The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

Device Description

REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned.

AI/ML Overview

The provided text describes the acceptance criteria and the results of a study for the "SteriSharp™ 2.5-Gallon RSDC" reusable sharps disposal container.

Here's the breakdown of the information requested:

1. Table of acceptance criteria and the reported device performance

Test	Reference	Acceptance Criteria / Description	Reported Device Performance
Puncture	Health Devices 22	Needle penetration force	Pass
Vibration	49 CFR 178.608	1 hour repetitive bounce	Pass
Free Fall Drop	49 CFR 178.603	-18° C 5 drops 1.2 meter	Pass
Stacking	49 CFR 178.606	24 hrs. under 30 kg	Pass
Penetration	49 CFR 178.609(h)(1)	7 kg steel rod - 1 meter	Pass
Overall Containment	N/A (implied by individual tests)	Preventing the loss or dispersal of contents during transport	Pass ("visually appears to satisfy the test criteria and be capable of preventing the loss or dispersal of the contents for conditions normal to transport.")

2. Sample size used for the test set and the data provenance

The document does not specify a numerical sample size for the test set. For instance, for "Free Fall Drop," it states "5 drops," implying a small sample for that specific test, but a general sample size for the overall device testing isn't provided.

The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely the testing was conducted in a U.S.-based lab and was a prospective evaluation of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The tests are engineering and performance-based, governed by specific regulations and standards (e.g., 49 CFR), rather than relying on human expert interpretation of results that would require "ground truth" establishment in the typical sense (e.g., for medical imaging). The 'ground truth' for these tests is defined by the passing criteria of the regulations themselves.

4. Adjudication method for the test set

This information is not applicable and not provided. The tests are objective, pass/fail evaluations based on defined physical criteria and regulations, not subjective assessments requiring adjudication among multiple observers.

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

This section is not applicable. The device is a physical sharps disposal container, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth for this device is based on regulatory standards and established test criteria. For example:

Puncture: Defined by a specific needle penetration force.
Vibration: Defined by "1 hour repetitive bounce" as per 49 CFR 178.608.
Free Fall Drop: Defined by surviving "5 drops 1.2 meter" at "-18° C" as per 49 CFR 178.603.
Stacking: Defined by withstanding "24 hrs. under 30 kg" as per 49 CFR 178.606.
Penetration: Defined by resistance to a "7 kg steel rod - 1 meter" as per 49 CFR 178.609(h)(1).

The overall ground truth is that the container must visibly prevent loss or dispersal of contents under these tested conditions.

8. The sample size for the training set

This section is not applicable. This is a physical device, and the concept of a "training set" is typically associated with machine learning algorithms.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

MAY 28 1900

Tel 610.756.3003
Fax 610.756.3004
Post Office Box 84
Kempton, PA 19529,
Toll Free 888.756.3003 www.sterilogic.com

99116.12

STERILOGIC
WASTE SYSTEMS INC

510(k) SUMMARY

807.92(1)

COMPANY NAME:

COMPANY ADDRESS:

TELEPHONE: FAX:

(610) 756-3003 (610) 756-3004

CONTACT PERSON: CALVIN A. ODHNER, V.P.

SUMMARY PREPARATION DATE: May 6, 1999

807.92(2)

STERISHARP™ 2.5-GALLON RSDC TRADE OR PROPRIETARY NAME:

REUSABLE SHARPS DISPOSAL CONTAINER COMMON NAME:

CLASSIFICATION:

807.92(3)

EQUIVALENT DEVICE (A):

GRAPHICS CONTROLS - POINT-OF-USE II SHARPS-A-GATOR MAIL-DROP TORTUROUS PATH TUMBLER LID (510[k] #K964387)

CLASS II -- ACCESSORY DEVICE

STERILOGIC WASTE SYSTEMS, INC.

KEMPTON, PA 19529-0084

9948 KISTLER VALLEY ROAD, SUITE 102

EQUIVALENT DEVICE (B):

ROTONICS MANUFACTURING, INC. (RMI) ROTATIONALLY MOLDED PLASTIC REUSABLE SHARPS CONTAINER (510[k] #K964026)

{1}------------------------------------------------

807.92(4) DESCRIPTION:

807.92(5)

INTENDED USE:

Reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

807.92(6) LID:

The Graphics Controls' lid will be used on the top of the container. This lid is approved in 510(k) #K964387.

The bottom portion of the unit has the same technological characteristics and a CONTAINER: similar design to the Rotonics Manufacturing Sharps Plus 5-Gallon Reusable Sharps Container, being made of the same process, material, densities and thickness. The only comparable changes are (1) the size of the container (reduced from 5 gallons to 2.5 gallons) and (2) the lid receiving channel, which was increased from 5/16" to 9/16" to accommodate the slightly larger rim that is present on the Graphic Controls lid.

The container is made from linear low-density polyethylene with a thickness of 0.125", rotationally molded (by building up layers of plastic).

The SteriSharp™ 2.5 Gallon RSDC meets and exceeds the primary design 807.92(6)(b) characteristics needed to comply with the OSHA Bloodborne Pathogens Standard. Data for the following tests have been provided and are as follows:

Puncture	Health Devices 22	Needle penetration force	Pass
Vibration	49 CFR 178.608	1 hour repetitive bounce	Pass
Free Fall Drop	49 CFR 178.603	-18° C 5 drops 1.2 meter	Pass
Stacking	49 CFR 178.606	24 hrs. under 30 kg	Pass
Penetration	49 CFR 178.609(h)(1)	7 kg steel rod - 1 meter	Pass

"The package, as submitted and tested, visually appears to satisfy the test criteria and be capable of preventing the loss or dispersal of the contents for conditions normal to transport." (Container Testing Laboratory, Inc.)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1999

Mr. Calvin A. Odhner Vice President Sterilogic Waste Systems, Incorporated 9948 Kistler Valley Road, Suite 102 PO Box 84 Kempton, Pennsylvania 19529

Re : K991612 Trade Name: SteriSharp™ 2.5 Gallon RSDC, Model #RSDC2.5G Regulatory Class: II Product Code: MMK Dated: May 6, 1999 Received: May 10, 1999

Dear Mr. Odhner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Odhner

this response to your premarket notification Please note: r submission does not affect any obligation you might have under Submitblor. acob ough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborizone in formalence of your device to a legally rinding of bubbeandad on results in a classification for your markets produce, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

ﺰ ﺗ

Page

510(k) Number (if known): K 991612 Device Name: STECLSHARP™ 2.5 GALLEN

Indications For Use:

(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 801.1(19) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital ኝ 1 በሀk) Number

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).