The sharpsCAN™ Model I Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.

Device Description

The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model.

sharpsCAN™ Model 1 pint,
The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device (sharpsCAN™) meets those criteria. The device is a sharps container, and the study involves performance testing against recognized standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Standard / Requirement	Reported Device Performance
Puncture Resistance Testing	ASTM F2132-01	Met and exceeded performance testing according to design specifications.
Leak-Proof Testing	29 CFR 1910.1030	Met and exceeded performance testing according to design specifications.
Toppling Resistance	CSA Z316.6-07	Met and exceeded performance testing according to design specifications.
Impact Resistance and Spillage Testing	Not explicitly stated (likely internal)	Met and exceeded performance testing according to design specifications.
Stability Testing	Not explicitly stated (likely internal)	Yes (Table 5-1 indicates "Stability Testing" was performed and passed).

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

Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Four types of performance tests were performed."
Data Provenance: The data is generated from internal performance testing conducted by Medical Engineering Development Solutions, Inc. (MEDS). The country of origin is implicitly the United States, as MEDS is based in Colorado, and the submission is to the U.S. FDA. The study is a prospective performance test designed to evaluate the physical characteristics of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable to this type of device and study. The "ground truth" for a sharps container's performance is established by objective engineering standards and regulations (e.g., ASTM F2132-01 for puncture resistance, 29 CFR 1910.1030 for leak-proof). There are no human experts "interpreting" results in the way a medical image might be interpreted. The device's performance is measured against quantifiable physical criteria.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human interpretation or consensus is required to establish a gold standard, such as in clinical trials involving diagnostic accuracy or image interpretation. For physical performance testing of a sharps container, the results are objectively measured against predefined standards, and no human adjudication process is mentioned or necessary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields. The sharpsCAN™ is a physical medical device (a sharps container), and its evaluation focuses on its physical performance characteristics, not on human interpretation or diagnostic accuracy assisted by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical product, not an AI algorithm. Its performance is intrinsic to its design and material properties, tested through physical simulations and measurements, not through an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the sharpsCAN™ study is based on established engineering standards and regulatory requirements. These include:

ASTM F2132-01 (for Puncture Resistance)
29 CFR 1910.1030 (for Leak-Proof Testing)
CSA Z316.6-07 (for Toppling Resistance)
The FDA guidance document "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers," issued in October 1993, also served as a basis for evaluation.

These standards define the objective and measurable criteria that the device must meet to be considered safe and effective.

8. The Sample Size for the Training Set

This question is not applicable. The sharpsCAN™ is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development. The "training" for this device would refer to its design and manufacturing process, optimized through engineering principles.

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

This question is not applicable, as there is no training set for this device. The design and manufacturing process would be informed by established engineering principles, material science, and regulatory requirements, rather than a data-driven training set with an established ground truth.

Summary

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MEDS
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.

SECTION 5 - 1

JUL 2 3 2013

K123807

sharpsCAN™ Traditional 510(k) Submission

・・

5 510(k) Summary खन्न Terri

5.1 Submitted by:

Owner:	Medical Engineering Development Solutions, Inc.11060 Irma DriveNorthglenn, Colorado 80233
Contact Person:	Tim CoresselV.P. EngineeringOffice Phone: (303) 452-0484Cell Phone: (303) 563-9263
Date of Summary Preparation:	June 12, 2013

5.2 Device Identification:

Trade Name of Device:	sharpsCAN™
Common Name:	Sharps Container
Classification Name:	MMKAccessory to hypodermic single lumen needles
CFR Reference:	21CFR 880.5570- Class II
Classification Panel:	General Hospital

5.3 Predicate Device Identification

Substantial equivalence is being claimed to the following legally marketed device:

Trade Name:	Demolizer #47 1 Gallon Point of Generation Sharps Container (K982781)
Common Name:	Sharps Container
Classification Name:	MMK
CFR Reference:	Accessory to hypodermic single lumen needles 21CFR 880.5570- Class II
Classification Panel:	General Hospital

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Image /page/1/Picture/0 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white and features the acronym "MEDS" in large, bold letters. Above and below the acronym are thin, stylized lines that add a visual element to the logo. Below the acronym, the full name of the company is written in smaller letters.

K123807

5.4 Description of Device

The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model.

- sharpsCAN™ Model 1 pint,
  The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory.

