(168 days)
The MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of the muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application is an application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.
The MY01 device is a single-use, sterile, prescription medical device. It consists of two major components: the Introducer (with a plastic housing and 17-gauge stainless-steel needle that allows for placement of a pressure sensor into muscle compartments) and the Pressure Monitor. The Pressure Monitor is a battery-powered, software/firmware controlled component that uses a capacitive Micro-Electro-Mechanical System (MEMS) sensor to measure muscle compartment pressure relative to atmospheric pressure obtained using a second MEMS sensor embedded within the device enclosure. The embedded software/firmware system in the Pressure Monitor handles all processing functions of the MY01 device. Pressure measurements, user notifications, and device status information are displayed on the LCD screen of the Pressure Monitor and stored in non-volatile memory. The MY01 device communicates securely via Bluetooth with the MY01 Mobile Application (the MY01 App) to transmit and display continuously in real time the measured muscle compartment pressure, user notifications and device status information. The muscle compartment pressure is displayed on the MY01 App along with the estimated muscle perfusion pressure that is derived using a manually entered diastolic pressure. The perfusion pressure is calculated using a simple subtraction: Muscle Perfusion Pressure - Muscle Compartment Pressure. The muscle compartment pressure is displayed as real-time numerical values and a continuously updated graph to visualize pressure trends over time. The muscle perfusion pressure is also displayed continuously with a dashed black line, indicating the estimated perfusion pressure based on the latest diastolic pressure entry. The time points of diastolic pressure entries are marked with solid black dots, indicating the calculated perfusion pressure at those specific times. The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device. The MY01 App is not intended for active patient monitoring. Optionally, the MY01 App may connect via an encrypted Wi-Fi/Cellular network to the MY01 Application Server (a cloud-based server managed by MY01 Inc.) to transmit the recorded session and pressure data for off-line review, reporting and archival purposes. Registered clinicians using a MY01 device may reviously recorded session data on the MY01 App and may download this data from the cloud server as a comma separated value (.csv) file. The MY01 Application Server is a Non-Device MDDS; it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data.
The provided text is a 510(k) summary for the MY01 Continuous Compartmental Pressure Monitor. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states that clinical testing was not required and therefore does not provide a study to prove the device meets specific acceptance criteria in a clinical setting.
The performance data section (807.92 (b)(1), (b)(3)) focuses on software system verification and validation, cybersecurity, and shelf-life testing, rather than clinical performance measuring against diagnostic accuracy or other clinical endpoints.
Therefore, many of the requested details about acceptance criteria derived from a clinical study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies cannot be extracted from this document as such studies were not deemed necessary for this 510(k) submission.
Here's the information that can be extracted or inferred based on the provided text, with clarifications where details are missing due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "performance data" pertains to engineering and software validation, not clinical performance metrics. The implicit acceptance criteria are that the device modifications (software updates for perfusion pressure display and extended shelf life) do not adversely affect the device's function, safety, or effectiveness compared to the predicate.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Software System Verification & Validation | Unit-level and functional, system-level (end-to-end) testing of the modified device were successfully conducted in accordance with IEC 62304:2015, 21 CFR 820 (design controls), and FDA guidance following ISO 14971:2019. |
| Cybersecurity Risks | The modified software system was assessed for cybersecurity risks and subjected to vulnerability scanning in accordance with FDA guidance. |
| Shelf-Life Extension (Sterile Device) | Validation by successful completion of sterile package integrity and performance testing using real-time aged devices in accordance with ISO 11607-1:2019. This means the device maintained sterility and functionality for 24 months. |
| Impact of Software/Firmware Changes (v1.8.0 vs. v1.7.0) | "Non-significant changes verified as per IEC 62304:2015. There is no impact on device function, safety or effectiveness." |
| Impact of MY01 Mobile Application Changes (v1.22.0 vs. v1.16.0) | "The software has been updated with the notable functional changes listed below. It includes technical changes for improved user experience and cybersecurity. The changes do not adversely affect device function, safety or effectiveness." This includes new functionality like setting diastolic blood pressure for multiple devices, periodic reminders, and editing previously entered values, all deemed to have "No adverse impact on device safety and effectiveness." Display of perfusion pressure on the app also deemed to have "No adverse impact on device safety and effectiveness," with clinicians able to independently validate results. |
| Diastolic Blood Pressure Range | The change from "0-200 mmHg" to "10-200 mmHg" was noted as "Same, with minor (not clinically significant) change in the acceptable input range." This implies the device functions correctly within the new range. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not applicable/not provided for clinical performance as "Clinical testing was not required to demonstrate substantial equivalence for this device type." The testing mentioned (software, cybersecurity, shelf-life) used other forms of validation, but the "sample size" in a clinical sense is zero.
