(252 days)
No
The document does not mention AI, ML, deep learning, or any related terms. The technology described is based on a "signal processor" and "SenSmart™ technology platform," which are not indicative of AI/ML. The performance studies focus on standard accuracy metrics for oximetry.
No
The device is intended for noninvasive measuring of functional oxygen saturation, carboxyhemoglobin saturation, and pulse rate, serving diagnostic or monitoring purposes rather than direct treatment or therapy.
Yes
The device is described as "noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate." This involves measuring physiological parameters to provide information about a patient's health status, which is a diagnostic function. Although it's stated "This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms," it still contributes to the diagnostic process by providing quantitative measurements.
No
The device description explicitly states it is a "Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor". This indicates the device includes a physical sensor component, making it a hardware and software system, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for noninvasive measuring of physiological parameters (%SpO2, %COHb, and pulse rate) directly from the patient's finger. IVDs, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body).
- Device Description: The description confirms it's a noninvasive system using a finger clip sensor.
- Testing: While the accuracy testing compares the device's readings to arterial blood samples analyzed by a co-oximeter (which is an in vitro method), the device itself is not performing the in vitro analysis. It's a noninvasive measurement being validated against an in vitro standard.
Therefore, this device falls under the category of a noninvasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.
Product codes
DOA
Device Description
Nonin Medical's Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor, is based on Nonin's SenSmart™ technology platform, displays (%COHb), pulse oxygen saturation (%SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of a signal processor to the monitor. The model 8330AA sensor provides real time data output of COHb, SpO2, and PR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients (> 66 lbs/30 kg).
Intended User / Care Setting
Professional healthcare facilities, mobile, and EMS settings.
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
COHb Accuracy Testing: conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 95 - 100% SaO2.
COHb Accuracy Testing with Elevated HHb (Deoxyhemoglobin): conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 80 - 100% SaO2.
SpO2 Accuracy Testing in Presence of COHb: conducted during no-motion conditions at an independent research laboratory, during induced hypoxia studies on healthy, male and female, non-smoking, light-to dark-skinned subjects that were 18 years of age and older. The measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO2 range of 70-100%, range 0-3% COHb and 80 – 100%, range 0 – 15% COHb. Testing was also conducted over the SpO2 range of 70-100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Nonin Model 8330AA sensor when used with Multi-Sensing Oximetry System is supported by electrical safety testing, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices.
Testing types and results:
- Strain Relief Pull Strength: Pass
- Operating Temp & Humidity: Pass
- Thermal Shock: Pass
- Drop & Swing (Free Fall): Pass
- ESU Interference: Pass
- Defib Proof: Pass
- Storage & Transport Tempo & Humidity: Pass
- Dielectric Strength, Patient Leakage Current, Pre-conditioning: Pass
- Excessive Temp: Pass
- Hyperbaric Pressure: Pass
- Sensor Image SW V&V: Pass
- CoHb Clinical Study: Pass
- SpO2 Clinical Study: Pass
- Pulse Rate Testing: Pass
key results:
The proposed Model 8330AA Sensor meets all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8330AA when used with Nonin Medical's Multi-Sensing Oximetry System is substantially equivalent to the predicate device for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
COHb Accuracy Testing: Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
COHb Accuracy Testing with Elevated HHb (Deoxyhemoglobin): Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
SpO2 Accuracy Testing in Presence of COHb: Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment— Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Accuracy table:
- Carboxyhemoglobin Accuracy (Adults, Pediatrics):
- ±3 Arms (COHb range of 0-15%, SaO2 95-100%)
- ±3 Arms (COHb range of 0-5%, SaO2 95-100%)
- ±2 Arms (COHb range of 5-10%, SaO2 95-100%)
- ±2 Arms (COHb range of 10-15%, SaO2 95-100%)
- Carboxyhemoglobin Accuracy with elevated HHb (Adults, Pediatrics):
- ±3 Arms (COHb range of 0-15%, SaO2 80-100%)
- ±3 Arms (COHb range of 0-5%, SaO2 80-100%)
- ±2 Arms (COHb range of 5-10%, SaO2 80-100%)
- ±3 Arms (COHb range of 10-15%, SaO2 80-100%)
- Oxygen Saturation (SpO2) with elevated Carboxyhemoglobin (Adults, Pediatrics):
- ±2 Arms (COHb range of 0-3%, SaO2 70-100%)
- ±3 Arms (COHb range of 0-3%, SaO2 70-80%)
- ±2 Arms (COHb range of 0-3%, SaO2 80-90%)
- ±2 Arms (COHb range of 0-3%, SaO2 90-100%)
- Pulse Rate Accuracy non-motion (Adults, Pediatrics): ±3 digits (40-250 bpm)
Predicate Device(s):
Model X-100C System with Model 8300AA Sensor (K160231)
Reference Device(s):
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2018
Nonin Medical Inc. Kim Aves Principal Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K172625
Trade/Device Name: Multi-Sensing Oximetry System with Model 8330AA Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: April 3, 2018 Received: April 9, 2018
Dear Kim Aves:
We have reviewed vour 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.
