(204 days)
No
The document describes a standard oximetry system and its components, focusing on measurement accuracy and usability. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
Yes
The device is indicated for monitoring and measuring physiological parameters (SpO2, pulse rate, rSO2), which are used to assess a patient's condition, fitting the definition of a therapeutic device that supports treatment through monitoring.
Yes
The device is intended for "measuring, displaying, monitoring, and recording" physiological parameters like oxygen saturation and pulse rate, which are used to assess a patient's health status. This information is typically used by healthcare professionals to aid in the diagnosis, treatment, or prevention of disease.
No
The device description explicitly states that the system consists of hardware components including sensors, signal processors, a hub, and a monitor with display, alarms, and memory. While there is "SenSmart Download Software" mentioned, it is described as an optional accessory for data management, not the primary medical device itself.
Based on the provided information, the Nonin SenSmart™ Model X-100 Universal Oximetry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body.
- Device Function: The SenSmart X-100 system measures physiological parameters directly from the patient's body:
- SpO2: Functional oxygen saturation of arterial hemoglobin, measured non-invasively through the skin (e.g., on a finger).
- rSO2: Cerebral or somatic hemoglobin oxygen saturation, measured non-invasively underneath a sensor placed on the body.
- Pulse Rate: Measured non-invasively.
- No Specimen Analysis: The system does not analyze blood samples, urine, tissue, or any other specimen taken from the body. It uses optical and electronic methods to measure parameters in vivo (within the living body).
Therefore, the SenSmart X-100 system falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes
MUD, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood underneath the sensor, index finger, middle finger, or ring finger
Indicated Patient Age Range
adult, pediatric, infant, and neonate
Intended User / Care Setting
hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, Emergency Medical Services (EMS), including patient transport.
operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical 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. 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). Usability validation was conducted with 20 health care professionals who performed the use case scenarios.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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. 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 Study: Usability validation was conducted with 20 health care professionals who performed the use case scenarios. Operator effectiveness, efficiency, and operator satisfaction were assessed. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: ±2% in non-motion conditions and ±3 in motion conditions.
rSO2 Accuracy: 8004CA 3.9 +/-Arms absolute, 8004CB 5.9 +/-Ams absolute, 8003CA 3.6 Ams Trending
SpO2: ±2 digits (± 1 Arms)
Low Perfusion SpO2: ±2 digits (± 1 Arms)
Pulse Rate: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate: 40 to 240 BPM ±3 digits
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
2. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 763-553-9968 |
| Fax: | 763-553-7807 |
| Contact Person: | Brodie Pedersen
Senior Regulatory Engineer |
| Date Prepared: | September 13, 2013 |
| Trade Name: | Model X-100 |
| Common Name/
Classification Name
and Number: | Oximeter
Class II, 21 CFR 870.2700 |
| Product Code: | MUD, DQA |
| Predicate Device(s): | Nonin's SenSmart™ Model X-100 Universal Oximetry System is
equivalent to the predicate Model 7600 system 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. |
1
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.
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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2
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™ 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 | Nonin's non-invasive
Model 7600 4- Channel
Regional Oximeter System
is intended for use as an
absolute real-time adjunct
monitor of regional
hemoglobin oxygen
saturation of blood
underneath the sensor. It
is intended for spot-
checking or continuous
monitoring of adult, or
neonate, infant and
pediatric patients. It is
intended for use in
environments including
the operating room,
surgical recovery, critical
care, emergency room,
long-term care and mobile
environments. | The Nonin Model 7500
Digital Pulse Oximeter is
a portable tabletop
device indicated for use
in measuring, displaying,
and recording functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse rate of
adult, pediatric, infant
and neonatal patients. It
is indicated for spot
checking and or
continuous monitoring
of patients during both
motion and non-motion
conditions, and for
patients who are well or
poorly perfused. |
| | ldentical/ | | | |
| CATEGORY | Different | Model X-100 | Model 7600 | Model 7500 |
| | | (SpO2) functionality is
suitable for use in both
motion and non-motion
conditions, including
patients who are well or
poorly perfused. | | |
| Indications for use | Similar | 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. | NA | Nonin's Model 8000SX-
Series Reusable Soft
Sensors are indicated for
non-invasive spot-
checking and/or
continuous monitoring of
adult and pediatric
patients who are well or
poorly perfused. It is
intended for use in
environments including
operating room, surgical
recovery, critical care,
emergency room, long-
term care, home use,
and mobile
environments. |
| Indications for use | Similar | 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. | eVISION Data
Management Software
(eVISION) is an optional
accessory for use with
Nonin's Model 7600
Regional Oximeter System.
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. | The nViSiON Data
Management Software is
an optional accessory for
compatible Nonin
oximeters: 2120, 2500,
3100, 3150, 4000 7500,
7800, 8500, 8800, 9600,
9700, and 9847. It is
intended for use by
healthcare professionals
when (1) transferring
data from pulse
oximeters to computers
in order to maintain
individual records of
pulse oximetry data, (2)
reviewing data according
to user-selected
parameters, and (3)
generating reports. |
| SYSTEM
CONFIGURATIONS | | | | |
| 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 smart
sensors, 8004CA, 8003CA,
8004CB, 8004CB-NA | All Nonin DE9 connector
pulse oximeter sensors
including Model 8000S(x) |
| Download software | Similar | SenSmart Download | evision | nVISION |
| Batteries | Similar | Li ION | Li ION | NiMH |
| Operator's
instructions | Similar | CD | CD | CD |
| OVERALL
SPECIFICATIONS | | | | |
| 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 absolute
8004CB 5.9 +/-Ams absolute
8003CA 3.6 Ams Trending | 8004CA 3.9 +/-Arms absolute
8004CB 5.9 +/-Ams absolute
8003CA 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 Pulse
Rate | 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 1
Channel |
| Connectivity | | | | |
| | Identical | Saber Bluetooth Module | Saber Bluetooth Module | N/A |
| Package | Similar | Box | Box | Box |
Table 1: Technological Characteristics
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: : : : : :
:
5
| Testing: | Nonin's Model X-100 Oximeter system is supported by both laboratory
and clinical hypoxia accuracy testing in order to ensure that it has
appropriate performance and functional features to fully comply with
recognized standards and is substantially equivalent to the predicate
device. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and
Safety Testing: | Laboratory testing included: software verification, safety testing for
electrical, mechanical, biocompatibility analysis, ingress protection,
electromagnetic compatibility, device performance, usability evaluation,
wireless Bluetooth certification and mechanical durability. These tests
have been performed to demonstrate equivalency with the predicate
devices and compliance with recognized standards. As shown in the
table below the device met the relevant requirements of the applicable
recognized standards. |
| | rSO2 Accuracy Testing |
| | The rSO₂ accuracy was demonstrated through detailed device
comparison and testing showing how the X-100SP is equivalent to the
Model 7600PA pod used with the Model 7600 system regarding rSO2
measurements. The regional sensors are identical to those used with
the 7600PA. The testing shows via the clinical data how the output
from 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 and | ||
| Emissions | IEC 60601-1-2 | Pass |
| Bluetooth Wireless certification | 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 Durability | ISO 80601-2-61 | Pass |
| Atmospheric Pressure | IEC 60601-1 | Pass |
| Usability | IEC 60601-1-6 | Pass |
·
6
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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7
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
8
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.
9
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
10
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
11
1. Indications for Use Statement
K132402 510(K) Number:
Device Name:
Nonin Medical, Inc. Model X-100
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 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
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.
AND/OR -Prescription Use __ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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