(326 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on signal processing and display of data, not AI/ML algorithms.
No
The device measures and monitors physiological parameters (%SpO2, %COHb, %MetHb, pulse rate) but does not provide treatment or directly alleviate a condition. Its output is for clinical decision-making when combined with other assessments, rather than being a therapeutic intervention itself.
Yes
The device is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin, carboxyhemoglobin saturation, methemoglobin saturation, and pulse rate, which are all measurements used to assess a patient's physiological state and contribute to diagnosis.
No
The device description explicitly mentions a "signal processor" and a "monitor" which are hardware components. The system also includes a "reusable finger clip sensor" (Model 8300AA). Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, a disease or to monitor therapeutic measures.
- Device Function: The Model X-100C CO-Met Oximetry System and its sensor measure parameters noninvasively from the patient's finger. It measures functional oxygen saturation, carboxyhemoglobin saturation, methemoglobin saturation, and pulse rate directly from the body.
- No Specimen Examination: The device does not examine specimens (like blood or tissue) in vitro (outside the body).
Therefore, because the device performs its measurements directly on the patient's body and does not involve the examination of specimens in a laboratory setting, it does not fit the definition of an In Vitro Diagnostic. It is a non-invasive patient monitoring device.
N/A
Intended Use / Indications for Use
The Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including 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.
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), 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.
Product codes
DQA
Device Description
The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, 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
Trained personnel in clinical settings, including Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments.
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 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 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.
MetHb 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 methemoglobin value (%MetHb) 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 measured over the MetHb 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.
During no-motion conditions at an independent research laboratory, SpO2 accuracy testing was conducted 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 witha laboratory co-oximeter. The accuracy of the sensors in comparison tothe 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, Medical Electrical Equipment— Particular requirements for basic safety and essential performance of pulse oximeter equipment.
During no-motion conditions at an independent research laboratory, SpO2 accuracy testing in the presence of COHb and MetHb was conducted 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 measured over the SpO2 range of 80 - 100%, range 0 - 15% COHb and SpO2 range of 80 – 100%, range 0 – 15% MetHb. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Nonin Model X-100C and 8300AA sensors are supported by electrical and mechanical safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Model X-100 system. The results of the testing demonstrate equivalency with the predicate. The proposed Model X-100C CO-Met Oximetry System meets all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model X-100C CO-Met Oximetry System performance is substantially equivalent to the predicate device for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy data was calculated using the root-mean-squared (Arms value).
Predicate Device(s)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
Nonin Medical, Inc. Kim Aves Principal Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K160231
Trade/Device Name: Model X-100C CO-Met™ Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 28, 2016 Received: December 1, 2016
Dear Kim Aves:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
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Indications for Use
510(k) Number (if known) K160231
Device Name
Model X-100C CO-Met™ Oximetry System
Indications for Use (Describe)
Model X-100C
Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including 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.
Model 8300AA
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), 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.
| 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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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: | January 29, 2016; Revised December 22, 2016 |
| Trade Names: | Model X-100C CO-Met™ Oximetry System |
| Common Name: | Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | DQA, Anesthesiology |
| Predicate Device(s): | Masimo Rainbow SET Radical 7 Pulse CO-Oximeter, K061204 |
| | Device Description: The Masimo Rainbow SET® Radical 7 Pulse CO-
Oximeter (Radical 7) with Rainbow technology allows for noninvasive
monitoring of arterial oxygen saturation (%SpO2), pulse rate,
carboxyhemoglobin saturation (%SpCO), and/or methemoglobin
saturation (%SpMet). The Radical 7 features an LCD display that
continuously displays numeric values for %SPO2 and pulse rate. Other
information displayed by the Radical 7 include: %SpCO and/or %SpMet,
Low Signal IQ (Low SIQ), Perfusion Index (PI), alarm status, alarm
silence, battery life, sensor status, trends, and pleth waveform. The
Radical 7 has output interfaces including SatShare connection to multi- |
The Radical 7 is intended to be used with Masimo LNOP series of oximetry sensors, LNCS series of oximetry sensors, and patient cables. The Radical 7 is also intended to be used with Masimo Rainbow (SpCO/SpMet) sensors and Rainbow patient cables, cleared under K061204 (July 27, 2006.)
parameter monitors, Nurse Call analog output, and RS-232 serial output.
Radical 7 Indications for Use (as cleared under K061204)
The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02), pulse rate (measured by an SP0 2 sensor), carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both
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no motion and motion conditions, and for patients who are well or poorly perfused in hospitals. hospital-tvpe facilities, mobile, and home environments. In addition, the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (Sp0-) and pulse rate (measured by an Sp0- sensor) to multiparameter devices for the display of those devices.
Device Description: The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, SpO2, and PR.
Intended Use: Model X-100C
Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. 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, 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.
Model 8300AA
The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), 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.
