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510(k) Data Aggregation
(238 days)
The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:
- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap
The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.
The product is sold sterile, single use, and non-pyrogenic.
The ReavillMED Pressure Monitoring System is a combination product consisting of a blood pressure monitoring line with an end cap, a disposable pressure transducer, a single lumen polyurethane reverse taper catheter, and a catheter hub with suture wing tabs and a slip tip cap. It is intended for continuous measurement of blood pressure or other physiological pressures, and the catheter is for short-term peripheral access to the central venous system.
1. Table of acceptance criteria and the reported device performance
| Testing Performed | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sensor Testing | ANSI/AAMI BP-22, 1994 | Operating Pressure Range: -50 mmHg to +300 mmHg | Meets Requirements |
| Sensitivity: 5µV/V/mmHg, +/- 2% (typically < +/- 1%) | Meets Requirements | ||
| Zero Drift with Time: +1.0 mmHg/8 hours after 10 minute warm up to operating temperature | Meets Requirements | ||
| Leakage Current: < 2µA @ 115 VAC RMS and 60 Hz | Meets Requirements | ||
| Unbalance: +75 mmHg | Meets Requirements | ||
| Overpressure Protection: -400 mmHg to +4000 mmHg | Meets Requirements | ||
| Operating Temperature: 15 C to 40 C | Meets Requirements | ||
| Excitation Voltage and Frequency: 2 to 10 VDC or VAC RMS to 50kHz | Meets Requirements | ||
| Operating Life: >500 hours | Meets Requirements | ||
| Storage Temperature: -25 C to +65 C | Meets Requirements | ||
| Defibrillation Withstand: 5 discharges/5 minutes of 360 joules @ 50 Ω load | Meets Requirements | ||
| Natural Frequency: > 20 Hz in saline | Meets Requirements | ||
| Phase Shift: < 5 degrees at 5 Hz | Meets Requirements | ||
| Output Impedance: 270 Ω to 400 Ω | Meets Requirements | ||
| Input Impedance: 270 Ω to 400 Ω | Meets Requirements | ||
| Luer taper and lock fittings | ISO 594-1 | Conical fitting and 6% luer taper, Liquid leakage from fitting assembly under pressure, Air leakage into fitting assembly during aspiration, Separation force of fitting assembly, Unscrew torque of fitting assembly, Ease of assembly, Resistance to overriding | Meets Requirements |
| Tensile Testing | ISO 10555 Parts 1 and 3 | Minimum break force of 4N (or 0.89923 lbs of force) | Meets requirements |
| Biocompatibility testing (Monitoring Line) | ISO 10993-1 | Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility | Meets requirements |
| Biocompatibility testing (Catheter) | ISO 10993-1 | Cytotoxicity, Sensitization, Irritation Reactivity, Systemic Toxicity, Hemolysis, Implantation, Genotoxicity | Meets requirements |
| Risk Analysis | ISO 14971 | No unacceptable risks | Acceptable |
| EtO sterilization validation | ANSI/AAMI/ISO 11135-1 | No growth of the test organism from any of the processed indicators for ethylene oxide sterilization following incubation | To be performed prior to product release |
| EtO residual testing | ISO 10993-7 | EO = 60mg/30days | To be performed prior to product release |
The study details provided here are for the ReavillMED Pressure Monitoring System. The “Results” column in the table above indicates "Meets Requirements" or "Acceptable" for all tests performed and reported. For EtO sterilization validation and EtO residual testing, the results were "To be performed prior to product release", implying these were pending and not part of the initial submission for assessment.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for any of the non-clinical tests. Furthermore, it does not provide information about the data provenance (country of origin), nor if the data was retrospective or prospective.
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 provided in the document. The tests performed are primarily non-clinical, laboratory-based functional and safety tests, rather than studies requiring expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided in the document, as the tests are non-clinical, not requiring a human adjudication method for interpretation.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (a pressure monitoring system and catheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests was established by predefined objective acceptance criteria based on recognized international and national standards (e.g., ANSI/AAMI BP-22, ISO 594-1, ISO 10555 Parts 1 and 3, ISO 10993-1, ISO 14971, ANSI-AAMI/ISO 11135-1, ISO 10993-7). The "ground truth" here refers to the quantitative and qualitative pass/fail thresholds defined by these standards.
8. The sample size for the training set
This information is not applicable. The development of this medical device does not involve a "training set" in the context of machine learning or AI. The product undergoes design, manufacturing, and testing according to engineering and quality standards, not algorithm training.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" as understood in machine learning contexts for this device.
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