The Maxtec MaxCap Neo and MaxCap Ped are indicated to provide a semi-quantitative visualization of the CO2 in the patient airvay. 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.

Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg

Environment of Use: Hospital, sub-acute, pre-hospital, transport.

Device Description

The proposed MaxCap Neo and MaxCap Ped are comprised of several components:

. Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device 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

AI/ML Overview

The Maxtec MaxCap Neo and MaxCap Ped devices are semi-quantitative CO2 detectors that use a colorimetric, pH-sensitive dye to visualize CO2 in a patient's airway. The devices are intended for use as an adjunct in patient assessment.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance metric, but rather lists specifications and performance data for the proposed devices and compares them to predicate and reference devices. We can infer the acceptance criteria from the context of these comparisons and discussions of "similar" or "lower" than predicates.

Feature / Acceptance Criteria (Inferred)	Reported Device Performance (MaxCap Neo and MaxCap Ped)
Color change accuracy	Tested and performed
Color change response time	Tested and performed
Drop test	Tested and performed
Duration of Use	Up to 6 hours
Flow Resistance / Back Pressure	MaxCap Neo: < 2.1 cmH2O @ 5 Lpm; < 5.2 cmH2O @ 10 Lpm; < 9.8 cmH2O @ 15 Lpm MaxCap Ped: < 0.2 cmH2O @ 5 Lpm; < 0.5 cmH2O @ 10 Lpm; < 2.8 cmH2O @ 30 Lpm
Internal Volume (Dead space)	MaxCap Neo: 1.0 cc MaxCap Ped: 2.4 cc
Device weight	MaxCap Neo: < 5 g MaxCap Ped: < 4 g
Shelf-life (aging)	1 year
Detected % CO2 ranges and Colors	0% CO2 - Purple 1.0 to 2.0% CO2 - Beige > 5.0% CO2 - Yellow
Means of communicating meaning of color changes	Matching Colored Label on the Outside of the device
Means of detecting patient exhalation	Color change
Breathes to effect color change	< 6 breaths
Packaging integrity (per ISTA 2A)	Performed on reference device (Maxtec FloCap K133540) and applicable due to identical packaging.
Operational environment	Performed on reference device (Maxtec FloCap K133540) and applicable due to identical litmus element materials/chemistry.
Biocompatibility (per ISO 10993-1)	Materials similar to reference device (Maxtec FloCap K133540), which met ISO 10993-1 for cytotoxicity, sensitization, and intracutaneous reactivity. Gas emission VOC and PM2.5 testing also performed.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing that was conducted.

Sample size: Not explicitly stated for each individual test. The statement "We have performed the following performance data and testing for the new models" implies that a sufficient number of devices were tested to evaluate each listed metric.
Data provenance: Bench testing results performed by Maxtec, LLC. The document does not specify a country of origin for the data beyond that. It is retrospective in the sense that the testing has already been completed and is being reported as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided as the device is a colorimetric CO2 detector. The "ground truth" for the performance tests (e.g., CO2 concentration, flow rate, internal volume) would be measured by laboratory equipment and calibrated standards, not by human experts interpreting clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the described studies are non-clinical performance bench tests, not studies involving human interpretation or clinical adjudication.

5. 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:

This information is not applicable. The device is a physical, colorimetric CO2 indicator, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical, colorimetric CO2 indicator, not an algorithm. The reported performance is based on the device's physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the non-clinical performance tests (e.g., color change accuracy, flow resistance, internal volume) was established using calibrated laboratory equipment and controlled gas mixtures to represent specific CO2 concentrations and flow rates. This is an objective measurement rather than expert consensus or pathology.

8. The sample size for the training set:

This information is not applicable. The device is a colorimetric indicator and does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".

