DOYLE EXTRACTOR

K955748 · Safetech Intl., Inc. · FMI · Mar 14, 1996 · General Hospital

Device Facts

• Record ID: K955748
• Device Name: DOYLE EXTRACTOR
• Applicant: Safetech Intl., Inc.
• Product Code: FMI · General Hospital
• Decision Date: Mar 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports. It is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.

Device Story

Manual needle extraction tool; accessory to IV administration sets. Design utilizes simple lever principle to apply force for withdrawing right-angle needles from skin and implanted IV ports. Features slot on top blade to secure IV tubing during procedure. Used in clinical settings by healthcare providers. Benefits include providing leverage for safe, controlled needle removal.

Clinical Evidence

Bench testing only. Testing determined force required to withdraw right-angle needles from skin and injection ports and confirmed material/design adequacy to provide necessary force.

Technological Characteristics

Material: Polypropylene. Principle: Simple lever mechanism. Form factor: Handheld tool with top blade slot for IV tubing. Non-powered, manual device.

Indications for Use

Indicated for use in the removal of right-angle needles from implanted IV ports in patients requiring IV access.

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.

Predicate Devices

• AutoSuture skin staple remover (K810187, K914130)
• Ethicon skin staple extractor (K760733)

Submission Summary (Full Text)

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MAR 14 1996
K955748
510(k) Summary
for
Safetech International Inc.'s Doyle Extractor

1. DATE PREPARED
December 14, 1995

2. SPONSOR INFORMATION
Address: Safetech International, Inc.
511 W. Grove Street, Suite 202
Middleboro, MA 02346
Telephone: [phone]
Contact: Patricia A. Doyle

3. DEVICE NAME
Proprietary Name: Doyle Extractor
Common/Usual Name: Needle Extractor
Classification Name: IV Administration Set/Accessory
(21 CFR 880.5440, Product Code: 80 FPA)

4. DEVICE DESCRIPTION AND INTENDED USE
The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports. It is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.

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# 5. PREDICATE DEVICES

The Doyle Extractor is similar in design, function, and intended use to accessories for other temporary or removable devices. Examples include the AutoSuture skin staple remover (K810187, K914130)--a disposable staple remover which is similar in design, appearance, and function to the Doyle Extractor, as well as the Ethicon skin staple extractor (K760733). Skin staple removers utilize the principle of a simple lever to apply adequate force for removal of the skin staple; the Doyle Extractor utilizes this same principle for removal of the right angle infusion needle from an implanted port. The devices are very similar in design, shape, and size, and even intended use, since all are intended to remove items which are puncturing the skin.

# 6. DEVICE TESTING

Testing was designed to determine the force required to withdraw a right-angle needle from the skin and injection port, as well as to determine that the material and design characteristics of the device were adequate to meet/provide that required force. Testing results confirmed the suitability of the device material and design for its intended use.

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