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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OmniCap device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
CO2 Range	12 – 76 mmHg
Accuracy of CO2	+/- 3.268 mm Hg or + 8% of reading
Respiratory Rate (RR) Range	5 to 40 bpm
Accuracy of RR	+/- 1 bpm between 5 to 40 bpm
Compliance with Standards	Meets ISO 80601-2-55 (for applicable parts), ANSI/AAMI/ES 60601-1, IEC 60601-1-2
Time to Steady State	2 minutes
Flow Rate	285 mL/min
Shelf-life of Disposable (sensor cartridge)	6 months
Duration of Use (per cartridge)	8 hours

Study Information

The document describes non-clinical bench testing to demonstrate performance and substantial equivalence.

Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes (e.g., number of test points, number of sensor cartridges) used for each individual test. It broadly mentions "various concentrations of CO2" and "the sensor cartridges."
- Data Provenance: Not specified, but implied to be laboratory bench testing conducted by Respirion, Inc. (the manufacturer). No information on country of origin for data. The study is retrospective as it involves testing of the manufactured device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for the bench tests would have been established using reference gas mixtures with known CO2 concentrations and controlled respiration rates, not through expert opinions.
Adjudication method for the test set:
- Not applicable, as ground truth was established by calibrated reference equipment/methods, not by human adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. The document refers to "Comparative performance to the predicate - IR technology" but this is described as bench testing at various concentrations and respiration rates, not a multi-reader study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary performance evaluation described is a standalone (algorithm only) bench test. The device's sensor detects color change and converts it to a numerical value, which is then assessed against known reference values. There is no human involved in interpreting the color change for the subject device's reported performance, unlike the reference device (Maxtec FloCap) where a user visually interprets color.
The type of ground truth used:
- Reference gas mixtures with known CO2 concentrations and controlled respiration rates generated by test equipment. This falls under a form of "reference standard" based on calibrated instrumentation and scientific principles.
The sample size for the training set:
- Not applicable. This is a non-AI/ML device. The device's technology uses a pre-set colorimetric system with a sensor, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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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);

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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 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

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Indications for Use

510(k) Number (if known)

K171235

Device Name

OmniCap™

Indications for Use (Describe)

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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	510(k) Summary
	Page 1 of 7
	27-Dec-17
Official Contact:	Ed Fadel, CEORespirion, Inc.212 Jewell DriveChapel Hill, NC 27516Tel: 919-280-2534
Proprietary or Trade Name:	OmniCap
Common/Usual Name:	analyzer, gas, carbon-dioxide, gaseous-phase
Classification Name:	analyzer, gas, carbon-dioxide, gaseous-phaseCCK, 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 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:

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

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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.

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510(k) Summary Page 3 of 7 27-Dec-17

Feature	Primary Predicate	Reference	Subject device
	Oridion MicroCap / NellcorN-85 (K981114)	Maxtec FloCap (K133540)	OmniCap
Classification	CCKCFR 868.1400analyzer, gas, carbon-dioxide, gaseous-phase
Indications for Use	The use of the Microcapcapnography monitor isindicated whenever aprofessionally trained healthcare providers determinethat a patient requires thecontinuous, non-invasivemeasurement andmonitoring of carbondioxide concentration of theexpired and inspired breathand respiration rate	The FLOCAP is toprovide a semi-quantitative visualizationof the C02 in the patientairway. It is an adjunct inpatient assessment, to beused in conjunction withother methods todetermine clinical signsand symptoms by or onthe order of a physician.The FLOCAP has avisual indicator tovisually detect the end ofexhalation. For use up to24 hours. For patientsgreater than 15 kg (33lbs.) Environment of use -hospital, sub-acute, pre-hospital, transport	The use of theOmniCapTM capnometeris indicated to providemeasurement andmonitoring of carbondioxide concentration ofthe expired breath andrespiration rate of adultpatients. It is an adjunctin patient assessment, to beused in conjunctionwith other methods todetermine clinical signsand symptoms by or onthe order of a qualifiedhealthcare provider.Environment of Use:Hospitals, Sub-acutecare facilities andintra-hospitaltransport.
Patients	Adult, pediatric, andinfant/neonatal patients	Patients >15 kg (33 lbs.)	Adult
Environment ofUse	HospitalsMobile use	HospitalsSub-acutePre-hospitalTransport	HospitalsSub-acute care facilitiesIntra-hospital transport
Technology forCO2 measurement	InfraredPresents values	ColormetricUser reads the colorchange	ColormetricSensor for reading colorchangePresents values
Duration of	Unlimited	Up to 24 hours	8 hours then sensorcartridge 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.

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510(k) Summary
Page 4 of 7
27-Dec-17

