The SteriSharp™ 3-Gallon RSDC reusable containers are intended for use 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 until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.

Device Description

The SteriSharp™ 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid and they are deposited automatically into the container. When the container is full the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, SteriLogic employees will empty and sanitize the unit and return it to your facility to use for the next switch out. The durable high-density polyethylene construction of the SteriSharp™ 3 makes it leak-proof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SteriSharp™ 3-Gallon RSDC, based on the provided FDA 510(k) Notification:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Standard)	Reported Device Performance
Puncture Resistance	Health Devices 22 (Needle penetration force)	Pass
Leak Resistance	Health Devices 22 (24 hrs filled with water)	Pass
Vibration	49 CFR 178.608 (1 hour repetitive bounce)	Pass
Free Fall Drop	49 CFR 178.603 (5 drops 1.2 meter)	Pass
Stacking	49 CFR 178.606 (24 hrs. under 30 kg)	Pass
Simulated Life-Use (Durability)	Withstand 100 cycles of use without visible signs of failure and subsequent performance testing.	Pass (no visible signs of failure, then performance tested and passed)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: A "random sampling" of the SteriSharp™ 3 container was used for the simulated life-use testing and subsequent performance tests. The exact number of units in this random sampling is not specified in the document.
Data Provenance: The tests were conducted by the manufacturer or a contracted testing laboratory ("Container Testing Laboratory, Inc."). The document does not specify a country of origin for the data that would imply a geographical bias for the test set. All testing described is prospective, as it was performed specifically for this 510(k) submission to demonstrate the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the device is not an AI/diagnostic device that relies on expert interpretation for ground truth. The acceptance criteria are based on objective physical performance standards. The "ground truth" for these tests is the direct measurement of the device's physical properties against established safety and performance standards.

4. Adjudication Method for the Test Set:

This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The tests involve objective measurements and pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. The SteriSharp™ 3 is a physical sharps disposal container, so this type of study is not relevant to its evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable. The SteriSharp™ 3 is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on objective performance standards and regulations (e.g., Health Devices 22, 49 CFR 178.603, 178.608, 178.606). These standards define the acceptable physical properties and performance characteristics (puncture resistance, leak resistance, vibration resistance, drop resistance, stacking strength) for disposable medical sharps containers. For the simulated life-use, the ground truth was the observable absence of failure and satisfactory functional performance after 100 cycles.

8. The Sample Size for the Training Set:

This is not applicable. The SteriSharp™ 3 is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

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

Summary

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MAY 1 4 2002

FDA 510(k) Notification

SteriLogic Waste Systems, Inc. February 15, 2002

KQX064

510(k) SUMMARY

807.92(a) (1)

COMPANY NAME:

COMPANY ADDRESS:

STERILOGIC WASTE SYSTEMS, INC.

6691 PICKARD DRIVE SYRACUSE, NY 13211

TELEPHONE: FAX:

(215) 914-1110 (215) 914-0110

CONTACT PERSON:

ERIK R. SYNNESTVEDT FEBRUARY 15, 2002

SUMMARY PREPARATION DATE:

807.92(a)(2)

STERISHARP™ 3-GALLON RSDC TRADE OR PROPRIETARY NAME:

REUSABLE SHARPS DISPOSAL CONTAINER COMMON NAME:

CLASSIFICATION:

CLASS II -- ACCESSORY DEVICE

807.92(a)(3)

EQUIVALENT DEVICE #1: BEMIS SHARPS DISPOSAL CONTAINER (510[k] #K931664)

CONTAINER LID: The Bemis Sharps Disposal Container lid ('lid'') is used on the top of the SteriSharp™ 3 container. This Bemis Sharps Disposal Container has been approved under 510(k) #K931664.

EQUIVALENT DEVICE #2: STERISHARP™ 2.5-GALLON RSDC (510]k] #K991662)

CONTAINER BASE: The bottom portion of the unit (the "container") is a reusable polyethy lene cavity with a wall thickness of 0.125" ± 0.002"similar to that of the SteriSharp™ 2.5. The SteriSharp™ 2.5 container has been approved under 510(k) #K991662.

