K Number

Device Name

Compremium Compartment Compressibility Monitoring System (CPM#1)

Manufacturer

Compremium AG

Date Cleared

2023-04-14

(143 days)

Product Code

LXC

Regulation Number

N/A

Intended Use

The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility. The relative compartment compressibility (CP Value) is not meant for trend analysis.

Device Description

The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K210525

Reference Devices

K163443

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on direct measurement and calculation based on physical principles (ultrasound distance and pressure), with no mention of AI/ML algorithms for analysis or interpretation.

Therapeutic

No
The device is described as a monitoring system that calculates and displays a relative compartment compressibility value, but there is no mention of it providing any therapeutic intervention or treatment.

Diagnostic

Yes

Explanation: The device is described as a "Compartmental Compressibility Monitoring System" that provides a "relative compartment compressibility value (CP Value)". While it states the CP Value is "not meant for trend analysis," monitoring physiological parameters to obtain a value related to the body's state falls under the definition of a diagnostic device, as it provides information that can be used for diagnosis, even if not for trend monitoring. Furthermore, the clinical testing aimed to validate repeatability and reproducibility of measurements, which is characteristic of diagnostic tools.

SaMD (Software as a Medical Device)

The device description explicitly states it combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Compartmental Compressibility Monitoring System (CPM#1) is a non-invasive device that uses ultrasound and pressure to measure the compressibility of a compartment in the body. It does not analyze samples taken from the body.
Intended Use: The intended use is for monitoring relative compartment compressibility, which is a physical characteristic measured directly on the patient.

Therefore, the CPM#1 falls under the category of a medical device but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis.

Product codes

LXC

Device Description

The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Not Found

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

Biocompatibility Testing
The biocompatibility testing for the CPM#1 System was conducted in accordance with ISO 10993-1:2018, following the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and with ISO 14971:2019, "Medical devices - application of risk management to medical devices".

Electrical Safety Testing
Electrical safety testing for the CPM#1 System was conducted in accordance with IEC 60601-1:2005/AMD1:2012. EMC testing was also conducted in accordance with IEC 60601-1-2:2014/AMD1:2020.

Usability Testing
Usability testing was conducted in accordance with IEC 62366-1:2015 + A1:2020.

Cleaning and Disinfection Testing
The manual cleaning and low-level disinfection process was validated in accordance with ISO 17664-2:2021.

Ultrasound Performance Testing
The acoustic output of the CPM#1 System was tested in accordance with IEC 60601-2-37:2007/AMD1:2015 and IEC 62359:2.1/AMD1:2017. The image quality was tested to confirm compliance with design input requirements.

CP Value Performance Testing
The accuracy, repeatability, and reproducibility of the CP Value was confirmed using an in-vitro bench test model.

The collective results of the nonclinical testing demonstrate that the design, the materials chosen, and the manufacturing processes of the CPM#1 System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the CPM#1 System does not raise different questions of safety or effectiveness for its intended use when compared to the predicate device.

Clinical Testing
A study was performed to validate the repeatability and reproducibility of the CPM#1 System relative compartment compressibility measurements in healthy volunteers.

Key Metrics

Not Found

Predicate Device(s)

MY01 Continuous Compartmental Pressure Monitor (K210525)

Reference Device(s)

Interson USB Ultrasound System (K163443)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 14, 2023

Compremium AG % Philippe Etter Senior Partner Medidee Services LLC 300 Welsh Road, Building 1. Suite 100 Horsham, Pennsylvania 19044

Re: K223509

Trade/Device Name: Compremium Compartment Compressibility Monitoring System (CPM#1) Regulatory Class: Unclassified Product Code: LXC Dated: April 3, 2023 Received: April 4, 2023

Dear Philippe Etter:

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 (OS) 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,

Limin Sun -

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

Indications for Use

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

510(k) Number (if known) K223509

Device Name

Compremium Compartmental Compressibility Monitoring System (CPM#1)

Indications for Use (Describe)

The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.

The relative compartment compressibility (CP Value) is not meant for trend analysis.

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

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Image /page/3/Picture/1 description: The image contains the logo for Compremium. The logo consists of a circular icon with four curved lines inside, followed by the text "Compremium" in a sans-serif font. The logo and text are both in a dark blue color.

510(k) Summary

| Submitter | Compremium AG
Worbstrasse 46
3074 Muri bei Bern
Switzerland |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vincent Baumann, CEO
Phone: +41 79 933 96 48
Email: v.baumann@compremium.ch |
| Date Prepared | April 4th, 2023 |
| Name of Device | Compremium Compartmental Compressibility Monitoring System (CPM#1) |
| Classification Name | Intracompartmental pressure monitor |
| Classification Panel | Orthopedic |
| Classification | Pre-amendment, Unclassified |
| Product Code(s) | LXC |
| Predicate Device | MY01 Continuous Compartmental Pressure Monitor (K210525) |
| Reference Device | Interson USB Ultrasound System (K163443) |
| Description of Device | The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value. |
| Indication for Use | The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis. |

Image /page/4/Picture/1 description: The image contains the logo for Compremium. The logo consists of a dark blue rounded square with four white curved lines inside, resembling sound waves. To the right of the icon is the word "Compremium" in a dark blue sans-serif font.

