(485 days)
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.
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.
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: 0150mmHg and InsCO₂: 350mmHg.
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.
The provided text describes the acceptance criteria and study for the CMI Health Inc. Capnograph and Oximeter, Model Capno-H (K170820).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for performance are primarily based on equivalence to a predicate device (Shenzhen Creative Industry Co., Ltd, Vital Signs Monitor, Model PC-900A, K093016) and compliance with various international standards. The document explicitly states: "All of the pre-determined acceptance criteria were met."
| Parameter / Standard | Acceptance Criteria (Predicate / Standard Requirement) | Reported Device Performance (Capno-H) |
|---|---|---|
| EtCO2 | ||
| EtCO2 Range | 0 – 150mmHg or 0 – 20kPa or 0 – 19.7% (v/v) (from predicate) | 0 – 150mmHg or 0 – 20kPa or 0 – 19.7% (v/v) |
| EtCO2 Accuracy (0-40 mmHg) | ±2mmHg (from predicate) | ±2mmHg |
| EtCO2 Accuracy (41-70 mmHg) | ±5% of reading (from predicate) | ±5% of reading |
| EtCO2 Accuracy (71-100 mmHg) | ±8% of reading (from predicate) | ±8% of reading |
| EtCO2 Accuracy (101-150 mmHg) | ±10% of reading (from predicate) | ±10% of reading |
| Respiration Rate | ||
| Respiration Rate Range | 3-150 breaths/minute (from device description) / 2-150rpm (Sidestream) or 0-150rpm (Mainstream) (from predicate) | 3-150 breaths/minute |
| Respiration Rate Accuracy | ±1% of reading or ±1 breaths/min whichever is greater (from device description) / ±2rpm (from predicate) | ±1% of reading or ±1 breaths/min whichever is greater |
| SpO2 | ||
| SpO2 Range | 0-100% (from predicate) | 0-100% |
| SpO2 Accuracy (70-100%) | ±3% (for SpO2 range from 70-100%) (from predicate) | ±3% (for SpO2 range from 70-100%) |
| Low Perfusion Accuracy (SpO2 and PR) | Accuracy meets precision described above when modulation amplitude is as low as 0.6% (from predicate's SpO2 module) | Accuracy meets precision described above when modulation amplitude is as low as 0.6% (Capno-H uses the same SpO2 module, K063641) |
| Pulse Rate | ||
| Pulse Rate Range | 30-240 bpm (from predicate) | 30-240 bpm |
| Pulse Rate Accuracy | ±2bpm or ±2% (whichever is greater) (from predicate) | ±2bpm or ±2% (whichever is greater) |
| Safety and Performance Standards Compliance | ||
| IEC 60601-1: General requirements for safety | Testing complete, complies (predicate) | Testing complete, complies |
| IEC 60601-1-2: EMC requirements | Testing complete, complies (predicate) | Testing complete, complies |
| IEC 60601-1-8: Alarm systems | Testing complete, complies (predicate) | Testing complete, complies |
| ISO 80601-2-55 (Respiratory Gas Monitors) | Compliance with ISO 21647:2004 (predicate) or ISO 80601-2-55 | Tested to ISO 80601-2-55, Complies |
| ISO 10993-1: Biocompatibility (principles) | Testing regimen developed (predicate) | Testing regimen developed |
| ISO 10993-5: Biocompatibility (in vitro cytotoxicity) | Testing complete, complies (predicate) | Testing complete, complies |
| ISO 10993-10: Biocompatibility (irritation/sensitization) | Testing complete, complies (predicate) | Testing complete, complies |
| ISO 9919 (Pulse Oximeters) | Utilizes an FDA approved SpO2 device (predicate, K063641) | Testing complete, complies (SpO2 component previously cleared under K063641) |
| EN 61000-3-2: Harmonic Current Emissions | Not explicitly stated for predicate but implied acceptance is to comply with standard | Testing complete, complies |
| EN 61000-3-3: Voltage Changes/Fluctuations | Not explicitly stated for predicate but implied acceptance is to comply with standard | Testing complete, complies |
| FDA Guidance for Software in Medical Devices | Used as guidance in development (predicate) | Used as guidance in development |
| IEC 60601-1-4: Programmable Electrical Medical Systems | Used as guidance in development, testing performed to prove V&V (predicate) | Used as guidance in development, testing performed to prove V&V |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify human clinical trials or a "test set" in the context of diagnostic accuracy for the entire device. The performance data for SpO2 and CO2 accuracy are stated as ranges and thresholds without detailing specific patient data used for testing.
