(252 days)
No
The description focuses on standard electronic and mechanical components for measuring CO2 and respiration rate, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is indicated for measurement and monitoring of carbon dioxide concentration and respiration rate, serving as an adjunct in patient assessment. It does not provide treatment or therapy.
Yes
Explanation: The device measures and monitors carbon dioxide concentration of expired breath and respiration rate, which are physiological parameters used to assess a patient's condition and aid in determining clinical signs and symptoms. This directly supports diagnostic decision-making as an "adjunct in patient assessment."
No
The device description explicitly lists hardware components such as a monitor housing electronics (color sensor, LED light source, vacuum pump, battery), a sensor cartridge, and an AC power adapter. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the OmniCap™ capnometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- OmniCap's Function: The OmniCap measures and monitors the carbon dioxide concentration of expired breath. While breath is expelled from the body, it's not typically considered a "specimen" in the same way as blood or tissue for the purpose of IVD classification. The device is analyzing the composition of the gas being exhaled, not performing a test on a biological sample taken from within the body.
- Intended Use: The intended use is to provide measurement and monitoring of expired breath and respiration rate as an adjunct in patient assessment. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the OmniCap falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider.
Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
The OmniCap system incorporates three parts:
- . OmniCap monitor
- . Sensor cartridge with a colorimetric litmus media
- AC power adapter .
The OmniCap monitor houses the electronics including the color sensor, a LED light source, a miniature vacuum pump, internal sample gas tubing, a rechargeable nickel metal hydride battery pack, and the user interface.
The OmniCap Sensor cartridge is a colorimetric litmus media sealed in a plastic cartridge with clear windows on each side.
The AC power adapter is IEC 60601-1 compliant. The AC power adapter converts supplied AC power to DC power to facilitate charging the battery.
The OmniCap unit can operate with or without the AC adapter connected and powered.
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 patients.
Intended User / Care Setting
qualified healthcare provider.
Hospitals, Sub-acute care facilities and intra-hospital transport.
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)
Bench -
We have performed bench tests and found that the met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following:
- ANSI/AAMI/ES 60601-1
- IEC 60601-1-2
- ISO 80601-2-55
In addition and as part of the above standard we performed testing for:
- . Comparative performance to the predicate - IR technology
- Tested as various concentrations of CO2and respiration rate
- . Accuracy and repeatability of measured CO2the sensor cartridges
- . Respiration rate accuracy and repeatability
- Shelf-life and Effects of Aging
- Useful Life .
The results demonstrate that the device performs as intended and can be found to be substantially equivalent to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
CO2 range: 12 – 76 mmHg
Accuracy of CO2: +/- 3.268 mm Hg or + 8% of reading
Respiratory Rate (RR): 5 to 40 bpm
Accuracy of RR: +/- 1 bpm between 5 to 40
Time to Steady state: 2 minutes
Flow rate: 285 mL/min
Shelf-life of Disposable: 6 months
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.
Oridion Microcap / Nellcor N-85 - K981114
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.
Maxtec Flocap - K133540
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
January 4, 2018
Respirion, Inc. % Paul Dryden Consultant ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K171235
Trade/Device Name: OmniCap Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: December 6, 2017 Received: December 8, 2017
Dear Paul Dryden:
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
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
2
Indications for Use
510(k) Number (if known)
K171235
Device Name
OmniCap™
Indications for Use (Describe)
The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider.
Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| XX Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740
3
| 510(k) Summary | |
|---|---|
| Page 1 of 7 | |
| 27-Dec-17 | |
| Official Contact: | Ed Fadel, CEO |
| Respirion, Inc. | |
| 212 Jewell Drive | |
| Chapel Hill, NC 27516 | |
| Tel: 919-280-2534 | |
| Proprietary or Trade Name: | OmniCap |
| Common/Usual Name: | analyzer, gas, carbon-dioxide, gaseous-phase |
| Classification Name: | analyzer, gas, carbon-dioxide, gaseous-phase |
| CCK, Class II, 21CFR 868.1400 | |
| Predicate Device: | Oridion Microcap / Nellcor N-85 - K981114 |
| Reference Device: | Maxtec Flocap - K133540 |
Device Description:
The OmniCap system incorporates three parts:
- . OmniCap monitor
- . Sensor cartridge with a colorimetric litmus media
- AC power adapter .
The OmniCap monitor houses the electronics including the color sensor, a LED light source, a miniature vacuum pump, internal sample gas tubing, a rechargeable nickel metal hydride battery pack, and the user interface.
The OmniCap Sensor cartridge is a colorimetric litmus media sealed in a plastic cartridge with clear windows on each side.
The AC power adapter is IEC 60601-1 compliant. The AC power adapter converts supplied AC power to DC power to facilitate charging the battery.
The OmniCap unit can operate with or without the AC adapter connected and powered.
