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510(k) Data Aggregation
(78 days)
The I.V. Catheter System is designed to gain access to and deliver a short term (
The I.V. Catheter System contains a short term intravascular catheter and a catheter introducer. The intravascular catheter consists of a slender catheter tube and a catheter hub. The catheter introducer consists of a housing that contains a flash chamber, a flash plug, a stainless steel needle and a needle safety mechanism. The I.V. Catheter System is designed to reduce the risk of accidental needlesticks.
The provided 510(k) submission for the I.V. Catheter System focuses on demonstrating substantial equivalence to predicate devices and the effectiveness of its sharps injury prevention feature.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as quantitative thresholds in the usual sense of a performance study for a diagnostic AI device. Instead, the submission focuses on meeting safety and performance aspects, particularly regarding the needlestick prevention feature, and demonstrating equivalence to existing products.
Below is a table summarizing the implicit acceptance criteria derived from the study and the reported device performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety - Sharps Injury Prevention | |
| Reduces risk of accidental needlesticks | 0 sharps injuries reported out of 500 insertions in a simulated use study. The device is designed with a self-blunting needle system activated automatically. |
| Protective feature functions reliably | 0 failures of the protective feature occurred out of 500 insertions. |
| Usability/Usability - User Experience | |
| Intuitive to use | "Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System is intuitive in nature." |
| Requires little or no change in usual technique | "Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System... requires little or no change in usual technique." |
| Meets customer requirements | "Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System... meets customer requirements." |
| Biocompatibility | |
| Meets material safety and biocompatibility standards | The I.V. Catheter System meets ISO 10993-1 requirements for material safety and biocompatibility. |
| Needle and Catheter Standards | |
| Introducer needle meets relevant ISO standards | The introducer needle meets the requirements of ISO 10555-5. |
| Catheter previously cleared by FDA | The I.V. catheter (component) has previously received FDA clearance. |
| Functional Equivalence to Predicate (via Comparison Matrix) | "The I.V. Catheter System is substantially equivalent to JJM's existing CRITIKON* OCR I.V. Catheter and to Bio-Plexus' existing Punctur-Guard® Blood Collection Needle." The comparison matrix (Table 1) notes numerous factors where the device is "Yes" for the intended use and technological features. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- 50 participants were involved in the simulated use study.
- A total of 500 I.V. Catheter Systems were successfully inserted and evaluated.
- Data Provenance: The document does not explicitly state the country of origin for the simulated use study. It is a prospective study designed to assess the device's performance in a controlled, simulated environment. The manufacturer, Johnson & Johnson Medical, is located in Arlington, Texas, USA, suggesting the study likely took place in the USA or under their direct oversight.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of submission for a physical medical device (I.V. catheter) typically does not involve "ground truth" in the same way as an AI diagnostic device (e.g., pathology, expert consensus on images).
For this device:
- Ground Truth Establishment: The primary ground truth for the device's main claim (reducing needlestick injuries and functional performance) was established through direct observation and reporting of sharps injuries and failures of the protective feature during the simulated use study by the study participants and/or observers.
- "Experts": The "50 participants" acted as the evaluators of the device's usability and whether it met customer requirements. Their qualifications are not specified beyond being "participants" in a simulated use study, implying they are likely healthcare professionals or trained individuals who would use such a device. There is no mention of external adjudicating experts (e.g., radiologists) in the context of this device.
4. Adjudication Method for the Test Set
The reported simulated use study assessed the occurrence of sharps injuries and failures of the protective feature, and gathered feedback on usability.
- Sharps Injury/Protective Feature Failure: The criteria for these events would presumably be objective observations. There is no mention of a formal adjudication method (e.g., 2+1, 3+1 consensus) in the document. It's implied that these were directly observed and recorded events (or non-events).
- User Feedback: "Positive responses" from participants regarding insertion and use characteristics suggest qualitative feedback that was summarized. The method of collating or adjudicating this feedback (e.g., specific survey questions, interview analysis) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of AI algorithms on human reader performance, which is not applicable to this physical I.V. Catheter System. The study conducted was a simulated use study to evaluate safety and usability of the physical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an algorithm or AI was not done. This product is a physical I.V. Catheter System, not an AI or software-only device. The "standalone" performance here refers to the device's inherent ability to prevent needlestick injuries and its functional operation, which was tested in the simulated use study.
7. Type of Ground Truth Used
For the key claims:
- Sharps Injury Prevention & Protective Feature Functionality: The ground truth was based on direct observation of events (or non-events) during simulated use. The absence of sharps injuries and failures of the protective feature served as the ground truth for its effectiveness in this regard.
- Biocompatibility & Material Standards: The ground truth was established by compliance with recognized international standards (ISO 10993-1, ISO 10555-5) through material testing.
- Usability/Customer Requirements: The ground truth was gathered through participant feedback indicating satisfaction and ease of use.
8. Sample Size for the Training Set
Not applicable. This submission describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" that occurs is the manufacturing process and quality control to ensure all devices meet specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm or "training set," this question does not apply.
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