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Comparison of Intended Use (Indications for Use)
| Radical 7 | X-100C | Comment |
|---|---|---|
| Continuous monitoring | Multiple spot-checks to observe change and/or continuous monitoring | Multiple spot-checks to observe change is a form of monitoring. |
| Adult, pediatric and neonatal patients | Adult and pediatric | Nonin is not seeking clearance for X-100C in the neonate population. The Radical 7 applied part labeling indicates neonate use for SpO2 and pulse rate only. |
| Intended use does not specify patient size, weight or age | Nonin specifies patient population based on weight (>66 lbs./30kg) | The X-100C clarifies the use population regarding appropriate fit of the applied part, to ensure accuracy of measurements. |
| Does not specify user qualifications | For use by trained personnel | The X-100C is meant to be used by trained healthcare professionals to ensure proper use of the device and understanding of the display values. The X-100C is meant to be used in conjunction with additional methods of assessing clinical signs and symptoms. |
| Motion and no motion conditions | Nonin is not seeking motion claims for any parameters | The Radical 7 labeling indicates motion and no motion specific to SpO2 and pulse rate only. The X-100C is meant to be used in conjunction with additional methods of assessing clinical signs and symptoms. |
| Poorly perfused patients | Nonin is not seeking low perfusion claims | The Radical 7 labeling indicates poor perfusion specific to SpO2 and pulse rate only. The X-100C is meant to be used in conjunction with additional methods of assessing clinical signs and symptoms. |
| Hospitals, hospital-type facilities, mobile, and home environments. | Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. | The X-100C is intended for use by trained healthcare professionals, not the lay or home user who are not trained in the proper use of the device and/or understanding of the display values. |
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Testing: The Nonin Model X-100C and 8300AA sensors are supported by electrical and mechanical safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Model X-100 system. Table 1 summarizes the technological characteristics of the proposed device and the predicate device.
| CATEGORY | Identical/Similar/
Different | Model X-100C System
(Subject) | Radical-7™ K061204
(Predicate) |
|-------------------------------------------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Standalone
• AC Power
Requirements
• Power
consumption
• Fuses | Different | 100-240 VAC, 50-60 Hz | 100-240 VAC, 47-63 Hz
55 VA
1 Amp, Fast Acting, Metric,
(5x20mm), 250V |
| Batteries
• Type
• Capacity
• Charging Time | Different | 7.2 volt Li-ion battery pack, 2.4 Ah
when charged | NiMH (Handheld and docking
station) |
| | | 6 hours1 | 4 hours2 (Handheld)
10 hours3 (Docking station)
3 hours (Handheld)
6 hours (Docking station) |
| | | 2.5 hours | |
| Environmental
Operating
Temperature | Similar | 32 °F to 104 °F (0 °C to 40 °C) | 41 °F to 104 °F (5 °C to 40 °C) |
| Storage/Transport
Temperature | Similar | -22 °F to 158 °F (-30 ºC to 70 ºC) | -40 °F to 158 °F (-40 °C to 70 °C) |
| Operating Humidity | Similar | 15% to 93%, noncondensing | 5% to 95%, noncondensing |
| Storage/Transport
Humidity | Different | Up to 93%, noncondensing | Not specified |
| Operating Altitude | Different | 0 to 4,000 meters (0 to 13,124 feet) | -304 to 5,486 meters (-1,000 to
18,000 feet) |
| Physical Characteristics
Dimensions | Different | 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) | Handheld
• 8.9" x 3.3' x 2.1" (22.6 cm x
8.4 cm x 5.3 cm)
Standalone
• 3.5" x 10.5" x 7.7" (8.9 cm x
26.7 cm x 19.6 cm) |
| CATEGORY | Identical/Similar/
Different | Model X-100C System
(Subiect) | Radical-7 ™ K061204
(Predicate) |
| Weight | Different | X-100MM
• Approximately 900 grams (2 pounds)
X-100SPMM
• 40 grams (1.4 ounces) | Handheld: 1.3 lbs. (0.59 kg)
Docking station (RDS-1, RDS-2, RDS-3):
• 2.5 lbs. (1.14 kg)
Docking station (RDS-1B)
• 4.11 lbs. (1.86 kg)
Standalone (RDS-1, RDS-2, RDS-3)
• 3.8 lbs. (1.73 kg)
Standalone (RDS-1B)
• 5.4 lbs. (2.45 kg) |
| Trending | Different | Not specified | 72 hours of trending at 2 second
resolution, up to 18 days of
trending at 10 second resolution,
output to serial printer or other
serial devices. |
| SpO2 Averaging | Similar | 6 seconds | 2, 4, 8, 10, 12, 14, or 16 seconds4 |
| Display/Indicators | Similar | %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. | %SpO2, %SpCO, %SpMet,
pulserate, pleth waveform,
alarm status, trends, status
messages,battery status, visual
alarm indicator, Signal IQ,
perfusion index, pleth variability
index, APOD and FastSat. |
| Display Update
Rate | Similar | 2-5 seconds, typically