- SpO2 module: The document states that the Capno-H uses the "PC-60 SpO2 module cleared in K063641" and that "the sensors were clinically validated and intended to be used in K063641." This implies that the clinical validation for SpO2 accuracy was conducted as part of the K063641 submission, not for the current device directly. The provenance of that original SpO2 clinical validation data (K063641) is not provided in this document.
- CO2 module: The CO2 accuracy is presented as fixed ranges (e.g., ±2mmHg for 0-40mmHg). It mentions compliance with ISO 80601-2-55 (which governs respiratory gas monitors) and that the CO2 module (CapnoCore) uses the non-dispersive infrared gas (NDIR) technology. However, no specific details about a clinical test set (sample size, provenance) for CO2 accuracy are provided in this document for either the Capno-H or its CapnoCore module.
- Type of Study: The primary "study" described is a comparison to a predicate device and compliance with established performance and safety standards. This is a bench and engineering testing-based assessment rather than a typical clinical study with a specified "test set" of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a clinical study where experts established ground truth for a test set. The accuracy claims are numerical specifications that are likely verified through device calibration and bench testing against known gas concentrations or established reference devices/methods for SpO2.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oximeter and capnograph, not an AI-powered diagnostic imaging device involving human readers or interpretation of complex medical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device appears to be a standalone measurement device. Its performance specifications (e.g., SpO2 accuracy, EtCO2 accuracy) are inherently "standalone" in that they describe the device's direct measurement capability, without an AI component or complex human-in-the-loop interaction in its core function of displaying vital signs. The device is intended for "regular supervision of clinical personnel," but this refers to its clinical use, not the intrinsic performance validation of the measurement algorithms.
7. The Type of Ground Truth Used
The ground truth for the performance specifications (EtCO2, SpO2, Pulse Rate, Respiration Rate) would have been established using:
- Reference Standards/Known Concentrations: For CO2 accuracy, gas mixtures with precisely known CO2 concentrations would be used in bench testing.
- Reference Oximeters/Co-oximeters: For SpO2 accuracy, reference co-oximeters are typically used (e.g., during induced hypoxia studies) to establish arterial oxygen saturation (SaO2) values for comparison. The document clearly refers to "clinically validated" sensors in the SpO2 module (from K063641), implying such studies occurred for that module.
- Controlled Measurements: For pulse rate and respiration rate, comparison with ECG or manual counts, or simulated physiological signals, would likely be the ground truth.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device, not an AI/machine learning algorithm that requires a "training set." The device's algorithms for calculating SpO2, CO2, etc., are based on established physiological principles and signal processing, not on training data in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI algorithm.
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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)
| ☑ 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
| SubjectDevice | Trade Name | Capnograph and OximeterModel 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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| PredicateDevice | 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: 0150mmHg and InsCO₂: 350mmHg.
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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.
| SUBJECTIndications for Use | PREDICATE(K093016)Indications for Use |
|---|---|
| The Capnograph and Oximeter is designed formonitoring the vital physiological signs of thepatient. It is use for non-invasive continuousmonitoring of oxygen saturation (SpO2), pulserate, CO2 and respiration rate. | The Vital Signs Monitor is designed for monitoring thevital physiological signs of the patient. It is used fornon-invasive continuous monitoring of oxygensaturation (SpO2), pulse rate, CO2 and respiration rate. |
| The Capnograph and Oximeter is intended for usein adults in a hospital environment. It is intendedto be used only under regular supervision ofclinical personnel. | The Vital Signs Monitor is adaptable to adult andpediatric usage in a hospital environment. It is intendedto be used only under regular supervision of clinicalpersonnel. |
