The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc. The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.

Device Description

Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal. The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions. The top housing assembly and base are made of polypropylene plastic material and processed through injection molding. The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user. The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit. The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container. The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry. The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.

AI/ML Overview

The provided text describes the Point of Use II Sharps-A-Gator™ device, a sharps collection and disposal system. The information is from a 510(K) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results for acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth establishment, training set size) is largely absent from the provided text.

However, I can extract the stated acceptance criteria and the general claim of compliance.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Puncture Resistance per ASTM Draft #17	Complies with all acceptance criteria listed above
Functional Drop test based on ECRI's guidelines	Complies with all acceptance criteria listed above
Leak Resistance and Stability based on OSHA 1910.1030 Blood Pathogens Standards requirement	Complies with all acceptance criteria listed above
In-house assembly and wall thickness verification tests during manufacturing	Complies with all acceptance criteria listed above
Functional tests during manufacturing	Complies with all acceptance criteria listed above
Qualifying tests for moving tortuous path	Complies with all acceptance criteria listed above

Missing Information (Not available in the provided text):

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests mentioned (ASTM, ECRI, OSHA) are standards, but the specific testing data provenance is not detailed.

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

Not applicable/Not specified. The performance tests appear to be physical/mechanical tests against established standards, not requiring expert ground truth establishment in the diagnostic sense.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., image interpretation), which is not the nature of these engineering and safety tests.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This device is a physical sharps container, not an AI-assisted diagnostic 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:

For the physical performance tests, the "ground truth" would be the successful completion of the test criteria outlined by the respective standards (ASTM Draft #17 for puncture resistance, ECRI for functional drop, OSHA for leak resistance).

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable.

Summary

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K964387

Image /page/0/Picture/2 description: The image shows a stylized letter 'g' in white against a black circular background. The letter 'g' is in a cursive font. The letters 'TM' are in the bottom right corner of the circle.

Graphic Controls

ನ | ()( K ) Summary

. .

510(K) SUMMARY POINT OF USE II SHARPS-A-GATOR®

Date:	October 20, 1996
Manufacturer:	Graphic Controls. Devor Products9530 DeSoto AvenueChatsworth. CA 91311Registration # 2020423
	Graphic Controls Devor Products456 Lakeshore DriveRock Hill, SC 29730Registration # 1062224
Owner/Operator:	Graphic Controls CorporationP.O. Box 1271189 Van Rennselear StreetBuffalo, NY 14240-1271Registration # 13-7188
Contact Person:	George AustriaQuality Assurance ManagerGraphic Controls. Devon Products9530 DeSoto AvenueChatsworth, CA 91311Tel. # 818-709-6880 extension 207
Device Trade Name:	Point of Use II Sharps--Gator™
Common Name:	Sharps Collection/Disposal System
Classification Name :	Accessory to Hypodermic Needle, Class II

Devon

OR Products &
Safety Solutions

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Page 2 of 4 510(K ; Summary

Regulatory Reference: 80FMI

Predicate Device: Point of Use Sharps-A-Gator" Sage In-Room and Sharpstar Disposal System

Description:

Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal.
The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions.
. The top housing assembly and base are made of polypropylene plastic material and processed through injection molding.
. The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user.
. The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit.
. The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container
. The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry.
The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.

Intended Use:

. The intended use of this device is to contain used sharps in a puncture resistant container in order to aid the reduction of accidental needlestick injuries.
. The Point of Use II Sharps-A-Gator" can be used in any area requiring discarding prior of sharps prior to their final disposal. e g operating room, doctor's office. pediatrics, patient's room, etc.

Physical/Technical Comparison:

SIMILARITIES:

Point of Use II Sharps-A Gator" (New Device) and Point of Use Sharps-a-Gator" (Predicate Device)

. have the same intended use
are manufactured through injection molding .

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Page 3 of 4 >10(K · Summary

are made with the same polypropylene materials that contain no heavy metals and ● are safe to incinerate and autoclave
are both designed with comparable wall thickness .
are both puncture resistant per ASTM's draft # 17 requirements .
are both labeled in accordance with OSHA requirements .
both feature one hand, one step sharps disposing .
both feature a tortuous path that impedes hand entry �
both may be used as either wall mounted or floor standing models .
both have a clear top with clear or opaque base containers .

Point of Use II Sharps-A-Gator" (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device)

. have the same intended use
feature horizontal loading disposal .
both feature a moving tortuous path that restricts hand entry .
both feature an override system that enables the user to flush sharps into the . container sharps that may lodge in the tortuous path
both have the same intended use .
both have clear top assemblies .

DIFFERENCES

Point of Use II Sharps-A-Gator" (New Device) and Point of Use Sharps-A-Gator" (Predicate Device)

The new device features a moving tortuous path with an actuator that enables the . user to flush sharps that may lodge in the tortuous path
The moving tortuous path and flapper of the new device closes the top opening . when sharps are dropped into container
The new device features no needle unwinder The predicate device features a . manual needle unwinder

The Point of Use II Sharps-A-Gator" (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device)

The new device features horizontal top loading disposal while the predicate device . features horizontal front loading disposal

Performance Summary

The following tests assure safety and effectiveness of Graphic Controls, Devon Products Point of Use II Sharps-A-Gator"

Puncture Resistance test following ASTM Draft # 17 .
Functional Drop test based on ECRI's guidelines .

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· Leak Resistance and Stability based on OSHA 1910 1030 Blood Pathogens Standards requirement
11 - 1 - 1 - 1 - 1 - 1 - 1 -
ln-house assembly and wall thickness verification tests during manufacturing .
Functional tests during manufacturing +
Qualifying tests for moving tortuous path .

Point of Use II Sharps-A-Gator" complies with all acceptance criteria listed above

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Page 1 of 1

510(K) Number(if known) _ 5 964 387

Device Name; Point of Use II Sharps-A-Gator®

Indication For Use:

The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use_

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).