SHARPS CONTAINER by CUSTOM MEDICAL PLASTICS, INC.

Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

Device Description

Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.

AI/ML Overview

The provided text describes a 510(k) submission for a "Vertical Entry Sharps Container." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a full-fledged study with detailed metrics like accuracy or sensitivity.

Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable or not present in this document. The 510(k) process for this device type primarily relies on comparing design, materials, and intended use to existing devices, and ensuring compliance with general controls (like Good Manufacturing Practices).

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document does not describe specific quantitative acceptance criteria or performance metrics for this device beyond its intended function as a receptacle for sharps and its puncture-resistant property. The primary "performance" assessed is its substantial equivalence to predicate devices, implying it functions similarly and safely.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No specific test set or data from performance testing is mentioned. The submission is a comparison to predicate devices, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As there is no "test set" and no "ground truth" to establish in the context of a diagnostic or interpretive device, experts for this purpose were not involved and are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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

Not Applicable. This is a passive medical device (a sharps container), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this device.

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

Not Applicable. This is not an algorithmic or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. As this device collects sharps, there is no "ground truth" in the diagnostic sense. The "ground truth" for a sharps container would be its ability to safely contain sharps, which is often assessed through design verification, material testing, and compliance with standards, not diagnostic ground truth.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not Applicable. See point 8.

Summary of Device Information Provided:

Device Name: Vertical Entry Sharps Container
Manufacturer: Custom Medical Plastics, Inc.
Intended Use: Provides a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal.
Material: Injection-molded polypropylene container and lid.
Key Feature: Chimney-type opening for vertical sharps drop, designed to better protect user's fingers.
Safety Statement: Puncture-resistant, but not entirely puncture-proof; warns against overfilling, inspect before handling, and handle with care.
Disposal: Incineration in compliant medical waste incinerators.
Regulatory Class: Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.
Substantial Equivalence Claim: To Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical, based on similar materials (polypropylene), manufacturing process (injection molding), and design (chimney-type opening).
Date of Submission: December 24, 1996 (Amended April 4, 1997)
FDA Decision: Substantially Equivalent (July 3, 1997)

The 510(k) process for this device type primarily relies on comparing the device's design, materials, and intended use to existing legally marketed predicate devices, not on generating novel performance data against specific acceptance criteria.

Summary

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

K970398 K970398 ATTACHMENT 5, Rev. 1 JUL - 3 1997

510 (k) SUMMARY

THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.

510 (k) Summary of Safety & Efficacy Vertical Entry Sharps Container

Custom Medical Plastics, Inc. 11811 Calhoun Road Submitted By: Omaha, NE 68122 (402) 691-2855

Daniel R. Brown, President Contact:

December 24, 1996 (Amended April 4, 1997) Date Prepared:

Sharps Containers are classified as a Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.

Our Vertical Entry Sharps Container is substantially equivalent to Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical. These containers are all made of polypropylene by the injection molding process. They feature a chimney-type opening which better protects user's fingers when depositing sharps.

Our Vertical Entry Sharps Container provides a receptacle for used, contaminated sharps and for enclosure during transport to ultimate disposal. The product labeling includes a cautionary statement that the "container is puncture-resistant, but not entirely puncture-proof. To avoid the possibility of accidental sticks, do not overfill, inspect unit before handling and handle with care." Final disposal is typically accomplished by When incinerated in compliant medical waste inincineration. cinerators, these Sharps Containers do not present any environmental hazards resulting from plastics combustion.

Our Vertical Entry Sharps Container will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUM SERVICES USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel R. Brown ·President Custom Medical Plastics, Incorporated 14315 C Circle 68144 Omaha, Nebraska

JUL - 3 1997

Re : K970398 Sharps Container Trade Name: Requlatory Class: II Product Code: FMI May 14, 1997 Dated: Received: May 16, 1997

Dear Dr. Smith:

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, Druq, 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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

Page 2 - Dr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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" (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

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

K970398 ATTACHMENT 7, Rev. 1

Page 1 of 1

510(k) Number (if known): Unknown

Device Name: Sharps Container

Indications For Use:

Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

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

Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Info and General Hospita 5 ! (Xk) Number Over-the-Counter Use / OR Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)

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).