Sharps Away Disposable Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.

Device Description

Sharps Away Disposable Containers are injection molded polypropylene plastic. The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red and yellows. The label is white with the biohazard warning fluorescent orange. Sharps Away Disposable Containers are available in a variety of sizes. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space. Handles are present on the 2-quart, 5-quart, 2.5-gallon and the 6-gallon containers. They are strong, easy to grasp and permits control of the container with one hand. Wall brackets are available for the 2-quart, 5 quart and the 2.5-gallon size. A counter top holder is available for the 1-quart size.

AI/ML Overview

This document describes the Sharps Away Disposable Containers, which are medical devices for the safe disposal of hazardous sharps. The submission is a 510(k) premarket notification, indicating the device is intended to be substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request, highlighting the limited information available from this specific 510(k) document regarding acceptance criteria and study details:

Executive Summary: Sharps Away Disposable Containers

This 510(k) submission (K072667) for the "Sharps Away Disposable Containers" focuses on establishing substantial equivalence to a predicate device ("B-D Guardian Nestable Sharps Collectors") rather than presenting a novel device requiring extensive clinical trials with human subjects. Therefore, many of the details you requested (like multi-reader, multi-case studies, expert adjudication for test sets, and detailed ground truth for training) are not applicable or not provided in this type of submission.

The "studies" are primarily performance testing of the device's physical properties against established safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally derived from regulatory standards (e.g., OSHA, CFR) and recognized ASTM standards for medical sharps containers. The document states a device "meets or exceeds OSHA recommendations." The reported device performance is simply a "Passed" status for each test, implying compliance with the relevant standard's requirements. Specific quantitative acceptance limits are not detailed in this summary.

Acceptance Criteria (Based on Regulatory Standards)	Reported Device Performance
Puncture Resistance (49 CFR; Section 178.609(h)(2); ASTM 07P1152/ ASTM F2132-01)	Passed
Leak Resistance Test	Passed
Impact Test	Passed
Handle Test	Passed

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

The document does not specify the sample sizes used for the individual performance tests (e.g., how many containers were puncture tested, or how many underwent leak testing).

The "data provenance" for these performance tests is inherently from laboratory testing of the manufactured devices. There is no indication of country of origin for the data beyond the manufacturer being based in the USA, and these are not retrospective or prospective studies in the clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to this type of device and submission. "Ground truth" in the context of clinical studies with experts (e.g., radiologists interpreting images) is not relevant here. The "ground truth" for these physical performance tests is defined by the objective metrics and methods outlined in the cited ASTM and CFR standards, which are evaluated by laboratory technicians or engineers.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers interpret data, and their disagreements need to be resolved to establish a definitive "ground truth." For physical performance tests of a sharps container, there are objective pass/fail criteria based on quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. MRMC studies are used to evaluate the diagnostic performance of an AI system, often in comparison to human readers, typically in image interpretation or diagnostic tasks. This device is a physical sharps container, not a diagnostic AI system, and therefore, no MRMC study was performed.

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

This question is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of the Sharps Away Disposable Containers is based on:

Objective physical measurements and observations according to established industry and regulatory standards.
Compliance with specified performance criteria detailed in standards like ASTM F2132-01 for puncture resistance and 49 CFR 178.609(h)(2) for specific handling of hazardous materials.
Engineering specifications for leak resistance, impact, and handle strength.

There is no "expert consensus," "pathology," or "outcomes data" in the typical clinical sense used for establishing ground truth for this device type.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of AI/machine learning for this physical device. The device itself is manufactured, and its performance is tested against standards, not "trained" on data.

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

This question is not applicable for the same reason as above. There is no training set for a physical sharps container. The manufacturing process and quality control ensure the device's characteristics, which are then verified through performance testing.

Summary

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K072667

Executive Summary

307 1 0 2007

Company Name: Company Address Solutions Inc. 3600 Chamberlain Lane, Ste. 104 Louisville, KY 40241

Telephone: Fax:

(502) 228-2901 (502) 228-2931

Victor Anderson Contact Person:

Summary Preparation Date: July 27, 2007

Trade Name: Sharps Away Disposable Containers

Common Name: Sharps Container

Classification Name: Container, Sharps

Predicate Device Identification: CFR21 880.5570 Sharps Container Product Code: MMK Device Class: II

Legally Marketed Equivalent Device:

Company	Product	510(k) #
Becton Dickinson	B-D Guardian Nestable Sharps Collectors	K943575

Description:

Sharps Away Disposable Containers are available in a variety of sizes. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space.

