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 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

AI/ML Overview

The FLOCAP device, a colorimetric CO2 detector, was deemed substantially equivalent to the predicate device, Mercury Medical STAT CO2 (K021576), based on non-clinical performance testing and comparative specifications.

Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate: Mercury Medical STAT CO₂)	Reported Device Performance (FLOCAP)
Indications for Use	Semi-quantitative visualization of CO₂ in patient airway; adjunct in patient assessment.	Identical: Semi-quantitative visualization of CO₂ in patient airway; adjunct in patient assessment, with a visual indicator for end of exhalation.
Patient Use / Duration if use	Single patient use, disposable, < 24 hours	Identical: Single patient use, disposable, < 24 hours
Environment of Use	Hospital, Transport	Hospital, Sub-acute, Pre-hospital, Transport (Clarification, considered similar)
Patient Population	Greater than 15 kg (33 lbs.)	Identical: Greater than 15 kg (33 lbs.)
Contraindications	Similar contraindications provided	Similar contraindications, with addition of "hypercarbia" which was deemed not to alter the contraindications materially.
Principle of Operation	Colorimetric, pH sensitive dye	Identical: Colorimetric, pH sensitive dye
Placement	Between manual resuscitator/pressure source and patient face mask/endotracheal tube	Identical: Between manual resuscitator/pressure source and patient face mask/endotracheal tube
Standard 15 / 22 mm connections per ISO 5356-1	Yes	Yes
Internal Volume (dead space)	25 ml	25 ml (Identical)
Weight	22 gr	23 gr (Similar)
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;@ 60 lpm - 2.7 cm H₂O;@ 90 lpm - 5.7 cm H₂O (Similar)
Shelf-life	2 years	2 years (Identical)
Packaging and method to "activate"	Polybag, remove plastic tab	Foil pouch, nothing required to be done to activate (Considered not to raise new concerns)
Detected % CO₂ ranges and Colors	0% CO₂ - Blue; 1.0-2.0% CO₂ - Green; > 5.0% CO₂ - Permanent Yellow	0% CO₂ - Purple; 1.0-2.0% CO₂ - Beige; > 5.0% CO₂ - Yellow (Different colors, but similar functionality of color change for CO₂ detection)
Method of Communicating Meaning of Color Changes	Matching Colored Label on the Outside of the device	Identical: Matching Colored Label on the Outside of the device
Meanings of detecting patient exhalation	Color change	Color change; Spinning vane - visual indicator (detects exhalation flow > 1 lpm) (Added feature, enhances detection)
Standards	ISO 5356-1	ISO 5356-1, ISO 9360-1 HME in part (Adherence to relevant standards)
Filter element	Present	Not present (Considered not to raise new concerns as patient secretions mitigation is similar to predicate's instructions)
Pull tab to activate	Present	Not present (Packaging demonstrated safe storage without deterioration)

Study Information

Sample size used for the test set and the data provenance: Not explicitly stated for specific tests. The summary indicates "comparative specifications" and "specific tests related to the device" were performed. The testing seems to be bench testing against the predicate's specifications rather than a clinical study with a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical ground truth establishment by experts is not described for the non-clinical performance testing.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC comparative effectiveness study was not performed. This is a non-AI medical device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Standalone performance was assessed through various non-clinical bench tests (e.g., color change response time, leakage, minimum static flow indication, anti-fog, shelf-life, drop test, duration of use, burst pressure, compliance, pressure drop, internal volume, usability).
The type of ground truth used: For the bench testing, the "ground truth" was established based on engineering specifications, physical measurements, and comparison to the predicate device's characteristics and performance parameters.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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

Maxtec, LLC
6526 S Cottonwood Street	Tel: 801.327.9870
Salt lake City, UT 84107	Fax: 801.270.5590
Official Contact:	Tammy Lavery, Regulatory Affairs & Quality
Proprietary or Trade Name:	FLOCAP
Common/Usual Name:	CO₂ detector
Classification Name:	Carbon dioxide gas analyzerCCK - 21 CFR 868.1400Class 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 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	PredicateMercury Medical STAT CO₂(K021576)	ProposedFLOCAP
Indications for use	The Mercury STAT CO₂ is intended to provide a semi-quantitative visualization of the CO₂ in the patientairway. It is an adjunct in patient assessment, to beused in conjunction with other methods to determineclinical signs and symptoms by or on the order of aphysician.	The FLOCAP is to provide a semi-quantitative visualizationof the CO₂ in the patient airway. It is an adjunct in patientassessment, to be used in conjunction with other methods todetermine clinical signs and symptoms by or on the order ofa physician. The FLOCAP has a visual indicator to visuallydetect 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	HospitalSub-acutePre-hospital
	Transport	Transport
Patient PopulationContraindications	Greater than 15 kg (33 lbs.)• Do not use to detect hypercapnia• Do not use to detect main stem bronchial intubation• Do not use during mouth-to-tube ventilation• Do not use to detect oropharyngeal tube placementWhen low pulmonary perfusion coincides with accidentalesophageal intubation, colorimetric CO₂ indication cannot beproperly interpreted. However, if proper tube placement isascertained by independent means, then the STAT CO₂ maybe used to help assess the progress of positive pressureventilation as evidenced by an increase in end-tidal CO₂.	Greater than 15 kg (33 lbs.)• Do not use to detect hypercapnia / hypercarbia• Do not use to detect main stem bronchial intubation• Do not use during mouth-to-tube ventilation• Do not use to detect oropharyngeal tube placementWhen low pulmonary perfusion coincides with accidentalesophageal intubation, colorimetric CO₂ indication cannotbe properly interpreted. However, if proper tube placementis ascertained by independent means, then the FLOCAP maybe used to help assess the progress of positive pressureventilation as evidenced by an increase in end-tidal CO₂.

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510(k) Summary

Features	PredicateMercury Medical STAT CO₂(K021576)	ProposedFLOCAP
Principle of Operation	Colorimetric, pH sensitive dye for detecting presence of CO₂and the amount	Colorimetric, pH sensitive dye for detecting presence ofCO₂ and the amount
Placement	Between manual resuscitator or pressure source and thepatient face mask or endotracheal tube	Between manual resuscitator or pressure source and thepatient face mask or endotracheal tube
Features, Specifications and Performance
Standard 15 / 22 mm connectionsPer 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@ 60 lpm - 2.7 cm H₂O@ 90 lpm - 5.7 cm H₂O
Shelf-life	2 years	2 years
Packaging and method to"activate"	PolybagRemove plastic tab to expose litmus media	Foil pouchNothing required to be done to activate
Detected % CO₂ ranges andColors	0% CO₂ - Blue1.0 to 2.0% CO₂ - Green> 5.0% CO₂- Permanent Yellow	0% CO₂ - Purple1.0 to 2.0% CO₂ - Beige> 5.0% CO₂- Yellow
Method of CommunicatingMeaning of Color Changes	Matching Colored Label on the Outside of the device	Matching Colored Label on the Outside of the device
Meanings of detecting patientexhalation	Color change	Color changeSpinning vane - visual indicator (detects exhalation flow > 1lpm)
Standards	ISO 5356-1 - Conical fittings	ISO 5356-1 - Conical fittingsISO 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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'

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).