May 23, 2019

Maxtec, LLC Paul Dryden Consultant 2305 S 1070 W Salt Lake City, Utah 84119

Re: K182362

Trade/Device Name: MaxCap Ped and MaxCap Neo Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: April 19, 2019 Received: April 22, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

for Michael Ryan

Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182362

Device Name

MaxCap Neo and MaxCap Ped

Indications for Use (Describe)

Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg

Environment of Use: Hospital, sub-acute, pre-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)

Page 1 of 1

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510(k) Summary
Page 1 of 8
23-May-19

Maxtec, LLC2305 South 1070 WestSalt lake City, UT 84119	Tel: (385) 549-8080Fax: (801) 973-6090
Official Contact:	Tammy Lavery, Regulatory Affairs & Quality
Proprietary or Trade Name:	MaxCap Neo and MaxCap Ped
Common/Usual Name:	CO2 detector
Classification Name:	Carbon dioxide gas analyzer,CCK – 21 CFR 868.1400Class II
Predicate Devices:	Mercury Medical - Mercury Medical Mini Stat CO2 EndTidal CO2 - K031411Mercury Medical - Mercury Medical NeoStatCO2 <Kg -K083056
Reference device:	Maxtec - FloCap CO2 Indicator - K133540

Device Description

The proposed MaxCap Neo and MaxCap Ped are comprised of several components:

. Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device 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

Indications for Use

The Maxtec MaxCap Neo and MaxCap Ped are indicated 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.

Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg

Environment of Use: Hospital, sub-acute, pre-hospital, transport.

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Predicate Device Comparison:

The proposed Maxtec MaxCap Neo and MaxCap Ped CO2 detectors are similar except for their intended patient population. In order to make a substantial equivalence comparison, we have to use 2 predicates which match the proposed patient population.

These predicates are:

Mercury Medical Mini-Stat CO2 K031411 for pediatrics .
Mercury Medical Neo-Stat CO2 K083056 for neonates. ●

In addition, since the technological characteristics, construction, materials and CO2 detection performance is equivalent to the Maxtec FloCap (K133540) we have included it as a reference device.

The Maxtec MaxCap Neo and MaxCap Ped CO2 detectors are viewed as substantially equivalent to the predicate devices 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 transport for patients between 250g and 6kg (MaxCap Neo) or 1kg and 15kg (MaxCap Ped) and up to 6 hours of use are similar to the predicates.
Discussion - The indications for use are similar for the proposed and predicate devices, Mercury Medical - Mini Stat CO2 - K031411 and Mercury Medical - Neo-Stat CO2 -K083056.

Contraindications -

The contraindications are similar 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 - Mini Stat CO2 - K031411 and Mercury Medical - Neo-Stat CO2 -K083056, and reference Maxtec - FLOCAP - K133540.

Technology -

The technology of a colorimetric, pH sensitive, media to detect the presence and the ● amount of CO2 is identical to the reference K133540 and similar to the predicates. Discussion - There are no differences in technology between the proposed device and the predicates - Mercury Medical - Mini Stat CO2 - K031411 and Mercury Medical - Neo-Stat CO2 - K083056, and reference Maxtec - FLOCAP - K133540.

Environment of Use -

Hospital, sub-acute, Pre-hospital, and transport environments of use are similar to the ● predicate and reference devices.
Discussion - The environments of use are similar between the proposed device and the predicates - Mercury Medical - Mini Stat CO2 - K031411 and Mercury Medical - Neo-Stat

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	510(k) SummaryPage 3 of 823-May-19
--	--------------------------------------------	--

CO2 - K083056, and reference Maxtec - FLOCAP - K133540. While the predicate Mercury Medical - Mini Stat CO2 - K031411 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 use environments.

Non-clinical Performance

We have performed the following performance data and testing for the new models:

Color change accuracy ●
. Color change response time
Drop test ●
Duration of Use
Flow Resistance / Back Pressure ●
Internal Volume (Dead space)
Device weight
Shelf-life (aging) ●

Tests applicable to the MaxCap Ped and MaxCapNeo that were performed on the reference Maxtec FloCap K133540 include:

. Packaging integrity per ISTA 2A
- The packaging for the proposed devices is identical o
Operational environment
- o The operating environment for the proposed devices is identical
ISO 10993-1 for biocompatibility
- o The materials for the proposed devices are identical, except they do not include the anti-fog coating

Therefore, the reference FloCap (K133540) can be used to represent the proposed models.

