FLOCAP

K133540 · Maxtec, Inc. · CCK · Mar 28, 2014 · Anesthesiology

Device Facts

• Record ID: K133540
• Device Name: FLOCAP
• Applicant: Maxtec, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FLOCAP is to provide a semi-quantitative visualization of the CO2 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

Device Story

FLOCAP is a disposable, single-patient-use CO2 detector used in hospital, sub-acute, pre-hospital, and transport settings. It connects between a manual resuscitator/pressure source and a face mask or endotracheal tube. The device utilizes colorimetric, pH-sensitive litmus media to provide semi-quantitative CO2 visualization (Purple to Yellow color change). It includes a mechanical spinner/vane that rotates during expiratory flow (>1 lpm) to provide a visual indicator of exhalation. Operated by clinicians, the device serves as an adjunct to other clinical assessment methods to monitor patient airway status and ventilation progress. It does not require activation tabs and is designed for up to 24 hours of use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including color change response time, leakage, minimum static flow indication, anti-fog, packaging integrity (ISTA 2A), shelf-life, drop testing, duration of use, burst pressure, ISO 9360-1 compliance (pressure drop, internal volume), and usability (BS EN 62366).

Technological Characteristics

Colorimetric, pH-sensitive litmus media; mechanical spinner/vane for flow indication. Standard 15/22 mm conical fittings per ISO 5356-1. Dead space: 25 ml. Weight: 23g. Pressure drop: 0.7 cm H2O @ 30 lpm, 2.7 cm H2O @ 60 lpm, 5.7 cm H2O @ 90 lpm. Disposable, single-patient use. Shelf-life: 2 years. Biocompatibility tested per intracutaneous reactivity standards.

Indications for Use

Indicated for patients >15 kg (33 lbs) requiring semi-quantitative CO2 visualization in airway as an adjunct to clinical assessment. Contraindicated for hypercarbia detection, main stem bronchial intubation, mouth-to-tube ventilation, oropharyngeal tube placement, or cases where low pulmonary perfusion complicates interpretation.

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

• Mercury Medical - StatCO₂ (K021576)

Submission Summary (Full Text)

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#### 510(k) Summary Page 1 of 5 27-Mar-14

| Maxtec, LLC | | |
|----------------------------|-----------------------------------------------------------------|--|
| 6526 S Cottonwood Street | Tel: [phone] | |
| Salt lake City, UT 84107 | Fax: [phone] | |
| Official Contact: | Tammy Lavery, Regulatory Affairs & Quality | |
| Proprietary or Trade Name: | FLOCAP | |
| Common/Usual Name: | CO₂ detector | |
| Classification Name: | Carbon dioxide gas analyzer<br>CCK - 21 CFR 868.1400<br>Class 2 | |
| Predicate Devices: | Mercury Medical - StatCO₂ – K021576 | |

#### Device Description

The proposed FLOCAP is comprised of several components:

- Housing with standard 15 mm / 22 mm fittings to connect to ventilatory assist devices and a face . mask or endotracheal tube
- . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH
- . A spinner / vane which spins when there is expiratory flow. It is to detect presence of expiratory flow

#### Indications for Use

The FLOCAP is to provide a semi-quantitative visualization of the CO2 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

#### Predicate Device Comparison:

The Maxtec FLOCAP CO2 detector is viewed as substantially equivalent to the predicate device based upon the following:

#### Indications -

Indicated to provide semi-quantitative visualization of the CO2 in the patient airway and as an adjunct in patient assessment for use in hospital, sub-acute and pre-hospital, and

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#### 510(k) Summary Page 2 of 5 27-Mar-14

- . transport for patient greater than 15 kg and up to 24 hours of use are identical to the predicate.
Discussion - The indications for use are identical for the proposed and predicate device. Mercury Medical STAT CO2 - K021576.

#### Contraindications -

The contraindications are almost identical to the predicate. .

Discussion - We added hypercarbia as part of the contraindications, but this does not alter the contraindications and they can be found to be substantially equivalent to the predicate -Mercury Medical STAT CO2- K021576.

