(301 days)
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
The V10 vital signs monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana V10 vital signs monitor is a lightweight and compact device (249 x 211 x 154 (mm) (WxHxD) and 3.0 kg) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment LED displays.
The provided text describes the Mediana V10 vital signs monitor, which measures non-invasive blood pressure (NIBP), pulse rate (PR), functional arterial oxygen saturation (SpO2), and temperature (Temp). The document is a 510(k) summary for FDA clearance.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the device's ability to demonstrate substantial equivalence to its predicate device (Mediana V10, K152659) and compliance with relevant international standards. The performance is reported in terms of equivalence to the predicate and compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance | Study Type |
|---|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | Substantially equivalent to predicate device (Mediana V10, K152659). | ||
| Compliance with ISO 81060-2 standard for NIBP accuracy. | NIBP measurement specifications and performance are equivalent to the predicate device. | ||
| Added display of Mean Arterial Pressure (MAP). | |||
| Clinical evaluation performed on adult, pediatric, and neonate to verify accuracy. | |||
| Complies with ISO 81060-2 standard. | Clinical (NIBP) | ||
| Pulse Rate (PR) | Substantially equivalent to predicate device (Mediana V10, K152659). | Pulse rate specifications and performance derived from NIBP or SpO2 are equivalent to the predicate device. | Not explicitly detailed as a separate clinical study, likely part of NIBP/SpO2 validation. |
| Pulse Oximetry (SpO2) | Substantially equivalent to predicate device (Mediana V10, K152659). | SpO2 specifications and performance are equivalent to the predicate device. | Not explicitly detailed as a separate clinical study, but implied accuracy is equivalent. |
| Temperature (Temp) | Substantially equivalent to predicate device (Mediana V10, K152659). | Temperature specifications and performance are equivalent to the predicate device. | Clinical (Temp) |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-49 standards. | Tested in accordance with IEC 60601-1 and IEC 60601-2-49. | Performance Testing (Electrical Safety) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Tested in accordance with IEC 60601-1-2. | Performance Testing (EMC) |
| Biocompatibility | No patient contact material (for the monitor itself). Patient contact accessories subject to biocompatibility testing. | Monitor does not contain patient contact material. Reference to Section 16 for accessory biocompatibility. | Performance Testing (Biocompatibility) |
| System Verification & Validation (V&V) | Compliance with system V&V plan #MDR-EG161022-02. | Tested in accordance with system V&V plan #MDR-EG161022-02. | Verification and Validation Testing |
| Risk Management | Risk analysis identifying potential hazards and documenting mitigation. | Risk analysis developed and applied as part of Mediana design control procedure. | Design Control/Quality System |
2. Sample Sizes Used for the Test Set and Data Provenance
- NIBP Clinical Evaluation: The text states, "To verify the accuracy of measuring, the clinical evaluation was performed on adult, pediatric and neonate." It does not specify the exact sample size (number of patients) within each age group.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether the studies were retrospective or prospective. Given the submitter's location (Republic of Korea), it's plausible the studies were conducted there. The nature of clinical evaluations for device clearance typically implies prospective data collection, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical evaluations (NIBP and Temperature).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a vital signs monitor, and the performance evaluation is based on the accuracy of its measurements against established standards and predicate device performance, not on a human-in-the-loop diagnostic task that would typically involve MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary clinical evaluation for NIBP and Temperature accuracy is a standalone performance assessment of the device's measurement capabilities. The device directly measures these parameters; it is not an AI algorithm assisting human interpretation of images, for instance.
7. The Type of Ground Truth Used
The ground truth for NIBP and Temperature measurements would typically be established using a reference standard method for blood pressure (e.g., intra-arterial measurement or an established oscillometric reference device for NIBP accuracy, and a high-accuracy reference thermometer for temperature) in a clinical setting. While not explicitly stated, compliance with ISO 81060-2 for NIBP implies a rigorous clinical validation against an accepted reference.
8. The Sample Size for the Training Set
The document describes performance testing for a finished device, not a machine learning model that would require a separate "training set." Therefore, there is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a machine learning model or a training set, this question is not applicable. The device's performance is based on its underlying hardware and signal processing, validated through the clinical and performance tests described.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).