(1191 days)
Not Found
No
The summary describes a device that measures and trends PCO2 readings. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent processing of the data beyond simple measurement and display.
Nominal: No
Explanation: The device is indicated for monitoring and providing trending information, not for treating or diagnosing any condition directly. It serves as an adjunct to other monitoring tools to assess a patient's peripheral circulation status.
Yes.
Explanation: The device is indicated for "monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters" and is used to "assess a patient's peripheral circulation status." This monitoring and assessment of physiological parameters for clinical interpretation falls under the definition of a diagnostic device.
No
The device description explicitly states the system is composed of a "Monitor, disposable POMCO2 Sensor, and associated connectors," indicating the presence of hardware components beyond just software.
Based on the provided information, the MicroTrend device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- MicroTrend's Function: The MicroTrend directly measures PCO2 in the oral mucosa in vivo (within the living body) using a sensor placed against the tissue. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic parameters. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the MicroTrend falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa, specific region Buccal mucosa
Indicated Patient Age Range
Adults
Intended User / Care Setting
qualified medical personnel, Hospital/ICU setting
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 Tests To Demonstrate Substantial Equivalency:
- Test: Package and functional integrity; Description of Evaluations: The packaging and MicroTrend System performances after simulated distribution and at the end of shelf life.; Result: Pass
- Test: Biocompatibility evaluations; Description of Evaluations: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity evaluations per ISO10993-5, -10, and -11, respectively.; Result: Pass
- Test: Software; Description of Evaluations: Software design, validation, and documentation per the FDA Guidance document: Guidance for the Content of Premarket Submissions for Software Content in Medical Devices.; Result: Pass
- Test: EMC, Electrical Safety; Description of Evaluations: MicroTrend System conformance with IEC 60601-1-2:2014 and IEC 60601-1:Edition 3.1 (2012).; Result: Pass
- Test: Bench Verification evaluations; Description of Evaluations: Battery operation and recharging, POMCO2 Sensor Useful life, Operating Environment, POMCO2 measurement performance, Temperature measurement accuracy (supporting measurement not displayed), and Usability analyses.; Result: Pass
- Test: System Error Check; Description of Evaluations: Evaluate MicroTrend Sensor design and the error checking function for the MicroTrend System when a MicroTrend Disposable Sensor is subjected to human chewing; Result: Pass
- Test: Simulated Bite/Chewing; Description of Evaluations: Assess damage to the MicroTrend Sensor assembly when exposed to typical human biting/chewing forces, and assess the risk of a potential choking hazard.; Result: Pass
Animal Tests to Demonstrate Substantial Equivalence:
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 Equivalence:
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.
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.
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.
Not Found
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
N/A
0
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"
1
(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).
2
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
3
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for ExoStat Medical. The logo has the word "ExoStat" in a combination of green and blue colors. The word "MEDICAL" is written in green below the word "ExoStat".
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 100
Prior 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 II
Product Code: CCK |
| Predicate Device: | K984579, CapnoProbe-A
Optical Sensors, Inc.
7615 Golden Triangle Drive, Suite A
Eden 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.
5
Image /page/5/Picture/0 description: The image shows the logo for ExoStat Medical. The word "Exo" is in green, and the word "Stat" is in blue. Underneath the word "ExoStat" is the word "Medical" in green. The logo is simple and professional.
| Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | MicroTrend™™ | ||
| System | |||
| (Subject: Under | |||
| Review) | CapnoProbe-A | ||
| (Predicate: K |
-
| Equivalence Comments |
| Indications for Use | | | |
| Intended Use | Regional oral
mucosal tissue
PCO2
monitoring. | Regional oral
mucosal tissue
PCO2
monitoring. | Both devices measure oral mucosal tissue
PCO2. |
| Anatomical
Structure of
Use | Oral mucosa,
specific region
Buccal mucosa | Oral mucosa,
specific region
Sublingual
mucosa | Both are oral mucosa with similar tissue
and vascularization. |
| Indicated
Patient
Population | Adults – hospital
patients | Hospital patients | The predicate patient population includes
the MicroTrend System patient population. |
| Indicated
Environment
of Use | Hospital/ICU
setting | Hospital/ICU
setting | Same |
| Prescription
Use Only | Yes | Yes | Same |
| Duration of
Use | Intermittent
monitoring | Intermittent
monitoring | The subject and predicate devices measure
PCO2 intermittently; the predicate supports
one measurement per sensor, while the
subject device supports up to four (4) hours
of measurement per sensor. |
| Condition
being
diagnosed | Patients at risk of
hemodynamic
instability | Patients at risk of
hemodynamic
instability | Same |
| Single-
patient use,
disposable
sensors | Yes | Yes | Same |
| Technology Comparison | | | |
| Principle of
Mucosal
pCO2
measurement | Hydrogen ion
detection by
Conductance | Hydrogen ion
detection by
Fluorescence | Both sensors measure positive Hydrogen
ions. The hydrogen ions are detected by
either a fluorescence change (CapnoProbe-
A) or a conductance change (MicroTrend
System). Both conductance and
fluorescence technologies depend on the
sensor cell's hydrogen ion density. |
| Oral
Mucosal
pCO2 results
display | Range: 30 to 150
mmHg
Resolution: 1
mmHg | Range: 20 to 150
mmHg
Resolution: 1
mmHg | Both devices display measured oral
mucosal tissue CO2. |
| Substantial Equivalence Technical Characteristics | | | |
| Feature | MicroTrendTM System
(Subject: Under Review) | CapnoProbe-A
(Predicate: K 984579) | Equivalence Comments |
| Oral
Mucosal
pCO2
display units | mmHg or kPa | mmHg or kPa | Same |
| Calibration
required | Yes, before use | Yes, before use | Same |
| Monitor
Power
Source | AC Mains
Power or
Internal
Battery | AC Mains Power | Same – Both devices are powered by the
AC mains.
The MicroTrend System may also be
operated on the internal battery for up to
four (4) hours. |
| Electrical
Safety
Compliance | IEC 60601-1 | EN 60601-1 | Same |
| EMC
Compliance | IEC 60601-1-2 | EN 60601-1-2 | Same |
6
Image /page/6/Picture/0 description: The image contains the logo for ExoStat Medical. The word "Exo" is in green, and the word "Stat" is in blue. Underneath the word "ExoStat" is the word "MEDICAL" in green. The logo is simple and clean, and the colors are bright and eye-catching.
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 functional | ||
| integrity | The packaging and MicroTrend System performances after | |
| simulated distribution and at the end of shelf life. | Pass | |
| Biocompatibility | ||
| evaluations | Cytotoxicity, Intracutaneous Reactivity, Sensitization, and | |
| Acute Systemic Toxicity evaluations per ISO10993-5, -10, | ||
| and -11, respectively. | Pass | |
| Software | Software design, validation, and documentation per the FDA | |
| Guidance document: Guidance for the Content of Premarket | ||
| Submissions for Software Content in Medical Devices. | Pass | |
| EMC, Electrical Safety | MicroTrend System conformance with IEC 60601-1-2:2014 | |
| and IEC 60601-1:Edition 3.1 (2012). | Pass | |
| Bench Verification | ||
| evaluations | Battery operation and recharging, POMCO2 Sensor Useful | |
| life, Operating Environment, POMCO2 measurement | ||
| performance, Temperature measurement accuracy | ||
| (supporting measurement not displayed), and Usability | ||
| analyses. | Pass |
7
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 checking | |
| function for the MicroTrend System when a MicroTrend | ||
| Disposable Sensor is subjected to human chewing | Pass | |
| Simulated Bite/Chewing | Assess damage to the MicroTrend Sensor assembly when | |
| exposed to typical human biting/chewing forces, and assess | ||
| the 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.