(241 days)
Not Found
No
The description focuses on hardware components (MEMS pressure sensor, PCB circuits) and basic software functions (displaying pressure values, warning messages). There is no mention of AI, ML, or any algorithms that would learn or adapt from data. The "trend arrows" are explicitly stated as informational and not for diagnosis, suggesting a simple calculation rather than an intelligent analysis.
No.
The device is used to diagnose compartment syndrome, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measured compartmental pressures can be used "as an aid in the diagnosis of compartment syndrome." Additionally, the "Device Description" reiterates that the device "should always be used along with the current standard of care as an aid in the diagnosis of compartment syndrome."
No
The device description explicitly states it contains hardware components, including an Introducer (plastic housing and needle), a Pressure Monitor with a capacitive MEMS pressure sensor, and associated circuitry. The performance studies also mention hardware and software verification and validation.
Based on the provided information, the MY01 Continuous Compartmental Pressure Monitor is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the measured compartmental pressures "can be used as an aid in the diagnosis of compartment syndrome." This directly aligns with the definition of an IVD, which is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. While the device measures pressure in situ within the body, the use of that measurement is for diagnosis.
- Device Description: The device measures "intracompartmental pressure relative to a secondary atmospheric pressure sensor." This measurement is a physiological parameter derived from the human body.
- Predicate Device: The predicate device listed, K131966 Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III), is also a device used for measuring compartmental pressure as an aid in diagnosis, further supporting the classification as an IVD.
While the device itself is placed in vivo to collect the data, the purpose of collecting that data is for in vitro diagnostic use (interpreting the pressure values to aid in diagnosis). The pressure reading is the "specimen" in this context, derived from the human body and used for diagnostic information.
N/A
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 along with the current standard of care as an aid in the diagnosis of compartment syndrome. The trend arrows provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.
Product codes
LXC
Device Description
The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressured 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 can be used up to a maximum of 18 hours, at which point a warning message is displayed cautioning the user. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscle compartments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Systematic risk analysis was conducted in accordance with ISO 14971 and risks were mitigated as far as possible considering device sterility at the point of care, the biological safety of device materials, electrical safety and electromagnetic compatibility (EMC), hardware and software component specifications, and human factors for the intended use:
- Device sterility, shelf life, and packaging integrity to the point of use were validated according to FDA recognized industry standards and guidance documents.
- The biological safety of final finished, sterile device was evaluated in accordance with FDA guidance on the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2016), and the current FDA recognized standard ISO 10993-1. for externally communicating devices with limited contact duration (
N/A
0
July 30, 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
MY01, Inc. Charles Allan Chief Executive Officer 85 Rue Saint-Paul Ouest, Suite 200 Montreal, H2Y 3V4 Ca
Re: K193321
Trade/Device Name: MY01 Continuous Compartmental Pressure Monitor Regulatory Class: Unclassified Product Code: LXC Dated: July 29, 2020 Received: July 30, 2020
Dear Charles Allan:
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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
1
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 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).
Sincerely,
Vesa Vuniqi Assistant Director DHT6A: Division of Joints Arthroplasty OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193321
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 provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CER 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."
3
Image /page/3/Picture/0 description: The image shows a logo with the text "MY01" to the right of an abstract graphic. The graphic consists of an orange circle overlapping a light orange, elongated shape. The text is in a simple, sans-serif font and is black.
510(k) Summary for the MY01 Continuous Compartmental Pressure Monitor
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.
A. SUBMITTERS INFORMATION
| Submitted by: | MY01, Inc.
