(72 days)
The HOSPIRA CathLab Convenience Kits are intended for use in cardiac catheterization and radiology procedures requiring the use of contrast media. These procedures include right heart studies, venogram and arteriogram. The kit provides the user with a "ready-to-use" set up avoiding the need to acquire / assemble components from various manufacturers. The kit is intended for one-time use.
The intended use of the antiseptic contained within a kit is to prepare the patient's skin prior to surgery.
The HOSPIRA CathLab Convenience Kits are comprised of variations of the following components: Needles, guide wires, vessel dilators, slide clamps, suture wings, suture wing clips, syringes, table covers, stopcocks, absorbent towels, gauze sponges, Lidocaine HCl injection, drapes, scalpels, silk cutting needle suture, dressings and sharps stick pads.
The provided text describes a Special 510(k) submission for HOSPIRA CathLab Convenience Kits. This is a premarket notification to the FDA for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of a novel device based on specific acceptance criteria.
The primary goal of this submission is to demonstrate that the modified device (HOSPIRA CathLab Convenience Kits with an alternate antiseptic) is as safe and effective as existing, legally marketed predicate devices. This type of submission relies on demonstrating similarities and justifying differences, rather than providing extensive performance data against predefined acceptance criteria for a new feature's clinical efficacy.
Therefore, many of the requested details about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies are not applicable or explicitly provided within this type of regulatory document.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a Special 510(k) for a convenience kit with a new antiseptic, the "acceptance criteria" primarily relate to the safety and functionality of the new component (ChloraPrep® antiseptic applicator) and the overall kit's continued substantial equivalence.
| Acceptance Criteria (Implied for the new antiseptic) | Reported Device Performance |
|---|---|
| Maintain material integrity after sterilization | ChloraPrep® applicator passed all test criteria after three EtO cycles. |
| Functionality as intended for antiseptic application | ChloraPrep® applicator passed all test criteria after three EtO cycles. |
| Overall kit retains substantial equivalence to predicate device (composition, intended use) | "The HOSPIRA CathLab Convenience Kits meet all functional claims and intended use... in terms of substantial equivalence as the predicate convenience kit(s)." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions the ChloraPrep® applicator was "tested," but the number of units tested is not provided.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer (Hospira or its suppliers) for regulatory submission purposes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable / Not provided. The "ground truth" here is the pass/fail result of specific engineering or compatibility tests for the antiseptic applicator, not a clinical assessment requiring expert interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. Adjudication typically applies to expert review of clinical data. For engineering tests, results are usually objective (e.g., material integrity, sterility testing which would be performed by lab personnel).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for a convenience kit and the addition of an antiseptic applicator. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not the scope of this device or regulatory submission.
6. Standalone Performance (Algorithm only without human-in-the-loop):
- Not applicable. This device is a collection of medical components, not an algorithm or AI system.
7. Type of Ground Truth Used:
- Engineering/Material Testing Results and Functional Performance: The "ground truth" for the new antiseptic applicator appears to be its ability to withstand sterilization and maintain its functional properties, as determined by laboratory tests. For the overall kit, the "ground truth" is its composition maintaining the same intended use attributes as the predicate device(s).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The "testing" refers to verification and validation of manufacturing processes and component compatibility.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML model, this question does not apply.
In summary, this document is a regulatory submission for a minor modification to an existing medical device, focusing on demonstrating substantial equivalence rather than presenting clinical efficacy data or advanced AI performance metrics.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).