(196 days)
Not Found
The PROTECTIV 2000 IV Catheter Safety System is a needle safety feature for an IV catheter. The IV catheter portion of the system is the same product that is currently marketed by JJMI. The PROTECTIV 2000 IV Catheter Safety System is designed to reduce needle stick injuries. The PROTECTIV 2000 IV Catheter Safety System is being provided on a variety of IV catheters.
The provided text describes a medical device, the PROTECTIV* 2000 IV Catheter Safety System, and mentions that it has passed tests for safety and effectiveness. However, it does not contain the specific information required to complete the detailed table and answer the questions related to acceptance criteria, device performance, study design, and ground truth establishment.
The section "Discussion of Tests/Studies with Conclusions" only lists general categories of tests (e.g., "Cannula Security Force," "IVC Safety Mechanism Efficacy," "Simulated Clinicals") and states "Passed the minimum requirement" or "Passed." It does not provide:
- Specific Acceptance Criteria: What were the "minimum requirements" for each test in quantifiable terms (e.g., force in Newtons, percentage of efficacy, etc.)?
- Reported Device Performance: What were the actual measured values that demonstrate the device met these criteria?
- Study Details: There's no information on sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, or training set details.
Therefore, the following table and answers are largely unable to be populated from the provided text. I will indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|---|
| Cannula Security Force | Not provided in text | Passed the minimum requirement |
| Advance/Lock IVC Safety Mechanism Efficacy | Not provided in text | Passed the minimum requirement |
| Tip Protector/Primary Member Security | Not provided in text | Passed the minimum requirement |
| Cannula Orientation | Not provided in text | Passed the minimum requirement |
| FIPG Efficacy | Not provided in text | Passed the minimum requirement |
| Biocompatibility | Per ISO 10993 | Passed |
| Simulated Clinicals | Not provided in text | Passed |
| Sterilization | Not provided in text | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective or prospective nature of "Simulated Clinicals").
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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
- An MRMC study is not applicable as this is a physical medical device (IV catheter safety system), not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as this is a physical medical device. The "standalone" performance would be the direct device performance as measured in the "Test" section, but specific metrics and acceptance criteria are missing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical tests (e.g., security force, efficacy), the "ground truth" would be established by objective measurement against engineering specifications and regulatory standards. The specific standards or objective metrics used are not detailed beyond "minimum requirement."
- For "Biocompatibility," the ground truth is established by adherence to ISO 10993 standards.
- For "Sterilization," the ground truth is established by standard sterilization validation protocols.
- For "Simulated Clinicals," the nature of the ground truth (e.g., successful procedure completion, absence of specific failures) is not specified.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI algorithm that typically uses a "training set" in the machine learning sense. The development likely involved iterative design and testing, but not a formally defined "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no mention of a training set for an AI algorithm.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).