(1191 days)
The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status.
The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
The MicroTrend System provides a method of assessing the partial pressure of carbon dioxide (PCO2) in the oral mucosa (POMCO2). The MicroTrend System is a device composed of a Monitor, disposable POMCO2 Sensor, and associated connectors. It is designed to be easy to use with minimum training. A single-use disposable POMCO2 sensor is calibrated and then secured against the inside of the patient's cheek. Once the sensor initiates monitoring, the value of POMCO2 is reported on the MicroTrend Monitor instrument display. The MicroTrend Monitor provides trending information on tissue PCO2 readings measured by the disposable sensor every two minutes over a maximum of a 4-hour continuous monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
The MicroTrend System is intended for use as an adjunct to other standard hemodynamic monitored parameters to help interpret the patient condition, treatment, and action by qualified medical professionals.
This document describes the MicroTrend System, a device for monitoring oral mucosal PCO2 (POMCO2), and its substantial equivalence to the predicate device, CapnoProbe-A, based on performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for a specific performance metric of the device in relation to the predicate. Instead, it states that the performance of the MicroTrend System was "demonstrated to be equivalent to the predicate CapnoProbe-A device" and that "measurements taken from healthy volunteer subjects using the MicroTrend System ... were found to be statistically similar to the historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A." Additionally, it mentions "no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility."
Therefore, the implicit acceptance criterion for the primary clinical performance metric (PoMCO2 measurement accuracy/similarity to predicate) is statistical similarity or equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| PoMCO2 Measurement Performance (Animal Study) | Equivalent to predicate CapnoProbe-A under hemorrhagic shock conditions. | Demonstrated recognition of onset of hemorrhagic shock, correlation with severity, and response to reversal, consistent with CapnoProbe-A in an animal study. Reinfusion of shed blood promptly reversed hemodynamic abnormalities and reestablished PoMCO2 near baseline. |
| PoMCO2 Measurement Performance (Clinical Study) | Statistically similar to predicate CapnoProbe-A in healthy volunteers. | Measurements taken from healthy volunteer subjects using the MicroTrend System were found to be statistically similar to historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A. |
| Repeatability and Reproducibility | No statistical difference to predicate CapnoProbe-A. | Volunteer clinical study results demonstrated no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility. These results indicate comparable levels of measurement variation. |
| Other Bench Verification | Pass (specific internal requirements) | Passed all listed bench tests including battery operation, useful life, operating environment, temperature measurement accuracy, and usability. |
| System Error Check | Sensor damage/chewing detected and accounted for. | Evaluation of MicroTrend Sensor design and error checking function when subjected to human chewing "Pass". |
| Simulated Bite/Chewing | Sensor damage and choking hazard assessed. | Assessment of damage to sensor assembly and risk of choking hazard "Pass". |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study: The document mentions "A swine animal study was conducted," but does not specify the sample size (number of animals). The data provenance is prospective (study was conducted to demonstrate performance). No country of origin is specified.
- Clinical Study: The document states "A prospective, non-randomized, single-site historically controlled clinical study was performed to evaluate the Microtrend System performance and compared it to published predicate device data." It involved "healthy volunteer subjects," but the sample size (number of subjects) is not specified. The data provenance is prospective for the subject device data, and retrospective/historical for the predicate device data ("published predicate device data" and "historical, combined values"). No country of origin is specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for either the animal or clinical test sets. The ground truth in the animal study appears to be physiological responses to induced hemorrhagic shock and reversal. In the clinical study, the ground truth for "historical, combined values" from the predicate device would presumably have been established previously, but details are not provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test sets. The clinical study was a "historically controlled clinical study" comparing the subject device's performance to historical predicate data.
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
No, a MRMC comparative effectiveness study was not done. This device is a measurement system and not an AI-assisted diagnostic or interpretive tool that human readers would interact with in a MRMC study context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a measurement system. The "clinical study" compares the standalone performance of the MicroTrend System to the standalone performance of the predicate device. Therefore, the clinical study could be considered a form of standalone performance evaluation where the algorithm/device output is directly compared to a reference (the predicate's historical performance). The study "evaluated the Microtrend System performance" directly.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Animal Study: The ground truth appears to be physiological responses/physiological state (e.g., induction of hemorrhagic shock, systemic lactic acidosis, and reversal of these conditions by reinfusion of blood). The PoMCO2 measurements from the MicroTrend System were expected to reflect these physiological changes similarly to the predicate.
