(90 days)
A single use disposable spinal needle/cannula intended for the injection of fluids into or retraction of fluids from the body. A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.
The provided text describes a 510(k) premarket notification for the MINRAD, Inc. LIGHT SABER™ SPINAL NEEDLE. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document focuses on:
- Device Identification: Name, sponsor, common/classification names.
- Predicate Devices: Lists similar devices.
- Intended Use: Specifies the purpose of the device (injection/aspiration of fluids, use with MINRAD Inc.'s Dual Radiation Targeting System™ for improved accuracy).
- Technological Characteristics: Describes the physical attributes of the needle (needle/collimator, stylet, cannula/hub assembly, Luer compliant with ISO-594, various gauges, lengths, and tip designs).
- Substantial Equivalence: Asserts the device's equivalence to predicate devices, stating minor differences in general indications for use and size/needle tip configurations raise no new safety/effectiveness issues.
- FDA Correspondence: Official FDA letter regarding the substantial equivalence determination, outlining regulatory compliance information.
- Indications for Use Form: A formal declaration of the device's intended use and indications.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as this data is absent from the provided text.
To answer your request, the input text would need to include details of specific performance metrics, benchmarks, and the results of any tests or studies conducted to demonstrate the device meets those metrics.
§ 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).