- Data Provenance: Not applicable for clinical performance. For the engineering tests, no country of origin or retrospective/prospective nature is specified in this summary.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Not applicable as clinical testing was not performed. The ground truth for software and shelf-life testing would be established by engineering and quality standards rather than expert clinical consensus.
4. Adjudication method for the test set
- Not applicable as clinical testing was not performed.
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
- Not applicable. This is not an AI-assisted diagnostic device in the traditional sense that requires human reader comparison studies. It monitors physical parameters and calculates a derived value based on physician input.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs continuous pressure measurement and calculation of perfusion pressure based on manual diastolic pressure input. The document states: "The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device." and "The MY01 Application Server is a Non-Device MDDS; it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data."
- Essentially, the device provides raw and derived numerical data, but the "standalone performance" isn't framed as a diagnostic algorithm. Its accuracy would be in the pressure measurement and calculation, which is implied by the software verification and validation. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) related to diagnosing Compartment Syndrome are provided because it is an "aid in diagnosis" and "Diagnosis should always be made in conjunction with clinical assessments."
7. The type of ground truth used
- For the engineering and software validation, the 'ground truth' would be the expected output or behavior according to design specifications, industry standards (e.g., IEC 62304, ISO 14971), and regulatory guidance.
- For the shelf-life testing, "real-time aged devices" would be compared against their original specifications for package integrity and performance, with the ground truth being these pre-defined specifications.
- No clinical ground truth (e.g., pathology, outcomes data, expert consensus on Compartment Syndrome diagnosis) was used as clinical testing was not required.
8. The sample size for the training set
- Not applicable/not provided. This device relies on pre-defined algorithms for pressure measurement and calculation, not machine learning models that require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable (as above).
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March 13, 2025
MY01 Inc. Olivier Bataille Chief Operating Officer 400 De Maisonneuve Boulevard West. Suite 700 Montreal, QC H3A 1L4 Canada
Re: K242997
Trade/Device Name: MY01 Continuous Compartmental Pressure Monitor Regulatory Class: Unclassified Product Code: LXC Dated: September 26, 2024 Received: February 11, 2025
Dear Olivier Bataille:
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.
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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" (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 QS 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 Rule"). 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-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-regulatory
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assistance/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).
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MY01 Continuous Compartmental Pressure Monitor
Indications for Use (Describe)
The MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of the muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application is an application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.
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
The following information is submitted in accordance with the requirements of 21 CFR 807.92.
Date Prepared: February 10, 2025
807.92 (a)(1): SUBMITTER'S INFORMATION
| Submitted by: | MY01, Inc.400 De Maisonneuve Boulevard West, Suite 700Montréal, Québec, H3A 1L4Canada |
|---|---|
| Contact Person: | Olivier BatailleChief Operating OfficerTel: +1 (855) 799-6901Email: olivier.bataille@my01.io |
| Establishment registration number: | 3017398927 |
| Owner Operator Number: | 10061277 |
807.92 (a)(2): DEVICE INFORMATION
| Device Trade Name: | MY01 Continuous Compartmental Pressure Monitor |
|---|---|
| Device Common Name: | Monitor, Pressure, Intracompartmental |
| Classification Name: | Unclassified |
| Classification Code: | LXC |
| Classification Panel | Orthopedic Devices (OHT6) |
| Regulation Number: | Pre-Amendment, Unclassified |
807.92 (a)(3): PREDICATE DEVICE
MY01 Continuous Compartmental Pressure Monitor, K220952 (MY01, Inc.)
807.92 (a)(4): DEVICE DESCRIPTION
The MY01 Continuous Compartmental Pressure Monitor (the MY01 device) allows for continuous measurement and real-time display of muscle compartment pressure that is intended to be used as an aid in the diagnosis of Compartment Syndrome (Acute and Chronic).
The MY01 device is a single-use, sterile, prescription medical device. It consists of two major components: the Introducer (with a plastic housing and 17-gauge stainless-steel needle that allows for placement of a pressure sensor into muscle compartments) and the Pressure Monitor. The Pressure Monitor is a battery-powered, software/firmware controlled component that uses a capacitive Micro-Electro-Mechanical System (MEMS) sensor to measure muscle compartment pressure relative to atmospheric pressure obtained using a second MEMS sensor
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embedded within the device enclosure. The embedded software/firmware system in the Pressure Monitor handles all processing functions of the MY01 device. Pressure measurements, user notifications, and device status information are displayed on the LCD screen of the Pressure Monitor and stored in non-volatile memory.
