The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X Pulse Oximeter 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 hospital-type facilities, intra hospital transport, and home environments.

The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.

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 prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpOz) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type 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 aifflow 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.

The Nellcor Bedside SpOz Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.

Device Description

The OxiMAX family of pulse oximeters (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.

The N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside Sp02 Patient Monitoring System are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMAX pulse oximetry sensors and the DOC-10 cable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Covidien pulse oximeters, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here is for the pulse oximeter's accuracy in measuring SpO2 (functional oxygen saturation of arterial hemoglobin) and pulse rate under both no-motion and motion conditions. The study implicitly aims to demonstrate that the device's accuracy remains within acceptable clinical ranges despite motion. The specific numerical acceptance criteria (e.g., standard deviation or RMS error) are not explicitly stated in the provided text as a table of criteria values. However, the study results confirm that the device was "validated for accuracy."

Metric / Condition	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
SpO2 Accuracy (Motion)	Device maintains acceptable clinical accuracy	Validated for accuracy in the presence of motion in human blood studies.
SpO2 Accuracy (No Motion)	Device maintains acceptable clinical accuracy	Inherited from previous clearances and confirmed.
Pulse Rate Accuracy (Motion)	Device maintains acceptable clinical accuracy	Validated for accuracy in the presence of motion in human blood studies. Additional bench testing for 25-250 bpm range.
Pulse Rate Accuracy (No Motion)	Device maintains acceptable clinical accuracy	Inherited from previous clearances and confirmed.

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of healthy adult volunteers for the invasive hypoxia study is not specified, but the study was conducted on "healthy, well-perfused adults."
- Data Provenance: The study was a prospective, induced hypoxia study conducted by Covidien. The country of origin of the data is not specified, but the device manufacturer (Covidien) has addresses in Boulder, CO (USA) and Galway, IRELAND. The study description implies it was performed under medical supervision.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for this medical device study. Instead, the ground truth was established by objective medical measurements:
  - SpO2 ground truth: SaO2 values from a CO-Oximeter (a laboratory instrument).
  - Pulse Rate ground truth: ECG values.
Adjudication method for the test set:
- No adjudication method (like 2+1 or 3+1 consensus) was used, as the ground truth was established by direct instrumental measurements (CO-Oximeter and ECG) rather than subjective expert interpretation.
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 MRMC study was done, as this is a pulse oximetry device, not an AI-assisted diagnostic imaging or interpretation tool. The study focuses on the device's accuracy against objective measurements, not human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the primary study detailed is essentially a standalone performance evaluation of the pulse oximeter's algorithm. The device measures SpO2 and pulse rate independently and then these measurements are compared to the ground truth from the CO-Oximeter and ECG. Human interpretation is not part of the measurement process being tested.
The type of ground truth used:
- Objective Instrumental Measurements:
  - For SpO2: SaO2 values obtained from a laboratory CO-Oximeter.
  - For Pulse Rate: ECG values.
The sample size for the training set:
- This document describes a clinical validation study for a medical device trying to expand its indications for use. It does not mention a "training set" in the context of machine learning, as this is not an AI/ML device that requires explicit training data for its core functionality. The device's algorithms for SpO2 and pulse rate measurement would have been developed and refined during its initial design process, but the details of that development (including any "training" data for the algorithms themselves) are not part of this 510(k) submission summary. The "training" in this context would implicitly refer to the data used during the initial development and validation of the N-600X and Nell-1 family of oximeters prior to this specific K-K123581 submission.
How the ground truth for the training set was established:
- Not applicable, as this submission does not detail a machine learning model's training process. The ground truth for the validation study was established using a CO-Oximeter for SpO2 and ECG for pulse rate, as mentioned above.

