(182 days)
The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.
Specifically,
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the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
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the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
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the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.
The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use.
The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use.
The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:
- One (1) 22g non-coring (Huber) Refill Needle
- One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, clamp, and female luer
- One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty syringe barrel
The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.
The provided text is a 510(k) summary for the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special Bolus Needles, and OR Prep Kit. It describes the device, its intended use, and a comparison to a predicate device, along with summary of testing conducted to demonstrate substantial equivalence.
However, the request asks for specific information related to acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered device. The submitted document pertains to a medical device that is a set of needles and an OR Prep Kit, not an AI/ML-powered medical device.
Therefore, the requested information elements (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and are not present in the provided document.
The document focuses on bench performance tests, sterilization validation, biocompatibility, and shelf-life validation to demonstrate substantial equivalence to a predicate device, which is typical for non-AI medical devices.
Here's the table of acceptance criteria and reported device performance from the document, which are performance criteria for the physical device components, not an AI algorithm:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Tests Conducted | Test Acceptance Criteria | Reported Device Performance (Implied "Met" or "Exceeded") |
|---|---|---|---|
| ISO 7864:2016 Sterile Hypodermic Needles for Single Use - Requirements and Test Methods | Visual inspections | Outside surface of the tubing shall be smooth and free from defects. Needle tube shall appear straight and of regular roundness. Surfaces of the tubing shall be free from metal soil and processing agents. | Met |
| Needle length tolerance verification | Needle length shall be within +1.5 mm/-2.5 mm of the nominal length. | Met | |
| Tensile Testing of needle/hub connections | Cannula/Hub connection shall withstand a 15 lbf tensile load. | Met | |
| Patency of Flow Testing | Stainless steel stylet of 0.30 mm shall pass through the needle to the non-coring feature. | Met | |
| Drag/Penetration force testing | Maximum Drag/Penetration force of 5 lbf. | Met | |
| Acidity / Alkalinity testing | Extract PH shall be within one unit of pH of that of the control fluid. | Met | |
| Extractables testing | Limit of 5 mg/L of lead, tin, zinc, and iron. Limit of 0.1 mg/L of cadmium. | Met | |
| ISO 9626:2016 Stainless Steel Needle Tubing for The Manufacture of Medical Devices - Requirements and Test Methods | Stiffness testing | Maximum deflection of 0.42 mm. | Met |
| Resistance to breakage testing | No visible breakage. | Met | |
| Corrosion testing | No visible sign of corrosion. | Met | |
| ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles | Non-Coring Testing | Absence of core in the needle cannula. | Met |
| ISO 8536-9:2015 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment | Leak Testing | Cannula/Hub connection shall maintain leak integrity when a pressure of 45 psi. | Met |
| Tensile testing of tubing luer connections | Each joint in the device shall withstand a tensile force of 5 lbs. | Met | |
| Leak testing of tubing luer connections | Flow path shall withstand a minimum of 50 psig of air. | Met | |
| ISO 594-1:1986 and ISO 594-2:1998 Conical Fittings With 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements and Part 2: Lock Fittings | Luer performance testing | The connectors fit within the limits of the gauge. No observed leakage sufficient to form a falling drop of water. Connectors remained attached under 35 N load. Connectors remained attached under 0.020 N·m unscrewing torque. Connectors successful connected to the reference fitting/male luer. Connector did not override threads under load. No signs of stress cracking observed. | Met |
| USP Particulate Matter in Injections | Particulate testing | Average number of particles present does not exceed 6000 per device equal to or greater than 10 µm and does not exceed 600 per device equal to or greater than 25 µm. | Met |
| Internal Intera Protocols | Clamp Flow Stoppage and Release Testing | Clamp shall prevent water at 45 psig from flowing once clamped for 2 minutes. Upon release of the clamp, water at 5 psig must flow through the clamped section. | Met |
| Internal Intera Protocols | Leak Testing (Syringe Barrel Lid) | No leakage when inverted with 18 mL of water present. | Met |
As the device is not an AI/ML device, the following points are not applicable and cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: Not applicable (no AI test set). For the physical device, testing was conducted on "samples" that were real-time aged, but specific sample sizes for each test are not detailed in this summary.
- 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 (no AI ground truth).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no AI test set requiring adjudication).
- 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 (not an AI device).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (no AI ground truth).
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
§ 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).