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. For use with 25, 27 and 30 gauge long and short dental needles.

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 Description

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.

AI/ML Overview

This document, K061933, describes two separate devices: the Hager MIRAMATIC Box Sharps Container and the Cap Trap Needle Re-capper. The provided text discusses the general characteristics, intended use, and preliminary testing activities for these devices, but it does not contain the specific details required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.

The document states that "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." However, it does not provide:

Specific acceptance criteria: No numerical targets (e.g., "must reduce needle sticks by X%") or qualitative benchmarks are listed.
Reported device performance: No results from the mentioned testing activities are presented.
Details of the study: Information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods is absent.

Therefore, for each of your specific questions, the answer based on the provided text is that the information is not available in this document.

Summary of Missing Information:

A table of acceptance criteria and the reported device performance: Not provided. The document mentions "testing activities were conducted to establish the performance and reliability characteristics," but it does not list the criteria or the results.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The document generally refers to "testing activities" and "simulated use evaluation" without detailing the study design or sample size.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The document does not mention the involvement of experts in establishing ground truth for any testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. These devices are mechanical, not AI-driven diagnostic tools.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are mechanical devices, not algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. The document vaguely mentions "simulated use evaluation" but doesn't specify what constituted the "ground truth" for evaluating performance (e.g., actual needle stick reduction, measured force, etc.).
The sample size for the training set: Not applicable (not an AI/algorithm). If interpreted as a sample size for an initial testing or development phase, it is not provided.
How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) summary provides an overview of the medical devices and their intended use, but it does not contain the detailed study results or acceptance criteria that you are requesting.

Summary

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Section 5

510(k) Summary

Submitted by:	Hager Worldwide, Inc.13322 Byrd DriveOdessa, FL 33556	NOV 16 2006
Prepared on:	October 25, 2006
Device name	The Hager MIRAMATIC Box Sharps ContainerThe Cap Trap Needle Re-capper
Classification name	Sharps Container Accessory to Hypodermic Single Lumen NeedleRe-capper Accessory to Hypodermic Single Lumen Needle
	The MIRAMATIC Box Sharps Container is classified as Class II, GeneralHospital 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 HospitalPanel (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 forcollection and disposal of contaminated wastes and sharps. Indicated for useas an aid in minimizing needle stick injuries during needle disposal.
	The Cap Trap Needle Re-capper is intended for use in dental offices duringuncapping/recapping procedures. Indicated for use as an aid in minimizingneedle stick injuries during re-capping and needle disposal.
TechnologicalCharacteristics	The MIRAMATIC Box Sharps Container is designed for use with theMIRAMATIC 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 allowsingle-handed re-sheathing so that the needle is re-sheathed without directingit toward any part of the body. It consists of a base, carrier plate andactivation plate
Testing	Testing activities were conducted to establish the performance and reliabilitycharacteristics of the accessories. Testing included mechanical testing,cleaning and sterilization efficacy and simulated use evaluation.

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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.

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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

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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)

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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)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).