Indications for Use:
The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider.
Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.
Contraindications:
We have listed the following contraindications:
- This product is not intended for use with anesthesia agents. ●
- Do not use OmniCap in an MR environment. ●
510(k) Summary
4
- Do not use in the presence of flammable anesthetics or gases. ●
- Do not use OmniCap during defibrillation.
Device Comparison
Substantial Equivalence Discussion
We have identified the primary predicate as the Oridion Microcap / Nellcor N-85, K981114, for its performance characteristics and intended use for measurement and monitoring of end-tidal carbon dioxide and respiration rate.
There is a difference in the technology of measuring the CO2 in the expired gas between the predicate and the subject device. Namely the OmniCap uses colorimetric litmus media which has been treated with chemical and a color sensor to detect carbon dioxide by color change of the media, while the Nellcor N-85 uses an infrared absorption (IR) technique to determine the level of carbon dioxide.
FDA has cleared CO2 detector, indicators, and measurement devices which utilize colormetric technology. We have identified the reference device Maxtec FloCap, K133540, for the similar technology and intended use. In the case of the reference device, the user must visually determine and read the color change to determine the CO2 level whereas the subject device, OmniCap, has a color sensor which detects the color change of the media and presents the change as a %CO2.
We believe that the technological characteristics are testable with acceptable methods.
Table 1 outlines the characteristics to support the primary predicate and reference device rationale for substantial equivalence.
5
510(k) Summary Page 3 of 7 27-Dec-17
| Feature | Primary Predicate | Reference | Subject device |
|---|---|---|---|
| Oridion MicroCap / Nellcor | |||
| N-85 (K981114) | Maxtec FloCap (K133540) | OmniCap | |
| Classification | CCK | ||
| CFR 868.1400 | |||
| analyzer, gas, carbon-dioxide, gaseous-phase | |||
| Indications for Use | The use of the Microcap | ||
| capnography monitor is | |||
| indicated whenever a | |||
| professionally trained health | |||
| care providers determine | |||
| that a patient requires the | |||
| continuous, non-invasive | |||
| measurement and | |||
| monitoring of carbon | |||
| dioxide concentration of the | |||
| expired and inspired breath | |||
| and respiration rate | The FLOCAP is to | ||
| provide a semi- | |||
| quantitative visualization | |||
| of the C02 in the patient | |||
| airway. It is an adjunct in | |||
| patient assessment, to be | |||
| used in conjunction with | |||
| other methods to | |||
| determine clinical signs | |||
| and symptoms by or on | |||
| the order of a physician. | |||
| The FLOCAP has a | |||
| visual indicator to | |||
| visually detect the end of | |||
| exhalation. For use up to | |||
| 24 hours. For patients | |||
| greater than 15 kg (33 | |||
| lbs.) Environment of use - | |||
| hospital, sub-acute, pre- | |||
| hospital, transport | The use of the | ||
| OmniCapTM capnometer | |||
| is indicated to provide | |||
| measurement and | |||
| monitoring of carbon | |||
| dioxide concentration of | |||
| the expired breath and | |||
| respiration rate of adult | |||
| patients. It is an adjunct | |||
| in patient assessment, to be | |||
| used in conjunction | |||
| with other methods to | |||
| determine clinical signs | |||
| and symptoms by or on | |||
| the order of a qualified | |||
| healthcare provider. | |||
| Environment of Use: | |||
| Hospitals, Sub-acute | |||
| care facilities and | |||
| intra-hospital | |||
| transport. | |||
| Patients | Adult, pediatric, and | ||
| infant/neonatal patients | Patients >15 kg (33 lbs.) | Adult | |
| Environment of | |||
| Use | Hospitals | ||
| Mobile use | Hospitals | ||
| Sub-acute | |||
| Pre-hospital | |||
| Transport | Hospitals | ||
| Sub-acute care facilities | |||
| Intra-hospital transport | |||
| Technology for | |||
| CO2 measurement | Infrared | ||
| Presents values | Colormetric | ||
| User reads the color | |||
| change | Colormetric | ||
| Sensor for reading color | |||
| change | |||
| Presents values | |||
| Duration of | Unlimited | Up to 24 hours | 8 hours then sensor |
| cartridge replaced |
Table 1 Rationale for Predicate and Reference vs. Subject Device
Table of Comparison and Differences
Table 2 presents a technical comparison of the OmniCap and the predicate and reference devices to establish substantial equivalence.
6
| 510(k) Summary |
|---|
| Page 4 of 7 |
| 27-Dec-17 |
Table 2 - Device Comparison
| Feature | Subject device
OmniCapTM | Predicate
Oridion MicroCap / Nellcor N-85
(K981114) | Reference
Maxtec FloCap
(K133540) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Monitoring | Continuous | Continuous | Quantitative indicator |
| Duration of Use | 8 hours / cartridge | Unlimited |