Biocompatibility of Patient Contacting Materials -

The materials utilized in the MaxCap Neo and MaxCap Ped are similar to the reference Maxtec FloCap K133540 except the removal of the anti-fog coating.
Discussion - The devices have identical patient contact and the MaxCap has less duration of use, The materials were evaluated in K133540 tested in the final, finished form and found to meet ISO 10993-1 testing for cytotoxicity, sensitization, and Intracutaneous reactivity. In addition, we have performed gas emission VOC and PM2,5 testing. We note that the subject devices do not include the anti-fog material. The change in population does not raise different question of safety and effectiveness as less: maximum 6 hours vs. 24 hours.

Performance Testing

Full performance testing was completed on the Maxtec - FLOCAP - K133540, including testing such as shelf-life, color change response time, leakage, anti-fog, packaging integrity operational environment, usability, duration of use, burst pressure, and biocompatibility were previously performed and cleared in K133540. Much of the testing

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510(k) Summary
Page 4 of 8
23-May-19

is directly applicable to the MaxCap Ped and Neo, since only the form factor has changed.

Certain tests were performed on the reference FloCap (K133540) which were not repeated as the materials, assembly methods and packaging are identical. These tests included:

. Operational environment
- o Only the litmus element is affected by the operational environment, and it is identical in materials and chemistry to the FloCap
. Packaging integrity
- o The packaging is equivalent to FloCap so new testing is not required

Discussion - Through the bench testing as well as the comparative specifications we found the MaxCap Ped and Neo devices to be similar to the predicates.

