MaxCap Ped and MaxCap Neo

K182362 · Maxtec, LLC · CCK · May 23, 2019 · Anesthesiology

Device Facts

• Record ID: K182362
• Device Name: MaxCap Ped and MaxCap Neo
• Applicant: Maxtec, LLC
• Product Code: CCK · Anesthesiology
• Decision Date: May 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MaxCap Neo and MaxCap Ped are disposable, colorimetric CO2 detectors; used in hospital, sub-acute, pre-hospital, and transport settings. Device connects between manual resuscitator/pressure source and patient face mask or endotracheal tube. Operates via pH-sensitive litmus media that changes color (Purple to Beige to Yellow) based on CO2 concentration in exhaled breath. Clinicians observe color changes to verify airway placement and monitor ventilation status; used as an adjunct to standard clinical assessment. Provides semi-quantitative CO2 visualization; helps confirm endotracheal tube placement and monitor patient status during ventilation. Benefits include rapid, visual confirmation of CO2 presence in airway, aiding in emergency patient management.

Clinical Evidence

Bench testing only. Performance metrics included color change accuracy, response time, flow resistance/back pressure, internal volume (dead space), device weight, and shelf-life. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity). No clinical data.

Technological Characteristics

Colorimetric CO2 detector; pH-sensitive litmus media. Housing with 15mm/22mm fittings. Disposable, single-patient use. No electronics or software. Biocompatible materials evaluated per ISO 10993-1. MaxCap Neo: 1.0cc dead space, <5g. MaxCap Ped: 2.4cc dead space, <4g.

Indications for Use

Indicated for semi-quantitative CO2 visualization in patient airways as an adjunct to clinical assessment. MaxCap Neo: neonates/infants 250g-6kg. MaxCap Ped: pediatric patients 1kg-15kg. Contraindicated for detection of hypercapnia/hypercarbia, main-stem bronchial intubation, mouth-to-tube ventilation, or oropharyngeal tube placement.

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 Mini Stat CO2 (K031411)
• Mercury Medical NeoStatCO2 (K083056)

Reference Devices

• Maxtec FloCap CO2 Indicator (K133540)

Submission Summary (Full Text)

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

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.

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, LLC<br>2305 South 1070 West<br>Salt lake City, UT 84119 | Tel: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 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,<br>CCK – 21 CFR 868.1400<br>Class II |
| Predicate Devices: | Mercury Medical - Mercury Medical Mini Stat CO2 End<br>Tidal CO2 - K031411<br>Mercury Medical - Mercury Medical NeoStatCO2 <Kg -<br>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) Summary<br>Page 3 of 8<br>23-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 | Proposed<br>MaxCap Neo and<br>MaxCap Ped | Predicate<br>Mercury Neo-Stat CO2<br>K083056 | Predicate<br>Mercury Mini Stat CO2<br>K031411 | Reference<br>Maxtec FloCap<br>K133540 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Maxtec MaxCap Neo and<br>MaxCap Ped are indicated to<br>provide a semi-quantitative<br>visualization of the CO2 in the<br>patient airway. It is an adjunct<br>in patient assessment to be used<br>in conjunction with other<br>methods to determine clinical<br>signs and symptoms by or on<br>the order of a physician. | The Neo-Stat CO2 is<br>indicated to provide a semi-<br>quantitative visualization of<br>the CO2 in the patient<br>airway. It is an adjunct in<br>patient assessment to be used<br>in conjunction with other<br>methods to determine<br>clinical signs and symptoms<br>by or on the order of a<br>physician. Intended for use<br>with neonate and infant<br>patients from 250g to 6kg. | The Mercury Medical Mini<br>StatCO2 End Tidal CO2<br>Detector is to provide a semi-<br>quantitative visualization of<br>the CO2 in the patient airway.<br>It is an adjunct in patient<br>assessment, to be used in<br>conjunction with other<br>methods to determine clinical<br>signs and symptoms by or on<br>the order of a physician. | The FLOCAP is to provide a<br>semi-quantitative<br>visualization of the CO2 in<br>the patient airway. It is an<br>adjunct in patient assessment,<br>to be used in conjunction<br>with other methods to<br>determine clinical signs and<br>symptoms by or on the order<br>of a physician.<br><br>The FLOCAP has a visual<br>indicator to visually detect<br>the 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,<br>pre-hospital and transport | Hospital, sub-acute facilities,<br>pre-hospital and transport | Hospital, Transport | Hospital, sub-acute facilities,<br>pre-hospital and transport |
| Patient Population | MaxCap Neo - 250g to 6kg<br>MaxCap Ped – 1kg to 15kg | 250g to 6kg | 1kg to 15kg | >15 kg |
| 510(k) Summary | | | | |
| Page 6 of 8 | | | | |
| | | 23-May-19 | | |
| Features | Proposed<br>MaxCap Neo and<br>MaxCap Ped | Predicate<br>Mercury Neo-Stat CO2<br>K083056 | Predicate<br>Mercury Mini Stat CO2<br>K031411 | Reference<br>Maxtec FloCap<br>K133540 |
| 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) Summary<br>Page 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…