The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard label adhered to the containers with fill line printed on the front. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.

Device Description

The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is stable, puncture resistant, impact and shatter resistant, and leak-proof on the sides and bottom. The BWCSH-1 container is fitted with a rotating top, allowing safe one-handed disposal of used sharps. The container has a locking tamper resistant plastic lid that once snapped in place, cannot be manually removed. Labels are orange-red with black text and a black biohazard symbol printed on a white background. Labels are adhered to the containers at the time of manufacture with the fill line printed. The BWCSH-1 device is for single use, disposable and is not a secondary container.

The BWCSH-1 sharps container three main components are nested together to reduce storage and shipping requirements. The rotating top is made with uncolored translucent material. The translucent nature of the product allows for a visual determination of content level. The bottom of the rotating top's internal chute matches the fill line to physically prevent over filling.

AI/ML Overview

The provided text describes a 510(k) submission for a sharps container (BWCSH-1), which is a Class II medical device. As such, the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a comparative effectiveness study or a standalone algorithm performance study, which are more common for AI/ML-driven devices.

Here's an analysis of the provided information based on your requested categories:

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

Acceptance Criteria (Performance Standards)	Reported Device Performance
Puncture Resistance (ASTM F2132-01(2008))	Passed
Leak-Proof (29 CFR 1910.1030(d)(2)(viii)(c))	Passed
Impact and Shatter Resistance (ISO 23907:2012)	Passed
Stability (29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii))	Passed
No features to bend, break, or shear needle.	No Feature Present
Labeling: "Single Use"	Labeling is "Single Use"
Overfill Indication: Labeled "Do Not Fill Above This Line"	Labeled "Do Not Fill Above This Line"
Clarity: Minimum of one translucent component (base or top)	Each Container has a minimum of one translucent component, either base or top

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

The document does not specify the sample size for each performance test (e.g., how many sharps containers were tested for puncture resistance). It only states that performance testing was performed. The data provenance is not specified, but it's implied to be from a materials testing lab for the puncture resistance test.

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)

This type of information is not applicable to this device. The "ground truth" for a sharps container's performance is objective physical testing against established international standards and regulations, not expert consensus or interpretation of data.

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

This is not applicable to this device. Adjudication methods like 2+1 or 3+1 typically apply to studies where human experts are making judgments that need to be resolved. For physical performance tests, the results against the standard are generally definitive.

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

This is not applicable. The device is a physical sharps container, not an AI/ML-driven diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable. The device does not involve an algorithm.

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

The "ground truth" for the performance tests of the sharps container is based on objective measurements against established performance standards and regulations. These include:

ASTM F2132-01(2008) for Puncture Resistance
29 CFR 1910.1030(d)(2)(viii)(c) for Leak-Proof
ISO 23907:2012 for Impact and Shatter Resistance
29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii) for Stability

8. The sample size for the training set

This is not applicable. The device is a physical product and does not involve a training set as would be used for AI/ML models.

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

This is not applicable. There is no training set for this device.

Summary

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K 131708 Traditional 510(k) Submission

510(k) SUMMARY

MAR(0 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92

Preparation Date: February 24, 2014

ADMINISTRATIVE INFORMATION

Submitted by: Bradford Wright Companies, Inc. Organization Number: 338046 . PIN: MD6068894-956733 SBD135362 4092 Orchard Way Lake Oswego, OR 97035-1871 Phone/Fax: (503) 635-6908 Email: info@bradfordwright.com

Contact Person: Mike DeMello President Email: miked@bradfordwright.com

DEVICE IDENTIFICATION

510(k) Number:	K131708
Device Name:	BWCSH-1
Common Name:	Sharps Container
Classification Name:	MMK
	Accessory to hypodermic single lumen needles
CFR Reference:	21CFR 880.5570- Class II
Classification Panel:	General Hospital

This submission is the first and only existing FDA filing by this manufacturer. We have never marketed the device in the U.S.

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Indications for Use:

Predicate Device:

510(k) Number:	K982781
Trade Name of Device:	Demolizer #47 1 Gal. Point of Generation Sharps Container
Common Name:	Sharps Container
Classification Name:	MMK
	Accessory to hypodermic single lumen needles
	CFR Reference:
Classification Panel:	General Hospital

Legally Marketed Equivalent Devices:

Product	Company	510(k) #
Demolizer#47 1 Gallon Point ofGeneration SharpsContainer	Thermal WasteTechnologies, Inc.	K982781
B-D GuardianTMNestable SharpsCollectors	Becton Dickinson & Co.	K 943575

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DEVICE DESCRIPTIVE INFORMATION

Product Description:

The BWCSH-1 device underwent and passed performance testing that consisted of confirming its key safety and reliability aspects. The following four types of performance tests were performed:

. Puncture Resistance Testing - According to ASTM F2132-01(2008);
Leak-Proof Testing According to 29 CFR 1910.1030(d)(2)(viii)(c); .
. Impact and Shatter Resistance -; According to ISO 23907:2012 and
Stability According to 29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii). .