- Clinical Study: The ground truth for comparison appears to be historically established PoMCO2 values obtained from healthy volunteers using the predicate CapnoProbe-A. This implicitly relies on the predicate device's established accuracy. It's a comparison to a known, previously accepted measurement rather than an independent "gold standard" pathology or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a "training set" for an algorithm. The MicroTrend System is described as a measurement device rather than a machine learning/AI algorithm that would typically have a specific training set. The clinical and animal studies described are for validation of the device's performance, not for training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable/provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2024
ExoStat Medical, Inc. % Georgiann Keyport Regulatory Consultant Canopy Regulatory Solutions, Inc. 1073 Falls Curve Chaska, Minnesota 55318
Re: K212425
Trade/Device Name: MicroTrend System Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: November 4, 2022 Received: November 7, 2022
Dear Georgiann Keyport:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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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Indications for Use
510(k) Number (if known) K212425
Device Name MicroTrend System
Indications for Use (Describe)
The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status.
The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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510(k) Summary
This 510(k) summary was prepared to provide an understanding of the basis for determining substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitters Name: | ExoStat Medical, Inc.14162 Commerce Ave. NE, Suite 100Prior Lake, MN 55372-1480 |
|---|---|
| Contact Person: | Georgiann Keyport, Official Correspondent |
| Contact Phone: | (952) 855-4913 |
| Date Summary Prepared: | August 5, 2024 |
| Device Trade Name: | MicroTrend TM System |
| Common Name: | Carbon Dioxide Gas Monitor |
| Classification Name: | 21 CFR 868.1400, Class IIProduct Code: CCK |
| Predicate Device: | K984579, CapnoProbe-AOptical Sensors, Inc.7615 Golden Triangle Drive, Suite AEden Prairie, MN 55344 |
Device Description
The MicroTrend System provides a method of assessing the partial pressure of carbon dioxide (PCO2) in the oral mucosa (POMCO2). The MicroTrend System is a device composed of a Monitor, disposable POMCO2 Sensor, and associated connectors. It is designed to be easy to use with minimum training. A single-use disposable POMCO2 sensor is calibrated and then secured against the inside of the patient's cheek. Once the sensor initiates monitoring, the value of POMCO2 is reported on the MicroTrend Monitor instrument display. The MicroTrend Monitor provides trending information on tissue PCO2 readings measured by the disposable sensor every two minutes over a maximum of a 4-hour continuous monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
The MicroTrend System is intended for use as an adjunct to other standard hemodynamic monitored parameters to help interpret the patient condition, treatment, and action by qualified medical professionals.
Intended Use of the Device
The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status.
The MicroTrend Monitor provides trending information on tissue PoMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
Summary of Technological Characteristics
The following table provides a side-by-side comparison of the MicroTrend System to the predicate CapnoProbe-A device.
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| Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | MicroTrend™™System(Subject: UnderReview) | CapnoProbe-A(Predicate: K984579) | Equivalence Comments |
| Indications for Use | |||
| Intended Use | Regional oralmucosal tissuePCO2monitoring. | Regional oralmucosal tissuePCO2monitoring. | Both devices measure oral mucosal tissuePCO2. |
| AnatomicalStructure ofUse | Oral mucosa,specific regionBuccal mucosa | Oral mucosa,specific regionSublingualmucosa | Both are oral mucosa with similar tissueand vascularization. |
| IndicatedPatientPopulation | Adults – hospitalpatients | Hospital patients | The predicate patient population includesthe MicroTrend System patient population. |
| IndicatedEnvironmentof Use | Hospital/ICUsetting | Hospital/ICUsetting | Same |
| PrescriptionUse Only | Yes | Yes | Same |
| Duration ofUse | Intermittentmonitoring | Intermittentmonitoring | The subject and predicate devices measurePCO2 intermittently; the predicate supportsone measurement per sensor, while thesubject device supports up to four (4) hoursof measurement per sensor. |
| Conditionbeingdiagnosed | Patients at risk ofhemodynamicinstability | Patients at risk ofhemodynamicinstability | Same |
| Single-patient use,disposablesensors | Yes | Yes | Same |
| Technology Comparison | |||
| Principle ofMucosalpCO2measurement | Hydrogen iondetection byConductance | Hydrogen iondetection byFluorescence | Both sensors measure positive Hydrogenions. The hydrogen ions are detected byeither a fluorescence change (CapnoProbe-A) or a conductance change (MicroTrendSystem). Both conductance andfluorescence technologies depend on thesensor cell's hydrogen ion density. |
| OralMucosalpCO2 resultsdisplay | Range: 30 to 150mmHgResolution: 1mmHg | Range: 20 to 150mmHgResolution: 1mmHg | Both devices display measured oralmucosal tissue CO2. |
| Substantial Equivalence Technical Characteristics | |||
| Feature | MicroTrendTM System(Subject: Under Review) | CapnoProbe-A(Predicate: K 984579) | Equivalence Comments |
| OralMucosalpCO2display units | mmHg or kPa | mmHg or kPa | Same |
| Calibrationrequired | Yes, before use | Yes, before use | Same |
| MonitorPowerSource | AC MainsPower orInternalBattery | AC Mains Power | Same – Both devices are powered by theAC mains.The MicroTrend System may also beoperated on the internal battery for up tofour (4) hours. |
| ElectricalSafetyCompliance | IEC 60601-1 | EN 60601-1 | Same |
| EMCCompliance | IEC 60601-1-2 | EN 60601-1-2 | Same |
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As summarized above, the MicroTrend System and the CapnoProbe-A have comparable intended uses, technological characteristics, and specifications.