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172625
Device Name
Multi-Sensing Oximetry System with Model 8330AA Sensor
Indications for Use (Describe)
The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms.
· For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg).
· For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
5. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 763 577 3196 |
| Fax: | 763 553 7807 |
| Contact Person: | Kim E. Aves
Principal Regulatory Affairs Specialist |
| Date Prepared: | 10 May, 2018 |
| Trade Names: | Multi-Sensing Oximetry System with Model 8330AA Sensor |
| Common Name: | Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Model X-100C System with Model 8300AA Sensor (K160231) |
| | The Model 8300AA reusable finger clip sensor is intended for noninvasive
measuring of functional oxygen saturation of arterial hemoglobin
(%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate of
adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be
multiple spot-checks to observe change and/or continuous monitoring. It
is intended for use in Emergency Medical Service (EMS), hospitals,
medical facilities, and mobile environments. This device is not meant for
sole use in clinical decision making; it must be used in conjunction with
additional methods of assessing clinical signs and symptoms. |
| Device Description: | Nonin Medical's Multi-Sensing Oximetry system, when used with Model
8330AA reusable finger clip sensor, is based on Nonin's SenSmart™
technology platform, displays (%COHb), pulse oxygen saturation (%SpO2),
and pulse rate (PR) data transmitted from one channel of data through a
direct connection of a signal processor to the monitor. The model
8330AA sensor provides real time data output of COHb, SpO2, and PR. |
| Intended Use: | Multi-Sensing Oximetry System with 8330AA Sensor |
| | The Multi-Sensing Oximetry System when used with Model 8330AA
sensor, is intended for noninvasive measuring of functional oxygen
saturation of arterial hemoglobin ( $%SpO2$ ), carboxyhemoglobin
saturation ( $%COHb$ ), and pulse rate. The measurements may be multiple
spot-checks to observe change and/or continuous monitoring. This
device is not meant for sole use in clinical decision making; it must be
used in conjunction with additional methods of assessing clinical signs
and symptoms. |
| | • For $%SpO2$ and pulse rate, the multi-sense system is intended for use
in professional healthcare facilities, mobile, and EMS settings in adult and
pediatric patients (> 66 lbs/30 kg). |
| | • For $%COHb$ , the multi-sense system is intended for use in professional
healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This
device should not be used to screen, diagnose or make treatment
decisions related to suspected carbon monoxide poisoning. |
| Testing: | The Nonin Model 8330AA sensor when used with Multi-Sensing
Oximetry System is supported by electrical safety testing,
electromagnetic compatibility, device performance, and clinical testing
to ensure appropriate functionality and to demonstrate substantial
equivalence to the predicate devices. |
| Functional Testing: | The results of the testing demonstrate equivalency with the predicate
devices and compliance to current recognized standards. Table 1
summarizes test results for the proposed devices, which met the relevant |
4
| Table 1 | ||
|---|---|---|
| Test | Reference | Results |
| Strain Relief Pull Strength | Internal | Pass |
| Operating Temp & Humidity | IEC 60601-1:2005 Sub-Clause 7.9.3.1, | |
| EN1789:2007 Sub-clause 6.3.2 | ||
| IEC 60601-1-11:2010 Sub-clause 4.2.2. | Pass | |
| Thermal Shock | IEC 60601-1-11:2010 Sub-clause 4.2.3 | Pass |
| Drop & Swing | ||
| (Free Fall) | IEC 60601-1:2005 Sub-clauses 15.3.4.1 and 15.3.4.2 | |