ProductDescription	Accessopeningsize	Accessopening andclosure	OverallSizeL x W x H(inches)	Weight(pounds)	Capacity atfull line
------------------------	---------------------------	----------------------------------	------------------------------------------	--------------------	--------------------------

General Specification Table

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Bradford Wright Companies, Inc.

Component	Material	Depth(inches)	Width(inches)	Height(inches)
Canister at Top	Tinplate Steel	4"	10"	8"
Canister Bottom	Tinplate Steel	3"	9"	N.A.
Sharps Chute closed	Molded Polypropylene	4 ¾"	10 ½"	2 ¼"
Sharps Chute alone	Molded Polypropylene	3 ¾"	9 ½"	2"
Top Rim	Molded Polystyrene	4 ¾"	10 ½"	¼"
Lid Plug	Molded Polystyrene	3 ¾"	9 ¾"	¾"
Sharps Container	Metal & Plastic	4 ¾"	10 ½"	8 ¼"

Table showing sharps container component dimensions:

BWCSH-1 Sharps Container

Revision 4 Page 7 of 40

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PREDICATE DEVICES:

(K982781) Demolizer # 47 One-Gallon Point of Generation Sharps Container by Thermal Waste Technologies, Inc. and (K943575) B-D Guardian TM Nestable Sharps Collectors by Becton Dickinson & Co. are substantially equivalent to the applicant's BWCSH-1 Sharps Container.

Element ofComparison	Subject Device	Predicate Device#1	Predicate Device#2
Company	Bradford WrightCompanies, Inc.	Thermal WasteTechnologies, Inc.	Becton Dickinson& Co.
Device Name	BWCSH-1 SharpsContainer	Demolizer # 47One-Gallon Pointof GenerationSharps Container	B-D Guardian™Nestable SharpsCollectors
FDA 510(k) Number	K131708	K982781	K943575
Intended Use(s)	BWCSH-1 sharpscontainer isintended to be usedfor the safe disposalof hazardoussharps.	Intended for thedisposal of various-sized contaminatedmedical sharps(including needles,syringes, slides,and ampoules) inclinical andlaboratoryhealthcare settings.	B-D sharpscontainers areintended to be usedfor the safe disposalof hazardous sharps
Target Population	Healthcareprofessional	Healthcareprofessional	Healthcareprofessional
Where Used	HealthcareFacilities	Intended forclinical, nonclinicalhealthcare settingssuch aslaboratories,dentists' office,doctor's office,corporate clinicsand nursing homes.	HealthcareFacilities
Material	Polypropylene,Polystyrene &Tinplate steel	Tinplate steel	Polypropylene
Sharps Access	Sharps insertedthrough the top	Sharps insertedthrough the top	Sharps insertedthrough the top
Sharps Closure	Lid is locked inplace for removal	Closure feature isclosed then locked	Flaps are closedand locked in place
		in place forremoval	for removal
Impact Resistance	Yes	Not tested	Yes
Puncture Resistance	Yes	Yes	Yes
Leak Proof	Yes	Yes	Yes
Non-sterile	Yes	Yes	Yes
Single Use	Yes	Yes	Yes
Capable ofmaintaining a stable,upright position	Yes	Not tested	Yes
No features to bend,break, or shearneedle.	No Feature Present	No Feature Present	No Feature Present
Reusable SharpsContainers	Labeling is "SingleUse	Labeling is "SingleUse	Labeling is "SingleUse
Overfill Indication	Labeled "Do NotFill Above ThisLine"	Labeled "Do NotFill Above ThisLine"	"Do Not Overfill"or "Fill to thisLevel Only" islabeled orembossed on thecontainer at thelocation of theoverfill. Labelingincludes a "FillLine"
Clarity	Each Container hasa minimum of onetranslucentcomponent, eitherbase or top	Temporary/Permanent Opening forvisual inspection.	Each Collector hasa minimum of onetranslucentcomponent, eitherbase or top
Construction	Injection MoldedLid and Rotatingtop and 2 pieceseamed &gluedtinplate base	3 piece seamed&glued tinplate	Injection MoldedContainers, Lidsand Closure
Dimensions	10.5 inches by 4.75inches by 8.25inches	6.5 inches indiameter by 8inches	12 inches by 13.5inches by 6 inches
Fill Capacity	One US gallon	One US gallon	7.6 Liters (2.01 USgallons)

Comparison table with predicate device:

BWCSH-1 Sharps Container

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SUBSTANTIAL EQUIVALENCE DISCUSSION of Similarities and Differences:

The BWCSH-1 Sharps Container is similar to both the Demolizer # 47 One-Gallon Point of Generation Sharps Container and the B-D Guardian™ Nestable Sharps Collectors in:

. Intended use
. Target Population
. Materials
. Design
t Performance testing

Intended use comparison:

The intended use of the new BWCSH-1 Sharps Container is the same as both predicate devices. BWCSH-1 sharps container is intended to be used for the safe disposal of hazardous sharps.

