Techen Safety Sharps Disposal Containers with Screw Top Caps are intended for single use disposal of used or contaminated medical sharps, including but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in a variety of healthcare settings. They are suitable for physicians offices, dental offices, laboratories, home health, patient room, and other generation of medical waste.

Device Description

The Sekurit Sharps Collection Container is a single piece container which is blow molded of High Density Polyethylene plastic and is available in 1 Gallon, 3 Gallon, 3 Gallon and 1.4 quart sizes. Each container is of the same design type and altered only in its height to achieve the needed capacities. The containers are available in translucent red and yellow colors as well as . opaque red and yellow colors. Sekurit Sharps Collection Containers have a threaded screw neck and utilize a puncture resistant screw cap molded from Polypropylene. These containers are NOT reusable.

AI/ML Overview

The provided text focuses on the K063722 510(k) submission for "Sekurit Sharps Collection Containers," which are physical medical devices, not AI/ML-driven software. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available within this document. The document primarily concerns the regulatory clearance of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific acceptance criteria or performance metrics in a quantitative manner as would be expected for an AI/ML device. For physical devices like sharps containers, "performance" relates to their physical integrity and ability to safely contain sharps. The 510(k) summary states that the device is "substantially equivalent" to predicate devices, implying it meets the same implicit safety and performance standards.

The primary "acceptance criteria" for this type of device would generally involve meeting certain standards for puncture resistance, leakage prevention, and safe closure, which are usually tested against established industry or regulatory standards (e.g., OSHA guidelines, ISO standards). However, these specific criteria and their measured performance are not explicitly detailed in the provided text.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical sharps container, not an AI/ML device processing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is not relevant for this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. 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. This is a physical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Exhibit C

K063722

510(k) Summary

Name and address of sponsor of the510(k) submission:	Techen Safety, Inc.1901 Powis Ct. West Chicago, IL 60185
Official contact person for allcorrespondence:	John Allegretti, (address as above)
	Phone: 800-832-4361, Fax: 630-797-7305
	E-mail: cja@techensafety.com
Date Prepared:	November 28, 2006
Device Name:	Sekurit Sharps Collection Containers
Generic name of the device:	Sharps Container
Classification, Product Code andCFR Regulation Number:	Class II, MMK and 21 CFR 880.5570
Classification Panel:	General Hospital
Predicate Device Name and 510(k)Number :	1)B-D@ Guardian One Piece Sharps Collectors, K9431392) Sage Products, Sharps Disposal Containers with ScrewTop Caps, K980490

Device Description:

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Techen Safety, Incorporated C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAR 0 5 2007

Re: K063722

Trade/Device Name: 1GL01-001 -1 Gallon Red Transluscent Sekurit Sharps Collection Container; 1GL01-002-1 Gallon Red Opaque Sekurit Sharps Collection Container; 1GL01-003-1 Gallon Yellow Transluscent Sekurit Sharps Collection Container; 1GL01-004-1 Gallon Yellow Opaque Sekurit Sharps Collection Container; 2GL01-001-2 Gallon Red Transluscent Sekurit Sharps Collection Container; 2GL01-002-2 Gallon Red Opaque Sekurit Sharps Collection Container; 2GL01-003-2 Gallon Yellow Transluscent Sekurit Sharps Collection Container; 2GL01-004-2 Gallon Yellow Opaque Sekurit Sharps Collection Container; 3GL01-001-3 Gallon Red Transluscent Sekurit Sharps Collection Container; 3GL01-002-3 Gallon Red Opaque Sekurit Sharps Collection Container; 3GL01-003-3 Gallon Yellow Transluscent Sekurit Sharps Collection Container; 3GL01-004-3 Gallon Yellow Opaque Sekurit Sharps Collection Container; 1QT01-001-1.4 Quart Red Transluscent Sekurit Sharps Collection Container; 1QT01-002-1.4 Quart Red Opaque Sekurit Sharps Collection Container; 1QT01-003-1.4 Ouart Yellow Transluscent Sekurit Sharps Collection Container; 1QT01-004-1.4 Quart Yellow Opaque Sekurit Sharps Collection Container Regulation Number: 880.5570

Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: February 16, 2007 Received: February 20, 2007

Dear Mr. Devine:

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

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Page 2 – Mr. Devine

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.

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.

Snyde y. Michael Davis.

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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INDICATIONS FOR USE

Page 1

510(k) Number (if known): Not Assigned as of this time

Device Name: Sekurit Sharps Collection Container

Model numbers: 1GL01-001 - 1 Gallon Red Transluscent Sekurit Sharps Collection Container 1GL01-002 - 1 Gallon Red Opaque Sekurit Sharps Collection Container 1GL01-003 - 1 Gallon Yellow Transluscent Sekurit Sharps Collection Container 1GL01-004 - 1 Gallon Yellow Opaque Sekurit Sharps Collection Container 2GL01-001 - 2 Gallon Red Transluscent Sekurit Sharps Collection Container 2GL01-002 - 2 Gallon Red Opaque Sekurit Sharps Collection Container 2GL01-003 - 2 Gallon Yellow Transluscent Sekurit Sharps Collection Container 2GL01-004 - 2 Gallon Yellow Opaque Sekurit Sharps Collection Container 3GL01-001 - 3 Gallon Red Transluscent Sekurit Sharps Collection Container 3GL01-002 - 3 Gallon Red Opaque Sekurit Sharps Collection Container 3GL01-003 - 3 Gallon Yellow Transluscent Sekurit Sharps Collection Container 3GL01-004 - 3 Gallon Yellow Opaque Sekurit Sharps Collection Container 1QT01-001 - 1.4 Quart Red Transluscent Sekurit Sharps Collection Container 1QT01-002 - 1.4 Quart Red Opaque Sekurit Sharps Collection Container 1QT01-003 - 1.4 Quart Yellow Transluscent Sekurit Sharps Collection Container 1QT01-004 - 1.4 Quart Yellow Opaque Sekurit Sharps Collection Container

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D) Over-The Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

K063722

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).