Performance testing consisted of confirming the key safety and reliability aspects of the sharpsCAN™ container. Four types of performance tests were performed:

Puncture Resistance Testing- According to ASTM F2132-01 .
. Leak-Proof Testing- According to 29 CFR 1910.1030
. Toppling Resistance - According to CSA Z316.6-07
Impact Resistance and Spillage Testing .

The performance test results have proved the sharpsCAN™ not only met but exceeded in one case performance testing according to its design specifications and is substantially equivalent to the predicate device.

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SECTION 5 - 3

Image /page/2/Picture/1 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white, with the letters "MEDS" in large, bold font. Below the logo, the full name of the company is written in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical engineering and development.

K123807

sharpsCAN™ Traditional 510(k) Submission

5.5 Indications For Use

The sharpsCAN™ Model 1 Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.

ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

5.6 Predicate Device

The sharpsCAN™ containers are similar in design and intended use to the Demolizer #47 1 Gallon Point of Generation Sharps Container (K982781). Substantial equivalence to the predicate device was evaluated according to the criteria identified in the FDA guidance document "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers," issued in October , 1993.

Tables 5-1 shows the device comparisons of the SharpsCAN™ and the predicate device respectively.

	sharpsCAN™	Demolizer #47
510(k) Number	TBD	K982781
Construction	3 Piece Construction	3 Piece Construction
Material	Tin plated steel	Tin plated steel
Sharps Closure	Metal Cover	Metal Cover
Sharps Access	Vertical Inlet	Vertical Inlet
Geometry	Cylindrical	Cylindrical
Leak Proof	Yes	Yes
Puncture Resistance	Yes	Yes
Non-sterile	Yes	Yes
Single Use	Yes	Yes
Stability Testing	Yes	No
Impact & Spillage Testing	Yes	No

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SECTION 5 - 4

Image /page/3/Picture/1 description: The image shows the alphanumeric string "K123807" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, with the "K" standing out as the only letter.

K123807

sharpsCAN™

Traditional 510(k) Submission

Aperture Dimension	2.5"	2-3/8"
Temporary/PermanentClosure	Both	Both
Mechanism to PreventHand/Finger Access	No	No
Mechanism to PreventSpillage	No	No
Mechanism to PreventOverfilling	Yes	Yes
Description of Accessories	Yes	No
Intended Use	Intended for the disposal ofcontaminated medicalsharps in health carefacilities.	Intended for clinical, non-clinical healthcare settingssuch as laboratories,dentists' office, doctor'soffice, corporate clinicsand nursing homes.

•

Table 5-1.

5.7 Design and Materials

The design and construction of the sharpsCAN™ and the predicate device are similar. They both are of a three piece constructed design using seam welded tin plated steel with a tin plated steel metal cover lid.

They both use a vertical opening for the disposal of sharps waste.

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Image /page/4/Picture/0 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white, with the letters "MEDS" in large, bold font. Below the letters is the full name of the company in a smaller font. There are some decorative lines above and below the letters.

K123807

sharpsCAN™ Traditional 510(k) Submission

5.8 Description of Accessory

wall mount unit is a required accessory intended to be used with the The sharpsCAN™. The accessory is a fixture secured to a stable vertical surface providing a restrictive aperture and a secured lockable containment for the sharpsCAN™ .

The sharpsCAN™ is required to be used with the wall mount unit accessory.

5.9 Conclusion

The sharpsCAN™ is substantially equivalent to the predicate device based on the descriptive data, compliance with standards and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person with outstretched arms, with three wavy lines representing the body and arms. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

July 23, 2013

Medical Engineering Development Solutions. Incorporated Mr. Tim Coressel Vice President Engineering 11060 Irma Drive NORTHGLENN CO 80233

Re: K123807

Trade/Device Name: SharpsCANTM Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 12, 2013 Received: June 14, 2013

Dear Mr. Coressel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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Page 2 - Mr. Coressel

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 (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/McdicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohi
Clinical Deputy
DAGRID

Teiashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4- 1

K123807

sharpsCAN™ Traditional 510(k) Submission

Indications for Use Statement 4

気になる。

Indications for Use

510(k) Number: K123807

Device Name: sharpsCAN™

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use 117. (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth Gutala -5 2013.07.18 15:12:36 -04'00'

Division Sign-Off)

Page | of | |

: iection Control, Dental Devices

Pivision of Anesthesiology, General Hospital

510(k) Number: K123601

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).