Design and Material Comparison:

The design and functional characteristics of the BWCSH-1 Sharps Container and both predicate devices are similar. The BWCSH-1 Sharps Container and the B-D Guardian™ Nestable Sharps Collectors predicate device's parts are nestable, whereas the Demolizer # 47 One-Gallon Point of Generation Sharps Container is not. When assembled all form a single unit. BWCSH-1 Sharps Container and the B-D Guardian™ Nestable Sharps Collectors predicate device both have features to prevent contact between user and the contents and all are designed for a visual determination of the maximum capacity. None of the devices have features that bend, break, or shear needles. BWCSH-1 Sharps Container and both predicate devices are all designed for single use by a locking feature in the lids and closure or access door. BWCSH-1 Sharps Container's lid and sharps chute as well as the B-D Guardian 101 Nestable Sharps Collectors predicate device are constructed of polymeric materials which are injection molded. The material of construction differs from the B-D Guardian™ Nestable Sharps Collectors is the BWCSH-1 Sharps Container's lower canister is made of seamed and glued tin plated steel same as the whole Demolizer # 47 One-Gallon Point of Generation Sharps Container predicate device. BWCSH-1 Sharps Container and the predicate devices all allow for a visual determination of content level.

Summary of Non-Clinical Performance Bench Testing:

Performance Standards:

The Recognition Number 6-215 identifies ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps."

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Bradford Wright Companies, Inc.

The Recognition Number 6-293 identifies ISO 23907 First Edition 2012-09-01. "Sharps injury protection - Requirements and test methods - Sharps containers"

The performance testing demonstrates compliance with the recognized consensus standards. ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps" and the applicable portions of ISO 23907 First Edition 2012-09-01. "Sharps injury protection - Requirements and test methods - Sharps containers"

In addition the relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(k)] Submission for Sharps Collectors dated October 1993", was used to identify applicable physical and mechanical features of the BWCSH-1 Sharps Container and predicate devices. All applicable standards have been used to show that the BWCSH-1 Sharps Container is substantially equivalent to the appropriately listed predicate devices.

The performance testing summary demonstrates substantial equivalence between the BWCSH-1 Sharps Container and the predicate devices. The BWCSH-1 Sharps Container has been tested by appropriate methods with respect to the relevant standards: FDA recognized ASTM standards F2132-01 and OSHA regulations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the BWCSH-1 Sharps Container is considered substantially equivalent to its predicate device.

Performance Testing (Bench) - Product Testing

The BWCSH-1 Sharps Container incorporates equivalent collector design features and performance characteristics. The results of the product performance testing demonstrated equivalent performance to the predicate device performance and no new issues were raised.

Test Methods:

Puncture Resistance (Performed by and independent materials testing lab) - Passed ASTM F 2132-01 (2008) "Standard Specification for the Puncture Resistance of Materials used in containers for the Discarded Medical Needles and Other Sharps".

Leak Resistance of bottom and sides - Passed

Impact Resistance - Passed Based on ISO 23907:2012

Stability: - Passed

BWCSH-1 Sharps Container

Revision 4 Page 11 of 40

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Bradford Wright Companies, Inc.

Conclusion:

The performance testing summary demonstrates substantial equivalence between the BWCSH-1 Sharps Container and the predicate devices. BWCSH-1 Sharps Container has been tested by appropriate methods with respect to the relevant standards. FDA recognized ASTM standards F2132-01. No new issues of safety and effectiveness were raised with the testing performed and the BWCSH-1 Sharps Container is considered substantially equivalent to its predicate device.

*B-D Guardian™ Nestable Sharps Collector is a registered trademark of Becton Dickinson and Company.

BWCSH-1 Sharps Container

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or being supported by three abstract shapes. The logo is printed in black and white.

Public Health Service

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

March 10, 2014

Bradford Wright Companies, Inc. Mr. Mike DeMello President 4092 Orchard Way Lake Oswego, OR 97035

Re: K131708

Trade/Device Name: BWCSH-1 Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Sharps Container Regulatory Class: II Product Code: MMK December 31, 2013 Dated: Received: January 28, 2014

Dear Mr. DeMello:

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.

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Page 2 - Mr. DeMello

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 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/ResourcesforYou/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/MedicalDevices/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 vours.

Image /page/10/Picture/8 description: The image contains a combination of text and graphic elements. The text includes the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." There is also the acronym "DAGRID" present. The image also contains a decorative graphic element on the left side.

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131708

Device Name BWCSH-1 sharps container

Indications for Use (Describe)

The BWCSH-1 sharps container has a one-gally that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard the containers with fill line printed on the BWCSH-1 device is for single use, disposable and is not a secondary container. BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . : ...

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth 2014.03.09 (

FORM FDA 3881 (9/13)

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).