Capnograph and Oximeter
Device Facts
| Record ID | K170820 |
|---|---|
| Device Name | Capnograph and Oximeter |
| Applicant | Cmi Health, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Jul 18, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
Indications for Use
The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate. The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
Device Story
Capno-H is a portable monitor for adult patients in hospital settings; measures EtCO2, InsCO2, respiration rate, SpO2, and pulse rate. Inputs: infrared light absorption for CO2 (sidestream) and SpO2 (via peripheral sensors). Device transforms optical absorption data into physiological values using internal processing; includes barometric pressure compensation and automatic zero calibration for CO2. Outputs: numeric values and waveforms on LED/LCD display; includes configurable high/low alarms and nurse call function. Operated by clinical personnel. Benefits: provides continuous airway integrity assessment and vital sign monitoring to assist clinical decision-making.
Clinical Evidence
Bench testing only. Performance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), ISO 80601-2-55 (respiratory gas monitors), and ISO 10993 (biocompatibility). SpO2 module performance validated via predicate K063641. All pre-determined acceptance criteria met.
Technological Characteristics
Portable monitor with LED/LCD display. Materials: ABS plastic (biocompatible per ISO 10993). CO2 sensing: NDIR sidestream module (CapnoCore) with 3-way valve for auto-zeroing and barometric pressure sensor. SpO2 sensing: infrared/red LED module (PC-60). Power: 5VDC adapter or internal 3.6V 3000mAH Li-ion battery. Connectivity: Nurse call interface. Safety: Class I, Type BF, IEC 60601-1 compliant.
Indications for Use
Indicated for non-invasive continuous monitoring of SpO2, pulse rate, CO2, and respiration rate in adult patients in hospital environments under clinical supervision.
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Predicate Devices
- Vital Signs Monitor, Model PC-900A (K093016)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CMI Health Inc. % Charles Mack Principal Engineer International Regulatory Consulting 7808 Rush Creek Drive Pasco, Washington 99301
Re: K170820
Trade/Device Name: Capnograph and Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, CCK Dated: June 16, 2018 Received: June 22, 2018
Dear Charles Mack:
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 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);
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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 comprehensive regulatory information about medical devices and radiation-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.
for
# Todd D. Courtney -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
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## Indications for Use
510(k) Number (if known)
#### K170820
Device Name Capnograph and Oximeter, Capno-H
Indications for Use (Describe)
The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel
Type of Use (Select one or both, as applicable)
| <span></span> | <span></span> |
|------------------------------------------------|-----------------------------------------------|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 18, 2018
Submitter Information
Submitter name Address
CMI Health Inc. 5975 Shiloh Road, Suite 114 Alpharetta, Georgia 30005
Telephone Fax Contact Positon
1-678-389-3280 1-866-222-0128 Mr. Jiacheng Ren Technical Support Manager
US Agent and Correspondent
> Name Address
Mr. Charles Mack 7808 Rush Creek Drive Pasco, Washington 99301
Telephone Email
1931-625-4938 charliemack@irc-us.com
| Subject<br>Device | | Trade Name | Capnograph and Oximeter<br>Model Capno-H |
|-------------------|--|----------------------|------------------------------------------|
| | | Common Name | Oximeter |
| | | Regulation Number | 21 CFR 870.2700 |
| | | Regulation Name | Oximeter |
| | | Regulation Class | Class II |
| | | Product Code | DQA, CCK |
| | | Classification Panel | Anesthesiology |
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| Predicate<br>Device | Trade Name | Vital Signs Monitor, Model PC-900A |
|---------------------|----------------------|------------------------------------|
| | 510(k) Number | K093016 |
| | Common Name | Oximeter |
| | Regulation Number | 21 CFR 870.2700 |
| | Regulation Name | Oximeter |
| | Regulation Class | Class II |
| | Product Code | DQA, CCK |
| | Classification Panel | Anesthesiology |
Purpose of Submission:
This is a new submission of an oximeter and capnograph, Capnograph and oximeter, model Capno-H, submitted by CMI Health Inc. There have been no previous submissions of this product.
