MY01 Continuous Compartmental Pressure Monitor

K202635 · MY01, Inc. · LXC · Dec 10, 2020 · OR

Device Facts

• Record ID: K202635
• Device Name: MY01 Continuous Compartmental Pressure Monitor
• Applicant: MY01, Inc.
• Product Code: LXC · OR
• Decision Date: Dec 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows displayed are meant for qualitative purposes only and are not intended to have any clinical significance.

Device Story

Device measures intracompartmental pressure via capacitive MEMS sensor on flexible PCB; includes introducer with 17-gauge stainless-steel needle for muscle compartment placement. Monitor attaches to patient skin via adhesive; displays real-time pressure on LCD. Modification adds Bluetooth Low Energy (BLE) for data transmission to mobile app for logging/archival. Mobile app does not analyze/interpret data, aid in diagnosis, or control device functions. Data transmitted via encrypted BLE link to app, then forwarded via encrypted network to cloud server. Used in clinical settings; operated by healthcare providers. Provides continuous pressure values to assist clinical decision-making for compartment syndrome diagnosis.

Clinical Evidence

Bench testing only. Verification and validation testing performed per IEC 60601-1-1, IEC 60601-1-2/CISPR 11, IEC 62304, and FDA guidance for cybersecurity and interoperability. No clinical data presented.

Technological Characteristics

Components: Introducer (plastic housing, 17-gauge stainless-steel needle), Pressure Monitor (capacitive MEMS sensor, flexible/rigid PCB). Connectivity: BLE wireless. Power: Battery-operated. Sterilization: Sterile, single-patient use. Software: Embedded firmware with BLE communication. Standards: IEC 60601-1-1, IEC 60601-1-2, CISPR 11, IEC 62304.

Indications for Use

Indicated for real-time, continuous measurement of compartmental pressures as an aid in diagnosing compartment syndrome.

Predicate Devices

• MY01 Continuous Compartmental Pressure Monitor (K193321)

Submission Summary (Full Text)

{0}------------------------------------------------

December 10, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MY01, Inc. Anthony Sirgi Regulatory Affairs and Compliance Officer 400 De Maisonneuve Boulevard West, Suite 700 Montreal, Quebec H3A 1L4 Canada

Re: K202635

Trade/Device Name: MY01 Continuous Compartmental Pressure Monitor Regulatory Class: Unclassified Product Code: LXC Dated: October 21, 2020 Received: October 23, 2020

Dear Anthony Sirgi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

{1}------------------------------------------------

combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K202635

#### Device Name

MY01 Continuous Compartmental Pressure Monitor

Indications for Use (Describe)

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows displayed are meant for qualitative purposes only and are not intended to have any clinical significance.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size:20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span>☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

#### 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 [e-mail]

"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."

{3}------------------------------------------------

# 510(k) Summary

In accordance with the requirements of 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness for the MY01 Continuous Compartmental Pressure Monitor.

# SUBMITTERS INFORMATION

| Submitted by: | MY01, Inc. |
|------------------------------------|-------------------------------------------------------|
| | 400 De Maisonneuve Boulevard West, Suite 700 |
| | Montréal, Quebec, H3A 1L4 |
| | Canada |
| Establishment Registration Number: | 3017398927 |
| Owner Operator Number: | 10061277 |
| Contact Person: | Anthony Sirgi |
| | Address: 400 De Maisonneuve Boulevard West, Suite 700 |
| | Montréal, Quebec, H3A 1L4 |
| | Canada |
| | Regulatory Affairs and Compliance Officer |
| | Tel: [phone] |
| | Email: [e-mail] |
| Date Prepared: | December 08, 2020 |

#### DEVICE INFORMATION

| Device Trade Name: | MY01 Continuous Compartmental Pressure Monitor |
|------------------------------|------------------------------------------------|
| Device Common Name: | Monitor, Pressure, Intracompartmental |
| Classification Name: | Unclassified |
| Classification Product Code: | LXC |
| Classification Panel: | Orthopedic |
| Regulation Number: | Pre-Amendment, Unclassified |

{4}------------------------------------------------

### PREDICATE DEVICE

#### K193321 MY01 Continuous Compartmental Pressure Monitor

#### DEVICE DESCRIPTION

The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressure. The measured compartmental pressures should always be used along with the current standard of care as an aid in the diagnosis of compartment syndrome.

The device is supplied sterile for single patient use and intended to be used for 18 hours, it contains two major components that are referred to as the Introducer (plastic housing and 17gauge stainless-steel needle) and the Pressure Monitor. The Pressure Monitor consists of a capacitive Micro-Electro-Mechanical System (MEMS) pressure sensor, which allows for the measurement of intracompartmental pressure relative to a secondary atmospheric pressure sensor. It is embedded on a flexible PCB circuit, which extends via a lead-wire to a rigid PCB circuit within the Pressure Monitor. The Introducer allows for placement of the pressure sensor into muscle compartments. The Pressure Monitor continuously outputs pressure values on the LCD screen and can be attached on the patient's skin using the provided adhesive strip on the underside.

Modification: The purpose of this submission is an enhancement of the device functionality to include wireless communication over Bluetooth Low Energy (BLE) to transmit data to a compatible mobile application for data logging and archival purposes.

The MY01 mobile application does not analyze of interpret recorded pressure data. It is not intended to aid in diagnosis or monitoring. The application is not able to control any functions or configuration parameters of the MY01 device. Authenticated users of the mobile application can securely connect to a MY01 device and enable the transmission of pressure data via an encrypted BLE link. The current pressure data measurement is displayed on the application and forwarded via an encrypted network link to a cloud-based server (MY01 application server) for data logging and archival purposes.

## INTENDED USE/INDICATIONS FOR USE

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows displayed are meant for qualitative purposes only and are not intended to have any clinical significance.

#### Technological Similarities and Differences to the Predicate

The subject MY01 device has the same intended use and indications for use as the cleared predicate MY01 device (K193321).

The subject MY01 device has the same technical specifications as the predicate MY01 device with the exception of the enabled BLE wireless connectivity.

{5}------------------------------------------------

## PERFORMANCE DATA

Systematic risk analysis of the modified device was conducted in accordance with ISO 14971 considering possible cybersecurity vulnerabilities and interoperability characteristics introduced by the BLE connectivity. The following established test methods, FDA recognized standards and FDA guidance were used to evaluate the safety and performance of the modified device and support substantial equivalence:

- Electrical Safety per IEC 60601-1-1 ●
- EMC emissions per IEC 60601-1-2/CISPR 11 and 21 CFR 47 Part 15
- EMC Immunity per IEC 60601-1-2 ●
- Software verification per IEC 62304 ●
- Cybersecurity assessment per FDA guidance: Content of Premarket Submissions for . Management of Cybersecurity in Medical Devices.
- Interoperability assessment per FDA guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
- Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and ● FDA Staff.

The subject MY01 device with BLE wireless connectivity successfully PASSED all verification and validation testing, demonstrating the effectiveness of risk mitigations and providing a high level of assurance that the MY01 device fulfills design input requirements and meets established performance criteria for the intended use.

## SUBSTANTIAL EQUIVALENCE CONCLUSION

The subject MY01 device has the same intended use and indications for use as the predicate device. Additionally, the modified subject device uses the same fundamental technology, basic design and operating principle for its intended use and is manufactured and sterilized using the same materials and processes as the predicate device. Except for the modifications described in this submission, the subject device is identical to the predicate devices, and the performance data and risk analysis demonstrate that any differences between these devices do not raise new questions of safety and effectiveness and the subject device is at least as safe and effective as the legally marketed predicate device.