| ISO 80601-2-61:2011 Sub-Clause 201.15.3.5.101.2 | ||
| IEC 60601-1-11:2010 Sub-clause 10.1.3 | ||
| IEC 60601-1-12:2014 Sub-clause 10.1.3 | ||
| EN 1789:2007 Sub-clause 6.4.2 | Pass | |
| ESU Interference | ANSI/AAMI EC 13:2002/(R) 2007 | Pass |
| Defib Proof | IEC 60601-1:2005 Clause 8.5.5 | Pass |
| Storage & Transport Tempo & Humidity | IEC 60601-1-11:2010 Sub-clause 4.2.1 & 4.2.2 | |
| IEC 60601-1-12 Sub-clause 4.2.1 & 4.2.2 | ||
| IEC60601-1:2005/Al:2012 Sub-clause 7.9.3.1 | Pass | |
| Dielectric Strength, Patient Leakage | ||
| Current, Pre-conditioning | IEC 60601-1:2005 Sub-clause 5.7, 6.3 8.7 & 8.8.3 | Pass |
| Excessive Temp | IEC 60601-1:2005 Sub-clause 11.1.2 | Pass |
| Hyperbaric Pressure | Internal | Pass |
requirements of the applicable recognized standards.
5
| Sensor Image SW V&V | FDA 938:2002
IEC 62304:2008 | Pass |
|---------------------|-----------------------------------|------|
| CoHb Clinical Study | ISO 14155
ISO 80601-2-61 (REF) | Pass |
| SpO2 Clinical Study | ISO 14155
ISO 80601-2-61 (REF) | Pass |
| Pulse Rate Testing | ISO 80601-2-61 (REF) | Pass |
Accuracy (clinical) testing:
COHb Accuracy Testing
COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 95 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
COHb Accuracy Testing with Elevated HHb (Deoxyhemoglobin)
COHb accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
The measured carboxyhemoglobin value (%COHb) of the sensors was compared to simultaneous arterial blood samples as assessed by cooximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the COHb range of 0-15% with 80 - 100% SaO2. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment.
SpO2 Accuracy Testing in Presence of COHb
During no-motion conditions at an independent research laboratory, SpO2 accuracy testing in the presence of COHb was conducted during induced hypoxia studies on healthy, male and female, non-smoking, lightto dark-skinned subjects that were 18 years of age and older.
6
| The measured arterial hemoglobin saturation value (SpO₂) of the sensors |
|---|
| was compared to arterial hemoglobin oxygen (SaO₂) value, determined |
| from blood samples with a laboratory co-oximeter. |
The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO₂ range of 70-100%, range 0-3% COHb and 80 – 100%, range 0 – 15% COHb. Testing was also conducted 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, Medical Electrical Equipment— Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Testing conclusion: The proposed Model 8330AA Sensor meets all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8330AA when used with Nonin Medical's Multi-Sensing Oximetry System is substantially equivalent to the predicate device for its intended use.
| Summary of
Substantial
Equivalence: | The Model 8330AA Sensor has the following similarities to the predicate devices:
• Similar indications for use - different wording, same indications
• Similar intended use environments
• Identical patient population
• Same primary mode of operation
• Performs equivalently to the similar specifications
A comparison table is on the following pages. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The proposed system is substantially equivalent to the predicate |
system.
7
Page 5 of 8
K172625 Comparison of Proposed Multi-Sensing Oximetry System with Model 8330AA Sensor to Predicate, Model X-100C CO-Met Oximetry System with Model 8300AA
| CATEGORY | Identical/
Similar/
Different | Model X-100C CO-Met Oximetry System
Multi-Sensing Oximetry System
With Model 8330AA Sensor (Proposed) | Model X-100C System
With Model 8300AA Sensor (Predicate) |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | | |
| System | Similar – The
indications
are differently
worded for
clarification of
intended use
environments.
