(264 days)
The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi
Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.
This document describes a 510(k) premarket notification for the "Nipro SafeTouch IV Catheter". Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove optimal performance against specific clinical acceptance criteria in the same way a new drug or novel high-risk device might.
Based on the provided information, the device is an Intravascular Catheter with a passive anti-needle stick safety mechanism. The acceptance criteria and supporting studies are focused on its non-clinical performance and a simulated clinical study for the safety mechanism.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are not explicitly stated with quantitative thresholds in the provided document beyond "All of the above tests were performed within the specifications of the standards listed above." The performance is reported as "passed with zero failures" for the simulated clinical study and "performs equivalent to the predicate device" for other tests.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | 1. Disengagement force between components | Performed within specifications of internal test method |
| 2. Penetration force | Performed within specifications of internal test method | |
| 3. Air leakage | Performed within specifications of internal test method | |
| 4. Flow rate | Performed within specifications of internal test method | |
| 8. Corrosion resistance (ISO 10555-1:1995) | Performed within specifications of ISO 10555-1:1995 | |
| Safety Mechanism | 5. Safety mechanism performance (simulated clinical study) | Passed with zero failures |
| Sterilization & Packaging | 6. Package integrity/microbial barrier (ISO 11607-2) | Performed within specifications of ISO 11607-2 |
| 9. Sterilization validation (ISO 11135-1:2007, ISO 11135-2:2008) | Performed within specifications of ISO 11135-1/11135-2 | |
| 10. EtO residuals (ISO 10993-7) | Performed within specifications of ISO 10993-7 | |
| 11. Transportation tests (ASTM-d4169-09) | Performed within specifications of ASTM-d4169-09 | |
| 14. Shelf-life testing (ASTM F1980-07) | Performed within specifications of ASTM F1980-07 | |
| Biocompatibility | 7. Chemical testing / acid, alkalinity and extractable metals (ISO 7864:1993) | Performed within specifications of ISO 7864:1993 |
| 12. Biocompatibility (ISO 10993, various sub-parts) | Performed within specifications of ISO 10993 | |
| 13. Pyrogen testing (USP 35-NF30:2012, ) | Performed within specifications of USP 35-NF30:2012, | |
| Particulate matter testing | Performed within specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size used for any of the non-clinical tests or for the "simulated clinical study" that evaluated the safety mechanism.
- The provenance of the data (country of origin, retrospective/prospective) is not mentioned. These are likely internal laboratory tests conducted by Nipro Medical Corporation or a contracted testing facility.
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)
- This information is not provided. Since the tests are largely non-clinical engineering and laboratory tests, "experts" in the context of clinical interpretation or diagnostic decision-making are not relevant. The "ground truth" for these tests would be defined by the specifications of the relevant international standards (e.g., ISO, ASTM, USP).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is generally not applicable to the types of non-clinical, objective tests described here. Adjudication methods are typically used in clinical studies where subjective human interpretation of conditions or outcomes requires consensus.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is an IV catheter, not an AI-assisted diagnostic tool or imaging device. There is no AI component, and therefore no assessment of human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is an IV catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is established by the specifications and requirements defined within the referenced international and national standards (e.g., ISO, ASTM, USP). The device performance is compared against these predefined physical, chemical, and biological limits or parameters.
- For the "simulated clinical study" of the safety mechanism, the ground truth would be a binary outcome of successful activation/engagement of the safety mechanism as per its design specifications.
8. The sample size for the training set
- This device is not an AI/machine learning device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
- This question is not applicable as the device does not involve a training set.
§ 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).