The MY01 device communicates securely via Bluetooth with the MY01 Mobile Application (the MY01 App) to transmit and display continuously in real time the measured muscle compartment pressure, user notifications and device status information. The muscle compartment pressure is displayed on the MY01 App along with the estimated muscle perfusion pressure that is derived using a manually entered diastolic pressure. The perfusion pressure is calculated using a simple subtraction: Muscle Perfusion Pressure - Muscle Compartment Pressure. The muscle compartment pressure is displayed as real-time numerical values and a continuously updated graph to visualize pressure trends over time. The muscle perfusion pressure is also displayed continuously with a dashed black line, indicating the estimated perfusion pressure based on the latest diastolic pressure entry. The time points of diastolic pressure entries are marked with solid black dots, indicating the calculated perfusion pressure at those specific times.
The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device. The MY01 App is not intended for active patient monitoring.
Optionally, the MY01 App may connect via an encrypted Wi-Fi/Cellular network to the MY01 Application Server (a cloud-based server managed by MY01 Inc.) to transmit the recorded session and pressure data for off-line review, reporting and archival purposes. Registered clinicians using a MY01 device may reviously recorded session data on the MY01 App and may download this data from the cloud server as a comma separated value (.csv) file. The MY01 Application Server is a Non-Device MDDS; it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data.
Notable changes from the predicate device:
The device modification that necessitated this 510(k) submission entails the calculation and continuous display of the estimated muscle perfusion pressure.
Additionally, the shelf life of the sterile MY01 Continuous Compartmental Pressure Monitor device (introducer and pressure monitor) has been extended to 24 months.
807.92 (a)(5): INTENDED USE/ INDICATIONS FOR USE
The MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.
The subject MY01 Continuous Compartmental Pressure Monitor has the same intended use and indications for use as the predicate device.
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807.92 (a)(6): TECHNOLOGICAL SIMILARITIES AND DIFFERENCES TO THE PREDICATE
| DeviceCharacteristic | Predicate Device (K220952) | Subject Device | Comparison |
|---|---|---|---|
| Manufacturer | MY01 Inc. | MY01 Inc. | Same |
| Device TradeName | MY01 Continuous CompartmentalPressure Monitor | MY01 Continuous CompartmentalPressure Monitor | Same |
| Product Code | LXC - Monitor, Pressure,Intracompartmental | LXC - Monitor, Pressure,Intracompartmental | Same |
| Regulation | Pre-Amendment, Unclassified | Pre-Amendment, Unclassified | Same |
| Indications forUse | The MY01 ContinuousCompartmental Pressure Monitor isused for real-time and continuousmeasurement of the musclecompartment pressure. Themeasured muscle compartmentpressure can be used as an aid indiagnosis of CompartmentSyndrome (Acute and Chronic).The MY01 Mobile Application is anapplication intended for storing anddisplaying identical pressure valuesfrom the MY01 ContinuousCompartmental Pressure Monitordevice and calculating criticalmuscle perfusion pressure utilizingdiastolic pressure manual entry bythe physician. Diagnosis shouldalways be made in conjunction withclinical assessments. | The MY01 ContinuousCompartmental Pressure Monitor isused for real-time and continuousmeasurement of the musclecompartment pressure. Themeasured muscle compartmentpressure can be used as an aid indiagnosis of CompartmentSyndrome (Acute and Chronic).The MY01 Mobile Application is anapplication intended for storing anddisplaying identical pressure valuesfrom the MY01 ContinuousCompartmental Pressure Monitordevice and calculating criticalmuscle perfusion pressure utilizingdiastolic pressure manual entry bythe physician. Diagnosis shouldalways be made in conjunction withclinical assessments. | Same |
| Prescription Use | Yes | Yes | Same |
| Target PatientPopulation | Patients susceptible to developingcompartment syndrome | Patients susceptible to developingcompartment syndrome | Same |
| IntendedAnatomical Site | Extremities | Extremities | Same |
| Environment ofUse | Healthcare environment | Healthcare environment | Same |
| Means ofAccessingAnatomical Siteto MeasurePressure | Introducer consisting of plastichousing with attached 17-gaugestainless-steel needle | Introducer consisting of plastichousing with attached 17-gaugestainless-steel needle | Same |
| Pressure sensingtechnology | Capacitive Micro-Electro-MechanicalSensor (MEMS) | Capacitive Micro-Electro-MechanicalSensor (MEMS) | Same |
| CompartmentalPressure Display | Handheld LCD with adhesive stripbacking for optional attachment topatient's skin | Handheld LCD with adhesive stripbacking for optional attachment topatient's skin | Same |
| Pressure Range | -99.9 to 99.9 mmHg | -99.9 to 99.9 mmHg | Same |
| Device Characteristic | Predicate Device (K220952) | Subject Device | Comparison |
| Sold Sterile | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Shelf Life | 12 Months | 24 Months | Different. Validated as per ISO 11607-1:2019 |
| Maximum Intended Duration of Use | 18 hours | 18 hours | Same |