Summary

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9 2013 MAY

K123581

3. 510(K) SUMMARY

Applicant Name and Address:	Covidien llc.6135 Gunbarrel AveBoulder, CO 80301Phone: (303) 305-2750Fax: (303) 305-2212
Establishment Registration Number:	2936999
Device Name(s):	OxiMax N-600X Pulse Oximeter with OxiMax Sensors and Cables (aka "Accessories")Covidien Nellcor Bedside SpO2 Patient Monitoring SystemCovidien Nellcor Bedside Respiratory Patient Monitoring System
Classification:	Class II
Classification Name:	Oximeter (74DQA) (per 21 CFR §870.2700)
Product Code:	DQA
Date Prepared:	11/27/2012
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:	8020893
Registered Establishment Name:	Covidien (formerly: Nellcor Puritan Bennett Ireland, Ltd)
Address:	Michael Collins Road, Mervue, Galway, IRELAND
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 Nellcor OxiMax N-600X Pulse Oximeter, Nellcor Bedside SpO2 Patient Monitoring System, and Nellcor rine Releor Unitial N 00011 marketed predicate device:

Nellcor Puritan Bennett Model N-595 Pulse Oximeter, cleared under 510(k) # K012891 on 03/07/2002.

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Purpose of this 510(k):

This submission is to expand the indications for use for the OxiMAX pulse oximeters using the Nell-1 oximetry board (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) to include SpO2 and Pulse Rate accuracy during motion and no motion conditions.

Summaries of clinical and non-clinical testing were provided to support 1) the expansion in the indications for use to include accuracy in the presence of motion, and 2) modifications to the device(s) labeling to incorporate the results of clinical trials described in peer-reviewed publications regarding the use of Nellcor pulse oximeters and sensors intended to screen newborn patients for critical congenital heart disease (CCHD). FDA Guidance for Industry and FDA Staff - Bundling Multiple Indications in a Single Submission was used in the preparation of this Traditional 510(k) submission.

General Description:

Current N-600X Indications for Use (cleared via K083325 on 03/09/2009):

The N600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.

The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospital-type facilities, intra-hospital transport, and home environments.

The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and in to the lungs.

Current Nellcor Bedside Respiratory Patient Monitoring System Indications for Use (cleared via K121806 on 09/28/2012) :

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 prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients who are well or poorly perfused. The monitoring system is intended for use in 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.

Current Nellcor Bedside Sp02 Patient Monitoring System Indications for Use (cleared via K120773 on 06/10/2012):

The Nellcor Bedside SpO2 Patient Monitoring System is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospital-type facilities, and intra-hospital transport.

Proposed N-600X Indications for Use:

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The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.

Proposed Nellcor Bedside Respiratory Patient Monitoring System 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 prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpOz) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type 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.

Proposed Nellcor Bedside SpO2 Patient Monitoring System Indications for Use:

The Nellcor Bedside SpO2 Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.

Summary of Technical Characteristics

The Nellcor Bedside Respiratory Patient Monitoring System, Bedside SpO₂ Patient Monitoring System and the OxiMAX N-600X Pulse Oximetry System, the Nell-1 family of pulse oximeters, are technologically identical. They have the same oximetry PCBA and software. This submission includes clinical reports to expand the indications for use and labeling claims for the Nell-1 pulse oximeters. The N-600X Pulse Oximetry System, the representative model of the Nell-1 family of pulse oximeters, is substantially equivalent to the N-595 Pulse Oximeter, the predicate device in this submission, as evidenced in 510(k) K060576. The test method used to demonstrate performance during motion as described in the motion testing Clinical Trial Protocol uses the same definition of standard motion as was used in the invasive hypoxia clinical study which validated the accuracy in the presence of motion of the N-595 Pulse Oximeter, the predicate device. Based on the results of the studies, Covidien has established that the Nell-1 family of pulse oximeters including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems, are substantially equivalent to the predicate device.

Tests Performed to Support Determination of Substantial Equivalence

Non-clinical/bench-testing data

The performance testing section of this submission references the previous Non-clinical data submitted in previously cleared 510(k)s K060576, K120773, and K121806. Additional testing incorporating simulated motion performed to validate the pulse rate accuracy of N-600X in the range of 25 -250 beats per minute during motion using a functional tester, is provided for review.

