The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.

When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.

Device Description

The Sharp Chute ™ is a portable, 1.5 quart sharps container designed to be used in . environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet™ Blood Collection Tray.
The Sharp Chute ™ is available in either translucent red or translucent yellow.
Each component of the container assembly is made of injection molded polypropylene.
The end user will be required to attach the dome assembly to the base by inserting the . connection tabs into their corresponding slots.
The Sharp Chute "1 is designed to withstand punctures by syringes, pen needles, and . lancets.
The Sharp Chute "M is autoclavable and incineratable. .
The Sharp Chute TM is NOT reusable. .

AI/ML Overview

This document describes a 510(k) submission for the "Sharp Chute" sharps container. However, it does not contain information about specific acceptance criteria, study designs, sample sizes for testing, ground truth establishment methods, or the use of experts in the context of device performance evaluation as typically requested for AI/ML-based devices or studies requiring such detailed clinical validation.

The information provided focuses on the device's substantial equivalence to predicate devices, its intended use, technological characteristics, and compliance with general FDA regulations.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt because the provided input document does not contain this information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical performance study with the metrics you've asked for.

Here's what I can extract based on the provided text, and where I must state "Not applicable" or "Not provided":

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated, Derived from General Sharps Container Safety)	Reported Device Performance (as stated in the document)
Withstand punctures by syringes, pen needles, and lancets	"The Sharp Chute™ is designed to withstand punctures by syringes, pen needles, and lancets."
Function of permanent lock	"When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of."
Close functions prior to permanent lock	"All predicate devices feature a close functions prior to permanent lock. The new device also has this feature. In addition to a close position, the new device also provides close icons on the outer dome to show the close position to avoid confusion from false locking."
Support full capacity during transport	"The new device offers a similar handle and has been tested to be able to support the full capacity of the unit."
Pass tests against various standards	"The Sharp Chute™ has passed all tests against various standards by third party review. The third party involved in review was: Intertek."
Autoclavable	"The Sharp Chute™ is autoclavable."
Incineratable	"The Sharp Chute™ is incineratable."

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

Sample size: Not provided. The document mentions "tests against various standards" but does not specify the number of units or conditions tested.
Data provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing was conducted by a third-party review company, Intertek, located in Grand Rapids, MI.

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

Not applicable/Not provided. This device is a physical sharps container, not an AI/ML diagnostic tool that would typically involve expert-established ground truth for a test set. Evaluation would likely involve engineering and materials science experts conducting specific tests.

4. Adjudication method for the test set:

Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for interpreting ambiguous results in studies involving human interpretation or subjective assessments, which is not the context for this physical device.

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 physical sharps container, not an AI/ML system, so an MRMC study is irrelevant.

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

Not applicable. This is a physical sharps container, not an AI algorithm. Its performance is evaluated through physical and material testing, not algorithmic standalone performance.

7. The type of ground truth used:

Not explicitly stated in terms of "expert consensus, pathology, outcomes data." For a physical device like a sharps container, ground truth would likely be based on established engineering standards, material properties, and regulatory requirements (e.g., ability to resist puncture as defined by a standard, mechanical strength for a handle, proper functioning of locking mechanisms).

8. The sample size for the training set:

Not applicable/Not provided. This is a physical device, not an AI/ML model that requires training data in the typical sense.

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

Not applicable/Not provided. As above, this is not an AI/ML model.

Summary

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K091690.

eathrow Scientific LLC

1901 8 8 2008

510 (k) Notification

Section 5: 510 (k) Summary

Date of Preparation:

Device Names:	Sharp Chute TM
Model number(s):	HS21001A - Red color material
	HS21001B - Yellow color material

Common Name:

Sharps Container

Accessory to needles, hypodermic, single lumen, lancets Classification Name:

21 CFR 880.5570 Regulation Number:

Proposed Regulatory Class: Class II

80 MMK Device Product Code:

General Hospital Medical Specialty:

Manufacturer:

Predicates:

Heathrow Scientific LLC. 620 Lakeview Parkway Vernon Hills, IL 60061

Official Contact Person: Peter Hadjis Product Development Manager

Predicate devices to which Sharp Chute ™ is substantially equivalent:

K943139 – B-D, Guardian One Piece-Sharps Collectors o

K990936 Stik Stoppers, The Vault 0
K980490 Sage Products, Sharps Containers with ೧ Screw Top Caps
K964387 Graphic Controls, Point of use II Sharps-A-Gator

Device Description:

The Sharp Chute ™ is a portable, 1.5 quart sharps container designed to be used in . environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet™ Blood Collection Tray.
The Sharp Chute ™ is available in either translucent red or translucent yellow.
Each component of the container assembly is made of injection molded polypropylene.

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Image /page/1/Picture/0 description: The image contains the logo for Heathrow Scientific LLC. The logo features a stylized atom-like graphic on the left, followed by the text "Heathrow Scientific" in a bold, sans-serif font. To the right of "Scientific" is the superscripted trademark symbol and the letters "LLC" in a smaller font size.

The end user will be required to attach the dome assembly to the base by inserting the . connection tabs into their corresponding slots.
The Sharp Chute "1 is designed to withstand punctures by syringes, pen needles, and . lancets.
The Sharp Chute "M is autoclavable and incineratable. .
The Sharp Chute TM is NOT reusable. .

Intended Use:

The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps 0 container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.
When the container is filled to the max-capacity indicator, it is intended to be . permanently locked and ultimately disposed of.

Technological Characteristics:

Predicate devices and new device is made from same material; polypropylene. .
All predicate devices feature a close functions prior to permanent lock. The new device . also has this feature. In addition to a close position, the new device also provides close icons on the outer dome to show the close position to avoid confusion from false locking.
Predicate devices feature detailed labels with warning cautions. The new devices feature . similar cautions with additional warnings for added safety.
Predicate devices offer handle for transport. The new device offers a similar handle and t has been tested to be able to support the full capacity of the unit.
The new device has a unique rotating dome. Predicate units have screw top lids. Screw . top lids and the new device rotating dome has lid on rail system as well to enclose device. Both methods of the screw top and rotating dome lid provide lock and close mechanisms during transport and engage in lock.
The Sharp Chute " has passed all tests against various standards by third party review. . The third party involved in review was:

Intertek

4700 Broadmoor Ave SE, Suite 200 Grand Rapids, MI 49512

Discussion:

The Sharp Chute™ has similar materials of construction and indications for fill and lock as the predicate devices. The new device has similar technological characteristics as compared to predicate devices for safety, function, and uses. There are safety precautions that both the predicate devices and the new device used to display cautionary warnings to users. These safety precautions are listed on unit labels and instructional sheets.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2009

Heathrow Scientific, LLC C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K091690

Trade/Device Name: Sharp Chute™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: July 13, 2009 Received: July 15, 2009

Dear Mr. Kogoma:

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 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. Kogoma

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony V. Norton for
S. Rep. DDS. Mass.

Susan Runner, D.D.S., M.A. Acting 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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Image /page/4/Picture/0 description: The image shows the logo for Heathrow Scientific LLC. The logo features the company name in bold, black font. To the left of the name is a graphic of three intersecting circles.

510 [k] Notification

Section 4: Indications for Use Statement

510 (K) Number (if known):

Device Name: Sharp Chute TM HS21001A – Red color material Model number(s): HS21001B – Yellow color material

Indications For Use:

When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stalin A. Murgules

Ton Sign-Off) n of Anesthesiology, General Hospital ·· Control, Dental Devices

ber: Kng1690

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).