| Power Source | Two non-rechargeable and non-replaceable 3V batteries | Two non-rechargeable and non-replaceable 3V batteries | Same |
| IP Rating (Ingress Protection) | IP53 | IP52 | Different. The battery-powered Pressure Monitor is adequately protected in the intended use environment. |
| Wireless Connectivity | The monitor communicates securely via Bluetooth Low Energy (BLE) v4.2 with the MY01 Mobile Application | The monitor communicates securely via Bluetooth Low Energy (BLE) v4.2 with the MY01 Mobile Application | Same |
| EMC & Electrical Safety Standards | IEC 60601-1IEC 60601-1-2FCC Subpart 15C | IEC 60601-1IEC 60601-1-2FCC Subpart 15C | Same |
| Firmware | v1.7.0 | v1.8.0 | Different. Non-significant changes verified as per IEC 62304:2015. There is no impact on device function, safety or effectiveness. |
| MY01 Mobile Application | v1.16.0iOS and Android Mobile device compatibility | v1.22.0iOS and Android Mobile device compatibility | Different. The software has been updated with the notable functional changes listed below. It incudes technical changes for improved user experience and cybersecurity. The changes do not adversely affect device function, safety or effectiveness. |
| Does not provide a diagnosis;labelled not to be used for active patient monitoring | Does not provide a diagnosis;labelled not to be used for active patient monitoring | Same | |
| Display of device-measured muscle compartment pressure (numerical value & continuously updated graph) | Display of device-measured muscle compartment pressure (numerical value & continuously updated graph) | Same | |
| Manual entry and display of diastolic blood pressure (range: 0-200 mmHg) | Manual entry and display of diastolic blood pressure (range: 10-200 mmHg) | Same, with minor (not clinically significant) change in the acceptable input range. | |
| DeviceCharacteristic | Predicate Device (K220952) | Subject Device | Comparison |
| -- | -- | Option to set the diastolic bloodpressure value for multiple MY01devices used concurrently on thesame patient | Different. Functionalityadded to promoteconsistency of manualentries across multiplerecording devices. Noadverse impact on devicesafety and effectiveness. |
| -- | -- | Option to set a periodic reminder toupdate the diastolic blood pressurevalue | Different. Functionalityadded to promote the use ofthe most recent diastolicblood pressure measurementin calculating and displayingperfusion pressure.No adverse impact on devicesafety and effectiveness. |
| -- | -- | Option to edit previously entereddiastolic blood pressure values | Different. Functionalityadded to mitigate for useerror and ensure thedisplayed perfusion pressuretrend reflects actual clinicaldiastolic pressuremeasurement. No adverseimpact on device safety andeffectiveness. |
| Perfusion pressure is calculated andavailable off-line on the connectedMY01 Application Server (a cloud-based server managed by MY01Inc. as a Non-Device MDDS).There is no display of perfusionpressure on the MY01 MobileApplication | Perfusion pressure is calculatedusing manually entered diastolicpressure readings. The estimatedperfusion pressure is continuouslydisplayed together with the device-measured muscle compartmentpressure (numerical value &continuously updated graph) alongwith the time and value of the latestdiastolic pressure reading. | Different. Functionalityadded to display the valueand trend of a clinicallyuseful parameter that wouldbe otherwise estimated bythe attending clinicians.Clinicians can independentlyvalidate the results based ondisplayed values on theMobile Application and thedevice itself. No adverseimpact on device safety andeffectiveness. | |
| Access to cloud server via encryptedWi-Fi/Cellular network connectionfor off-line review, reporting andarchival purposes (Registration withMY01 Inc. required) | Access to cloud server via encryptedWi-Fi/Cellular network connectionfor off-line review, reporting andarchival purpose (Registration withMY01 Inc. required) | Same |
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807.92 (b)(1), (b)(3): PERFORMANCE DATA
Software system verification testing at the unit-level and functional, system-level (end-to-end) testing of the modified device were successfully conducted in accordance with the IEC 62304:2015 consensus standard, design control requirements per Quality System Regulation (21 CFR 820), and FDA guidance following systematic risk assessment in accordance with ISO 14971:2019. The modified software system was also assessed for cybersecurity risks, and it was subject to vulnerability scanning in accordance with FDA guidance.
The extended shelf life of the sterile device was validated by successful completion of sterile package integrity and performance testing using real-time aged devices in accordance with ISO 11607-1:2019.
Clinical testing was not required to demonstrate substantial equivalence for this device type.
807.92 (b)(1), (b)(3): SUBSTANTIAL EQUIVALENCE CONCLUSION
The software and labeling changes to the MY01 Continuous Compartmental Pressure Monitor device do not raise new questions of safety and effectiveness. The evidence submitted in this 510(k) Notification supports a finding of substantial equivalence, as it demonstrates that the subject device fulfills its design and risk management requirements, it is as safe and as effective for its intended use, and it performs as well as or better than the legally marketed predicate device.
N/A