Device Description:
This device is used to monitor up to four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor can be purchased having functions with two or more of the parameters mentioned above, but the manual can be used for the device in any configuration.
#### EtCO2
| Method: | Proprietary non-dispersive infrared spectroscopy |
|-----------|--------------------------------------------------|
| Range: | 0 – 150mmHg or 0 – 20kPa or 0 – 19.7% (v/v) |
| Accuracy: | ±2mmHg for EtCO2 range 0 - 40mmHg |
| | ±5% for EtCO2 range from 41 - 70mmHg |
| | ±8% for EtCO2 range from 71 - 100mmHg |
| | Over 100mmHg ±10% |
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#### Respiration Rate
| Range: | 3 - 150 breaths/minute |
|-----------|-----------------------------------------------------------------|
| Accuracy: | $\pm$ 1% of reading or $\pm$ 1 breaths/min whichever is greater |
| Memory: | 24 hours on Screen Trend and Numeric |
### SpO2
| Method: | Patented Proprietary Pulse Oximetry |
|-----------|--------------------------------------|
| Range: | 0- 100% |
| Accuracy: | ±3% for SpO2 range from 70 - 100% |
| Memory: | 24 hours on Screen Trend and Numeric |
## Pulse Rate
| Range: | 30 – 240bpm |
|-----------|----------------------------------------------|
| Accuracy: | ±2% of reading or ±2bpm whichever is greater |
| Memory: | 24 hours on Screen Trend and Numeric |
#### Power
- 100V 250V, 50Hz/60Hz to 5VDC Adapter AC Input: with 5V mini USB adapter Cable.
## Battery
| Type: | Built-in rechargeable lithium battery pack (3.6V, 3000mAH) |
|-----------------|------------------------------------------------------------|
| Charging Time: | 4 hours from full discharge |
| Operating Time: | 10 hours on full charge |
The Capno-H uses an infrared absorption method to measure in a sidestream or Mainstream mode. The measurement parameters are EtCO2, InsCO2 and Respiration Rate. InsCO₂, also called FiO₂ is the fraction of oxygen in the volume being measured. The CO2 response time is Sidestream: <3seconds (includes transport time and rise time) and Mainstream: <60ms (rise time). The unit of measurement is mmHg, kPa or Vol%. The CO2 measurement range is EtCOz: 0~150mmHg and InsCO₂: 3~50mmHg.
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The SpO2 measurements are also determined by infrared absorption. The measurement range is 0-100% at an accuracy of ±3% for SpO2 range from 70 -100% with a pulse rate range of 30-240 bpm at an accuracy of +/- 2bpm or +/- 2% (whichever is greater). For SpO2 and bpm, there are configurable high and low alarms.
Indication for use:
The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
| SUBJECT<br>Indications for Use | PREDICATE<br>(K093016)<br>Indications for Use |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Capnograph and Oximeter is designed for<br>monitoring the vital physiological signs of the<br>patient. It is use for non-invasive continuous<br>monitoring of oxygen saturation (SpO2), pulse<br>rate, CO2 and respiration rate. | The Vital Signs Monitor is designed for monitoring the<br>vital physiological signs of the patient. It is used for<br>non-invasive continuous monitoring of oxygen<br>saturation (SpO2), pulse rate, CO2 and respiration rate. |
| The Capnograph and Oximeter is intended for use<br>in adults in a hospital environment. It is intended<br>to be used only under regular supervision of<br>clinical personnel. | The Vital Signs Monitor is adaptable to adult and<br>pediatric usage in a hospital environment. It is intended<br>to be used only under regular supervision of clinical<br>personnel. |
The summaries of both the submitted Capno-H Capnograph and Oximeter are exactly the same, with a difference in the patient population. The submitted device is intended for use by adults and not pediatric patients. This does not change the intended use.
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Comparison with predicate device:
Both the submitted CMI Health Inc. Capnograph and Oximeter, Model Capno-H and the Shenzhen Creative Industry Co., Ltd, Vital Signs Monitor, Model PC-900A are used for monitoring the vital physiological signs of the patient. Both are used for non-invasive continuous monitoring of oxygen saturation (SpO2). Pulse Rate, CO2 and Respiration Rate.
