(143 days)
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 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.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria with a comparison table. The "Performance Data" section lists several types of testing performed but does not quantify acceptance criteria or present the results in a comparative manner with specific metrics.
However, based on the types of performance data mentioned and the overarching purpose of a 510(k) submission, we can infer some general categories of acceptance criteria and the nature of the "studies" conducted.
Here's an attempt to answer the questions based on the available information, noting where details are not provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported device performance for the CPM#1 System's functional output (CP Value). It lists types of tests conducted:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (General Statement in document) |
|---|---|
| Biocompatibility (ISO 10993-1, ISO 14971) | Complies with standards, materials meet specifications, does not raise different questions of safety or effectiveness. |
| Electrical Safety (IEC 60601-1, IEC 60601-1-2) | Conducted in accordance with standards. |
| Usability (IEC 62366-1) | Conducted in accordance with standards. |
| Cleaning and Disinfection (ISO 17664-2) | Validated in accordance with standards. |
| Ultrasound Performance (Acoustic Output - IEC 60601-2-37, IEC 62359; Image Quality) | Tested in accordance with standards, image quality confirmed compliance with design input requirements. |
| CP Value Performance (Accuracy, Repeatability, Reproducibility) | Confirmed using an in-vitro bench test model and validated in a clinical study with healthy volunteers. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- CP Value Performance (Clinical Testing): "A study was performed to validate the repeatability and reproducibility of the CPM#1 System relative compartment compressibility measurements in healthy volunteers."
- Sample Size: Not specified.
- Data Provenance: Not specified (country of origin or retrospective/prospective). Given it's a "study...in healthy volunteers," it is typically prospective.
- CP Value Performance (Bench Test Model): "The accuracy, repeatability, and reproducibility of the CP Value was confirmed using an in-vitro bench test model."
- Sample Size: Not specified (for the bench test).
- Data Provenance: Not applicable as it's an in-vitro test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The device measures "relative compartment compressibility" (CP Value) as a direct output. The ground truth for CP Value performance would likely come from established measurement techniques/standards for compressibility in the bench model, and the clinical study would assess repeatability and reproducibility of the device's own measurements, not against an expert-established ground truth for a diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is relevant for studies where expert interpretation or consensus is required to establish ground truth for a diagnostic task. The CPM#1 System directly measures a physical property (compressibility) and its performance is assessed based on the accuracy, repeatability, and reproducibility of these measurements.
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
No MRMC comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool that human readers would use to improve their performance over a baseline. It is a measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the various performance tests listed (Biocompatibility, Electrical Safety, Usability, Cleaning and Disinfection, Ultrasound Performance, and particularly CP Value Performance) describe the standalone performance of the device and its algorithms. The CP Value is "calculated and displayed on-screen as the CP Value" by the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- CP Value Performance (in-vitro): The ground truth for accuracy, repeatability, and reproducibility would be established by the design specifications of the device and reference standards or methods for measuring compressibility in the bench model.
- CP Value Performance (clinical): The clinical study assessed the repeatability and reproducibility of the device's own measurements in healthy volunteers, rather than comparing against a clinical "ground truth" diagnosis, as the "CP Value is not meant for trend analysis" and not for diagnosis of compartment syndrome.
8. The sample size for the training set
Not applicable. This device does not appear to be an AI/machine learning-based diagnostic device that requires a training set in the conventional sense. Its "performance" relies on the accuracy and precision of its physical sensors and calculations.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI/machine learning device with a training set.