Comparison of	CPM#1 System	MY01	Interson SP-L01
Technological
Characteristics with	(Subject Device	(Predicate Device)	(Reference Device)
Predicate and
Reference Devices
510(k) Number	K223509	K210525	K163443
Product Code(s)	LXC	LXC	IYN, IYO, ITX
Indication for Use	The Compartmental
Compressibility Monitoring
System (CPM#1) is
intended for real-time and
intermittent monitoring of
relative compartment
compressibility.
The relative compartment
compressibility (CP Value)
is not meant for trend
analysis.	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.
The MY01 Mobile
Application is an
optional application
intended for storing and
displaying identical
pressure values from
the MY01 Continuous
Compartmental Pressure
Monitor device.
The data is for
informational purposes
only and is not intended
to be used for diagnosis
of any nature or active
patient monitoring.	The Interson USB
Ultrasound System is
intended for diagnostic
ultrasound imaging in B,
color Doppler, or
Combined (B + Color)
modes. It is indicated for
diagnostic ultrasound
imaging and fluid flow
analysis in the following
applications:
Fetal/Obstetric,
Abdominal, Pediatric,
Small Organ, Musculo-
skeletal (conventional),
Musculo-skeletal
(superficial), Urology,
Gynecology, Pelvic Floor,
Neuro-muscular, and
Peripheral Vessel.
The system is intended
for use by healthcare
professionals.
Design	Non-invasive probe using
linear ultrasound array
with MEMS pressure
sensor, connected to
commercial off-the-shelf
(COTS) tablet.	Invasive MEMS pressure
sensor, LCD display
screen, optional mobile
application.	Non-invasive probe
using linear ultrasound
array, connected to
commercial off-the-shelf
(COTS) tablet.
Material	ABS housing, medical
grade silicone membrane,
stainless steel ring.
Commercial tablet with
USB cable.	Introducer with plastic
housing with stainless
steel needle, LCD
display monitor.	ABS housing.
Commercial tablet with
USB cable.
Sterilization	No	Yes	No
Single Use	No	Yes	No
Key Differences	The main difference between the subject device and the predicate device is that
the method of measurement using the subject device is non-invasive, whereas the
predicate device is invasive. In addition, the subject device provides a surrogate
metric of the compartment's compressibility in one ultrasound image plane only,
while the predicate device provides a direct measurement of compartment
pressure. The indications for use differ from the predicate device because the
subject device is not indicated for use to aid in the diagnosis of compartment
syndrome nor for trend analysis. The subject and predicate device have the same
general intended use to measure pressure-related conditions in the extremities.
Performance Data	The following performance data were provided in support of substantial
equivalence.
	Biocompatibility Testing
The biocompatibility testing for the CPM#1 System was conducted in accordance
with ISO 10993-1:2018, following the FDA guidance "Use of International Standard
ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process"" and with ISO 14971:2019, “Medical
devices - application of risk management to medical devices".
	Electrical Safety Testing
Electrical safety testing for the CPM#1 System was conducted in accordance with
IEC 60601-1:2005/AMD1:2012. EMC testing was also conducted in accordance with
IEC 60601-1-2:2014/AMD1:2020.
	Usability Testing
Usability testing was conducted in accordance with IEC 62366-1:2015 + A1:2020.
	Cleaning and Disinfection Testing
The manual cleaning and low-level disinfection process was validated in accordance
with ISO 17664-2:2021.
	Ultrasound Performance Testing
The acoustic output of the CPM#1 System was tested in accordance with IEC
60601-2-37:2007/AMD1:2015 and IEC 62359:2.1/AMD1:2017. The image quality
was tested to confirm compliance with design input requirements.
	CP Value Performance Testing
The accuracy, repeatability, and reproducibility of the CP Value was confirmed
using an in-vitro bench test model.
	The collective results of the nonclinical testing demonstrate that the design, the
materials chosen, and the manufacturing processes of the CPM#1 System meet
the established specifications necessary for consistent performance during its
intended use. In addition, the collective bench testing demonstrates that the
CPM#1 System does not raise different questions of safety or effectiveness for its
intended use when compared to the predicate device.
	Clinical Testing
A study was performed to validate the repeatability and reproducibility of the
CPM#1 System relative compartment compressibility measurements in healthy
volunteers.

Image /page/5/Picture/1 description: The image shows the logo for Compremium. The logo consists of a dark blue rounded square with four horizontal white lines inside, and the word "Compremium" in dark blue to the right of the square. The font is sans-serif and the overall design is simple and modern.

Image /page/6/Picture/1 description: The image contains the logo for Compremium. The logo consists of a circular icon with four curved lines inside, followed by the text "Compremium" in a sans-serif font. The icon and text are both in a dark blue color.

Conclusion	Based on the test results and additional supporting information provided for the CPM#1 System, it is concluded that the subject device is safe and effective for the stated intended use and is substantially equivalent to the predicate device.
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