85 Rue Saint-Paul Ouest, Suite 200,
Montréal, Québec, H2Y 3V4, CANADA |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Sirgi
Address: 85 Rue Saint-Paul Ouest, Suite 200,
Montréal, Québec, H2Y 3V4, CANADA
Regulatory Affairs and Compliance Officer
Email: anthony.sirgi@my01.io
Tel: (514) 963-6027 |
Date Prepared: November 27, 2019
B. DEVICE INFORMATION
| Registration Number: | TBD |
|---|---|
| Device Trade Name: | MY01 Continuous Compartmental Pressure Monitor |
| Device Common Name: | Monitor, Pressure, Intracompartmental |
| Classification Name: | Unclassified |
| Classification Code: | LXC |
| Classification Panel: | Orthopedic |
| Regulation Number: | Pre-Amendment, Unclassified |
C. PREDICATE DEVICE
| K131966 | Twin Star Extremity Compartment Monitor and Fluid Collection |
|---|---|
| System (ECM-III) |
D. DEVICE DESCRIPTION
The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressured 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 can be used up to a maximum of 18 hours, at which point a warning message is displayed cautioning the user. It contains two major components that are referred to as the Introducer (plastic housing and 17gauge stainless-steel needle)
4
Image /page/4/Picture/0 description: The image shows a logo with the text "MY01" to the right of a graphic. The graphic is an abstract shape in a light orange color, with a darker orange circle overlapping it. The text "MY01" is in a simple, sans-serif font and is black.
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.
E. 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 along with the current standard of care as an aid in the diagnosis of compartment syndrome. The trend arrows provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.
This intended use for the MY01 subject device is identical to the predicate device, with the exception of the latter's ability for fluid withdrawal for analysis. Since, this is an additional indication, it does not impact the intended use for continuous measurement of compartment pressures and thus, does not affect the safety and effectiveness of the subject device.
F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The MY01 device has the similar intended use and equivalent indications for use as the predicate Twin Star device.
The devices have the following technological similarities:
- Use of continuously inserted measuring pressure sensor; ●
- . Use of LCD display monitor to display pressure values in mmHg;
- Sterile and single use introducer mechanism;
- . Use of stainless-steel needle or trocar as introducers;
- Similar insertion sites;
- Use of software to provide pressure readings;
- . Use of external or built-in battery for power source.
The following technological differences exist between the subject and predicate device:
- . The predicate device uses fiber optics to sense a change in pressure while the MY01 device measures a change in sensor capacitance, however both devices use established effective methods incorporating membranes to measure relative pressure;
5
Image /page/5/Picture/0 description: The image shows a logo with the text "MY01" to the right of an abstract graphic. The graphic consists of a light orange, elongated shape with a darker orange circle overlapping it. The text is in a simple, sans-serif font and is black in color.
- . The predicate device uses a porous catheter to host the pressure sensor while MY01 device uses a flexible printed circuit to host the pressure sensor
- . The predicate device includes a reusable monitor, a sterile catheter for single-patient and a vacuum pump that may be connected to a fluid collection catheter, while the MY01 device supplied sterile for single-patient use and does not provide a means for fluid collection
The MY01 device is substantially equivalent to the Twin Star predicate device based on intended use and indications for use, method of use for measuring intracompartmental pressure, and compliance to FDA recognized safety and performance consensus standars. The differences in technological characteristics are not significant and do not raise additional questions of safety and effectiveness as it can be demonstrated by a review of predicate device characteristics, design and development standards, and non-clinical performance testing. The differences in materials and manufacturing processes have been successfully assessed for safety and effectiveness using the same industry testing methods for the subject device.
G. PERFORMANCE DATA
Systematic risk analysis was conducted in accordance with ISO 14971 and risks were mitigated as far as possible considering device sterility at the point of care, the biological safety of device materials, electrical safety and electromagnetic compatibility (EMC), hardware and software component specifications, and human factors for the intended use:
- . Device sterility, shelf life, and packaging integrity to the point of use were validated according to FDA recognized industry standards and guidance documents.
- The biological safety of final finished, sterile device was evaluated in accordance with . FDA guidance on the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2016), and the current FDA recognized standard ISO 10993-1. for externally communicating devices with limited contact duration (