Model X-100: Nonin's SenSmart™ Model X-100 Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Model 8100S(x): Nonin's Model 8100S(X) reusable soft sensor is indicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

SenSmart Download Software: The SenSmart Download Software is an optional accessory for use with Nonin's X-100M SenSmart Monitor only. It is intended for use by healthcare professionals when 1) transferring data from the X-100M to a computer in order to maintain individual records of oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

Device Description

The SenSmart X-100 Oximetry System performs both pulse oximetry and regional oximetry measurements. The SenSmart X-100 Oximetry System works with all Nonin Equanox regional oximetry sensors (Model 8004CA, Model 8003CA, Model 8004CB and Model 8004CB-NA). The SenSmart compatible pulse oximetry Soft Sensor Model 8100S(x) is used with the Model X-100 System. The system consists of the sensor, the X-100SP signal processor (up to 6), extensions cables, the X-100H hub for multiple channels, the X-100M SenSmart Monitor which includes display, alarms, and memory. The SenSmart Download software is included for data storage review and reporting on a Windows PC.

AI/ML Overview

The Nonin Medical, Inc. Model X-100 Universal Oximetry System is designed to measure and monitor arterial hemoglobin oxygen saturation (SpO2), pulse rate, and cerebral or somatic hemoglobin oxygen saturation (rSO2). The device underwent several tests to ensure its performance and safety, including functional and safety testing, rSO2 accuracy testing, SpO2 accuracy testing, and a usability study.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Measure	Acceptance Criteria (Predicate Device)	Reported Device Performance (Model X-100)
SpO2 Accuracy	±2 digits (±1 Arms)	±2% in non-motion conditions
		±3% in motion conditions (on index, middle, or ring finger)
Low Perfusion SpO2	±2 digits (±1 Arms)	Not explicitly stated for X-100, but "Similar" to predicate
rSO2 Accuracy	8004CA: 3.9 ±Arms absolute	8004CA: 3.9 ±Arms absolute
	8004CB: 5.9 ±Arms absolute	8004CB: 5.9 ±Arms absolute
	8003CA: 3.6 Arms Trending	8003CA: 3.6 Arms Trending
Pulse Rate Accuracy	20 to 250 BPM ±3 digits	20 to 250 BPM ±3 digits (Similar to predicate)
Low Perfusion Pulse	40 to 240 BPM ±3 digits	40 to 240 BPM ±3 digits (Similar to predicate)
Usability	Operator effectiveness, efficiency, and operator satisfaction	Model X-100 suitable for intended users, uses, and environments
Electrical Safety	IEC 60601-1	Pass
Temperature/Humidity	IEC 60601-1	Pass
Cleaning	IEC 60601-1	Pass
EMC	IEC 60601-1-2	Pass
Bluetooth Cert.	FCC wireless certification Grant	Pass
Performance	ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6	Pass
Ingress Protection	ISO 80601-2-61	Pass
Mechanical Durab.	ISO 80601-2-61	Pass
Atmospheric Pressure	IEC 60601-1	Pass
Usability	IEC 60601-1-6	Pass

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

SpO2 Accuracy Testing:
- Sample Size: 13 healthy, non-smoking, light-to-dark-skinned subjects.
- Data Provenance: Prospective, conducted in an independent research laboratory. The document does not specify the country of origin, but "Nonin Medical, Inc." is based in Plymouth, MN, USA.
Usability / Human Factors Study:
- Sample Size: 20 healthcare professionals.
- Data Provenance: Prospective, likely conducted within a controlled environment to simulate clinical use. Country of origin not specified, but implied to be in the same geographic region as the manufacturer.

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

SpO2 Accuracy Testing:
- The ground truth for SpO2 was established by comparing the device's SpO2 measurements to arterial hemoglobin oxygen (SaO2) values determined from blood samples using four (4) laboratory co-oximeters. The final SpO2 values were paired with the average of three Radiometer CO-oximeters (ALB80Flex OSM). While these are not "experts" in the human sense, the co-oximeters serve as a highly accurate, standardized ground truth instrument for SaO2 measurement. No human experts are mentioned for establishing this specific ground truth.
Usability Study:
- The "ground truth" for usability was established through the observations of the study personnel and user feedback captured via questionnaires. No specific number or qualifications of "experts" are provided to establish the ground truth for usability, beyond the general conduct by "Nonin personnel" who provided in-service training and an "observer" during task performance.

