(832 days)
Disposable syringe for insulin administration, for the patient with diabetes.
Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel, Piston, Plunger, Needle, Needle cover or protector.
This document describes the acceptance criteria and study results for the "Insulin syringe with integrated needle DL®" (proposed device), demonstrating its substantial equivalence to a predicate device (Disposable Insulin Syringe, K162180).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international standards (ISO series) and national standards (MGA, NOM). The "Specifications" column represents the acceptance criteria, and the "Insulin syringe with integrated needle DLPJECT®" column represents the reported device performance.
| # | Test | Acceptance Criteria (Specifications) | Reported Device Performance ("Insulin syringe with integrated needle DLPJECT®") |
|---|---|---|---|
| 1 | Product designation | Insulin syringe with integrated needle. Syringe type 7. Capacity: 0.3 mL and 1 mL. Sterile and disposable. | Insulin syringe with integrated needle. Syringe type 7. Capacity: 0.3 mL and 1 mL. Sterile and disposable. |
| 2 | Product description | Medical use article, disposable, sterile, pyrogen-free, non-reactive tissue materials. Must be sterile, non-toxic, pyrogen-free and non-reactive tissue. | Compliant (detailed description provided) |
| Cylinder or barrel (clarity, lubrication, length, scale) | Enough clarity to see dosage and identify bubbles. Interior lubricated with medical grade silicone (no drops). Minimum length 79 mm. Insulin unit scale (min 57 mm). Graduation lines on longitudinal axis. | Compliant (detailed description provided) | |
| Graduation lines (length, numbering, appearance) | Longer lines for zero and every five lines (approx half length of zero). Zero starts at perimeter. Clear numbering (10, 20...100 U.). "U.I." and "U-100" at end. "mL" or "ml" for total capacity. "Not reusing" symbol. Numbers >= 3mm. Lines 0.2-0.4mm thick. Clear contrast. | Compliant (detailed description provided) | |
| Plunger | Operated inside cylinder/barrel. Protrusion at distal end prevents slipping. Piston assembled at opposite end. Plunger + piston length 88 x 2 mm. | Compliant (detailed description provided) | |
| Needle | Puncture device attached to syringe for liquid introduction. May have medical grade silicone coating. | Compliant (detailed description provided) | |
| Needle cover or protector | Medical grade plastic, perfectly covers needle, protects edge, avoids accidental punctures. | Compliant (detailed description provided) | |
| 3 | Finish | Free of defects (burrs, bubbles, perforations, fractures, roughness, deformations, sharp parts, non-uniform thickness). Needle assembly firm and not separated by normal use. | Compliant (detailed description provided) |
| 4 | Dimensions | Volume (mL/cc): 0.3, 0.5, 1.0 | |
| Scale division (ml): 5 U.I. | |||
| Scale subdivision (ml): 1 U.I. (0.3/0.5ml), 2 U.I. (1.0ml) | |||
| Min length of scale (mm): 41.0 (0.3ml), 43.0 (0.5ml), 57.0 (1.0ml) | |||
| Max silicone mass (mg): Lubricant will not form fluid droplets on inner surface. | Compliant (values match specification) | ||
| Compliant (values match specification) | |||
| Compliant (values match specification) | |||
| Compliant (values match specification) | |||
| Compliant (matches specification) | |||
| Scale tolerance (when ref line > 50% nominal capacity) | ± 5% (0.3ml), ± 4% (0.5ml), ± 4% (1.0ml) | Compliant (values match specification) | |
| 5 | Scale numbering | 0.5 units (0.3ml), 1.0 units (0.5ml), 2.0 units (1.0ml) | Compliant (values match specification) |
| 6 | Scale position | Ends of similarly long graduation lines align vertically with barrel axis and each other (tolerance +0.5mm) when held vertically. | Compliant (matches specification) |
| 7 | Characteristics of the cylinder or barrel | Eyebrow/flange for finger support. Enough clarity. Lubricated with medical grade silicone (no drops). Useful capacity no less than 10% more than nominal capacity or 3mm plunger travel beyond scale mark (whichever is less). | Compliant (detailed description provided) |
| 8 | Flange | Syringe does not rotate more than 180° when placed on a flat surface with scale upwards at 10° from horizontal. | Compliant (matches specification) |
| 9 | Plunger and piston features | Plunger can be pushed by thumb when barrel is held with one hand. Plunger head has grooves to prevent slipping. | Compliant (matches specification) |
| 10 | Reference line | Defined, visible edge at piston end for capacity reference. In contact with inner surface of barrel. | Compliant (matches specification) |
| 11 | Dead space | Volume in barrel/cylinder and pivot when piston fully inserted: max 0.005 mL. | Compliant (matches specification) |
| 12 | Hypodermic Needle (Dimensions) | Gauge (G): 30, 31, 32 | |
| Nominal external diameter (mm): 0.298-0.320 (30G), 0.254-0.266 (31G), 0.229-0.241 (32G) | |||
| Minimum nominal inner diameter (mm): 0.133 (30G), 0.114 (31G), 0.089 (32G) | |||
| Useful length: Needle length tolerance within ± 1.25 mm. | |||
| Primary angle: 9° to 11° | |||
| Color code: Orange for U-100 | Compliant (values match specification) | ||
| Compliant (values match specification) | |||
| Compliant (values match specification) | |||
| Compliant (matches specification) | |||
| Compliant (matches specification) | |||
| Compliant (matches specification) | |||
| 13 | Cannula adhesion (N) | Minimum joint resistance of needle tube with nominal external diameter |
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).