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 formonitoring the vital physiological signs of the patient.lt is use for non-invasive continuous monitoring ofoxygen saturation (SpO2), pulse rate, CO2 andrespiration rate.The Capnograph and Oximeter is adaptable to adultusage in a hospital environment. It is intended to beused only under regular supervision of clinicalpersonnel. | The Vital Signs Monitor is designed for monitoringthe vital physiological signs of the patient. It is usefor non-invasive continuous monitoring of oxygensaturation (SpO2), pulse rate, CO2 and respirationrate.The Vital Signs Monitor is adaptable to adult andpediatric usage in a hospital environment. It isintended to be used only under regular supervisionof 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 DC5VUnit Consume:≤5VA | 100-250V 50/60Hz 90VA | Much lower power consumption than the Predicatedevice, as we adopt chips with lower powerconsumption and power management circuit withhigher efficiency and meanwhile these circuits havepassed the test of IEC 60601-1 and IEC 60601-1-2. |
| The type of protection againstelectric shock | Class I and internally powered per IEC 60601-1. | Class I and internally powered per IEC 60601-1. | Identical |
| The degree of protectionagainst 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.Same SpO2 module as Predicate which the sensorswere clinically validated and intended to be used inK063641 |
| SpO2 display range | 0%~100% | 0%~100% | Identical |
| SpO2 measure range foraccuracy | 70-100% | 70%~99% | Identical |
| Accuracy of SpO2 | Adult:±3% (during 70% | Adult and Pediatric:±3% (during 70% | Identical |
| Alarm of SpO2 | High and lower alarms.The limits are adjustable. | High and lower alarms.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 isgreater) | ±2bpm or ±2% (whichever isgreater) | Identical |
| Alarm of pulse rate | High and lower alarms.The limits are adjustable. | High and lower alarms.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(SpO2) and pulse by means of the radiograph ofinfrared light and the red light emitted by LEDthrough body's peripheral areas (such as fingers),whereby the photoelectric detecting circuits willanalyze the absorptivity of the oxyhemoglobin andreduced hemoglobin respectively, and give the photoabsorption rates before and after pulsation. Using themeasure of photo absorption change due to pulsatoryarterial blood flow caused by PLETH waveform, theSpO2 can be obtained. | This monitor measures the pulse oxygen saturation(SpO2) and pulse by means of the radiograph ofinfrared light and the red light emitted by LEDthrough body's peripheral areas (such as fingers),whereby the photoelectric detecting circuits willanalyze the absorptivity of the oxyhemoglobin andreduced hemoglobin respectively, and give the photoabsorption rates before and after pulsation. Usingthe measure of photo absorption change due topulsatory arterial blood flow caused by PLETHwaveform, the SpO2 can be obtained. | Identical |
| CO2 | |||
| CO2 module | CapnoCore | Respironics LoFlo™ EtCO2 (Side-stream)Module(K053174) and CAPNOSTAT 5 EtCO2(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 SidestreamORMainstream to measure CO2, these twomodelscan not coexist /work at the same time inclinicaluse and can only choose one way tomeasure;-The CO2 module of Predicate device isexternal, but new device is built-in. Itdoesn't affect the measurement;-The operation principle of Sidestreammodule issame as Predicate device's;- The new device is complying withISO80601-2-55 for the Particularrequirements for the basic safety andessential performance of respiratory gasmonitors 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 andrise time).Mainstream: <60ms (rise time) | CO2 response time depends on the length of thesample line.If we adopt sampling line with 1.5 meterlong, the time of the gas transmission anduprising will be less than 1 seconds, thistime is shorter than that of the Predicatedevice. Response time is the shorter thebetter. But to monitoring device, the onesecond difference of response time will notinfluence 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 | EtCO2: 0 | Identical |
| CO2 Accuracy | 0 | 0 | Identical |
| Respiration Rate measurerange | 3 - 150 breaths/minute | 2 | For adults, 2 RPM of respiration rate will beabnormal. This device will alert and themedical professional when respiration dropsbelow this rate. |
| Respiration Rate accuracy | ±1% of reading or ±1 breaths/min whichever isgreater | ±2rpm | Identical |
| Flow Rate | 50-250cc/min | 50ml/min ±10 ml/min (Sidestream) | Sampling flux can be adjusted, which doesnot influence measurement accuracy ofCO2 concentration and respirationfrequency. |
| NO CO2 Detected AlarmDelay | 15~39s off | 10~60s | NO CO2 Detected time alarm is controlled by doctor,which is as same as the Predicate device so there isno new risk. |
| Alarm of EtCO2 | High and lower alarms.The limits are adjustable. | High and lower alarms.The limits are adjustable. | Identical |