4. Adjudication Method for the Test Set

SpO2 Accuracy Testing: The method involved taking multiple arterial blood samples at different plateaued SpO2 levels and running them on four co-oximeters. The average of three Radiometer co-oximeters was used as the reference against which the device's SpO2 readings were compared. This isn't a traditional "adjudication" in the sense of multiple human readers resolving discrepancies, but rather a robust method of establishing a highly accurate instrumental ground truth.
Usability Study: An observer was present to document whether tasks were performed appropriately and if the user had difficulty. User responses and body language were also documented. Task effectiveness was the primary objective, suggesting a pass/fail assessment based on predefined criteria, but no formal adjudication process by multiple individuals is described.

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, an MRMC comparative effectiveness study was not done. This device is an oximetry system and does not involve AI for interpretation or human-in-the-loop performance improvement. The studies described focus on the device's accuracy in measuring physiological parameters and its usability without, or as a replacement for, human interpretation of raw data.

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

Yes, a standalone performance study was clearly the primary focus for SpO2 and rSO2 accuracy. The SpO2 accuracy testing directly compared the device's measured SpO2 values to the co-oximeter reference, operating independently of human interpretation of the measurement output. The rSO2 accuracy was demonstrated through direct device comparison and testing with the predicate system. The Usability study evaluated human interaction with the device, but the core accuracy measurements were standalone.

7. The Type of Ground Truth Used

SpO2 Accuracy Testing: Instrumental Ground Truth (Laboratory Co-oximetry for SaO2 values).
rSO2 Accuracy Testing: Comparison to a predicate device's measured rSO2 values, which would have been established with similar instrumental ground truth methods.
Usability Study: User feedback and observation of task completion against predefined usability criteria.

8. The Sample Size for the Training Set

The provided document describes pre-market testing for substantial equivalence. It does not mention a "training set" as would be relevant for machine learning algorithms. The device is hardware-based with embedded software, and its performance is verified through testing, not developed through machine learning. Therefore, this question is not applicable in the context of this device.

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

As the concept of a "training set" is not applicable to this pre-market submission for a hardware medical device, this question is also not applicable.

Summary

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2. "510(k) Summary" as required by section 807.92(c)

Submitter:	Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443
Phone:	763-553-9968
Fax:	763-553-7807
Contact Person:	Brodie PedersenSenior Regulatory Engineer
Date Prepared:	September 13, 2013
Trade Name:	Model X-100
Common Name/Classification Nameand Number:	OximeterClass II, 21 CFR 870.2700
Product Code:	MUD, DQA
Predicate Device(s):	Nonin's SenSmart™ Model X-100 Universal Oximetry System isequivalent to the predicate Model 7600 system cleared by the FDAunder K113215 on 5/18/2012 including the 8004CB and 8004CB-NAsensors, the Model 7600 cleared by the FDA under K102715 on12/17/2010 including the 8004CA and 8000CA sensors, and Model 7500Digital Pulse Oximeter and cleared by the FDA under K080255 on5/23/2008.

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Device Description:

Indications for Use:

Model X-100

Nonin's SenSmart™ Model X-100 Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Model 8100S(x)

Nonin's Model 8100S(X) reusable soft sensor is indicated for noninvasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

SenSmart Download Software

The SenSmart Download Software is an optional accessory for use with Nonin's X-100M SenSmart Monitor only. It is intended for use by healthcare professionals when 1) transferring data from the X-100M to a computer in order to maintain individual records of oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

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Technological Characteristics:

The Model X-100 system is the Model 7600 platform with the addition of the SpO2 module and sensor from the Model 7500. The Model X-100 provides both modalities of oximetry monitoring in one monitor. The indications for use are combined from the predicate monitors with no changes from the predicates.

The Model X-100 system connectors are modified to prevent misconnection with incompatible components. The Model 8000S(x) connector was modified to create the Model 8100S(x) sensor, consistent with the Model 8004CX regional sensor connector. The Model X-100 system has undergone significant testing and evaluation as described below to assure there is no effect on safety or effectiveness. As shown in Table 1 below, these predicate devices represent the same technical characteristics as the subject device utilizing the same materials, power source and communication technology to provide regional oximetry and pulse oximetry in one device.

