, class II, BZQ)

Purpose of Submission

The purpose of this submission is to introduce the Covidien Nellcor Bedside Respiratory Patient Monitoring System which effectively integrates Respiration Rate software parameter into a pulse oximetry monitor whose design is fundamentally similar to the proposed predicate. The intended use of the Bedside Respiratory Patient Monitoring System is the same as that of the predicate with the addition of the continuous noninvasive monitoring of respiration rate in adult patients.

This submission followed the "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, 2005," the "Guidance for Industry on General / Specific Intended Use, 1998," and the "Draft Guidance for Industry and FDA Staff: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, 2011."

Predicate Devices

Bedside Respiratory Patient Monitoring System was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

Trade Name:	N-600x Pulse Oximeter with Oximax SPD Alert
Device Common Name:	Oximeter
510(k) Number:	K083325 (cleared 3/2009)
Manufacturer:	Covidien, formerly Nellcor, a division of Tyco Healthcare
Trade Name:	Covidien Respiration Rate Software
Device Common Name:	Monitor, breathing frequency
510(k) Number:	K111933 (cleared 3/2012)
Manufacturer:	Covidien, formerly Nellcor, a division of Tyco Healthcare

SEP 2 8 2012

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Device Description

Intended Use

Technological and Performance Characteristics

The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert. There are no significant changes to the function of the device other than the addition of the respiration rate software as an optional parameter for use on the finished device.

Performance Data

The design of the Bedside Respiratory Patient Monitoring System features the same internal printed circuit board assembly as the predicate device thus performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission. Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission

Bench Testing: Design verification and validation testing was performed to confirm the system mechanical and software features met specified requirements. Performance testing included verification of the stated operating range and validation of accuracy claims through 20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests. All verification and validation activities met product requirements.

Animal Testing: Animal testing was not required to demonstrate that the proposed device met its design requirements and therefore there are no animal data associated with this device.

Usability / Human Factors

Usability was evaluated with users in simulated operating environments. These studies consisted of formative and Summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.

Substantial Equivalence

In establishing substantial equivalence of the Bedside Respiratory Patient Monitoring System to the predicate in establishing Subtainer oquindines o events, and instrument risk profiles. The use of the Bedside Respiratory Patient Monitoring System in patient events, and finstranient her promotive with a more withpes of safety and effectiveness compared with the predicate devices currently in use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. 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.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 8 2012

Covidien Ms. Elizabeth Malo Senior Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K121806

Trade/Device Name: Covidien Nellcor™ Bedside Respiratory Patient Monitoring System and the Covidien Nellcor 114 Bedside Respiratory Patient Monitoring System with Respiration Rate Software

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZQ Dated: August 31, 2012 Received: September 4, 2012

Dear Ms. Malo:

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 1 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. Malo

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 vours.

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

Enclosure

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Indications for Use Statement 4.1

. 510(k) Number (if known): 121806

Device Name: Covidien Nelloor™ Bedside Respiratory Patient Monitoring System and the Covidien Nellcor™ Bedside Respiratory Patient Monitoring System Respiration Rate Software

Indications for Use:

For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:

The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for The None - Butly as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. montoning of com is intenced 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.

Use Prescription (Part 21 CFR 801 Subpart D) AND/OR

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

Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulthe

Division of Anestheslology, General Ho Infection Control, Dental

510(k) Number: K121806

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).