(485 days)
No
The summary describes a standard vital signs monitor using established measurement techniques (infrared absorption) for SpO2, pulse rate, CO2, and respiration rate. There is no mention of AI, ML, or any advanced data processing that would suggest the use of these technologies. The performance metrics and testing described are typical for this type of device and do not indicate AI/ML involvement.
No.
The device is for monitoring physiological signs (SpO2, pulse rate, CO2, and respiration rate) and does not provide any treatment or therapy.
No
Explanation: A diagnostic device is used to identify or determine the cause of a disease or condition. This device is described as a monitor that continuously measures physiological signs (SpO2, pulse rate, CO2, respiration rate) to track a patient's vital signs, not to diagnose a disease.
No
The device description explicitly mentions using infrared absorption methods and describes physical components like modules (Sidestream, Mainstream, SpO2) and sensors, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Capnograph and Oximeter described here is a non-invasive monitoring device. It measures physiological parameters (SpO2, pulse rate, CO2, respiration rate) directly from the patient's body (e.g., finger for SpO2). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate" and "monitoring the vital physiological signs of the patient." This aligns with patient monitoring, not in vitro analysis of specimens.
Therefore, this device falls under the category of patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, CCK
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.
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
Adults
Intended User / Care Setting
Clinical personnel in a hospital environment.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate substantial equivalence to applicable standards:
- IEC 60601-1: 1990+A1+A2+A13: Both the predicate and the Capno-H underwent testing to prove compliance to the General requirements for safety and complied.
- IEC 60601-1-2: 2007: Both the predicate and the Capno-H underwent testing to show compliance for the EMC requirements and complied.
- IEC 60601-1-8: 2006: Both the submitted device and predicate device complied with this standard for alarm systems.
- ISO 80601-2-55: The submitted device was tested and complied with the criteria defined in ISO 80601-2-55. The predicate device was tested and complied with ISO 21647:2004. Both standards define basic safety and essential performance of respiratory gas monitors.
- ISO 10993-1: Both the predicate and the submitted Capno-H utilized this standard to develop biocompatibility testing protocols.
- ISO 10993-5: Both the predicate and submitted Capno-H underwent testing in accordance with this standard for in vitro biological compatibility and complied.
- ISO 10993-10: Both the predicate and the Capno-H underwent testing to assess potential for irritation and delayed-type hypersensitivity and complied.
- ISO 9919: The SpO2 component of the submitted Capno-H device has been previously cleared by the FDA under K063641.
- EN 61000-3-2:2006: The Capno-H complied with this standard for limits for harmonic current emissions. (Predicate testing not done)
- EN 61000-3-3: The Capno-H complied with this standard for limitation of voltage changes, fluctuations, and flicker. (Predicate testing not done)
- FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices: Used as guidance in development for both devices.
- IEC 60601-1-4: Used as guidance in development and testing performed to prove V&V for both devices.
All pre-determined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- EtCO2 Accuracy:
- 0 - 40mmHg: ±2mmHg
- 41 - 70mmHg: ±5%
- 71 - 100mmHg: ±8%
- Over 100mmHg: ±10%
- Respiration Rate Accuracy: ±1% of reading or ±1 breaths/min whichever is greater
- SpO2 Accuracy: ±3% for SpO2 range from 70 - 100%
- Pulse Rate Accuracy: ±2% of reading or ±2bpm whichever is greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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);
1
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
2
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
| Subject
Device | | Trade Name | Capnograph and Oximeter
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
| 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% |
5
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: in vitro with the appropriate biological parameters. Both
the predicate and submitted Capno-H underwent testing in
accordance with the bounds of ISO 10993-5 and complied with
the criterial in this standard. This shows the submitted device is
comparable 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 regards
to the device's potential to produce irritation and delayed-type
hypersensitivity. Both the predicate and the Capno-H
underwent testing to assess the medical devices' potential to
product irritation and delayed-type hypersensitivity. The Capno-
H and the predicate complied with this standard. This
demonstrates compliance to this biocompatibility standard and
shows compliance for patient safety. |
| ISO 9919 | Utilizes an FDA
approved SP02
device | Testing complete,
complies | The SP02 component of the submitted Capno-H device has
been previously cleared by the FDA under K063641, which is
the predicate device. |
| EN 61000-3-
2:2006 | Testing not done | Testing complete,
complies | This standard is for Electromagnetic Compatibility (emc) - Part
3-2: Limits -, which tests for limits For Harmonic Current
Emissions (equipment Input Current