The subject
device also
does not have
MetHb
functionality. | The Multi-Sensing Oximetry System with the Model 8330AA
reusable finger clip sensor is intended for noninvasive measuring
of functional oxygen saturation of arterial hemoglobin (%SpO2),
carboxyhemoglobin saturation (%COHb), and pulse rate. The
measurements may be multiple spot-checks to observe change
and/or continuous monitoring. This device is not meant for sole
use in clinical decision making; it must be used in conjunction
with additional methods of assessing clinical signs and
symptoms.
• For %SpO2 and pulse rate, the 8330AA is intended for use in
professional healthcare facilities, mobile, and EMS settings in
adult and pediatric patients (> 66 lbs/30 kg).
• For %COHb, the 8330AA is intended for use in professional
healthcare facilities settings in adult and pediatric patients (> 66
lbs/30 kg). This device should not be used to screen, diagnose or
make treatment decisions related to suspected carbon monoxide
poisoning.
Rxonly CAUTION: Federal law (USA) restricts this device to sale
by or on the order of a licensed practitioner. | Nonin's X-100C System is indicated for noninvasive spot-
checking and/or continuous monitoring of
Carboxyhemoglobin (COHb), Methemoglobin (MetHb),
functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate of adult and pediatric patients using the
8300AA sensor.
The X-100C System is indicated for use by trained personnel
in clinical and non-clinical settings, including Emergency
Medical Service (EMS), hospitals, medical facilities, mobile
environments, and home healthcare.
Rxonly CAUTION: Federal law (USA) restricts this device to
sale by or on the order of a licensed practitioner. |
| Oxygen Saturation
Range (%SpO2) | Identical | 0-100% | 0-100% |
| Carboxyhemoglobin
Saturation Range | Identical | 0-99% (%COHb) | 0-99% (%SpCO) |
| Methemoglobin
Saturation Range | Different –
Subject
devices does
not include
MetHb
measurement | N/A | 0-99.9% (%SpMet) |
| Pulse Rate Display
Range | Identical | 18-321 beats per minute (bpm) | 18-321 beats per minute (bpm) |
| K172625
Page 6 of 8 | | | |
| CATEGORY | Identical/
Similar/
Different | Multi-Sensing Oximetry System
With Model 8330AA Sensor (Proposed) | Model X-100C System
With Model 8300AA Sensor (Predicate) |
| Accuracy | | | |
| Oxygen Saturation
(%SpO₂) non-motion | Identical | Refer to Oxygen Saturation (SpO₂) with elevated
Carboxyhemoglobin and Oxygen Saturation (SpO₂) | Refer to Oxygen Saturation (SpO2) with elevated
Carboxyhemoglobin and Oxygen Saturation (SpO2) with
elevated Methemoglobin |
| Carboxyhemoglobin
Accuracy | Similar | Adults, Pediatrics
• ±3 Arms (COHb range of 0-15%, SaO₂ 95-100%)
• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)
• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)
• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) | Adults, Pediatrics
• ±2 Arms (COHb range of 0-15%, SaO₂ 95-100%)
• ±3 Arms (COHb range of 0-5%, SaO₂ 95-100%)
• ±2 Arms (COHb range of 5-10%, SaO₂ 95-100%)
• ±2 Arms (COHb range of 10-15%, SaO₂ 95-100%) |
| Carboxyhemoglobin
Accuracy with
elevated HHb | Similar | Adults, Pediatrics
• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)
• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)
• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)
• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) | Adults, Pediatrics
• ±3 Arms (COHb range of 0-15%, SaO₂ 80-100%)
• ±3 Arms (COHb range of 0-5%, SaO₂ 80-100%)
