ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)

• K Number: K970873
• Device Name: ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
• Manufacturer: AMERICAN MEDICAL DEVICES, INC.
• Date Cleared: 1997-05-20 ( 71 days)
• Product Code: HMX
• Regulation Number: 886.4350
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

For irrigation/aspiration during eye surgery.

Device Description

The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the American Medical Devices, Inc., 19 and 20 Ga. Endosoft™ Soft Tip Needles. It describes the device and claims substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on device characteristics, indications for use, materials, and sterilization methods, rather than performance metrics.

Regulation Number and Section

§ 886.4350 Manual ophthalmic surgical instrument.

(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.