(266 days)
Maxtec - FloCap CO2 Indicator - K133540
No
The device description and performance studies focus on the chemical reaction of a colorimetric litmus media to detect CO2, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is indicated to visualize CO2 in the patient airway, functioning as an adjunct in patient assessment rather than providing treatment.
Yes
Explanation: The device is indicated for "semi-quantitative visualization of the CO2 in the patient airway" and described as an "adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms." This direct involvement in patient assessment for determining clinical signs and symptoms classifies it as a diagnostic device.
No
The device description explicitly lists hardware components: a housing with fittings and colorimetric litmus media.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is indicated to provide a semi-quantitative visualization of CO2 in the patient airway. This is a measurement of a physiological process (respiration) occurring in vivo (within the living patient), not a test performed in vitro (outside the body) on a biological specimen.
- Device Description: The device connects directly to the patient's airway (via ventilator assist device, face mask, or endotracheal tube) to analyze the exhaled air. It uses a colorimetric method to detect CO2 in this air.
- Lack of Biological Specimen: IVDs typically analyze biological specimens such as blood, urine, tissue, etc. This device analyzes the composition of exhaled air, which is not considered a biological specimen in the context of IVD regulation.
Therefore, the Maxtec MaxCap Neo and MaxCap Ped are considered medical devices used for monitoring a physiological parameter in a living patient, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CCK
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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
Intended User / Care Setting
Environment of Use: Hospital, sub-acute, pre-hospital, transport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mercury Medical - Mercury Medical Mini Stat CO2 End Tidal CO2 - K031411, Mercury Medical - Mercury Medical NeoStatCO2 Kg - K083056
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Maxtec - FloCap CO2 Indicator - K133540
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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
3
| 510(k) Summary |
|---|
| Page 1 of 8 |
| 23-May-19 |
| Maxtec, LLC
2305 South 1070 West
Salt lake City, UT 84119 | Tel: (385) 549-8080
Fax: (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 868.1400
Class II |
| Predicate Devices: | Mercury Medical - Mercury Medical Mini Stat CO2 End
Tidal CO2 - K031411
Mercury Medical - Mercury Medical NeoStatCO2 15 kg |
| 510(k) Summary | | | | |
| Page 6 of 8 | | | | |
| | | 23-May-19 | | |
| Features | Proposed
MaxCap Neo and
MaxCap Ped | Predicate
Mercury Neo-Stat CO2
K083056 | Predicate
Mercury Mini Stat CO2
K031411 | Reference
Maxtec FloCap
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 | 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 | | | | |
8
9
- 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.
10
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