← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K955748 # DOYLE EXTRACTOR (K955748) _Safetech Intl., Inc. · FMI · Mar 14, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K955748 ## Device Facts - **Applicant:** Safetech Intl., Inc. - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Mar 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Regulatory 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](/device/K810187.md), [K914130](/device/K914130.md)) - Ethicon skin staple extractor ([K760733](/device/K760733.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 508-946-0096 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. Doyle Extractor 510(k) 12/14/95 Page E-1 {1} # 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. Doyle Extractor 510(k) 12/14/95 Page E-2 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K955748](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K955748) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com