Non-clinical Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the MicroTrend System, bench evaluations were conducted to confirm compliance with performance requirements.
| Test | Description of Evaluations | Result |
|---|---|---|
| Package and functionalintegrity | The packaging and MicroTrend System performances aftersimulated distribution and at the end of shelf life. | Pass |
| Biocompatibilityevaluations | Cytotoxicity, Intracutaneous Reactivity, Sensitization, andAcute Systemic Toxicity evaluations per ISO10993-5, -10,and -11, respectively. | Pass |
| Software | Software design, validation, and documentation per the FDAGuidance document: Guidance for the Content of PremarketSubmissions for Software Content in Medical Devices. | Pass |
| EMC, Electrical Safety | MicroTrend System conformance with IEC 60601-1-2:2014and IEC 60601-1:Edition 3.1 (2012). | Pass |
| Bench Verificationevaluations | Battery operation and recharging, POMCO2 Sensor Usefullife, Operating Environment, POMCO2 measurementperformance, Temperature measurement accuracy(supporting measurement not displayed), and Usabilityanalyses. | Pass |
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Image /page/7/Picture/0 description: The image shows the logo for ExoStat Medical. The word "ExoStat" is written in a combination of green and blue colors, with "Exo" in green and "Stat" in blue. Below the word "ExoStat", the word "MEDICAL" is written in green, in a smaller font size.
| Test | Description of Evaluations | Result |
|---|---|---|
| System Error Check | Evaluate MicroTrend Sensor design and the error checkingfunction for the MicroTrend System when a MicroTrendDisposable Sensor is subjected to human chewing | Pass |
| Simulated Bite/Chewing | Assess damage to the MicroTrend Sensor assembly whenexposed to typical human biting/chewing forces, and assessthe risk of a potential choking hazard. | Pass |
Animal Tests to Demonstrate Substantial Equivalencv
A swine animal study was conducted to demonstrate the equivalent performance of the MicroTrend compared to the CapnoProbe-A. The PoMCO2 was monitored at baseline after completion of animal preparation, during blood removal for induction of hemorrhagic shock, and during the return of blood removed. The severity of hemorrhagic shock was sufficient to elicit a critical reduction in systemic oxygen delivery, causing systemic lactic acidosis but enabling recovery after the return of blood withdrawn. The analysis focused on determining the ability of the MicroTrend System to recognize the onset of hemorrhagic shock, correlate with its severity, and respond to its reversal.
MicroTrend System performance in the study was demonstrated to be equivalent to the predicate CapnoProbe-A device under experimental conditions of hemorrhagic shock. In the MicroTrend animal study, like the CapnoProbe-A study, the reinfusion of shed blood promptly reversed the hemodynamic abnormalities and reestablished PoMCO2 to near baseline values. This contrasted with a delayed reversal of lactic acidosis.
Clinical Data to Demonstrate Substantial Equivalencv
A prospective, non-randomized, single-site historically controlled clinical study was performed to evaluate the Microtrend System performance and compared it to published predicate device data. Oral mucosal tissue PCO2 (POMCO2) measurements taken from healthy volunteer subjects using the MicroTrend System with a single-use disposable PoMCO2 Sensor for up to four (4) hours were found to be statistically similar to the historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A.
The volunteer clinical study results demonstrated no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility. These results indicate that the MicroTrend System provides comparable levels of measurement variation to the predicate CapnoProbe-A for assessing tissue PCO2.
A human factors validation study was conducted, and the MicroTrend System was concluded to be safe and effective for its intended users, uses, and use environments.
Conclusion
The MicroTrend System is substantially equivalent to the predicate device as supported by intended use, bench performance testing, and animal and clinical evaluations without raising different questions of safety and effectiveness.
N/A