| Alarm of RR | High and lower alarms.The limits are adjustable. | High and lower alarms.The limits are adjustable. | Identical |
| Element of comparison | Subject Device | Predicate Device | Discussion |
| Operation principles | The principle is based on the fact that CO2 moleculesabsorb infrared light energy of specific wavelengths, withthe amount of energy absorbed being directly related tothe CO2 concentration. When an IR light beam is passedthrough a gas sample containing CO2, the electronicsignal from an infrared sensor (which measures theremaining light energy), can be obtained. This signal isthen compared to the energy of the IR source, andcalibrated to accurately reflect CO2 concentration in thesample. To calibrated, the infrared sensor's response to aknown concentration of CO2 is stored in the monitor'smemory.Further, on the passage of the sample gas with a three-way valve, with the change of temperature and time, thevalve leading to the pure air will 3-4 seconds in order toadjust the zero point.In addition, the circuit module has the atmospheresabsolute pressure sensors and the flow measurement andcontrol of pressure sensor. Modules can measureatmospheric pressure, and atmospheric pressure cancompensate the calculation for the concentrations ofcarbon dioxide which improve the design accuracy.Then the monitor (CO2 module) determines CO2concentration in the breathing gases by measuring theamount of light absorbed by these gases.EtCO2 is displayas a numerical value in millimeters of mercury (mmHg),percent (%), or kilopascals (kPa). In addition, a CO2waveform (capnogram) may be displayed which is avaluable clinical tool that can be used to assess patientairway integrity and proper endotracheal tube placement.Respiration rate is calculated by measuring the timeinterval between detected breaths. | The principle is based on the fact that CO2molecules absorb infrared light energy of specificwavelengths, with the amount of energy absorbedbeing directly related to the CO2 concentration.When an IR light beam is passed through a gassample containing CO2, the electronic signal from aphotodetector (which measures the remaining lightenergy), can be obtained. This signal is thencompared to the energy of the IR source, andcalibrated to accurately reflect CO2 concentration inthe sample. To calibrated, the photodetector'sresponse to a known concentration of CO₂ is storedin the monitor's memory.The monitor determines CO2 concentration in thebreathing gases by measuring the amount of lightabsorbed by these gases.EtCO₂ is display as anumerical value in millimeters of mercury (mmHg),percent (%), or kilopascals (kPa). In addition, a CO2waveform (capnogram) may be displayed which is avaluable clinical tool that can be used to assesspatient airway integrity and proper endotracheal tubeplacement. Respiration rate is calculated bymeasuring the time interval between detectedbreaths. | Identical.This device uses different CO2 module CapnoCorefrom the Predicate device uses CO2 module (Loflomodule) but its measurement technology principle issame. Both of them adopt NDIR (non-dispersiveinfrared gas) technology.The difference of CapnoCore module and Loflomodule is that the former has three-way valve withautomatically zero calibration and barometricpressure sensor so as to avoid manual zerocalibration and manual inputting barometricpressure. |
| Materials | the upper case : ABSbattery cover : ABSthe lower case : ABSSpO2 module: K063641 | Front housing : ABSbattery cover : ABSrear housing: ABSSpO2 module: K063641 | Identical.All comply with ISO10993-1 Biocompatibilityrequirement. |
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Modules Used in Capno-H
| CO2 | SpO2 | |
|---|---|---|
| Side stream | ||
| Company | Beijing Kingst Commercial & Trade Co., Ltd. | Shenzhen Creative Industry Co., Ltd. |
| Model | CapnoCore | Creative Oximeter with the same principle as PC-60 |
| FDA510(K) Number | K063641 | |
| Main TechnicalSpecifications | CO2 Measurement Range:0 to 150 mmHg0 to19.7% (V/V)0 to 20 KPa (Barometric Pressure supplied by Host)CO2 Calculation Method: Non-dispersive infrared gas analysisCO2 Response Time: <1secondCO2 Accuracy: 0-40 mmHg ±2 mmHg41-70 mmHg ±5% of reading71-100 mmHg ±8% of reading101-150 mmHg ±10% of readingRespiration Rate Range: 3 to 150 breaths per minute (BPM)Respiration Rate Accuracy: ± 1 breathFlow rate: 50 cc/min~250cc/minOperating conditions: Temperature: 5°C ~40°CHumidity: 30% | SpO2 Display: 0% |
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The following performance testing was performed to demonstrate substantial equivalence of the subject device Capnograph and SPO2, Model Capno-H, and applicable standards:
| Standard | Predicate | Capno-H | Comparison |
|---|---|---|---|