• ±2 Arms (COHb range of 5-10%, SaO₂ 80-100%)
• ±3 Arms (COHb range of 10-15%, SaO₂ 80-100%) |
| Oxygen Saturation
(SpO₂) with elevated
Carboxyhemoglobin | Similar | Adults, Pediatrics
• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)
• ±3 Arms (COHb range of 0-3%, SaO₂ 70-80%)
• ±2 Arms (COHb range of 0-3%, SaO₂ 80-90%)
• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) | Adults, Pediatrics
• ±2 Arms (COHb range of 0-3%, SaO₂ 70-100%)
• ±2 Arms (COHb range of 0-3%, SaO₂ 70-80%)
• ±3 Arms (COHb range of 0-3%, SaO₂ 80-90%)
• ±2 Arms (COHb range of 0-3%, SaO₂ 90-100%) |
| Pulse Rate Accuracy | | | |
| Pulse Rate Accuracy
non-motion | Identical | Adults, Pediatrics: ±3 digits (40-250 bpm) | Adults, Pediatrics: ±3 digits (40-250 bpm) |
| Electrical | | | |
| Standalone
• AC Power
Requirements
• Power
consumption
• Fuses | Identical | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz |
| Batteries
• Type
• Capacity
• Charging Time | Identical | 7.2 volt Li-ion battery pack, 2.4 Ah when charged
6 hours¹
2.5 hours | 7.2 volt Li-ion battery pack, 2.4 Ah when charged
6 hours¹
2.5 hours |
| K172625
Page 7 of 8 | | | |
| CATEGORY | Identical/
Similar/
Different | Multi-Sensing Oximetry System
With Model 8330AA Sensor (Proposed) | Model X-100C System
With Model 8300AA Sensor (Predicate) |
| Environmental | | | |
| Operating
Temperature | Identical | 32 °F to 104 °F (0 °C to 40 °C) | 32 °F to 104 °F (0 °C to 40 °C) |
| Storage/Transport
Temperature | Identical | -22 °F to 158 °F (-30 °C to 70 °C) | -22 °F to 158 °F (-30 °C to 70 °C) |
| Operating Humidity | Identical | 15% to 93%, noncondensing | 15% to 93%, noncondensing |
| Storage/Transport
Humidity | Identical | Up to 93%, noncondensing | Up to 93%, noncondensing |
| Operating Altitude | Identical | 0 to 4,000 meters (0 to 13,124 feet) | 0 to 4,000 meters (0 to 13,124 feet) |
| Physical | | | |
| Characteristics | | | |
| Dimensions | Identical | Multi-Sensing Monitor
• 305 mm W x 180 mm H x 130 mm D (12.0" W x 7.2" H x
5.0" D)
X-100SPMM
• 21.4 mm H x 21.7 mm W x 72.7 mm L (including strain
relief) with 0.75 m cable
(0.84" H x 0.85" W x 3.1" L (including strain relief) with
2.5 ft cable) | X-100MM
• 305 mm W x 180 mm H x 130 mm D (12.0" W x 7.2"
H x 5.0" D)
X-100SPMM
• 21.4 mm H x 21.7 mm W x 72.7 mm L (including
strain relief) with 0.75 m cable
(0.84" H x 0.85" W x 3.1" L (including strain relief)
with 2.5 ft cable) |
| Weight | Identical | Multi-Sensing Monitor
• Approximately 900 grams (2 pounds)
X-100SPMM
• 40 grams (1.4 ounces) | X-100MM
• Approximately 900 grams (2 pounds)
X-100SPMM
• 40 grams (1.4 ounces) |
| Trending | Identical | Not specified | Not specified |
| Memory | Identical | Minimum of 280 hours | Minimum of 280 hours |
| SpO₂ Averaging | Identical | 6 seconds | 6 seconds |
| Display/Indicators | Identical | %SpO₂, %COHb, pulse rate, pleth waveform, alarm status, status
messages, sensor fault, poor signal indicator, signal processor
communication error, visual alarm indicator, alarm silence,
Bluetooth, battery indicator and date and time. | %SpO₂, %COHb, %MetHb, pulse rate, pleth waveform, alarm
status, status messages, sensor fault, poor signal indicator,
signal processor communication error, visual alarm indicator,
alarm silence, Bluetooth, battery indicator and date and
time. |
| Display Update Rate | Identical | 2-5 seconds, typically 1 Fully charged battery and screen at default brightness
9
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