← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K061933 # HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER (K061933) _Hager Worldwide, Inc. · FMI · Nov 16, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K061933 ## Device Facts - **Applicant:** Hager Worldwide, Inc. - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Nov 16, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The MIRAMATIC Box Sharps Container is intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. The Cap Trap Needle Re-capper is intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal. ## Device Story The Hager MIRAMATIC Box Sharps Container and Cap Trap Needle Re-capper are dental office accessories designed to reduce needle stick injuries. The Sharps Container facilitates single-handed disengagement, ejection, and disposal of needles when used with the MIRAMATIC cartridge syringe. The Cap Trap Needle Re-capper is a mechanical device consisting of a base, carrier plate, and activation plate; it enables single-handed re-sheathing of needles, preventing the need to direct the needle toward the body. Both devices are operated by dental staff during routine procedures. By automating or simplifying the handling of contaminated sharps, these devices minimize direct contact with needles, thereby reducing the risk of accidental injury to the clinician. ## Clinical Evidence No clinical data. Evidence consists of bench testing, including mechanical testing, cleaning and sterilization efficacy, and simulated use evaluation. ## Technological Characteristics Mechanical accessories for dental needle handling. Sharps container designed for single-handed needle ejection. Re-capper consists of a base, carrier plate, and activation plate for single-handed re-sheathing. Non-powered, mechanical operation. ## 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 - Sage Sharps Disposal Containers with Screw top ([K980490](/device/K980490.md)) - HypoGrip (needle re-capper) ([K924820](/device/K924820.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string is "KOG1933". The characters are written in a simple, slightly slanted style. The image is in black and white. # Section 5 . ## 510(k) Summary | Submitted by: | Hager Worldwide, Inc.
13322 Byrd Drive
Odessa, FL 33556 | NOV 16 2006 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Prepared on: | October 25, 2006 | | | Device name | The Hager MIRAMATIC Box Sharps Container
The Cap Trap Needle Re-capper | | | Classification name | Sharps Container Accessory to Hypodermic Single Lumen Needle
Re-capper Accessory to Hypodermic Single Lumen Needle | | | | The MIRAMATIC Box Sharps Container is classified as Class II, General
Hospital Panel (80), Pro Code MMX. The device is codified at 21 C.F.R. §
880.5570. | | | | The Cap Trap Needle Re-capper is classified as Class II, General Hospital
Panel (80), Pro Code FMI. The device is codified at 21 C.F.R. § 880.5570 | | | Predicate Devices | Sage Sharps Disposal Containers with Screw top K980490; and HypoGrip™
(needle re-capper) K924820 | | | Intended Use | The MIRAMATIC Box Sharps Container is intended for use in dental offices for
collection and disposal of contaminated wastes and sharps. Indicated for use
as an aid in minimizing needle stick injuries during needle disposal. | | | | The Cap Trap Needle Re-capper is intended for use in dental offices during
uncapping/recapping procedures. Indicated for use as an aid in minimizing
needle stick injuries during re-capping and needle disposal. | | | Technological
Characteristics | The MIRAMATIC Box Sharps Container is designed for use with the
MIRAMATIC cartridge syringe to enable single-handed disengagement,
ejection and disposal of needles during dental procedures. | | | | The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow
single-handed re-sheathing so that the needle is re-sheathed without directing
it toward any part of the body. It consists of a base, carrier plate and
activation plate | | | Testing | Testing activities were conducted to establish the performance and reliability
characteristics of the accessories. Testing included mechanical testing,
cleaning and sterilization efficacy and simulated use evaluation. | | : {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Hager Worldwide, Incorporated C/O Mr. James Delaney Consultant to Hager 4 Lincoln Street Andover, Massachusetts 01810 NOV 16 2006 Re: K061933 Trade/Device Name: Hager MIRAMATIC Box Sharps Container and Cap Trap Needle Re-Capper Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 25, 2006 Received: October 27, 2006 Dear Mr. Delaney: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Delaney Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sydette Y. Michael M.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Section 4 Indications for Use Statement #### Indications for Use 061933 510(k) Number (if known): Device Name: Hagar MIRAMATIC Box Sharps Container Indications for Use: Intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. For use with 25, 27 and 30 gauge long and short dental needles. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR ## Concurrence of CDRH, Office of Device Evaluation (ODE) Shule A. Murphy Page**_ of_** logy, General Hospi (Posted November 13, 2003) {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): _KO6 1933 Device Name: Cap Trap Needle Re-capper Indications for Use: Intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shule Murphy MD ion of Anesthesiology, General Hospital, ion Control, Dental Devices ber. K061933 Page __ of ___ (Posted November 13, 2003) --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K061933](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K061933) **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