CATEGORY	Identical/Different	Model X-100	Model 7600	Model 7500
INDICATIONS FOR USE	Similar	Nonin's SenSmart™ ModelX-100 Universal OximetrySystem is a modular systemand is indicated for use insimultaneously measuring,displaying, monitoring, andrecording up to six (6)channels of functionaloxygen saturation of arterialhemoglobin (SpO2) andpulse rate or cerebral orsomatic hemoglobin oxygensaturation (rSO2) of bloodunderneath the sensor.Patient populations includeadult, pediatric, infant, andneonate through the use ofSenSmart compatiblesensors.The SenSmart system isintended for use in hospitals,long-term care, medicalfacilities, sleep laboratories,sub-acute environments,and Emergency MedicalServices (EMS), includingpatient transport. The X-100SenSmart system may beused for spot-checking andcontinuous monitoring withpatient alarms. TheSenSmart pulse oximetry	Nonin's non-invasiveModel 7600 4- ChannelRegional Oximeter Systemis intended for use as anabsolute real-time adjunctmonitor of regionalhemoglobin oxygensaturation of bloodunderneath the sensor. Itis intended for spot-checking or continuousmonitoring of adult, orneonate, infant andpediatric patients. It isintended for use inenvironments includingthe operating room,surgical recovery, criticalcare, emergency room,long-term care and mobileenvironments.	The Nonin Model 7500Digital Pulse Oximeter isa portable tabletopdevice indicated for usein measuring, displaying,and recording functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate ofadult, pediatric, infantand neonatal patients. Itis indicated for spotchecking and orcontinuous monitoringof patients during bothmotion and non-motionconditions, and forpatients who are well orpoorly perfused.
	ldentical/
CATEGORY	Different	Model X-100	Model 7600	Model 7500
		(SpO2) functionality issuitable for use in bothmotion and non-motionconditions, includingpatients who are well orpoorly perfused.
Indications for use	Similar	Nonin's Model 8100S(X)reusable soft sensor isindicated for non-invasivespot checking and/orcontinuous monitoring ofadult and pediatric patientswho are well or poorlyperfused, during bothmotion and non-motionconditions. It is intended foruse in environmentsincluding the operatingroom, surgical recovery,critical care, emergencyroom, long-term care, andmobile environments.	NA	Nonin's Model 8000SX-Series Reusable SoftSensors are indicated fornon-invasive spot-checking and/orcontinuous monitoring ofadult and pediatricpatients who are well orpoorly perfused. It isintended for use inenvironments includingoperating room, surgicalrecovery, critical care,emergency room, long-term care, home use,and mobileenvironments.
Indications for use	Similar	The SenSmart DownloadSoftware is an optionalaccessory for use withNonin's X-100M SenSmartMonitor only. It is intendedfor use by healthcareprofessionals when 1)transferring data from the X-100M to a computer inorder to maintain individualrecords of oximetry data, 2)reviewing data according touser-selected parameters,and 3) generating reports.	eVISION DataManagement Software(eVISION) is an optionalaccessory for use withNonin's Model 7600Regional Oximeter System.It is intended for use byhealthcare professionalswhen 1) transferring datafrom the X-100M to acomputer in order tomaintain individual recordsof oximetry data, 2)reviewing data accordingto user-selectedparameters, and 3)generating reports.	The nViSiON DataManagement Software isan optional accessory forcompatible Noninoximeters: 2120, 2500,3100, 3150, 4000 7500,7800, 8500, 8800, 9600,9700, and 9847. It isintended for use byhealthcare professionalswhen (1) transferringdata from pulseoximeters to computersin order to maintainindividual records ofpulse oximetry data, (2)reviewing data accordingto user-selectedparameters, and (3)generating reports.
SYSTEMCONFIGURATIONS
Parts and Accessories
CATEGORY	Identical/Different	Model X-100	Model 7600	Model 7500
Sensor Models	Similar	All Nonin smart sensors,8004CA, 8003CA, 8004CB,8004CB-NA, 8100S(x)	All Nonin Regional smartsensors, 8004CA, 8003CA,8004CB, 8004CB-NA	All Nonin DE9 connectorpulse oximeter sensorsincluding Model 8000S(x)
Download software	Similar	SenSmart Download	evision	nVISION
Batteries	Similar	Li ION	Li ION	NiMH
Operator'sinstructions	Similar	CD	CD	CD
OVERALLSPECIFICATIONS
SpO2 Range	Similar	0% to 100% SpO2	NA	0% to 100% SpO2
rSO2 Range	Similar	0% to 100% 1502	0% to 100% 1502	NA
Pulse Rate Range	Similar	18-321 BPM	NA	18-321 BPM
Accuracy
rSOz	Similar	8004CA 3.9 +/-Arms absolute8004CB 5.9 +/-Ams absolute8003CA 3.6 Ams Trending	8004CA 3.9 +/-Arms absolute8004CB 5.9 +/-Ams absolute8003CA 3.6 Am, Trending	NA
SpOz	Similar	±2 digits (± 1 Arms)	NA	±2 digits (± 1 Arms)
Low Perfusion SpO2	Similar	±2 digits (± 1 Arms)	NA	±2 digits (± 1 Arms)
Pulse Rate	Similar	20 to 250 BPM ±3 digits	NA	20 to 250 BPM ±3 digits
Low Perfusion PulseRate	Similar	40 to 240 BPM ±3 digits	NA	40 to 240 BPM ±3 digits
Displays
	Similar	LCD Panel 6 Channels	.LCD Panel 4 Channels	7-Segment 3-Digit LED 1Channel
Connectivity
	Identical	Saber Bluetooth Module	Saber Bluetooth Module	N/A
Package	Similar	Box	Box	Box

