(96 days)
The PPS PI® curved safety Huber needle is indicated for:
- Administration or withdrawal of fluids through implanted ports.
- Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cPs is : - 5mL/sec. for 19 Ga. needle
- 5 mL/sec. for 20 Ga. needle
- 2 mL/sec. for 22 Ga. needle.
- The PPS PI® Curved Safety Huber needle is indicated to PPS PI® Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
The PPS PI® Pressure Injectable Safety Huber Needle is a curved safety Huber needle mounted with one connection line ideal for accessing pressure injectable ports. This device allows pressure injection of contrast media during CT (computerized tomography) scans or MRI (computerized tomography) and is MR Conditional. The PPS PI® curved Huber needle is available in various lengths and diameters; with or without a lateral injection site. Luer-Lock connectors, are provided, on which closed protective caps are screwed (end of the main line and of the Y site) which must not be used as sealing caps. One clamp is also provided (2 clamps for references with "Y" site) PPS PI® Pressure Injectable Safety Huber Needle is single use
The provided 510(k) summary (K120261) describes the PPS PI® Pressure Injectable Safety Huber Needle. This document does not contain the level of detail required for a comprehensive description of acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. This device is a medical instrument (needle) and not an AI/ML algorithm.
Therefore, many of the requested fields cannot be filled. However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, performance is demonstrated through general safety and functionality testing and biocompatibility.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | ✓ Meets biocompatibility requirements |
| Safety and Functionality | ✓ Meets safety and functionality requirements |
| Pressure Injection Rates | - 5 mL/sec. for 19 Ga. needle |
- 5 mL/sec. for 20 Ga. needle
- 2 mL/sec. for 22 Ga. needle. |
| Needle Stick Prevention | Indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document generally states "Performance data included with this submission" which typically refers to internal test reports, but the specifics of sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) for the safety and functionality tests are not disclosed in public-facing summarized documents like the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/provided. For a physical medical device like a Huber needle, ground truth is typically established through engineering specifications, material testing standards, and in vitro or in vivo (if applicable) performance testing against defined physical and mechanical benchmarks, not by expert consensus in image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable/provided for this type of device. Adjudication methods like 2+1 or 3+1 are relevant for studies where human readers are making subjective interpretations, typically in diagnostic imaging with AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used to evaluate the impact of AI on human reader performance, which is not relevant for this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device would be based on:
- Engineering Specifications: Adherence to design tolerances, material properties, and mechanical strength requirements.
- Biocompatibility Standards: Evidence that the materials used do not elicit adverse biological responses.
- Functional Testing: Verification that the needle delivers fluids at specified rates, the safety mechanism activates correctly, and the luer-lock connectors function as intended.
- Predicate Device Equivalence: Comparison to legally marketed predicate devices in terms of intended use, materials, design, and functionality.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As above, there is no "training set" for a physical medical device.
Summary regarding the device and AI/ML criteria:
The K120261 submission pertains to a physical medical device, the PPS PI® Pressure Injectable Safety Huber Needle. As such, the concept of "acceptance criteria" and "studies" as typically applied to AI/ML powered devices (e.g., diagnostic accuracy, sensitivity, specificity, MRMC studies) are not directly relevant. The performance data focuses on biocompatibility, safety, functionality, and specific flow rates, which are typical for this class of device. The primary method of demonstrating effectiveness and safety, and therefore meeting acceptable criteria, is through comparison to predicate devices and adherence to general device testing standards.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.