← Product Code [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK) · K964387 # POINT OF USE II SHARPS-A-GATOR (K964387) _Graphic Controls Corp. · MMK · Mar 27, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K964387 ## Device Facts - **Applicant:** Graphic Controls Corp. - **Product Code:** [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK.md) - **Decision Date:** Mar 27, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use The intended use of this device is to contain used sharps in a puncture resistant container in order to aid the reduction of accidental needlestick injuries. The Point of Use II Sharps-A-Gator* can be used in any area requiring discarding prior of sharps prior to their final disposal. e.g. operating room, doctor’s office, pediatrics, patient’s room, etc. ## Device Story Single-use puncture-resistant sharps container; used in clinical environments (OR, ER, patient rooms, clinics) for safe disposal of used sharps. Features horizontal top-load opening with moving tortuous path and actuator; allows user to flush lodged sharps into container without manual reach-in; restricts hand entry. Constructed of polypropylene via injection molding; heavy-metal free; incinerable and autoclavable. Can be wall-mounted, cabinet-secured, or free-standing. Reduces risk of accidental needlestick injuries by providing secure containment. ## Clinical Evidence Bench testing only. Performance validated via puncture resistance testing (ASTM Draft #17), functional drop testing (ECRI guidelines), leak resistance and stability testing (OSHA 1910.1030), and functional/qualifying tests for the moving tortuous path mechanism. ## Technological Characteristics Polypropylene plastic; injection molded. Puncture resistant per ASTM Draft #17. Features moving tortuous path with actuator, flapper, and lid. Wall-mounted or free-standing form factor. Heavy-metal free; safe for incineration and autoclaving. ## 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 - Point of Use Sharps-A-Gator ([K964387](/device/K964387.md)) - Sage In-Room and Sharpstar Disposal System ## 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} Graphic Corporation K964387 ![img-0.jpeg](img-0.jpeg) # Graphic Controls Page 1 of 4 510(K) SUMMARY # POINT OF USE II SHARPS-A-GATOR® Date: October 20, 1996 Manufacturer: Graphic Controls, Devon Products 9530 DeSoto Avenue Chatsworth, CA 91311 Registration # 2020423 Graphic Controls, Devon Products 456 Lakeshore Drive Rock Hill, SC 29730 Registration # 1062224 Owner/Operator: Graphic Controls Corporation P.O. Box 1271 189 Van Rennselear Street Buffalo, NY 14240-1271 Registration # 13*7188 Contact Person: George Austria Quality Assurance Manager Graphic Controls, Devon Products 9530 DeSoto Avenue Chatsworth, CA 91311 Tel. # 818-709-6880 extension 207 Device Trade Name: Point of Use II Sharps-A-Gator® Common Name: Sharps Collection/Disposal System Classification Name: Accessory to Hypodermic Needle, Class II Devon OR Products & Safety Solutions {1} Page 2 of 4 510(K) Summary **Regulatory Reference:** 80FMI **Predicate Device:** Point of Use Sharps-A-Gator* - Sage In-Room and Sharpstar Disposal System ## Description: - Devon’s Point of Use II Sharps-A-Gator* will be used as a single use only container for sharps collection/disposal. - The Point of Use II Sharps-A-Gator* comes in 2.3 +/- .5 gallon and 2.8 +/- .5 gallon containers. Both container buckets are available in clear, translucent and opaque color versions. - The top housing assembly and base are made of polypropylene plastic material and processed through injection molding. - The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user. - The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit. - The Point of Use II Sharps-A-Gator* has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to “flush” sharps that lodge in the tortuous path without reaching into the container. - The Point of Use II Sharps-A-Gator* moving tortuous path restricts hand entry. - The Point of Use II Sharps-A-Gator* is made with heavy metal free materials that are safe to incinerate and autoclave. ## Intended Use: - The intended use of this device is to contain used sharps in a puncture resistant container in order to aid the reduction of accidental needlestick injuries. - The Point of Use II Sharps-A-Gator* can be used in any area requiring discarding prior of sharps prior to their final disposal. e.g. operating room, doctor’s office, pediatrics, patient’s room, etc. ## Physical/Technical Comparison: ### SIMILARITIES Point of Use II Sharps-A Gator* (New Device) and Point of Use Sharps-a-Gator* (Predicate Device) - have the same intended use - are manufactured through injection molding {2} Page 3 of 4 STOCK - Summary - are made with the same polypropylene materials that contain no heavy metals and are safe to incinerate and autoclave - are both designed with comparable wall thickness - are both puncture resistant per ASTM's draft # 17 requirements - are both labeled in accordance with OSHA requirements - both feature one hand, one step sharps disposing - both feature a tortuous path that impedes hand entry - both may be used as either wall mounted or floor standing models - both have a clear top with clear or opaque base containers Point of Use II Sharps-A-Gator® (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device) - have the same intended use - feature horizontal loading disposal - both feature a moving tortuous path that restricts hand entry - both feature an override system that enables the user to flush sharps into the container sharps that may lodge in the tortuous path - both have the same intended use - both have clear top assemblies ## DIFFERENCES Point of Use II Sharps-A-Gator® (New Device) and Point of Use Sharps-A-Gator® (Predicate Device) - The new device features a moving tortuous path with an actuator that enables the user to flush sharps that may lodge in the tortuous path - The moving tortuous path and flapper of the new device closes the top opening when sharps are dropped into container - The new device features no needle unwinder. The predicate device features a manual needle unwinder The Point of Use II Sharps-A-Gator® (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device) - The new device features horizontal top loading disposal while the predicate device features horizontal front loading disposal ## Performance Summary The following tests assure safety and effectiveness of Graphic Controls, Devon Products Point of Use II Sharps-A-Gator® - Puncture Resistance test following ASTM Draft # 17 - Functional Drop test based on ECRI's guidelines {3} Page 4 of 4 510K Summary - Leak Resistance and Stability based on OSHA 1910 1030 Blood Pathogens Standards requirement - In-house assembly and wall thickness verification tests during manufacturing - Functional tests during manufacturing - Qualifying tests for moving tortuous path Point of Use II Sharps-A-Gator* complies with all acceptance criteria listed above. {4} Page 1 of 1 510(K) Number(if known): 5964387 Device Name: Point of Use II Sharps-A-Gator® Indication For Use: The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use iuk --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K964387](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K964387) **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. 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