(36 days)
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics: Radiopaque polyurethane catheters 4 Fr single-lumen BlueFlex® Tip and non-BlueFlex® Tip 5 Fr double lumen BlueFlex® Tip and non-BlueFlex® Tip Usable length of 4 Fr catheters are 40cm to 60cm Usable length of 5 Fr catheters are 40cm to 60cm Catheters are provided in sterile kit configurations The 4 Fr BlueFlex® Tip, 4Fr non-BlueFlex® Tip and 5 Fr BlueFlex® Tip catheters are labeled for "4ml/sec, pressure injectable" on the Luer hub(s) to facilitate the proper use of the device The 5 Fr non-BlueFlex® Tip catheter is labeled for "5ml/sec, pressure injectable" on the Luer hubs to facilitate the proper use of the device
The provided text does not contain information about acceptance criteria for a medical device's performance that would typically be evaluated through clinical studies with human patients, algorithms, or expert ground truth. Instead, it describes a 510(k) submission for a Pressure Injectable Peripherally Inserted Central Catheter (PICC) and focuses on bench testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information given.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Rate Qualification Test: (Specific criteria not provided in the text, but the test was performed.) | Met performance criteria. |
| Repeat Injection Test: (Specific criteria not provided in the text, but the test was performed.) | Met performance criteria. |
| Catheter Static Burst Pressure: (Specific criteria not provided in the text, but the test was performed after sterilization, simulated shipping, cleaning solutions, repetitive bending, and use of high vesicant fluid.) | Met performance criteria. |
| Substantial Equivalence: To the predicate device Arrow International's PICC (K061289) for safety and effectiveness. | Demonstrated substantial equivalence through bench tests. |
| Power Injection (Implied Criteria based on Indications for Use): Maximum pressure of power injector equipment not to exceed 300 psi. | Catheter is labeled for "4ml/sec, pressure injectable" or "5ml/sec, pressure injectable" on Luer hubs, facilitating proper use within indicated pressure limits. The successful bench tests support this capability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The tests are bench tests, likely involving a representative number of device units.
- Data Provenance: Bench test data; not human clinical data. No country of origin is specified for these bench tests, but the company is based in Reading, PA, USA. The data is prospective, as these are tests conducted specifically for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for these engineering/performance tests is defined by established engineering standards, test methods, and the performance of the predicate device, not by expert medical opinion on a clinical outcome.
4. Adjudication Method for the Test Set
- Not Applicable. As these are bench tests against predetermined engineering criteria, an adjudication method in the sense of reviewing ambiguous clinical cases is not relevant. The pass/fail criteria for each test (e.g., burst pressure, flow rate) would be objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a device submission based on bench testing of physical properties, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device (catheter), not an AI algorithm.
7. The Type of Ground Truth Used
- Engineering Performance Metrics: The ground truth for these tests is the performance of the device against predefined engineering specifications (e.g., flow rates, burst pressures) and comparison to the predicate device's established performance under similar test conditions.
8. The Sample Size for the Training Set
- Not Applicable. This submission is for a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI model or training set, this question is not relevant.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”