← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K963830 # SHARPS CONTAINER MODEL# SC001 (K963830) _Image Medical, Inc. · FMI · Feb 10, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K963830 ## Device Facts - **Applicant:** Image Medical, Inc. - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently encounter syringes and other sharps during searches of suspects, vehicles, property or location. ## Device Story One-piece 6061 aluminum container; designed for safe disposal of contaminated needles/syringes. Features screw-on, leak-proof lid; puncture-resistant walls. Capacity: two 1cc syringes. Used by law enforcement officials during field searches. Device provides physical containment of sharps to prevent accidental injury; disposable per local/state regulations. ## Clinical Evidence Bench testing only. Testing demonstrated 6061 aluminum container (wall thickness .007, base .02) resists penetration by 1cc insulin syringes. Needles bent at 0.632 oz and broke at 0.7 oz of direct pressure; no penetration occurred. Shake test (10 revolutions) confirmed no penetration through sides or bottom. ## Technological Characteristics Material: 6061 aluminum; wall thickness .007 inch, base .02 inch. Design: One-piece container with screw-on, leak-proof lid. Capacity: 2 syringes. Puncture resistance: 20,000 PSI shear rate. ## 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 - B.D. Home Sharps Container ([K943575](/device/K943575.md)) - Sage Sharps Disposal System ([K943660](/device/K943660.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} K 963830 FEB 10 1997 510(k) Summary K963830 Company: Imagination Medical Inc. 12655 Phillips Highway Jacksonville FL 32256 (904) 268-5531 Contact: Mr. Gary Burdette Device Name: SC001 Sharps Container Common Name: Sharps Container Classification Name: 21 CFR 880. Type II Date of Summary Submission: December 9, 1996 ## Predicate Devices: The SC001 is compared to the below mentioned containers in that it conforms to the same standards as its predicates. This container is made from aluminum with a water tight screw on lid. The material is puncture resistant. The predicate devices are made of pre molded plastic compared to our product which is made of 6061 aluminum. Both comparison models have tight fitting plastic lids and are disposal. Our product has a aluminum screw on lid which is tight fitting and prevents leakage of the contents. 1. B.D. Home Sharps Container K943575 2. Sage Sharps Disposal System K943660 ## Testing: 6061 aluminum has a shear rate of 20000 PSI with a wall thickness of .007 and a base of .02, it would take 3 lbs of direct pressure for a needle to penetrate this container. Test were designed to demonstrate when a 1cc insulin syringe with a .5 inch needle of .014 OD thickness collapse. It was found that in every situation that the needle bent when .632 ounces and broke at .7 oz of direct pressure was applied. At this amount of pressure it was determined that the needle would not penetrate the container. Needles are also placed in the container in an upright posture placing the sharp at the bottom of the container. A shake test at 10 revolutions showed that the needles were completely bent but, allowed no penetration through the sides or the bottom of the container. In conclusion it is felt that our product meets and exceeds the standards adopted by FDA and is substantially equivalent to other legally marketed sharps containers. {1} Description of Device: A one piece aluminum container designed for the safe and easy disposal of contaminated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lid. Container is designed to hold up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations. Intent for Use: This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently encounter syringes and other sharps during searches of suspects, vehicles, property or location. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K963830](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K963830) **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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