(28 days)
The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term periphcral access to the central venous system for intravenous therapy or blood sampling.
The 4 Fr single lumen silicone Groshong® NXT PICC catheter is a 60 cm, trimmable catheter with depth markings. It has a closed, rounded, atraumatic, radiopaque distal tip with the 3-position, pressure-sensitive Groshong® valve.
It has a 2-piece connection with extension leg and lucr lock connector that is designed to be attached by the clinician after trimming the catheter tube to length. The connector has suture wings that are StatLockcompatible for stability.
The provided document describes the 510(k) summary for the 4 Fr Single Lumen Groshong® NXT PICC Catheter, which is a medical device. This type of device is subject to performance testing against established criteria to demonstrate substantial equivalence to a predicate device, rather than a clinical study measuring diagnostic performance of an AI algorithm.
Therefore, many of the requested categories in your prompt (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set information) are not applicable to this type of device submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Testing was performed using the Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 included assessments of" a list of 12 tests, with an additional 9 non-guidance tests. The report indicates that "Performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC."
While the document lists the types of tests performed, it does not explicitly state specific quantitative acceptance criteria or the numerical results for each test. Instead, it concludes that the device "demonstrate[s] equivalence" and is "substantially equivalent" to the predicate device.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Guidance-based Tests | Demonstrated substantial equivalence to predicate device based on FDA guidance. | Achieved Substantial Equivalence: Performance data demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (K023374). Specific numerical results are not provided in this summary. |
| 1. Dimensions | ||
| 2. Priming Volume | ||
| 3. Flow Rate | ||
| 4. Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft | ||
| 5. Tensile Extension Leg to Proximal (2-piece) Connector | ||
| 6. Tensile Proximal connector to Distal Connector (2-picce) | ||
| 7. Tensile Catheter Shaft to Distal (2-piece) Connector | ||
| 8. Catheter Tip Tensile | ||
| 9. Assembly Leak (Leak at Hub) | ||
| 10. Catheter Assembly Burst | ||
| 11. Catheter Collapse | ||
| 12. Catheter Flexural Fatigue Tolerance (Cyclic Flexure) | ||
| Additional Non-Guidance Tests | Demonstrated substantial equivalence to predicate device. | Achieved Substantial Equivalence: Performance data demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (K023374). Specific numerical results are not provided in this summary. |
| 13. Creep (Static) | ||
| 14. Radiopacity | ||
| 15. Valve Function | ||
| 16. Kink Resistance | ||
| 17. Stylet Drag | ||
| 18. Flush-through Wire/fuer lock connector tensile | ||
| 19. Flush-through Sytlet Luer Taper | ||
| 20. Flush-through Stylet Air Leakage | ||
| 21. Flush-through Stylet Ease of Assembly |
Regarding the other points in your request:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This is a physical medical device. The "test set" refers to physical samples of the catheter that underwent various engineering and mechanical tests (e.g., tensile strength, flow rate). The sample sizes for these specific engineering tests are not provided in this 510(k) summary, nor is data provenance in terms of country of origin or retrospective/prospective.
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)
- Not Applicable: "Ground truth" in the context of diagnostic algorithms and expert consensus is not relevant here. The "ground truth" for a physical device is established by validated engineering standards and test methods. Scientific methods exist for assessing the effects of new characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are for human interpretation differences, typically in diagnostic studies. This is a physical device testing scenario applying established engineering principles.
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
- Not Applicable: An MRMC study is for evaluating diagnostic performance, often with AI. This document is for a physical medical device (catheter) and its inherent performance, not its use to assist human readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Inherent: The "ground truth" for the device's performance is based on established engineering and material science principles, against which the physical properties of the catheter (e.g., burst pressure, flow rate, tensile strength) are measured and compared to predefined specifications or performance of a predicate device. The document explicitly states, "Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. Design performance is in compliance with the FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/ 95."
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/machine learning device. The device is manufactured according to specifications, and samples from production are tested for quality control and performance verification.
9. How the ground truth for the training set was established
- Not Applicable: No training set or associated ground truth in this context.
§ 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.”