K960698 · Med Institute, Inc. · FMI · Apr 15, 1996 · General Hospital
Device Facts
Record ID
K960698
Device Name
NON-CORING NEEDLE
Applicant
Med Institute, Inc.
Product Code
FMI · General Hospital
Decision Date
Apr 15, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5570
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids.
Device Story
Device consists of stainless steel cannula with Luer hub; designed for penetrating septum of subcutaneous access ports; used to administer or withdraw fluids; supplied sterile for single-time use; operated by clinicians in clinical settings; facilitates port access; provides established biocompatibility via historical material use.
Clinical Evidence
Bench testing only; no clinical data provided. Biocompatibility supported by established history of use in medical manufacturing.
Indicated for patients requiring access to subcutaneous ports for fluid administration or withdrawal.
Regulatory Classification
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.
Submission Summary (Full Text)
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K960698
510(k) Premarket Notification
Non-Coring Needle
6
# I. 510 (K) SUMMARY
Submitted By: APR 15 1996
Neal E. Fearnot, Ph.D., E.E.
President
MED Institute, Incorporated
P.O. Box 2402
West Lafayette, IN 47906
(317) 463-7537
February 16, 1996
## Device:
**Trade Name:** Non-Coring Needle
**Common/Usual Name:** Non-Coring Needle, Huber-Type Needle, Tip-Deflected Needle, Septum Needle
**Proposed Classification Name:** Hypodermic Single Lumen Needle, 21 CFR Part 880.5570 (80FMI)
## Predicate Devices:
The Non-Coring Needle is similar to predicate non-coring needles that are currently marketed, having the same intended use of penetrating the septum of subcutaneous access ports, and being of similar technology, having a stainless steel cannula and Luer hub.
## Device Description:
The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Non-Coring Needle is provided by their established history of use in medical product manufacturing.
## Substantial Equivalence:
The Non-Coring Needle will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
