Compremium Compartment Compressibility Monitoring System (CPM#1)
Device Facts
| Record ID | K223509 |
|---|---|
| Device Name | Compremium Compartment Compressibility Monitoring System (CPM#1) |
| Applicant | Compremium AG |
| Product Code | LXC · OR |
| Decision Date | Apr 14, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
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.
Device Story
CPM#1 is a point-of-care, non-invasive system for monitoring relative compartment compressibility. It utilizes a handheld probe containing a linear ultrasound array and an integrated MEMS pressure sensor. The probe captures cross-sectional ultrasound images of a compartment while applying external pressure. The device measures the distance between two points within the compartment as a function of this applied pressure. This data is processed to calculate a relative compartment compressibility value (CP Value), which is displayed on a connected commercial off-the-shelf (COTS) tablet. The device is intended for use by healthcare professionals to monitor pressure-related conditions in extremities. Unlike invasive predicate devices, CPM#1 provides a surrogate metric rather than direct pressure measurement and is not intended for trend analysis or diagnostic aid for compartment syndrome.
Clinical Evidence
Clinical study conducted to validate repeatability and reproducibility of CPM#1 relative compartment compressibility measurements in healthy volunteers. Non-clinical evidence includes biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), cleaning/disinfection validation (ISO 17664-2), acoustic output (IEC 60601-2-37, IEC 62359), and in-vitro bench testing for CP Value accuracy and repeatability.
Technological Characteristics
Handheld probe with linear ultrasound array and MEMS pressure sensor. Materials: ABS housing, medical-grade silicone membrane, stainless steel ring. Connectivity: USB cable to COTS tablet. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37/IEC 62359 (acoustic output), ISO 10993-1 (biocompatibility), ISO 17664-2 (cleaning/disinfection). Non-sterile, reusable device.
Indications for Use
Indicated for real-time and intermittent monitoring of relative compartment compressibility in patients. Not indicated for trend analysis or as an aid in the diagnosis of compartment syndrome.
Predicate Devices
- MY01 Continuous Compartmental Pressure Monitor (K210525)
Reference Devices
- Interson USB Ultrasound System (K163443)
Submission Summary (Full Text)
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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
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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
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## 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 510(k) Summary
| Submitter | Compremium AG<br>Worbstrasse 46<br>3074 Muri bei Bern<br>Switzerland |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vincent Baumann, CEO<br>Phone: +41 79 933 96 48<br>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.<br>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.<br>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.<br>The relative compartment compressibility (CP Value) is not meant for trend analysis. |
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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<br>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<br>Compressibility Monitoring<br>System (CPM#1) is<br>intended for real-time and<br>intermittent monitoring of<br>relative compartment<br>compressibility.<br>The relative compartment<br>compressibility (CP Value)<br>is not meant for trend<br>analysis. | The MY01 Continuous<br>Compartmental Pressure<br>Monitor is intended for<br>real-time and<br>continuous<br>measurement of<br>compartmental<br>pressures.<br>The measured<br>compartmental<br>pressures can be used<br>as an aid in the<br>diagnosis of<br>compartment syndrome.<br>The trend arrows<br>displayed are meant for<br>qualitative purposes<br>only and are not<br>intended to have any<br>clinical significance.<br>The MY01 Mobile<br>Application is an<br>optional application<br>intended for storing and<br>displaying identical<br>pressure values from<br>the MY01 Continuous<br>Compartmental Pressure<br>Monitor device.<br>The data is for<br>informational purposes<br>only and is not intended<br>to be used for diagnosis<br>of any nature or active<br>patient monitoring. | The Interson USB<br>Ultrasound System is<br>intended for diagnostic<br>ultrasound imaging in B,<br>color Doppler, or<br>Combined (B + Color)<br>modes. It is indicated for<br>diagnostic ultrasound<br>imaging and fluid flow<br>analysis in the following<br>applications:<br>Fetal/Obstetric,<br>Abdominal, Pediatric,<br>Small Organ, Musculo-<br>skeletal (conventional),<br>Musculo-skeletal<br>(superficial), Urology,<br>Gynecology, Pelvic Floor,<br>Neuro-muscular, and<br>Peripheral Vessel.<br>The system is intended<br>for use by healthcare<br>professionals. |
| Design | Non-invasive probe using<br>linear ultrasound array<br>with MEMS pressure<br>sensor, connected to<br>commercial off-the-shelf<br>(COTS) tablet. | Invasive MEMS pressure<br>sensor, LCD display<br>screen, optional mobile<br>application. | Non-invasive probe<br>using linear ultrasound<br>array, connected to<br>commercial off-the-shelf<br>(COTS) tablet. |
| Material | ABS housing, medical<br>grade silicone membrane,<br>stainless steel ring.<br>Commercial tablet with<br>USB cable. | Introducer with plastic<br>housing with stainless<br>steel needle, LCD<br>display monitor. | ABS housing.<br>Commercial tablet with<br>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<br>the method of measurement using the subject device is non-invasive, whereas the<br>predicate device is invasive. In addition, the subject device provides a surrogate<br>metric of the compartment's compressibility in one ultrasound image plane only,<br>while the predicate device provides a direct measurement of compartment<br>pressure. The indications for use differ from the predicate device because the<br>subject device is not indicated for use to aid in the diagnosis of compartment<br>syndrome nor for trend analysis. The subject and predicate device have the same<br>general intended use to measure pressure-related conditions in the extremities. | | |
| Performance Data | The following performance data were provided in support of substantial<br>equivalence. | | |
| | Biocompatibility Testing<br>The biocompatibility testing for the CPM#1 System was conducted in accordance<br>with ISO 10993-1:2018, following the FDA guidance "Use of International Standard<br>ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process"" and with ISO 14971:2019, “Medical<br>devices - application of risk management to medical devices". | | |
| | Electrical Safety Testing<br>Electrical safety testing for the CPM#1 System was conducted in accordance with<br>IEC 60601-1:2005/AMD1:2012. EMC testing was also conducted in accordance with<br>IEC 60601-1-2:2014/AMD1:2020. | | |
| | Usability Testing<br>Usability testing was conducted in accordance with IEC 62366-1:2015 + A1:2020. | | |
| | Cleaning and Disinfection Testing<br>The manual cleaning and low-level disinfection process was validated in accordance<br>with ISO 17664-2:2021. | | |
| | Ultrasound Performance Testing<br>The acoustic output of the CPM#1 System was tested in accordance with IEC<br>60601-2-37:2007/AMD1:2015 and IEC 62359:2.1/AMD1:2017. The image quality<br>was tested to confirm compliance with design input requirements. | | |
| | CP Value Performance Testing<br>The accuracy, repeatability, and reproducibility of the CP Value was confirmed<br>using an in-vitro bench test model. | | |
| | The collective results of the nonclinical testing demonstrate that the design, the<br>materials chosen, and the manufacturing processes of the CPM#1 System meet<br>the established specifications necessary for consistent performance during its<br>intended use. In addition, the collective bench testing demonstrates that the<br>CPM#1 System does not raise different questions of safety or effectiveness for its<br>intended use when compared to the predicate device. | | |
| | Clinical Testing<br>A study was performed to validate the repeatability and reproducibility of the<br>CPM#1 System relative compartment compressibility measurements in healthy<br>volunteers. | | |
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| 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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