Table 2 - Device Comparison

Feature	Subject deviceOmniCapTM	PredicateOridion MicroCap / Nellcor N-85(K981114)	ReferenceMaxtec FloCap(K133540)
Monitoring	Continuous	Continuous	Quantitative indicator
Duration of Use	8 hours / cartridge	Unlimited	< 24 hours per device
Patient Population	Adults	Adult, pediatric, and infant/neonatalpatients	For patients greater than 15 kg (33 lbs.)
Environment of Use	HospitalsSub-acute care facilitiesIntra-hospital transport	HospitalsSub-acute care facilities (not stated)Mobile use	HospitalSub-acute care facilitiesPre-hospital transport
Technology to detectCO2 concentration	Colormetric media changes color andsensor detects color change and reports avalue	Infrared	Colormetric media changes color anduser uses guide to determine the % CO2
How CO2 are displayed?	mmHgValue as a number	mmHgValue as a numberWaveform	% CO2Color interpreted by the user
Respiratory Rate	Displayed value	Displayed value	Not displayed
Method of drawingsample	Pump pulls a vacuum to sample	Pump pulls a vacuum to sample	Patient inhales / exhales through thedevice
Patient interface	Nasal cannula	Nasal cannulaFace maskGas sampling line	Connected to a device through whichpatient exhales, e.g., endotracheal tubeor mask
510(k) SummaryPage 5 of 727-Dec-17
Feature	Subject deviceOmniCap	PredicateOridion MicroCap / Nellcor N-85(K981114)	ReferenceMaxtec FloCap(K133540)
Specifications
CO2 range	12 – 76 mmHg	0 - 99 mmHg	0 - 5%
Accuracy of CO2	+/- 3.268 mm Hg or + 8% of reading	+/- 2 mmHg between 0 – 38 mmHg+/- 5% of reading between 39 – 99 mmHgMeets ISO 80601-2-55	No accuracy stated
Respiratory Rate (RR)	Applicable parts of ISO 80601-2-555 to 40 bpm	0 -150 bpm	ISO 80601-2-55 not applicableDoes not measure rate
Accuracy of RR	+/- 1 bpm between 5 to 40Meets ISO 80601-2-55	0-70 bpm: ±1 bpm71-120 bpm: ±2 bpm121-150 bpm: ±3 bpm	Not applicable
Time to Steady state	2 minutes	1 minute	After 6 breathes
Flow rate	285 mL/min	50 mL/min	None
Shelf-life of Disposable	6 months	N/A	2 years
Alarms
EtCO2 value	LowHigh	LowHigh	None
Respiratory Rate	LowHigh	LowHigh	None
Low battery alarm	Yes	Yes	None
Technical Specifications
Power	ACRechargeable Battery	ACRechargeable Battery	None
Dimensions	5.8"H x 4.8"W x 1.3"D	8.1"H x 3.5"W x 2.1"D	3.3"W x 3.3"W x 1.3"D
Weight	320 grams	850 grams	23 grams
Biocompatibility	No materials in the gas pathway	No materials in the gas pathway	Externally communicatingTissueLimited duration of use
Performance Testing	Gas sampling accessories supplied by userShelf-lifeEffects of AgingAccuracy and repeatability of RR and CO2	Gas sampling accessories supplied by user	Limited duration of use
Standards	ANSI/AAMI/ES 60601-1IEC 60601-1-2IEC 60601-1-8	ANSI/AAMI/ES 60601-1IEC 60601-1-2IEC 60601-1-8	Not applicable, not electricallypowered

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510(k) Summary
Page 6 of 7
27-Dec-17

Substantial Equivalence Discussion and Rationale

In Table 2 we have compared the OmniCap to the predicate and reference devices for equivalence of:

Indications – The indications are for measuring and monitoring exhaled CO2 and respiratory rate in adult patients by qualified healthcare providers.

Discussion – The indications are similar to the predicate - Oridion MicroCap / Nellcor N-85 (K981114) but the predicate also includes SpO2 monitoring which is not included in the subject device. The measurement of expired CO2 can be and is a standalone physiological parameter. The predicate is a multi-parameter patient monitor. The subject device as an end-tidal CO2 monitor only does not affect the intended diagnostic use of measuring and monitoring end-tidal CO2.

Patient Population – The population for the subject device is for adults only. Discussion - The population of the predicate - Oridion MicroCap / Nellcor N-85 (K981114) includes neonates to adults. This difference which is included in the labeling does not affect substantial equivalence for the intended use.

Environment of Use - The subject device does not include pre-hospital while the predicate and reference devices include a larger range of environments of use. Discussion - This difference does not affect substantial equivalence.

Design and Technology - The OmniCap is using a combination of technologies, colormetric for detecting the amount of CO- present and a sensor to detect the color change and convert it to a numerical value. Discussion - The reference device - Maxtec FloCap (K133540) uses colormetric CO2 detection but does not quantify it except in a range which the user ten confirms. While the predicate - Oridion MicroCap / Nellcor N-85 (K981114) uses infrared to detect, measure and display a numerical value of CO2 detected and respiratory rate. While the technologies of the OmniCap are a combination of both, we have confirmed that

the accuracy of the OmniCap meets the performance requirements of ISO 80601-2-55 like the predicate. These differences have been evaluated and do not raise new concerns of safety and effectiveness.

Performance Specifications - The performance of the OmniCap complies with the applicable requirement specifications of the FDA recognized standard ISO 80601-2-55.

Discussion – Both the subject device and the predicate - Nellcor N-85 (K981114) meet the performance requirements of ISO 80601-2-55. We note that the reference device – Maxtec FloCap (K133540) does not meet ISO 80601-2-55. Differences noted are: range of measured EtCO2, range of measured respiratory rate, response time and sampling flow rate. These differences in performance are disclosed to the user and while narrower in scope, the intended use and compliance with ISO 80601-2-55 is non-specific. We have demonstrated that the differences do not raise concerns of safety and effectiveness that can be addressed in labeling.

Compliance with standards - The subject device has been tested to a number of standards, ISO 80601-2-55, ES 60601-1, and IEC 60601-1-2 and complies with the applicable requirements. Discussion - The predicate - Oridion MicroCap / Nellcor N-85 (K981114) also complies with these standards. These do not raise concerns of safety and effectiveness.

Performance Testing - Non-clinical

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:

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ANSI/AAMI/ES 60601-1 ●
IEC 60601-1-2 ●
ISO 80601-2-55

510(k) Summary
Page 7 of 7
27-Dec-17

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 o
. 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.

Biocompatibility and Materials -

There are no patient contacting materials.

Differences and Substantial Equivalence Conclusion

The OmniCap is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. The differences do not raise different questions of safety or effectiveness when compared to the predicate and reference devices for the proposed indications for use.

Regulation Number and Section

§ 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).