#### Technology -

- The technology of a colorimetric, pH sensitive, media to detect the presence and the . amount of CO2 is identical to the predicate.
Discussion - There are no differences in technology between the proposed device and the predicate - Mercury Medical STAT CO2 - K021576.

#### Environment of Use -

- Hospital, sub-acute, Pre-hospital, and transport environments of use are identical to the ● predicate.
Discussion - The environments of use are similar between the proposed device and the predicates - Mercury Medical STAT CO2 - K021576. While the predicate only specifies hospital and transport, sub-acute is a subset of hospitals and pre-hospital is a subset of transport (EMS). The proposed language is only to clarify the environments of use better.

#### Non-clinical Performance Testing

- We compared performance to specifications to the predicate as well as performed . specific tests related to the device. These tests included:
- o Color change response time
- Leakage o
- Minimum static flow indication o
- Anti-fog O
- Packaging integrity per ISTA 2A O
- Operational environment 0
- Shelf-life (aging) o
- Drop test O
- Duration of Use O
- Burst Pressure O
- Compliance per ISO 9360-1 O
- Pressure Drop per ISO 9360-1 O
- Internal Volume (Dead space) O
- 0 Usability per BS EN 62366

Discussion - The bench testing as well as the comparative specifications we found to be similar to the predicate - Mercury Medical STAT CO2 - K021576

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#### 510(k) Summary Page 3 of 5 27-Mar-14

Matcrials -

- • The materials ultized in the FLOCAP are typical and common and have been even so novel billion in in biocompatibility
Discussion The materials vere tested in the finish Intracutancous reactivity.

| Features | Predicate<br>Mercury Medical STAT CO₂<br>(K021576) | Proposed<br>FLOCAP |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Mercury STAT CO₂ is intended to provide a semi-<br>quantitative visualization of the CO₂ in the patient<br>airway. It is an adjunct in patient assessment, to be<br>used in conjunction with other methods to determine<br>clinical signs and symptoms by or on the order of a<br>physician. | The FLOCAP is to provide a semi-quantitative visualization<br>of the CO₂ in the patient airway. It is an adjunct in patient<br>assessment, to be used in conjunction with other methods to<br>determine clinical signs and symptoms by or on the order of<br>a physician. The FLOCAP has a visual indicator to visually<br>detect the end of exhalation. |
| Patient Use / Duration if use | Single patient use, disposable, < 24 hours | Single patient use, disposable, < 24 hours |
| Environment of Use | Hospital | Hospital<br>Sub-acute<br>Pre-hospital |
| | Transport | Transport |
| Patient Population<br>Contraindications | Greater than 15 kg (33 lbs.)<br>• Do not use to detect hypercapnia<br>• Do not use to detect main stem bronchial intubation<br>• Do not use during mouth-to-tube ventilation<br>• Do not use to detect oropharyngeal tube placement<br>When low pulmonary perfusion coincides with accidental<br>esophageal intubation, colorimetric CO₂ indication cannot be<br>properly interpreted. However, if proper tube placement is<br>ascertained by independent means, then the STAT CO₂ may<br>be used to help assess the progress of positive pressure<br>ventilation as evidenced by an increase in end-tidal CO₂. | Greater than 15 kg (33 lbs.)<br>• Do not use to detect hypercapnia / hypercarbia<br>• Do not use to detect main stem bronchial intubation<br>• Do not use during mouth-to-tube ventilation<br>• Do not use to detect oropharyngeal tube placement<br>When low pulmonary perfusion coincides with accidental<br>esophageal intubation, colorimetric CO₂ indication cannot<br>be properly interpreted. However, if proper tube placement<br>is ascertained by independent means, then the FLOCAP may<br>be used to help assess the progress of positive pressure<br>ventilation as evidenced by an increase in end-tidal CO₂. |

