OmniCap

K171235 · Respirion, Inc. · CCK · Jan 4, 2018 · Anesthesiology

Device Facts

• Record ID: K171235
• Device Name: OmniCap
• Applicant: Respirion, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jan 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended 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.

Device Story

OmniCap is a capnometer for adult patients; monitors expired CO2 concentration and respiration rate. System components: monitor, colorimetric litmus sensor cartridge, AC power adapter. Principle of operation: miniature vacuum pump draws expired breath through sensor cartridge; colorimetric litmus media changes color based on CO2 concentration; internal color sensor detects media color change; monitor converts optical data to numerical CO2 value (mmHg) and respiration rate. Used in hospitals, sub-acute facilities, and intra-hospital transport by healthcare providers. Output displayed on monitor; provides continuous monitoring with low/high alarms for EtCO2 and respiration rate. Benefits include adjunct clinical assessment of patient respiratory status. Device operates on AC or rechargeable NiMH battery.

Clinical Evidence

Bench testing only. Testing included compliance with ANSI/AAMI/ES 60601-1, IEC 60601-1-2, and ISO 80601-2-55. Comparative performance testing against the IR-based predicate device was conducted at various CO2 concentrations and respiration rates. Results confirmed accuracy and repeatability of CO2 and respiration rate measurements, shelf-life, and effects of aging met specifications.

Technological Characteristics

Colorimetric litmus media sensor cartridge; optical color sensor; miniature vacuum pump; rechargeable NiMH battery; AC power adapter (IEC 60601-1 compliant). Dimensions: 5.8"H x 4.8"W x 1.3"D. Weight: 320g. Standards: ANSI/AAMI/ES 60601-1, IEC 60601-1-2, ISO 80601-2-55. No patient-contacting materials in gas pathway.

Indications for Use

Indicated for adult patients requiring measurement and monitoring of expired carbon dioxide concentration and respiration rate. Used as an adjunct in patient assessment by qualified healthcare providers in hospitals, sub-acute care facilities, and during intra-hospital transport. Contraindicated for use with anesthesia agents, in MR environments, in the presence of flammable anesthetics/gases, or during defibrillation.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Oridion Microcap / Nellcor N-85 (K981114)

Reference Devices

• Maxtec Flocap (K133540)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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) | <input type="checkbox"/> 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, CEO<br>Respirion, Inc.<br>212 Jewell Drive<br>Chapel Hill, NC 27516<br>Tel: [phone] |
| Proprietary or Trade Name: | OmniCap |
| Common/Usual Name: | analyzer, gas, carbon-dioxide, gaseous-phase |
| Classification Name: | analyzer, gas, carbon-dioxide, gaseous-phase<br>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

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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 / Nellcor<br>N-85 (K981114) | Maxtec FloCap (K133540) | OmniCap |
| Classification | CCK<br>CFR 868.1400<br>analyzer, gas, carbon-dioxide, gaseous-phase | | |
| Indications for Use | The use of the Microcap<br>capnography monitor is<br>indicated whenever a<br>professionally trained health<br>care providers determine<br>that a patient requires the<br>continuous, non-invasive<br>measurement and<br>monitoring of carbon<br>dioxide concentration of the<br>expired and inspired breath<br>and respiration rate | The FLOCAP is to<br>provide a semi-<br>quantitative visualization<br>of the C02 in the patient<br>airway. It is an adjunct in<br>patient assessment, to be<br>used in conjunction with<br>other methods to<br>determine clinical signs<br>and symptoms by or on<br>the order of a physician.<br>The FLOCAP has a<br>visual indicator to<br>visually detect the end of<br>exhalation. For use up to<br>24 hours. For patients<br>greater than 15 kg (33<br>lbs.) Environment of use -<br>hospital, sub-acute, pre-<br>hospital, transport | The use of the<br>OmniCapTM capnometer<br>is indicated to provide<br>measurement and<br>monitoring of carbon<br>dioxide concentration of<br>the expired breath and<br>respiration rate of adult<br>patients. It is an adjunct<br>in patient assessment, to be<br>used in conjunction<br>with other methods to<br>determine clinical signs<br>and symptoms by or on<br>the order of a qualified<br>healthcare provider.<br>Environment of Use:<br>Hospitals, Sub-acute<br>care facilities and<br>intra-hospital<br>transport. |
| Patients | Adult, pediatric, and<br>infant/neonatal patients | Patients >15 kg (33 lbs.) | Adult |
| Environment of<br>Use | Hospitals<br>Mobile use | Hospitals<br>Sub-acute<br>Pre-hospital<br>Transport | Hospitals<br>Sub-acute care facilities<br>Intra-hospital transport |
| Technology for<br>CO2 measurement | Infrared<br>Presents values | Colormetric<br>User reads the color<br>change | Colormetric<br>Sensor for reading color<br>change<br>Presents values |
| Duration of | Unlimited | Up to 24 hours | 8 hours then sensor<br>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.