The submitted device and predicate both are used for continuous monitoring of CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR), utilizing the same technology. Both the submitted device and the predicate device have plastic cases and these have been biocompatibility tested for patient contact.
Technological Characteristics:
The submitted Capno-H utilizes the predicate's SPO2 module for SPO2 functions. For the CO2 function, the Capno-H uses the infrared absorption method with a side stream measurement mode, the same as the predicate. Please refer to the tables on the following pages for specific differences.
At a high level, the submitted Capno-H and the predicate Shenzhen Device serve the same functions:
- Devices are used to measure SPO2, CO2, pulse rate and respiration rate . in adult patients. The submitted Capno-H device is not used for pediatric patients.
- Both devices are portable and use a LED and LCD display to read the ● measured data
- Both devices use the same methodology for measuring SPO2, CO2, pulse rate.
- The submitted device and the predicate device have alarms for EtCO2, ● SPO2 and respiration rate.
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Please refer to the following table for a comparison of specific elements of the predicate device and the submitted device.
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| Element of comparison | Subject Device | Predicate Device | Discussion |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | CMI Health Inc. | Shenzhen Creative Industry Co., Ltd. | N/A |
| FDA510(K) Number | N/A | K093016 | N/A |
| Device Name | Capnograph and Oximeter | Vital Signs Monitor | N/A |
| Model Number | Capno-H | PC-900A | N/A |
| Indications for Use | The Capnograph and Oximeter is designed for<br>monitoring the vital physiological signs of the patient.<br>lt is use for non-invasive continuous monitoring of<br>oxygen saturation (SpO2), pulse rate, CO2 and<br>respiration rate.<br>The Capnograph and Oximeter is adaptable to adult<br>usage in a hospital environment. It is intended to be<br>used only under regular supervision of clinical<br>personnel. | The Vital Signs Monitor is designed for monitoring<br>the vital physiological signs of the patient. It is use<br>for non-invasive continuous monitoring of oxygen<br>saturation (SpO2), pulse rate, CO2 and respiration<br>rate.<br>The Vital Signs Monitor is adaptable to adult and<br>pediatric usage in a hospital environment. It is<br>intended to be used only under regular supervision<br>of clinical personnel. | Identical |
| Power Supply | Battery or AC | Battery or AC | Identical |
| Internal Power Supply | Rechargeable lithium battery, 3.6V 3.0AH | Rechargeable sealed lead-acid battery, 12V 2.3AH | All Comply with IEC requirement |
| AC Power Supply | 100V - 250V, 50Hz/60Hz DC5V<br>Unit Consume:≤5VA | 100-250V 50/60Hz 90VA | Much lower power consumption than the Predicate<br>device, as we adopt chips with lower power<br>consumption and power management circuit with<br>higher efficiency and meanwhile these circuits have<br>passed the test of IEC 60601-1 and IEC 60601-1-2. |
| The type of protection against<br>electric shock | Class I and internally powered per IEC 60601-1. | Class I and internally powered per IEC 60601-1. | Identical |
| The degree of protection<br>against electric shock | Type BF | Type BF | Identical |
## Comparison with Legally Marketed Predicate Device
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| Element of comparison | Subject Device | Predicate Device | Discussion |
|------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Display | LED and LCD display | LED and LCD display | Identical |
| Dimensions(mm) | 72(L) × 40(W) × 155(H) | 360(L) × 320(D) × 410(H) | N/A |
| Intended patient population | Adult patients | Adult, pediatric patients | Identical |
| Nurse call function | Yes | Yes | Identical |
| SpO2 | | | |
| SpO2 module | PC-60 SpO2 module cleared in K063641 | PC-60 SpO2 module cleared in K063641 | Identical.<br>Same SpO2 module as Predicate which the sensors<br>were clinically validated and intended to be used in<br>K063641 |