Handles are present on the 2-quart, 5-quart, 2.5-gallon and the 6-gallon containers. They are strong, easy to grasp and permits control of the container with one hand. Wall brackets are available for the 2-quart, 5 quart and the 2.5-gallon size. A counter top holder is available for the 1-quart size.

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The Sharps Away Disposable Containers meet or exceeds OSHA recommendations for sharps containers.

Intended Use:

Sharps Away Disposable Containers are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.

Manufacturer	Solutions Inc	Becton Dickinson
Trade Name	Sharps Away Disposable Container	B-D Guardian Nestable Sharps
K Number		K943575
Indication forUse	Sharps Away Disposable Containers areintended to be used for the safe disposalof hazardous sharps	B-D sharps containers are intended tobe used for the safe disposal ofhazardous sharps
Targetpopulation	Healthcare professional	Healthcare professional
Where used	Healthcare facilities	Healthcare facilities
Material	polypropylene	polypropylene
Sharps access	Sharps inserted through the top in avertical position with sharp side downthrough the hole formed with flapsthrough which the sharp is inserted	Sharps inserted through the top in avertical position with sharp side downthrough the hole formed with flapsthrough which the sharp is inserted
Sharps closure	Flaps are closed and locked in place forremoval	Flaps are closed and locked in placefor removal
ImpactResistance	Yes	Yes
PunctureResistance	Yes	Yes
Leak resistance:	Yes	Yes
Single Use:	Yes	Yes
Non-sterile:	Yes	Yes

Predicate Product Comparison Table:

Substantial Equivalence Discussion of Similarities and Differences:

The Sharps Away Disposable Containers are similar to the B-D Guardian Nestable Sharps containers in:

. Intended Use
. Target Population
. Materials
Design
. Performance testing

Sharps Away Disposable Sharps Container introduces no new questions concerning the safety or effectiveness of the Sharps Away disposable container and is thus substantially equivalent to the predicate device.

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K072667

Performance Testing

Puncture Resistance - 49 CFR; Section 178.609(h)(2); ASTM 07P1152/ ASTM F2132-01 - Passed

Leak Resistance Test -Passed

Impact Test-Passed

Handle Test - Passed

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with a snake winding around it, symbolizing medicine and health. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2007

Solutions, Incorporated Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K072667

Trade/Device Name: Sharps Away Disposable Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: October 4, 2007 Received: October 9, 2007

Dear Mr. Rongero:

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. Rongero

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 (OS) 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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely vours.

Chiu-Ling, Ph.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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Indications for Use

510(k) Number (if known): _K O7 2 ம்மு 2 முடி 2 ப

Device Name: Sharps Away Disposable Container

Indications for Use:

There are fourteen (14) containers and four (4) holders included in this submission. The model number, size, color and syringe size specification of each container and holder are as follows: (See attached sheet.)

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 A. Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page of

510(k) Number: -

K072667

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K072667

Indications for Use

Product specifications

Item #	Size	Color	Syringe Size
1901	1 Quart	Red	.5ml - 20ml
1902	1 Quart	Yellow	.5ml - 20ml
1903	2 Quart	Red	.5ml - 60ml
1904	2 Quart	Yellow	.5ml - 60ml
1905	5 Quart	Red	.5ml - 60ml
1906	5 Quart	Yellow	.5ml - 60ml
1907	2.5 Gal w/Horizontal Lid	Red	.5ml - 60ml
1908	2.5 Gal w/Horizontal Lid	Yellow	.5ml - 60ml
1909	2.5 Gal w/Vertical Lid	Red	.5ml - 60ml
1910	2.5 Gal w/Vertical Lid	Yellow	.5ml - 60ml
1911	6 Gal	Red	.5ml - 60ml
1912	6 Gal	Yellow	.5ml - 60ml
1915	.5 Quart	Red	Needles only
1916	.5 Quart	Yellow	Needles only
1951	2 Quart Wall Bracket	Beige	N/A
1952	5 Quart Wall Bracket	Beige	N/A
1953	2.5 Gal Wall Bracket	Beige	N/A
1954	1 Quart Countertop Holder	Blue	N/A

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).