(269 days)
The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device.
The devices are intended for pediatric and adult patient populations.
The Meritrans ECO Reusable Pressure Transducer is a non-invasive, reusable device used primarily for blood pressure monitoring. The housing assembly interfaces the pressure sensor assembly to the fluid channel of patient by coupling the transducer to the Meritrans ECO Disposable Dome. The fluid channel of patient is isolated from the pressure sensor by diaphragms. As the pressure signal of patient carried via the saline solution presses against the surface of transducer, the diaphragm is deflected, and the physiological pressure signal is transformed from the dome to the sensor of the reusable pressure transducer. Subsequently, the physiological pressure signal is transformed into electrical signal and displayed in a monitor that is connected via transducer interface cable.
The Meritrans ECO Disposable Domes are disposable diaphragm domes which are coupled with the reusable transducer for invasive blood pressure monitoring. The disposable diaphragm dome has a transparent hemispherical hollow cavity. The domes have two ports; one port of the dome has a rotating Luer Lock fitting where the patient line is connected. Another port has an adaptor for connection to a pressurized IV fluid bag or an infusion pump. The disposable diaphragm dome has a diaphragm membrane that isolates the patient's fluid-filled system from the reusable transducer. For dome models with flush devices, an integral flow/flush device provides continuous flow of fluid to maintain catheter patency during the invasive blood pressure measurements.
The provided text describes the acceptance criteria and the studies performed to demonstrate the device's conformance, but it does not detail a study proving the device meets the acceptance criteria in the format typically used for AI/ML performance evaluation (e.g., specific metrics for accuracy, sensitivity, specificity, clinical outcome studies). Instead, it focuses on compliance with various engineering, safety, and biological standards through a battery of tests.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document lists various standards that the device complies with, implying that meeting the requirements of these standards constitutes the acceptance criteria. The reported device performance is stated as "Results of the testing demonstrate that the subject devices met the acceptance criteria sufficient for their intended use." However, specific numerical performance metrics for each criterion against a defined acceptable range are not provided in this summary.
Generic Table based on the document's structure for Performance Bench Testing:
| Category / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Product Performances | ||
| ANSI/AAMI BP22:1994 (R)2016 (Blood pressure transducers) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| IEC 60601-1:2020 (Edition 3.2) (General safety and essential performance) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| IEC 60601-1-2:2020 (Edition 4.1) (Electromagnetic disturbances) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| IEC 60601-2-34:2011 (Edition 3.0) (Invasive blood pressure monitoring equipment) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| IEC 62366-1:2015 + Cor 1:2016 + Amd 1:2020 (Usability engineering) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 80369-7:2021 (Small-bore connectors for intravascular/hypodermic applications) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| FDA Guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices | Compliance with guidance recommendations | Met the acceptance criteria sufficient for intended use |
| Packaging and Transportation | ||
| EN ISO 2233:2001 (Packaging - Conditioning for testing) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ASTM D4169 - 16 (2016) (Performance Testing of Shipping Containers) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| EN ISO 11607-1:2020 (Packaging for terminally sterilized medical devices) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ASTM F1980 16 (2016) (Accelerated Aging of Sterile Barrier Systems) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| Biocompatibility (Meritrans ECO Disposable Domes) | ||
| ISO 10993-1:2018 (Biological evaluation - Risk management) | Compliance with all requirements of the standard and FDA guidance | Met the acceptance criteria sufficient for intended use (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility) |
| ISO 10993-4:2017 (Interactions with blood) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 10993-5:2009 (In vitro cytotoxicity) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 10993-10:2021 (Skin sensitization) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 10993-11:2017 (Systemic toxicity) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 10993-12:2021 (Sample preparation and reference materials) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ISO 10993-23:2021 (Irritation) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| FDA Guidance, Use of International Standard ISO 10993-1 | Compliance with guidance recommendations | Met the acceptance criteria sufficient for intended use |
| Sterilization / Sterility / EO residuals / Pyrogenicity (Meritrans ECO Disposable Domes) | ||
| EN ISO 11135:2014 (+ Amd 1:2018) (Ethylene oxide sterilization) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| EN ISO 10993-7:2008 (+ Cor 1:2009 + AMD 1:2019) (Ethylene Oxide sterilization residuals) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| AAMI TIR28:2016 (Product Adoption and process equivalency for ethylene oxide sterilization) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| ANSI/AAMI ST72:2019 (Bacterial endotoxins Test methods) | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| United States Pharmacopeia 43, National Formulary 38:2020 (USP), General Chapter Pyrogen Test | Compliance with all requirements of the standard | Met the acceptance criteria sufficient for intended use |
| FDA Guidance. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile | Compliance with guidance recommendations | Met the acceptance criteria sufficient for intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various standards and states that "A battery of tests was performed based on the requirements of the below FDA recognized / non-recognized consensus standards and guidance, as well as biocompatibility, sterilization, and labeling standards and guidance." However, it does not specify the sample sizes used for these tests or the data provenance (country of origin, retrospective/prospective). This information would typically be detailed in the test reports themselves, which are not included in this summary.
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)
This information is not applicable in the context of this 510(k) summary. The device in question, a pressure transducer and disposable domes, is a hardware medical device with electrical and mechanical performance, biocompatibility, and sterility requirements. Its evaluation is based on engineering testing and biological assays against recognized standards, not on image interpretation or diagnostic performance with expert-established ground truth. Therefore, there are no "experts" in the sense of clinical reviewers establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth, typically in AI/ML performance evaluations.
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
This is not applicable. The device is an extravascular blood pressure transducer, a piece of hardware for physiological monitoring. It does not involve AI assistance for human readers in any diagnostic or interpretive task.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hardware product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" is established by the specified requirements and test methods outlined in the recognized consensus standards (e.g., ANSI/AAMI BP22 for blood pressure transducers, ISO 10993 for biocompatibility). These standards define acceptable performance metrics, physical properties, and biological responses. The device's performance is measured against these established technical and biological benchmarks.
8. The sample size for the training set
This is not applicable. The device is a hardware medical device, and the evaluation described is for its physical and biological performance against standards, not for a trainable AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above. There is no AI/ML training set mentioned or implied for this device's evaluation.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).