Table 1: Technological Characteristics

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Testing:	Nonin's Model X-100 Oximeter system is supported by both laboratoryand clinical hypoxia accuracy testing in order to ensure that it hasappropriate performance and functional features to fully comply withrecognized standards and is substantially equivalent to the predicatedevice.
Functional andSafety Testing:	Laboratory testing included: software verification, safety testing forelectrical, mechanical, biocompatibility analysis, ingress protection,electromagnetic compatibility, device performance, usability evaluation,wireless Bluetooth certification and mechanical durability. These testshave been performed to demonstrate equivalency with the predicatedevices and compliance with recognized standards. As shown in thetable below the device met the relevant requirements of the applicablerecognized standards.
	rSO2 Accuracy Testing
	The rSO₂ accuracy was demonstrated through detailed devicecomparison and testing showing how the X-100SP is equivalent to theModel 7600PA pod used with the Model 7600 system regarding rSO2measurements. The regional sensors are identical to those used withthe 7600PA. The testing shows via the clinical data how the outputfrom each system is the same when the input signals of the same

Test	Reference	Result
Electrical Safety	IEC 60601-1	Pass
Temperature and Humidity	IEC 60601-1	Pass
Cleaning	IEC 60601-1	Pass
Electromagnetic Immunity andEmissions	IEC 60601-1-2	Pass
Bluetooth Wireless certification	FCC wireless certification Grant	Pass
Performance	ISO 80601-2-61IEC 60601-1IEC 60601-1-6	Pass
Ingress Protection	ISO 80601-2-61	Pass
Mechanical Durability	ISO 80601-2-61	Pass
Atmospheric Pressure	IEC 60601-1	Pass
Usability	IEC 60601-1-6	Pass

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Clinical Testing:

Clinical testing for SpO2 included induced laboratory hypoxia testing on healthy volunteers. A Usability / Human Factors Study was performed to get real user feedback from clinical oximeter users.

SpO2 Accuracy Testing

Clinical hypoxia accuracy testing conducted during induced hypoxia studies on 13 healthy, nonsmoking, light-to-dark-skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the device was compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the device is in comparison to the co-oximeter samples measured over the SpO2 range of 70-100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Standard Specification for Pulse Oximeters for Accuracy in a non-motion environment demonstrated a specified accuracy of ±2% in non-motion conditions and ±3 in motion conditions on the index finger, middle finger, or ring finger for all data points with an arterial oxygen saturation (SaO2) of greater than or equal to 70%. There were no reported adverse effects during these investigations.

Objectives: The purpose of this study was to verify SpO2 performance accuracy of the Nonin Medical Model X-100SP oximeter with the 8100S(X), pulse oximetry sensors on the finger in stationary (nonmotion) and motion conditions. These aims were achieved by comparing SpO2 measurements with those of arterial blood samples assessed by CO-oximetry. The study was designed in accordance with ISO 80601-2-61. The goal, in its entirety, was to show the SpO2 accuracy performance for the devices. It was expected that the Accuracy Root Mean Square (Arms) performance of the above pulse oximetry systems will meet a specification of ±3% for the range of 70 - 100% SaO2.

Methods: Subjects were connected to a breathing circuit, in which the gas flow delivery was adjusted for subject comfort. This gas circuit provided a gas mixture of medical grade oxygen and nitrogen. The program was run in manual mode, in which the gas mixture was changed by the controller. The program was used to induce hypoxia in a stair-stepped manner which allowed each subject to settle at his or her SpO2 level (e.g. plateau). At each plateau, arterial blood sampling was performed. After drawing a waste sample to clear the arterial line, an arterial sample was drawn. The beginning and end of each draw was noted on the data collection system. This series of waste draw, and arterial draws was repeated multiple times for each plateau. At the end of each plateau, the arterial line was flushed with sterile saline. Subsequently, the program was adjusted to allow the subject to reach a new level of SpO2 and the process was repeated. Samples were run on four (4) CO-oximeters. The SpO2 values at each draw were paired with the average of the three Radiometer CO-oximeters (ALB80Flex OSM).