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Discussion of clinical data

Device Description:

In order to support this claims expansion, Covidien performed an invasive hypoxia study on healthy, well perfused adults using the N-600X as the representative for the Nell-1 family of pulse oximeters including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems. In accordance to ISO 80601-2-61, an invasive hypoxia study was carried on healthy, well-perfused adults. Data was collected at targeted oxygen saturation plateaus during periods of motion. The SpO2 data was compared against SaO2 values from a CO-Oximeter. Pulse rate data was compared against ECG values.

Sensors Tested:

Performance claims during motion was demonstrated on the OxiMAX sensors, the same sensors as submitted and cleared in the 510(k) for the N-595 pulse oximeter,

Study Results and Adverse Events:

The Nell-1 family of pulse oximeters, including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems has been validated for accuracy in the presence of motion in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% Sp02 against a laboratory CO-oximeter and ECG monitor. There were no adverse events or complications observed in the invasive hypoxia studies.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

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Public Health Service

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

May 09, 2013

Ms. Mia M. Ware Senior Regulatory Affairs Specialist Covidien Limited Liability Company 6135 Gunbarrel Avenue BOULDER CO 80301

Re: K123581

Trade/Device Name: Nellcor OxiMAX N-600X Pulse Oximetry System Nellcor Bedside SpO2 Patient Monitoring System Covidien Nellcor Bedside Respiratory Patient Monitoring System and The Covidien Nellcor Bedside Respiratory Patient Monitoring System Respiration Rate Software

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 10, 2013 Received: April 11, 2013

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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

Kwame O. Ulmer -
S FDA

for

Anthony D. Watson, B.S., M.S., M.B.A. 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: KIZ 3581

Device Name: Nellcor OxiMAX N-600X Pulse Oximetry System

Indications for Use:

The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX The News and Cables is indicated for prescription use only for the continuous non-invasive monitoring School oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600X Pulse or functional oxygen suchratin of arratal, pediatric, and adult patients during both no motion and onalieter is intents and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra hospital transport, and home environments.

The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.

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

Over-the Counter Use (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)

Lester W. Schultheis Jr 2013.04.22 15:32:16-04'00

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

Page 1 of __ 1_

510(k) Number: K123581

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Indications for Use

510(k) Number: |〈インスS8 |

Device Name: Covidien Nellcor 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: For Coviden Respiratory Patient Monitoring System is a portable pulse oximeter intended for I he Nellcor bedslue Respiratory Tradent Monitor of arterial oxygen saturation (SpO-) and pulse prescription use only as a continuous non-unative of the motion and motion conditions and for patients rate of adult, peniatic, and neonating system is intended for use in hospitals, hospital-type in hospital-type who are well of pourly perfused. The momenting System is intert (SPD) feature is intended only for facility-use care of adults to detect patterns of desauration indicative of repetitive reductions in aifflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellor Bedside Respiration Patient I he Respiration Rate parameter, with ased in conjunted to be used for the continuous non-invasive Monitoring System and Weller Reoph accir School of School of Scilities. I

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

Over-the Counter Use (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)
Lester W. Schultheis Jr
2013.04.22-15:33:36 -04'00'
(Division Sign-Off)	Page 1 of 1
Division of Anestheslology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K123581

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Indications for Use

510(k) Number: |< |2 3 S 8 |

Device Name: Nellcor Bedside SpO2 Patient Monitoring System

Indications for Use:

Note:

Hospital use typically covers such areas as general care floors (GCFs), operating rooms, . ● special procedure areas, intensive and critical care areas within the hospital, and in hospital type facilities.
Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing . facilities, surgicenters, and sub-acute centers.
Intra-hospital transport includes transport of a patient within the hospital or hospital-type . facility.

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

Over-the Counter Use . (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)
Lester W. Schultheis Jr
2013.04.22 15:32:50-04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K123581
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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).