(87 days)
The ACIST|CVi®1 Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures.
The CVi1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CV1 Syringe Kits are also indicated for single patient use with ACISTCVi® Contrast Delivery Systems.
The ACIST|CVi®1 Contrast Delivery System is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
The ACIST CVi1 Contrast Delivery System is designed to aid the physician in the controlled infusion of radiopaque contrast media. The CVi1® Contrast Delivery System contains a software controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume. The CVi1 Contrast Delivery System is used in conjunction with ACIST provided consumable kits: A1000/A1000V Syringe Kit, BT2000 Manifold Kit, and the AT-P AngioTouch Hand Controller Kit. The current submission introduces the A1000/A1000V Syringe Kit provided in the consumable kits. Changes are also introduced into software and labeling to address single patient use for the consumable kit. The CVi1 Contrast Delivery System is used in interventional cardiology, radiology, and vascular surgical procedures. The operating environments for the CVi1 Contrast Delivery System are catheterization or radiological laboratories. The CVi1 system is used in interventional cardiology, radiology, and vascular surgical procedures. Like the predicate CVi system, the CVi1 system is used in adults and pediatrics patient populations.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML devices. The document is a 510(k) premarket notification for a medical device (ACIST | CVi®1 Contrast Delivery System) which is an angiographic injector and syringe. This type of device does not involve AI or algorithms in the way that would necessitate the kind of performance study you're asking about (e.g., diagnostic accuracy studies, reader studies).
The content describes:
- Device Name: ACIST | CVi®1 Contrast Delivery System
- Intended Use: Controlled administration of radiopaque contrast media and saline to human subjects during angiographic procedures.
- Key Change: The new device (CVi1) is a modification of a predicate device (K171646 ACIST CVi® Contrast Delivery System). The primary change is the removal of functionality that allowed the administration of contrast media from the same syringe to multiple patients. The CVi1 system is designed for single-patient use for the syringe and contrast media.
- Substantial Equivalence: The submission argues for substantial equivalence to the predicate device because the fundamental technological characteristics and principle of operation are unchanged, and the modifications do not introduce different questions of safety or effectiveness.
Regarding performance data, the document states:
"The CVi1 Contrast Delivery System was subjected to bench and biocompatibility testing, human factors and sterility assessment, software verification, and system level testing. Bench testing included burst, functional, life, pressure, bond pull, flow, and durability, Bench performance testing was repeated from the predicate device. The subject device met the same endpoints and criteria as the predicate. Test results demonstrate that the CVi1 Contrast Delivery System meets specification and performs as intended. No new safety or performance issues were raised during the testing."
And for the new component:
"The A1000V Syringe Kit contains a new contrast valve check scepter compared to the predicate device. To evaluate this change, the following biocompatibility tests were completed on the A1000V Syringe Kit of the CVi1 Contrast Delivery System: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity."
Given this information, it's not possible to populate the requested table or answer most of the questions about AI/ML device study parameters, as they are not relevant to this type of device submission.
Here’s what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Safety | No new safety issues raised during testing. |
| Effectiveness | No new effectiveness issues raised during testing. |
| Bench Performance (Burst, Functional, Life, Pressure, Bond Pull, Flow, Durability) | "The subject device met the same endpoints and criteria as the predicate. Test results demonstrate that the CVi1 Contrast Delivery System meets specification and performs as intended." |
| Biocompatibility (for new component) | "Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity" were conducted and presumably met acceptance criteria as the conclusion states substantial equivalence. |
| Software Verification | Conducted. |
| System Level Testing | Conducted. |
| Human Factors | No new critical tasks identified with the proposed CVi1 when compared with the CVi, thus no additional human factors validation testing is necessary. |
| Sterility | Assessed. |
Regarding the other questions:
- 2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML diagnostic or prognostic device. This refers to bench testing of mechanical properties and biocompatibility, not patient data sets. The document doesn't specify test sample sizes for these bench tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML performance is not relevant here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to engineering specifications and biological material compatibility, not clinical diagnostic accuracy.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.