(31 days)
The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.
The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.
The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.
Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.
Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments.
Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec.
Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi
The provided text is a 510(k) summary for a medical device (EmpowerCT/EmpowerCTA Injector System) and focuses on comparing the modified device to its predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or validation studies.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document provides performance specifications for the injector systems, which can be considered acceptance criteria based on their current marketing status and regulatory approval. However, it does not explicitly present these as "acceptance criteria" against which a new study's results are being compared to prove the device meets them. Instead, it describes "Proposed Devices" and "Currently marketed devices" with identical performance specifications, indicating that the modification (connectivity) does not alter these core performance aspects.
| Performance Characteristic | Acceptance Criteria (from "Proposed Devices" column, implying "met") | Reported Device Performance (Implied as "Same as Proposed") |
|---|---|---|
| Flow Rate | 0.1 to 10 mL/sec in user specified increments of 0.1 ml/sec. Accuracy: ±5% of programmed rate +0.1 mL/sec | Same as Proposed |
| Delivery Volume | 1 to 200 mL in user specified increments of 1 mL. Accuracy: ±2% of programmed volume +1ml) | Same as Proposed |
| Maximum Pressure | 40 to 300 psi in user specified increments of 1 psi. Accuracy: ±10% of programmed pressure limit + 10 psi | Same as Proposed |
| Connectivity | Yes either via a CT Trigger port or via a data communication method. The data communication method was developed in accordance with the CAN-CIA specification DSP 425. | Yes via a CT Trigger port only. (For currently marketed predicate) |
Missing Information (Not Available in the Provided Text):
The document describes a special 510(k) submission for a device modification (adding scanner connectivity) to a previously cleared device. It establishes substantial equivalence by demonstrating that the performance characteristics of the modified device are identical to the predicate device, except for the new connectivity feature. It does not present a new study with explicit acceptance criteria and corresponding results proving the device meets those criteria for the entire device system in the context of this submission. The focus is on the impact of the modification.
Therefore, the following points cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Summary of what is present:
The document is a regulatory submission demonstrating substantial equivalence for a modification to an existing device. It highlights that the core performance parameters (flow rate, volume, pressure) remain the same as the predicate devices, and the modification is primarily related to connectivity. Therefore, it relies on the previously established performance of the predicate devices rather than presenting new studies to re-prove these fundamental aspects.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.