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On one hand (the hand without the arterial line), two types of motion were evaluated. These included tapping and rubbing. Both were induced using a motion simulator, occurring at a frequency of 1 Hz, and moving the fingers approximately 1-2 inches. Subjects alternated between starting with rubbing or tapping. Subsequently, the motion type alternated for each stable plateau.

Conclusions: The X-100SP (software rev. 12085) with 8100S(X) sensors demonstrated a specified accuracy of ±2% in non-motion conditions and ±3 in motion conditions on the index finger, middle finger, or ring finger for all data points with an arterial oxygen saturation (SaO2) of greater than or equal to 70%.

USABILITY: The testing performed for this Usability / Human Factors Study was to acquire user feedback from clinical oximeter users.

The primary objective of this study was to collect data which demonstrates the usability of the Nonin Model X-100 SenSmart™ system user interface. The usability components to be tested in this study included operator effectiveness, efficiency, and operator satisfaction. These were assessed by recording the proportion of users who properly performed each task, the time it took to perform each step, and the operator's perception of the system, respectively. Operator effectiveness was the primary objective. Efficiency and operator satisfaction were secondary objectives. Secondary endpoints are descriptive in nature.

Methods: Each user was asked about their knowledge of regional and pulse oximetry. They were trained on system use through an in-service conducted by Nonin personnel. The training included a demonstration of the functions of the system. A minimum of two days after training, each user returned to demonstrate system use. The users were presented with two case scenarios that used specific functions of the system. Users had the benefit of Instructions for Use and In-Service materials as well as the opportunity to contact their clinical education specialist as would be the case with normal clinical use. An observer was present to watch the user perform each task and document whether the tasks were performed appropriately, and whether the user had difficulty using the system. User responses and body language were also documented. The users then completed a questionnaire regarding the various aspects of using the Model X-100 system.

Usability validation was conducted with 20 health care professionals who performed the use case scenarios. A list of effectiveness endpoints which were met and unmet was provided. Lists of modifications to the device, in-service and accompanying documentation were provided. On average, users agreed or strongly agreed with all statements about . system set-up except the ease of changing from %baseline to absolute

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alarm limits. On average users also agreed or strongly agreed with all statements about system use.

Conclusion: The Model X-100 has been found to be suitable to provide operator effectiveness, efficiency, and operator satisfaction for the intended users, uses and environments.

Conclusion:

Nonin's SenSmart™ Model X-100 Universal Oximetry System is substantially equivalent to the Model 7600 cleared by the FDA under K113215 on 5/18/2012 including the 8004CB and 8004CB-NA sensors, the Model 7600 cleared by the FDA under K102715 on 12/17/2010 including the 8004CA and 8000CA sensors and Model 7500 Digital Pulse Oximeter and cleared by the FDA under K080255 on 5/23/2008.

Nonin's Model 8100S(x) reusable soft sensor is substantially equivalent to Nonin's Model 8000S(x) reusable soft sensor cleared by the FDA with Model 7500 Digital Pulse Oximeter under K080255 on 5/23/2008 and in K092101 on 10/21/2009.

Nonin's SenSmart Download Software is substantially equivalent to Nonin's eVISION Data Management Software cleared by the FDA in K092678. This software like eVISION is an optional accessory to the SenSmart Model X-100 Universal Oximeter system.

The positive results of testing, lead to the conclusion that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

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

February 21. 2014

Nonin Medical, Inc. Mr. Brodie Pedersen Senior Regulatory Engineer 13700 151 Avenue North Plymouth, MN 55441-5443

Re: K132402

Trade/Device Name: SenSmart™ Model X-100 Universal Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, MUD Dated: January 17, 2014 Received: January 22, 2014

Dear Mr. Pedersen:

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. Iisting 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 complics with other requirements of the Act

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Page 2 - Mr. Pedersen

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/10/Picture/7 description: The image contains a signature or logo on the left side, followed by the text "Tejashri Purohit-Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". The text is arranged in a vertical manner, with the signature/logo appearing to the left of the text. The word "FOR" is located in the bottom right corner of the image.

Erin I. Keith, M.S. Acting 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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1. Indications for Use Statement

K132402 510(K) Number:

Device Name:

Nonin Medical, Inc. Model X-100

Indications for Use: Model X-100

The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Model 81005(x)

Nonin's Model 8100S(X) reusable soft sensor is indicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

SenSmart Download Software

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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).