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

# Table 2 - Device Comparison

| Feature | Subject device<br>OmniCapTM | Predicate<br>Oridion MicroCap / Nellcor N-85<br>(K981114) | Reference<br>Maxtec FloCap<br>(K133540) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Monitoring | Continuous | Continuous | Quantitative indicator |
| Duration of Use | 8 hours / cartridge | Unlimited | < 24 hours per device |
| Patient Population | Adults | Adult, pediatric, and infant/neonatal<br>patients | For patients greater than 15 kg (33 lbs.) |
| Environment of Use | Hospitals<br>Sub-acute care facilities<br>Intra-hospital transport | Hospitals<br>Sub-acute care facilities (not stated)<br>Mobile use | Hospital<br>Sub-acute care facilities<br>Pre-hospital transport |
| Technology to detect<br>CO2 concentration | Colormetric media changes color and<br>sensor detects color change and reports a<br>value | Infrared | Colormetric media changes color and<br>user uses guide to determine the % CO2 |
| How CO2 are displayed? | mmHg<br>Value as a number | mmHg<br>Value as a number<br>Waveform | % CO2<br>Color interpreted by the user |
| Respiratory Rate | Displayed value | Displayed value | Not displayed |
| Method of drawing<br>sample | Pump pulls a vacuum to sample | Pump pulls a vacuum to sample | Patient inhales / exhales through the<br>device |
| Patient interface | Nasal cannula | Nasal cannula<br>Face mask<br>Gas sampling line | Connected to a device through which<br>patient exhales, e.g., endotracheal tube<br>or mask |
| 510(k) Summary<br>Page 5 of 7<br>27-Dec-17 | | | |
| Feature | Subject device<br>OmniCap | Predicate<br>Oridion MicroCap / Nellcor N-85<br>(K981114) | Reference<br>Maxtec FloCap<br>(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<br>+/- 5% of reading between 39 – 99 mmHg<br>Meets ISO 80601-2-55 | No accuracy stated |
| Respiratory Rate (RR) | Applicable parts of ISO 80601-2-55<br>5 to 40 bpm | 0 -150 bpm | ISO 80601-2-55 not applicable<br>Does not measure rate |
| Accuracy of RR | +/- 1 bpm between 5 to 40<br>Meets ISO 80601-2-55 | 0-70 bpm: ±1 bpm<br>71-120 bpm: ±2 bpm<br>121-150 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 | Low<br>High | Low<br>High | None |
| Respiratory Rate | Low<br>High | Low<br>High | None |
| Low battery alarm | Yes | Yes | None |
| Technical Specifications | | | |
| Power | AC<br>Rechargeable Battery | AC<br>Rechargeable 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 communicating<br>Tissue<br>Limited duration of use |
| Performance Testing | Gas sampling accessories supplied by user<br>Shelf-life<br>Effects of Aging<br>Accuracy and repeatability of RR and CO2 | Gas sampling accessories supplied by user | Limited duration of use |
| Standards | ANSI/AAMI/ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-8 | ANSI/AAMI/ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-8 | Not applicable, not electrically<br>powered |

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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.