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# 510(k) Summary

| Features | Predicate<br>Mercury Medical STAT CO₂<br>(K021576) | Proposed<br>FLOCAP |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Principle of Operation | Colorimetric, pH sensitive dye for detecting presence of CO₂<br>and the amount | Colorimetric, pH sensitive dye for detecting presence of<br>CO₂ and the amount |
| Placement | Between manual resuscitator or pressure source and the<br>patient face mask or endotracheal tube | Between manual resuscitator or pressure source and the<br>patient face mask or endotracheal tube |
| Features, Specifications and Performance | | |
| Standard 15 / 22 mm connections<br>Per ISO 5356-1 | Yes | Yes |
| Internal Volume (dead space) | 25 ml | 25 ml |
| Weight | 22 gr | 23 gr |
| Compliance per ISO 9360-1 | Not provided | 0.44 ml/kPa |
| Leakage per ISO 9360-1 | Not provided | 0.0 ml/min |
| Pressure Drop per ISO 9360-1 | @ 60 lpm - 3.0 cm H₂O | @ 30 lpm - 0.7 cm H₂O<br>@ 60 lpm - 2.7 cm H₂O<br>@ 90 lpm - 5.7 cm H₂O |
| Shelf-life | 2 years | 2 years |
| Packaging and method to<br>"activate" | Polybag<br>Remove plastic tab to expose litmus media | Foil pouch<br>Nothing required to be done to activate |
| Detected % CO₂ ranges and<br>Colors | 0% CO₂ - Blue<br>1.0 to 2.0% CO₂ - Green<br>> 5.0% CO₂- Permanent Yellow | 0% CO₂ - Purple<br>1.0 to 2.0% CO₂ - Beige<br>> 5.0% CO₂- Yellow |
| Method of Communicating<br>Meaning of Color Changes | Matching Colored Label on the Outside of the device | Matching Colored Label on the Outside of the device |
| Meanings of detecting patient<br>exhalation | Color change | Color change<br>Spinning vane - visual indicator (detects exhalation flow > 1<br>lpm) |
| Standards | ISO 5356-1 - Conical fittings | ISO 5356-1 - Conical fittings<br>ISO 9360-1 HME in part |

.

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510(k) Summary Page 5 of 5 27-Mar-14

#### Differences -

There are limited differences between the proposed FLOCAP and the predicate.

- Filter element .
- The predicate includes a filter element to capture any gross particulates that may o come from the device or to protect the colorimetric media from an patient secretions
- o The proposed device does not contain a filter element, as some predicate colorimetric CO2 detectors. For the FLOCAP gas passes around the media and does not have to go through it so protection from patient secretions is less of an issue.

Discussion - All these devices contain notes that if the device is subjected to patient secretions it should be removed and replaced. Therefore this difference is not significant and does not raise any new concerns of safety or effectiveness.

- . Pull tab to active the device
- o The predicate has a tab which seals the media from any ambient air and must be removed prior to use.
- The proposed FLOCAP does not require this tab as the media as the packaging o has demonstrated that it can be safely stored for 2 years without deterioration in performance.

Discussion - The proposed FLOCAP without the pull tab does not raise any new concerns.

#### Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

April 9, 2014

Maxtec, Limited Liability Company Mr. Paul Dryden Consultant 6526 South Cottonwood Street Salt Lake City, UT 84107

Re: K133540

Trade/Device Name: FLOCAP Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 21, 2014 Received: February 24, 2014

Dear Mr. Dryden:

This letter corrects our substantially equivalent letter of March 28, 2014.

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.

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Page 2 – Mr. Dryden

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Todd D. Courtney -S 2014.04.09 14:38:11 -04'00'

for

Erin I. Keith, M.S. 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 Statement

Page 1 of 1

K133540 510(k) Number: (To be assigned)

Device Name: FLOCAP

Indications for Use:

The FLOCAP is to provide a semi-quantitative visualization of the CO2 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

| Prescription Use XX | or | Over-the-counter use |
|-----------------------------|----|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Todd D. Courtney -S 2014.03.24 13:52:13 -04'00'