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FDA 510(k) Notification

807.92(a)(4)

DESCRIPTION:

807.92(a)(5)

INTENDED USE:

The SteriSharp™ 3 reusable container is intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics, and other 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 until 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(a)(6)

The SteriSharp™ 3 reusable container is substantially equivalent to the Bemis Sharps Disposal Container in that the lid is identical; a semi-transparent natural colored polypropylene mail drop, torturous path tumbler lid. It is injection molded and varies in thickness from 0.05" to 0.07". The base container is similar in design and ergonomic characteristics to the Bemis Sharps Disposal Container. While the base of the Bemis unit is manufactured using polypropylene, the SteriSharp unit is manufactured with a thicker wall (0.125" + 0.002" as compared to 0.06" +0.01") and stronger polymer (HDPE) to help confer reusable qualities.

COMPARISON TABLE (LID)	Bemis 3-Gallon	SteriSharpTM3
Indications for use	healthcare sharps	same
Target population	healthcare professionals	same
Design	torturous path, mail-drop	same
Materials	polypropylene	same
Performance	single use	multiple use
Mechanical safety	mail-drop	same
Where used	healthcare facilities/labs	same
Standards met	49 CFR / HD 22 (single use)	same/multi-use

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The SteriSharp™ 3 reusable container is also substantially equivalent to the SteriSharp™ 2.5 reusable container. They are both a combination of a polypropylene tumbler lid with a polyethylene base. The SteriSharp™ 2.5 base is a red, rotationally molded linear low density Polyethylene cavity while the SteriSharp™ 3 base is a red, injection molded high density polyethylene cavity. Both units are designed to be opened and sanitized automatically using the SteriLogic Sharps Consolidation Unit which is consistent with all applicable OSHA and DOH standards.

COMPARISON TABLE (CONTAINER)	SteriSharp™2.5	SteriSharp™3
Indications for use.	healthcare sharps	same
Target population.	healthcare professionals	same
Design.	rotationally molded	injection mold tapered
Materials.	LLDPE	HDPE
Performance.	multiple use	same
Where used.	healthcare facilities/labs.	same
Standards met	49 CFR / HD 22	same

807.92(b)(1)

Over a two-day period from July 25, 2001 to July 26, 2001, all components of a random sampling of the SteriSharp™ 3 container were subjected to a simulated life-use of 100 cycles of closing, filling, depositing waste, opening, emptying, washing and sanitizing. A detailed report is included below under section "TAB 3." After simulated use, there were no visible signs of failure. Containers were then performance tested and passed. (see below)

807.92(b)(2) and (3)

The SteriSharp™ 3-Gallon RSDC meets and exceeds the primary design 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
Leak Resistance	Health Devices 22	24 hrs filled with water	Pass
Vibration	49 CFR 178.608	1 hour repetitive bounce	Pass
Free Fall Drop	49 CFR 178.603	5 drops 1.2 meter	Pass
Stacking	49 CFR 178.606	24 hrs. under 30 kg	Pass

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Erik R. Synnestvedt SteriLogic Waste Systems, Incorporated 6691 Pickard Drive Syracuse, New York 13211

Re: K020664

Trade/Device Name: Sterisharp 3-Gallon RSDC, Model RSDC3G Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK and FMI Dated: February 15, 2002 Received: March 1, 2002

Dear Mr. Synnestvedt:

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.

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.

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Page 2 - Mr. Synnestvedt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Tunney

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

Enclosure

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510(k) NOTIFICATION

STERILOGIC WASTE SYSTEMS, INC. FEBRUARY 15, 2002

510(k) NUMBER (IF KNOWN) :

DEVICE NAME : STERISHARP 3-GALLON RSDC, MODEL RSDC3G

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 801.109)		OR		Over-The-Counter-Use (optional format 1-2-96)

Sftr Clin

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number	K020664
---------------	---------

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).