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter | Compremium AGWorbstrasse 463074 Muri bei BernSwitzerland |
|---|---|
| Contact Person | Vincent Baumann, CEOPhone: +41 79 933 96 48Email: 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. |
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| Comparison of | CPM#1 System | MY01 | Interson SP-L01 |
|---|---|---|---|
| TechnologicalCharacteristics 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 CompartmentalCompressibility MonitoringSystem (CPM#1) isintended for real-time andintermittent monitoring ofrelative compartmentcompressibility.The relative compartmentcompressibility (CP Value)is not meant for trendanalysis. | The MY01 ContinuousCompartmental PressureMonitor is intended forreal-time andcontinuousmeasurement ofcompartmentalpressures.The measuredcompartmentalpressures can be usedas an aid in thediagnosis ofcompartment syndrome.The trend arrowsdisplayed are meant forqualitative purposesonly and are notintended to have anyclinical significance.The MY01 MobileApplication is anoptional applicationintended for storing anddisplaying identicalpressure values fromthe MY01 ContinuousCompartmental PressureMonitor device.The data is forinformational purposesonly and is not intendedto be used for diagnosisof any nature or activepatient monitoring. | The Interson USBUltrasound System isintended for diagnosticultrasound imaging in B,color Doppler, orCombined (B + Color)modes. It is indicated fordiagnostic ultrasoundimaging and fluid flowanalysis in the followingapplications:Fetal/Obstetric,Abdominal, Pediatric,Small Organ, Musculo-skeletal (conventional),Musculo-skeletal(superficial), Urology,Gynecology, Pelvic Floor,Neuro-muscular, andPeripheral Vessel.The system is intendedfor use by healthcareprofessionals. |
| Design | Non-invasive probe usinglinear ultrasound arraywith MEMS pressuresensor, connected tocommercial off-the-shelf(COTS) tablet. | Invasive MEMS pressuresensor, LCD displayscreen, optional mobileapplication. | Non-invasive probeusing linear ultrasoundarray, connected tocommercial off-the-shelf(COTS) tablet. |
| Material | ABS housing, medicalgrade silicone membrane,stainless steel ring.Commercial tablet withUSB cable. | Introducer with plastichousing with stainlesssteel needle, LCDdisplay monitor. | ABS housing.Commercial tablet withUSB cable. |
| Sterilization | No | Yes | No |
| Single Use | No | Yes | No |
| Key Differences | The main difference between the subject device and the predicate device is thatthe method of measurement using the subject device is non-invasive, whereas thepredicate device is invasive. In addition, the subject device provides a surrogatemetric of the compartment's compressibility in one ultrasound image plane only,while the predicate device provides a direct measurement of compartmentpressure. The indications for use differ from the predicate device because thesubject device is not indicated for use to aid in the diagnosis of compartmentsyndrome nor for trend analysis. The subject and predicate device have the samegeneral intended use to measure pressure-related conditions in the extremities. | ||
| Performance Data | The following performance data were provided in support of substantialequivalence. | ||
| Biocompatibility TestingThe biocompatibility testing for the CPM#1 System was conducted in accordancewith ISO 10993-1:2018, following the FDA guidance "Use of International StandardISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process"" and with ISO 14971:2019, “Medicaldevices - application of risk management to medical devices". | |||
| Electrical Safety TestingElectrical safety testing for the CPM#1 System was conducted in accordance withIEC 60601-1:2005/AMD1:2012. EMC testing was also conducted in accordance withIEC 60601-1-2:2014/AMD1:2020. | |||
| Usability TestingUsability testing was conducted in accordance with IEC 62366-1:2015 + A1:2020. | |||
| Cleaning and Disinfection TestingThe manual cleaning and low-level disinfection process was validated in accordancewith ISO 17664-2:2021. | |||
| Ultrasound Performance TestingThe acoustic output of the CPM#1 System was tested in accordance with IEC60601-2-37:2007/AMD1:2015 and IEC 62359:2.1/AMD1:2017. The image qualitywas tested to confirm compliance with design input requirements. | |||
| CP Value Performance TestingThe accuracy, repeatability, and reproducibility of the CP Value was confirmedusing an in-vitro bench test model. | |||
| The collective results of the nonclinical testing demonstrate that the design, thematerials chosen, and the manufacturing processes of the CPM#1 System meetthe established specifications necessary for consistent performance during itsintended use. In addition, the collective bench testing demonstrates that theCPM#1 System does not raise different questions of safety or effectiveness for itsintended use when compared to the predicate device. | |||
| Clinical TestingA study was performed to validate the repeatability and reproducibility of theCPM#1 System relative compartment compressibility measurements in healthyvolunteers. |
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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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N/A