| IEC 60601-1:1990+A1+A2+A13 | Testing complete,complies | Testing complete,complies | Both the predicate and the Capno-H underwent testing to provecompliance to the General requirements for safety. Both thepredicate and the submitted Capno-H complied with thisstandard. This demonstrates that the predicate and submitteddevices are safe to operate. |
| IEC 60601-1-2:2007 | Testing complete,complies | Testing complete,complies | Both the predicate and the Capno-H underwent testing to showcompliance for the EMC requirements in IEC 60601-1-2. Boththe predicate and the submitted Capno-H complied with thisstandard. This demonstrates that the Capno-H and thepredicate operate within the defined parameters of the IECEMC standard. |
| IEC 60601-1-8:2006 | Testing complete,complies | Testing complete,complies | IEC Standard 60601-1-8 defines the basic safety and essentialperformance tests and guidance to show compliance for alarmsystems in medical electrical equipment. Both the submitteddevice and predicate device complied with this standard,establishing conformity to the standard conditions. |
| ISO 80601-2-55 | Testing complete,complies | Tested to ISO21647:2004; Complies | The submitted device was tested and complied with the criteriadefined in ISO 80601-2-55, whereas the predicate device wastested and complied with ISO 21647:2004. Both of thesestandards define the basic safety and essential performance ofrespiratory gas monitors. Both standards define the physicalconstruction requirements, electrical safety, alarms andmeasurement accuracy of a respiratory gas monitor. Both thepredicate and the submitted Capno-H complied with thesecomparable standards, exhibiting compliance to equipmentsafety and performance standards. |
| Standard | Predicate | Capno-H | Comparison |
| ISO 10993-1 | Testing regimendeveloped. | Testing regimendeveloped. | ISO 10993-1 defines the principles of biological evaluation, thecategorization of devices according to type and duration ofbody contact and the selection of appropriate tests for thedevices. Both the predicate and the submitted Capno-H utilizedthis standard to develop the testing protocols forbiocompatibility testing. |
| ISO 10993-5 | Testing complete,complies | Testing complete,complies | ISO 10993-5 defines methods of incubation of cultured cellsdirectly or through diffusion in contact with the medical device.The methods determine the biological response of mammaliancells in vitro with the appropriate biological parameters. Boththe predicate and submitted Capno-H underwent testing inaccordance with the bounds of ISO 10993-5 and complied withthe criterial in this standard. This shows the submitted device iscomparable to the predicate for in vitro biological compatibility. |
| ISO 10993-10 | Testing complete,complies | Testing complete,complies | ISO 10993-10 defines the assessment procedure with regardsto the device's potential to produce irritation and delayed-typehypersensitivity. Both the predicate and the Capno-Hunderwent testing to assess the medical devices' potential toproduct irritation and delayed-type hypersensitivity. The Capno-H and the predicate complied with this standard. Thisdemonstrates compliance to this biocompatibility standard andshows compliance for patient safety. |
| ISO 9919 | Utilizes an FDAapproved SP02device | Testing complete,complies | The SP02 component of the submitted Capno-H device hasbeen previously cleared by the FDA under K063641, which isthe predicate device. |
| EN 61000-3-2:2006 | Testing not done | Testing complete,complies | This standard is for Electromagnetic Compatibility (emc) - Part3-2: Limits -, which tests for limits For Harmonic CurrentEmissions (equipment Input Current <= 16 A Per Phase) |
| Standard | Predicate | Capno-H | Comparison |
| EN 61000-3-3 | Testing not done | Testing complete,complies | This standard is for Electromagnetic Compatibility (emc) - Part3-3: Limits - , which tests for the limitation Of Voltage Changes,Voltage Fluctuations And Flicker In Public Low-voltage SupplySystems, For Equipment With Rated Current 16 A Per PhaseAnd Not Subject To Conditional Connection |
| FDA Guidance forthe content ofPremarketSubmissions forSoftwareContained inMedical Devices | Used as guidancein development | Used as guidancein development | Guidance for the approach for development and testing ofsoftware in medical devices. |
| IEC 60601-1-4 | Used as guidancein development.Testing performedto prove V&V. | Used as guidancein development.Testing performedto prove V&V. | This standard specifies the requirements for the process bywhich a programmable electrical medical system is designed. |
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All of the pre-determined acceptance criteria were met.
Summary of Substantial Equivalence:
Based on the indications for use, technological characteristics, and performance testing, the subject Capnograph and Oximeter, Model Capno-H has demonstrated to be substantially equivalent to the predicate Vital Signs Monitor, Model PC-900A.
END
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).