(265 days)
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in various model numbers. The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths: 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc. 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.
The provided text describes the non-clinical performance data for the ISP Safety Huber Needle Infusion Set, which is a medical device. This information is typically found in a 510(k) premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:
Acceptance Criteria and Reported Device Performance
The device's performance is compared against internal requirements, national standards, international standards, and the predicate device (Millennium Huber Plus Safety Infusion Set, K993848).
| Acceptance Criteria / Test Description | Reported Device Performance (ISP Safety Huber Needle Infusion Set) | Predicate Device Performance (Millennium Huber Plus Safety Infusion Set) |
|---|---|---|
| Needle Insertion/Removal Force | Passed (Same forces required as predicate device: Insertion 2.20 – 2.75 lbs, Removal 2.20 – 2.50 lbs) | Insertion 2.20 – 2.65 lbs, Removal 2.20 – 2.50 lbs |
| Occlusion Testing | Passed (No occlusions at 45 psi) | No occlusions at 45 psi |
| Leak Testing | Passed (No leaks at 100 psi; also no leaks at 330 psi) | No leaks at 100 psi |
| Bonding Forces | Passed (All bonds withstood 10 lbs of force) | All bonds withstood 10 lbs of force |
| Flow Rate | Passed (Achieved 45 ml/min at 150 mmHg) | Achieved 45 ml/min at 150 mmHg |
| Simulated Clinical Study - Puncture Resistance of Safety Wings | Passed (Same as predicate: 5.9 – 6.1 lbs) | 5.5 – 6.0 lbs |
| Simulated Clinical Study - Force to Lock Safety Wings | Passed (Required less force than predicate device: 160 – 180g) | 240 – 260g |
| Simulated Clinical Study - Safety Wing Activation (Durability) | Passed (Successfully activated 200 times without failure) | Successfully activated 200 times without failure |
| Sharps Injury Protection (ISO 23908) - Activation Force of Safety Wing | Met acceptance criterion of ≤ 2.5 lbs | Not explicitly stated for predicate |
| Sharps Injury Protection (ISO 23908) - Force to Remove Needle from Port and Continue Full Activation | Met acceptance criterion of ≤ 5 lbs at each of three (3) pull speeds | Not explicitly stated for predicate |
| Sharps Injury Protection (ISO 23908) - Force to Over-ride Safety Wing Feature | Met requirement to withstand minimum of 8 lbs force | Not explicitly stated for predicate |
| Simulated Use testing | Passed (Demonstrated as safe and effective in preventing potential needle-stick injuries; may be used with one hand) | Not explicitly stated for predicate |
| Biocompatibility (ISO 10993) | Passed acceptance criteria for cytotoxicity (ISO 10993-5); irritation/intracutaneous reactivity, sensitization (ISO 10993-10); systemic toxicity and subchronic toxicity (ISO 10993-11); hemocompatibility (ISO 10993-4) including hemolysis, partial thromboplastin, complement activation assay (c3a), and complement activation assay (sc5b-9). | Not explicitly stated for predicate, but stated "equvalence in that no different questions of safety are raised." |
| Sterilization by Ethylene Oxide (ISO 11135) | Obtained SAL of 10⁻⁶; EO residuals met release acceptance criteria of |
§ 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).