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510(k) Data Aggregation
(77 days)
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
ACIST CVi®1 Contrast Delivery System: 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 CVi®1 Syringe Kits, Manifold Kit and AngioTouch® Hand Controller Kit must be discarded after each patient procedure. The CVi@1 Syringe Kits are also indicated for single patient use with ACIST CVi® 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.
ACIST CVi® Contrast Delivery System: The ACIST CVi® Contrast Delivery System is indicated for controlled administration of radiopaque contrast media and saline to human subjects while undergoing angiographic procedures. The ACIST CVi® Contrast Delivery System is specifically indicated for use in angiographic procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of ten (10) hours. The Syringe Kit must be discarded after six (6) patient procedures. The Manifold Kit and AngioTouch Kit must be discarded after each patient procedure. The ACIST CVi® 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 CVi/CVi1 System is designed to aid the physician in the controlled infusion of radiopaque contrast media. Radiographic imaging devices are used in conjunction with the delivery of contrast media to produce angiograms. Operating environments for the CVi/CVi1 System are catheterization and radiological laboratories. The CVi/CVi1 System contains a software-controlled motor-driven pump that delivers contrast media at a user-determined flow rate and volume via the ACIST provided consumable kits and a hospital provided angiographic patient catheter. The CVi/CVi1 System is also equipped to synchronize with commercially available X-ray imaging systems. The CVi/CVi1 System is used in interventional cardiology, radiology, and vascular surgical procedures. The CVi/CVi1 System device modification that is the subject of this 510k premarket notification is a material component change to the AngioTouch Hand Controller.
The provided text is a 510(k) summary for the ACIST CVi®1 Contrast Delivery System, focusing on a modification to its AngioTouch Hand Controller. This document primarily addresses the substantial equivalence of the modified device to a predicate device and includes information about the types of testing performed to support this claim, but it does not contain the level of detail typically found in a clinical study report or a publication detailing specific acceptance criteria and detailed performance data for a diagnostic algorithm.
Therefore, many of the requested sections about acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for training sets cannot be extracted from this document.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
The document describes "bench testing" and "biocompatibility testing" to demonstrate that the modified device meets specifications and performs as intended. Specific numerical acceptance criteria and precise performance values are not given, but the summary states the device met specifications.
| Test Type | Reported Device Performance |
|---|---|
| Bench Testing (Burst) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Functional) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Life) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Pressure) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Bond Pull) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Flow) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Bench Testing (Durability) | Test results demonstrate that the modified device meets specification and performs as intended. |
| Biocompatibility (Cytotoxicity) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Sensitization) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Irritation) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Acute Systemic Toxicity) | Completed (Implies passed relevant criteria) |
| Biocompatibility (Material Mediated Pyrogenicity) | Completed (Implies passed relevant criteria) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench and biocompatibility testing" without enumerating the number of samples or tests.
- Data Provenance: Not specified. Bench and biocompatibility testing are typically laboratory-based and do not involve patient data provenance in the same way clinical studies do.
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)
Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software. Ground truth in this context refers to engineering specifications and biological safety standards, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device (contrast delivery system) modification.
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 is a medical device (contrast delivery system) modification, not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (contrast delivery system) modification.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, "ground truth" would be established by engineering specifications and industry standards for device performance (e.g., burst pressure limits, flow rate accuracy). For biocompatibility, "ground truth" is established by recognized standards for biological safety (e.g., ISO 10993 series). The document states the modified device "meets specification and performs as intended," implying conformity to these established engineering and biological safety standards.
8. The sample size for the training set
Not applicable. This is a medical device (contrast delivery system) modification, not an AI/diagnostic software that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device (contrast delivery system) modification.
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