| SpO2 display range | 0%~100% | 0%~100% | Identical |
| SpO2 measure range for<br>accuracy | 70-100% | 70%~99% | Identical |
| Accuracy of SpO2 | Adult:<br>±3% (during 70%~100%)<br>Undefined (during 0~70%) | Adult and Pediatric:<br>±3% (during 70%~99%)<br>Undefined (during 0~70%) | Identical |
| Alarm of SpO2 | High and lower alarms.<br>The limits are adjustable. | High and lower alarms.<br>The limits are adjustable. | Identical |
| Pulse rate display range | 30 bpm~240 bpm | 30 bpm~240 bpm | Identical |
| Accuracy of pulse rate | ±2bpm or ±2% (whichever is<br>greater) | ±2bpm or ±2% (whichever is<br>greater) | Identical |
| Alarm of pulse rate | High and lower alarms.<br>The limits are adjustable. | High and lower alarms.<br>The limits are adjustable. | Identical |
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| Element of comparison | Subject Device | Predicate Device | Discussion |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation principles | This monitor measures the pulse oxygen saturation<br>(SpO2) and pulse by means of the radiograph of<br>infrared light and the red light emitted by LED<br>through body's peripheral areas (such as fingers),<br>whereby the photoelectric detecting circuits will<br>analyze the absorptivity of the oxyhemoglobin and<br>reduced hemoglobin respectively, and give the photo<br>absorption rates before and after pulsation. Using the<br>measure of photo absorption change due to pulsatory<br>arterial blood flow caused by PLETH waveform, the<br>SpO2 can be obtained. | This monitor measures the pulse oxygen saturation<br>(SpO2) and pulse by means of the radiograph of<br>infrared light and the red light emitted by LED<br>through body's peripheral areas (such as fingers),<br>whereby the photoelectric detecting circuits will<br>analyze the absorptivity of the oxyhemoglobin and<br>reduced hemoglobin respectively, and give the photo<br>absorption rates before and after pulsation. Using<br>the measure of photo absorption change due to<br>pulsatory arterial blood flow caused by PLETH<br>waveform, the SpO2 can be obtained. | Identical |
| CO2 | | | |
| CO2 module | CapnoCore | Respironics LoFlo™ EtCO2 (Side-stream)<br>Module(K053174) and CAPNOSTAT 5 EtCO2<br>(Main-stream) Module(K042601) | N/A |
| CO2 measurement method | Infrared absorption method | Infrared absorption method | Identical |
| Element of comparison | Subject Device | Predicate Device | Discussion |
| CO2 measure mode | Sidestream | Sidestream OR Mainstream | - The Predicate device can use Sidestream<br>OR<br>Mainstream to measure CO2, these two<br>models<br>can not coexist /work at the same time in<br>clinical<br>use and can only choose one way to<br>measure;<br>-The CO2 module of Predicate device is<br>external, but new device is built-in. It<br>doesn't affect the measurement;<br>-The operation principle of Sidestream<br>module is<br>same as Predicate device's;<br>- The new device is complying with<br>ISO80601-2-55 for the Particular<br>requirements for the basic safety and<br>essential performance of respiratory gas<br>monitors same as Predicate device; |
| Measuring parameters | EtCO2, InsCO2 and Respiration Rate | EtCO2, InsCO2 and Respiration Rate | Identical |
| CO2 Response Time | <1second | Sidestream: <3seconds (includes transport time and<br>rise time).<br>Mainstream: <60ms (rise time) | CO2 response time depends on the length of the<br>sample line.<br>If we adopt sampling line with 1.5 meter<br>long, the time of the gas transmission and<br>uprising will be less than 1 seconds, this<br>time is shorter than that of the Predicate<br>device. Response time is the shorter the<br>better. But to monitoring device, the one<br>second difference of response time will not<br>influence the usage effect. |
| Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% | Identical |
| Element of comparison | Subject Device | Predicate Device | Discussion |
| CO2 measure range | EtCO2: 0~150mmHg<br>InsCO2: 3~50mmHg | EtCO2: 0~150mmHg<br>InsCO2: 3~50mmHg | Identical…
