This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.

Device Description

The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposable, point of generation sharps container, constructed out of tin-plated steel. The device has a friction fit lid and black foam plastisol sealant for container closure. It is designed to hold contaminated disposable sharps, such as various-sized hypodermic, intravenous syringes or other medical needles, scalpel blades, disposable knives and lancets, and broken glass such as slides, slip covers and ampoules. The device is not a secondary container.

The sharps container is a three-piece construction, one-gallon metal drum with a friction fit lid and sealant used to close the container. The minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches. The container is opaque and measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening in the center of the top of the container. The lid is 2-3/4 inches in diameter, with a thickness of .0088 inches. Lining the perimeter of the posterior side of the lid is a black foam plastisol which acts as an additional safety seal; this foam ensures a closed container. A built-in vent port, approximately 1 mm in diameter, is located on the top of the sharps container.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria or a specific study that proves the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification for a sharps container, focusing on its substantial equivalence to predicate devices.

However, based on the information available, I can infer some aspects related to "acceptance criteria" through the lens of regulatory submission for a medical device. In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as a predicate, and has either the same technological characteristics or, if different technological characteristics, that they do not raise new questions of safety and effectiveness and are as safe and effective as the predicate.

Here's an attempt to structure the answer based on the provided text, acknowledging its limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) regulatory requirements)	Reported Device Performance (from K982781)
Intended Use: Device is intended for the collection of disposable sharps in clinical and nonclinical healthcare settings.	The Demolizer #47 One-Gallon Point of Generation Sharps Container is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings. (Matches predicate's intended use)
Technological Characteristics: Similar to predicate devices, or differences do not raise new questions of safety and effectiveness.	Differences: Constructed of tin-plated steel and lap welded (predicates are plastic). Once closed, resistant to manual opening (unlike predicates).Similarities: Single use, disposable, nonsterile, opaque, similar capacity, vertical inlet openings. The document implies these differences do not raise new questions of safety and effectiveness, as it was deemed substantially equivalent.
Material Composition: Must be suitable for the intended use and maintain sharps containment.	Constructed of tin-plated steel.
Dimensions/Capacity: Must be appropriate for containing sharps (1-gallon).	Measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening. A 1-gallon capacity container.
Closure Mechanism: Must ensure safe and resistant closure.	Friction fit lid and black foam plastisol sealant for container closure. Once closed, "resistant to manual opening."
Sharp Inlet: Must allow for sharps disposal.	2-3/8 inch sharps inlet opening in the center of the top.
Strength/Integrity: Minimum nominal body wall thickness and overall robustness.	Minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches.

Study Proving Acceptance Criteria:

The document describes a 510(k) Premarket Notification process. In this context, the "study" is the submission itself, which presents information to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It's not a traditional clinical study with patients or human readers.

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

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data or images as one would find in an AI/diagnostic device study. The "test" for a sharps container typically involves engineering specifications and performance testing (e.g., leak resistance, sharps penetration resistance, drop tests, closure robustness), but details of these specific tests (sample sizes, results) are not provided in this summary. The data provenance would be from manufacturing and engineering specifications, likely in the USA where the manufacturer is located.

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

This information is not applicable. The ground truth for a sharps container's performance is established by engineering standards and regulatory requirements, not by expert medical assessment of patient data.

4. Adjudication Method:

This information is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images. The device in question is a physical container for sharps disposal.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

The "ground truth" in this context is based on engineering specifications, regulatory standards (e.g., for sharps containers to prevent injury and contain biohazardous waste), and a comparison to the design and performance of predicate devices. The claim is that the device is "as safe and effective" as its predicates.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the machine learning sense for this type of device. The design and manufacturing process would involve prototypes and quality control checks, but these are not referred to as a "training set."

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

This information is not applicable. The design and manufacturing would be validated against established engineering principles and regulatory guidelines (e.g., FDA guidance for sharps containers), not from a "training set."

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the detailed study design elements (like test sets, human readers, ground truth establishment for AI/diagnostic purposes) that would be found for more complex diagnostic or AI-powered devices. The "acceptance criteria" are implied by the regulatory hurdles of proving substantial equivalence, primarily based on intended use and technological characteristics compared to predicates.

Summary

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SEP 3 0 1998

ATTACHMENT 9

(As required by 21 C.F.R. §§ 807.87(h), 807.92)

Manufacturer 1.
Contact Person

Thermal Waste Technologies, Inc. 19 Stony Hill Road Bethel, CT 06801 (203) 778-2210

Bill Ransone Vice President Sales & Marketing (203) 778-1039

1. Device

Demolizer® #47 One-Gallon Point of Trade or Proprietary Name a. Generation Sharps Container Sharps Container Common Name b. Classification Name Accessory to Hypodermic Needle C. II Classification d.
Intended Use: The sharps container is intended for the collection of disposable sharps 4. in both clinical and nonclinical healthcare settings, such as laboratories, dentists' offices, doctors' offices, veterinarian offices, corporate clinics, nursing homes, and other types of healthcare centers.

క్ Predicate Devices

The Demolizer # 47 One-Gallon Point of Generation Sharps Container is substantially equivalent to the 1.0 Gallon Leaktight Locking Top Translucent Red Sharps Disposal Container marketed by Post Medical, Inc. (#K925816), and to the 5-Quart Round Sharps Container marketed by Sage Products, Inc. (#K943659).

6.. General Description

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7. Detailed Description

8. Summary of Technological Characteristics

The Demolizer # 47 One-Gallon Point of Generation Sharps Container differs slightly from its predicate devices, in that the Demolizer sharps container is constructed of tinplated steel and lap welded. The two predicate devices are constructed of plastic. Further, unlike the predicate devices, once the Demolizer sharps container is closed, it is resistant to manual opening.

The Demolizer sharps container is similar to the two predicate devices, in that all are single use, disposable, nonsterile, opaque containers of roughly the same capacity, and all feature vertical inlet openings for the disposal of sharps.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

MAR 2 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bill Ransone Vice President Sales & Marketing Thermal Waste Technologies, Incorporated 19 Stony Hill Road Bethel, Connecticut 06801

Re: K982781

Trade/Device Name: Demolizer #47 One-Gallon Point of Generation Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Codes: MMK Dated: August 26, 1998 Received: August 31, 1998

Dear Mr. Ransone:

This letter corrects our substantially equivalent letter of September 30. 1998.

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 (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 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. Ransone

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 continue 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 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Syute Y. Mcheioms

Chiu S. 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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ATTACHMENT 11

INDICATIONS FOR USE STATEMENT

(REVISION)

Page 1 of 1

510(k) Number: K982781 Device Name: Demolizer #47 One-Gallon Point of Generation Sharps Container Indications for Use: This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division Infection Control,
and General Hospital Devices

510(k) Number	K982781
---------------	---------

Prescription Use
(Per 21 C.F.R. § 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).