(130 days)
No
The device description and performance studies focus on physical and chemical properties (colorimetric change, mechanical spinner) and do not mention any computational analysis, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for semi-quantitative visualization of CO2 and detection of expiratory flow, which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
Explanation: The device provides "semi-quantitative visualization of the CO2 in the patient airway" and "visually detect the end of exhalation," which are forms of assessment contributing to a diagnosis or monitoring of a patient's condition. While it is an adjunct, it provides information for patient assessment.
No
The device description clearly lists physical components like a housing, colorimetric litmus media, and a spinner/vane, indicating it is a hardware device with a chemical indicator and mechanical flow detection, not software-only.
Based on the provided information, the FLOCAP device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The FLOCAP is placed in the patient's airway to analyze the CO2 in the exhaled breath. It's directly interacting with the patient's respiratory system, not analyzing a sample removed from the body (like blood, urine, or tissue).
- The mechanism is a direct chemical reaction with exhaled gas. The colorimetric media changes color based on the pH change caused by the presence of CO2 in the breath. This is a direct interaction with the gas in the airway, not an analysis of a biological sample.
- The intended use is for monitoring and assessment in vivo. The device is used as an adjunct in patient assessment by visualizing CO2 in the airway during breathing, which is an in vivo process.
Therefore, the FLOCAP falls under the category of a respiratory monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
CCK
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airway
Indicated Patient Age Range
patients greater than 15 kg (33 lbs.)
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mercury Medical - StatCO₂ – K021576
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 analyzer | |
| CCK - 21 CFR 868.1400 | ||
| 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
1
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
2
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
Mercury Medical STAT CO₂
(K021576) | Proposed
FLOCAP |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Mercury STAT CO₂ is intended 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 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. |
| Patient Use / Duration if use | Single patient use, disposable, 5.0% CO₂- Permanent Yellow | 0% CO₂ - Purple
1.0 to 2.0% CO₂ - Beige
5.0% CO₂- Yellow |
| Method of Communicating
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
exhalation | Color change | Color change
Spinning vane - visual indicator (detects exhalation flow > 1
lpm) |
| Standards | ISO 5356-1 - Conical fittings | ISO 5356-1 - Conical fittings
ISO 9360-1 HME in part |
.
4
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.
5
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.
6
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
7
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)