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510(k) Summary Page 5 of 8

23-May-19

Features	ProposedMaxCap Neo andMaxCap Ped	PredicateMercury Neo-Stat CO2K083056	PredicateMercury Mini Stat CO2K031411	ReferenceMaxtec FloCapK133540
Indications for Use	The Maxtec MaxCap Neo andMaxCap Ped are indicated toprovide a semi-quantitativevisualization of the CO2 in thepatient airway. It is an adjunctin patient assessment to be usedin conjunction with othermethods to determine clinicalsigns and symptoms by or onthe order of a physician.	The Neo-Stat CO2 isindicated to provide a semi-quantitative visualization ofthe CO2 in the patientairway. It is an adjunct inpatient assessment to be usedin conjunction with othermethods to determineclinical signs and symptomsby or on the order of aphysician. Intended for usewith neonate and infantpatients from 250g to 6kg.	The Mercury Medical MiniStatCO2 End Tidal CO2Detector is to provide a semi-quantitative visualization ofthe CO2 in the patient airway.It is an adjunct in patientassessment, to be used inconjunction with othermethods to determine clinicalsigns and symptoms by or onthe order of a physician.	The FLOCAP is to provide asemi-quantitativevisualization of the CO2 inthe patient airway. It is anadjunct in patient assessment,to be used in conjunctionwith other methods todetermine clinical signs andsymptoms by or on the orderof a physician.The FLOCAP has a visualindicator to visually detectthe end of exhalation.
Patient Use	Single patient use, disposable	Single patient use, disposable	Single patient use, disposable	Single patient use, disposable
Environment of Use	Hospital, sub-acute facilities,pre-hospital and transport	Hospital, sub-acute facilities,pre-hospital and transport	Hospital, Transport	Hospital, sub-acute facilities,pre-hospital and transport
Patient Population	MaxCap Neo - 250g to 6kgMaxCap Ped – 1kg to 15kg	250g to 6kg	1kg to 15kg	>15 kg
510(k) Summary
Page 6 of 8
		23-May-19
Features	ProposedMaxCap Neo andMaxCap Ped	PredicateMercury Neo-Stat CO2K083056	PredicateMercury Mini Stat CO2K031411	ReferenceMaxtec FloCapK133540
Contraindications	Do not use the MaxCap for the detection of Hypercapnia/ Hypercarbia. Do not use the MaxCap for the detection of main-stem bronchial intubation. Do not use the MaxCap during mouth to tube ventilation. Do not use the MaxCap to detect oropharyngeal tube placement. Standard clinical assessment must be used.	Do not use for detection of hypercapnia Do not use for the detection of main-stem bronchial intubation Do not use during mouth to tube ventilation Do not use the CO2 detector to detect oropharyngeal tube placement Standard clinical assessment must be used	Unknown	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 placement
Principle of Operation	Colorimetric, pH sensitive dye for detecting presence of CO2 and the amount	Colorimetric, pH sensitive dye for detecting presence of CO2 and the amount	Colorimetric, pH sensitive dye for detecting presence of CO2 and the amount	Colorimetric, pH sensitive dye for detecting presence of CO2 and the amount
Placement	Between manual resuscitator or pressure source and the patient face mask or endotracheal tube	Between manual resuscitator or pressure source and the patient face mask or endotracheal tube	Between manual resuscitator or pressure source and the patient face mask or endotracheal tube	Between manual resuscitator or pressure source and the patient face mask or endotracheal tube
Breathes to effect color change	< 6 breaths	< 6 breaths	< 6 breaths	< 6 breaths
Duration of Use	Up to 6 hours	Up to 24 hours	Up to 24 hours	Up to 24 hours
510(k) SummaryPage 7 of 8
23-May-19
Features	Proposed	Predicate	Predicate	Reference
	MaxCap Neo	Mercury Neo-Stat CO2	Mercury Mini Stat CO2	Maxtec FloCap
	MaxCap Ped	K083056	K031411	K133540
Features, Specifications and Performance
Standard 15 / 22 mm	Yes	Yes	Yes	Yes
connections
Internal Volume	MaxCap Neo - 1.0 cc	1cc	3cc	N/A
(dead space)	MaxCap Ped - 2.4 cc
Weight	< 5 g MaxCap Neo	3g	5g	N/A
	< 4 g MaxCap Ped
Resistance to Flow	MaxCap Neo			N/A
(Pressure Drop)	2.1 cmH2O @ 5 Lpm	3.41 cmH2O @ 5 Lpm
	5.2 cmH2O @ 10 Lpm	11.22 cmH2O @ 10 Lpm
	9.8 cmH2O @ 15 Lpm	23.77 cmH2O @ 15 Lpm
		(As tested)
	MaxCap Ped
	0.2 cmH2O @ 5 Lpm		1.2 cmH2O @ 10 Lpm+
	0.5 cmH2O @ 10 Lpm		2.5 cmH2O @ 10 Lpm*
	2.8 cmH2O @ 30 Lpm		8.8 cm H2O @ 30 Lpm+
Shelf-life	1 year	2 years	2 years	3 years
Detected % CO2 ranges	0% CO2 - Purple	0% CO2 – Blue	0% CO2 – Blue	0% CO2 - Purple
and Colors	1.0 to 2.0% CO2 - Beige	1.0 to 2.0% CO2 - Green	1.0 to 2.0% CO2 - Green	1.0 to 2.0% CO2 - Beige
	> 5.0% CO2 - Yellow	2.0 to 5.0% CO2 -	2.0 to 5.0% CO2 -	> 5.0% CO2- Yellow
		Yellow /Green	Yellow Green
		> 5.0% CO2-	> 5.0% CO2-
		Permanent Yellow	Permanent Yellow
Method of	Matching Colored Label on the	Matching Colored Label on	Matching Colored Label on	Matching Colored Label on
Communicating Meaning	Outside of the device	the Outside of the device	the Outside of the device	the Outside of the device
of Color Changes
Means of detecting patient	Color change	Color change	Color change	Color change
exhalation

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The reported specification in the predicate literature is presented above which is different than that presented in the 510(k) Summaries.

These are values from K083506 510(k) Summary.

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510(k) Summary Page 8 of 8 23-May-19

Differences

The differences in the proposed device and the predicates relate to:

Small differences in internal volume ●
Lower resistance to flow ●
. Shorter shelf-life
- o Shelf-life is not a clinical concern
. Shorter duration of use
- o These devices are used in emergency situations and typically the duration of use is < 1 hour, so having a 6 hour duration of use is acceptable for the intended use

These differences do not raise different questions of safety and effectiveness compared to the predicates.

Substantial Equivalence Conclusion

Testing and comparison to the predicates have demonstrated that the proposed devices can be found substantially equivalent and any differences do not raise different issues of safety and effectiveness.

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).