(57 days)
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.
SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.
Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.
This document is a 510(k) Premarket Notification from the FDA regarding the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set. It establishes substantial equivalence to existing predicate devices, indicating that no new clinical study was required to prove safety and effectiveness for a new medical device. Instead, the submission focuses on demonstrating that the new packaging configurations and additional kit components of the subject devices do not alter their fundamental safety and performance characteristics compared to the previously cleared predicate devices.
Therefore, the typical acceptance criteria and study design for proving the performance of a novel AI-powered medical device are not applicable in this context. This submission is for a conventional medical device (infusion sets and needles) and relies on bench testing, material comparisons, and risk management rather than clinical performance studies with AI.
However, I can extract information related to the acceptance criteria for this specific submission, which pertains to the device's substantial equivalence and safety/performance after changes, rather than a de novo AI device.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance (as applicable to this submission):
For this 510(k) submission, the "acceptance criteria" are not related to a specific performance metric of an AI model (like accuracy, sensitivity, specificity). Instead, they revolve around demonstrating that the new configurations and kit components of the PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set maintain the same safety and performance profiles as their cleared predicate devices.
The document implicitly states that for the original devices (the predicates), their performance was deemed acceptable for their stated indications. For this new submission, the acceptance criteria are met by demonstrating "substantial equivalence" based on:
| Acceptance Criterion (Implicit) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence: Subject devices share the same intended use as predicate devices. | Met: "Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory, are intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports." (Page 5) |
| Indications for Use Equivalence: Subject devices share the same indications for use as predicate devices. | Met: "Same as predicate." for both PowerLoc® MAX and SafeStep® Huber Needle Set Indications for Use. (Pages 6, 11) |
| Technological Characteristics Equivalence: Subject devices have substantially similar technological characteristics (design, materials, dimensions, etc.) to predicate devices. | Met: Detailed comparison tables (Pages 6-9, 11-14) explicitly state "Same as predicate" for numerous attributes including: |
- Product Code
- Review Branch
- Intended Use
- Indications for Use
- General Device Description
- Y-Site presence
- Duration of Use
- Device Materials
- Sterility Method (Ethylene Oxide)
- Sterility Assurance Level (SAL 10-6)
- Number of Uses (Single-use)
- Anatomical Site Use
- Principle of Operation
- Safety Infusion Set Device Components
- Sizes (Needle Gauge, Needle Length)
- Needle OD
- Tubing Dimensions (ID, OD, Length)
Note: The addition of new kit components is acknowledged but they are themselves legally marketed, cleared devices. |
| Safety and Performance After Changes: The new packaging configurations and additional kit components do not negatively impact the biological safety or functional efficacy of the devices. | Met: "Testing was performed to show that the kit components maintain their biological safety and functional efficacy after ethylene oxide (EO) sterilization. The kit components met all predetermined acceptance criteria. Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Risk Management for Medical Devices. The risks were analyzed, mitigated and reduced to an acceptable level, and re-evaluation showed that the remaining risks are outweighed by the benefits of the device, and that the device is acceptable for its intended use." (Page 14) |
2. Sample Size Used for the Test Set and Data Provenance:
- This 510(k) submission does not involve a "test set" in the context of an AI model's performance on clinical data.
- The evaluation is based on "safety and performance tests" (Page 15) conducted on the physical devices and their components. The document does not specify the sample sizes for these bench tests, but it states that the "kit components met all predetermined acceptance criteria" and that a "risk management" process was followed.
- Data provenance is not applicable in the sense of patient data from specific countries or retrospective/prospective studies. The "data" here refers to engineering and biocompatibility test results.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as there is no "ground truth" in the context of clinical images or patient data being interpreted by AI.
- The ground for proving substantial equivalence relates to regulatory standards, engineering specifications, and established biocompatibility principles. The FDA review team acts as the expert body for evaluating this submission.
4. Adjudication Method for the Test Set:
- Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This submission is for physical medical devices (infusion sets/needles), not an AI algorithm assisting human readers. Therefore, there is no AI assistance component to measure improvement.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is not an AI algorithm.
7. Type of Ground Truth Used:
- The "ground truth" in this submission is the accepted safety and performance of the predicate devices and the physical/chemical characteristics of the materials and design, verified through bench testing and adherence to recognized standards (e.g., sterilization, biocompatibility, risk management according to ISO 14971:2012).
8. Sample Size for the Training Set:
- Not applicable. There is no AI model or training set involved.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above.
In summary, this FDA 510(k) document demonstrates substantial equivalence for conventional medical devices after a minor change (new packaging/kit components), rather than proving the performance of a novel AI-powered medical device through clinical studies. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence and ensuring that the modified devices maintain their established safety and functional efficacy through engineering and biocompatibility testing.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).