(102 days)
The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated or use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV 1000 Clinical Platform and the ClearSightTM Finger Cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs is a non-invasive system that continuously measures blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform. The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (EVHRS or also referred to as HRS), and the ClearSight™ Finger Cuffs. EV1000M may be attached to the patient bedside, an IV pole or roll stand. The subject of this 510(k) is a change of the tubing material and its establishment of shelf life for the EVHRS, a component of the subject device, EV1000 Clinical Platform NI and the ClearSight Finger Cuff.
This document is a 510(k) premarket notification for a medical device called the EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System. The submission, K182245, is seeking substantial equivalence to a previously cleared device (K160552) for a change in tubing material and shelf life of a component, the Heart Reference Sensor (EVHRS).
Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria related to its performance as a blood pressure measurement system after the material change. The provided text primarily focuses on demonstrating substantial equivalence for engineering/material changes, not clinical performance changes.
Therefore, many of the requested details cannot be extracted from this document because they pertain to a performance study for a medical device AI/software, not a material change to an existing device component.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
The document states: "functional testing was conducted to show performance is not affected. The EVHRS has been shown to be substantially equivalent to the predicate device for its intended use in hospitals and other appropriate clinical environments. The Heart Reference Sensor (EVHRS) accessory to the subject device, EV1000 Clinical Platform NI and the ClearSight™ Finger cuffs have successfully passed functional and performance testing, including mechanical, shelf life, biocompatibility, and bench studies, demonstrating that the subject device is substantially equivalent to the predicate device."
This implies that the acceptance criteria for this specific 510(k) (K182245) related to the change in tubing material were that the performance characteristics of the device, as measured by functional, mechanical, shelf life, biocompatibility, and bench studies, remained equivalent to the predicate device. However, specific numerical acceptance criteria or reported performance data are NOT provided in this document. It only states that the tests were "successfully passed."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance is not affected by tubing material change | "functional and performance testing, including mechanical, shelf life, biocompatibility, and bench studies, demonstrating that the subject device is substantially equivalent to the predicate device." |
| Biocompatibility in accordance to ISO 10993-10 | "biocompatibility was conducted in accordance to ISO 10993-10" |
| Maintains shelf life | "establishment of shelf life" and "shelf life...successfully passed" |
The remaining questions (2-9) cannot be answered from the provided text as they relate to clinical performance studies, particularly for AI/software, which are not the subject of this specific 510(k) submission. This 510(k) (K182245) is for a material change and shelf-life establishment of a component (EVHRS), not the initial clinical validation of the blood pressure measurement capabilities of the EV1000 system. The clinical performance and ground truth for the overall device would have been established during the clearance of the predicate device (K160552 and K140312).
§ 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).