The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities for the storage and transport for disposal of syringes and other medical sharps waste.

Device Description

The Stericycle Sharps Management Service Reusable Sharps Container is a single piece, reusable, sharps container that is intended to be used in health care facilities where medical sharps waste is generated. The container is injection molded of polypropylene copolymer with a uniform nominal thickness of 0.125". The container is available in 2 and 4 gallon sizes and in red or yellow color. The lid of the container is constructed so that the sharps waste is disposed safely and effectively by gravitational force when the waste is placed in the inner tray. The Stericycle Sharps Containers utilize a counterbalanced lid design that acts as a protective barrier to keep sharps objects within the container from coming back up through the lid and anyone from reaching into the container to retrieve sharps waste.

AI/ML Overview

The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in healthcare facilities for the storage and transport for disposal of syringes and other medical sharps waste.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The device passed all performance tests, indicating it meets the defined acceptance criteria.

Acceptance Criteria (Test Standard / Description)	Reported Device Performance
Life-cycle testing (Subsequent to conditioning of units representative of reprocessing and transport of the 2- and 4-gallon Reusable Sharps Containers, the units were tested and evaluated for the following parameters):
• Vibration Resistance (ISTA 3E)	Pass
• Impact Resistance (The filled container maintains its integrity when dropped 4 ft. to a concrete surface and retains its solid contents.)	Pass
• Leak Resistance (The container loses no liquid over a 24-hour period.)	Pass
• Needle Puncture Resistance (ASTM F2132-01:2008)	Pass
DOT Standards:
• DOT Vibration Resistance (49 CFR 178.608)	Pass
• DOT Impact Resistance (49 CFR 178.603)	Pass
• DOT Stacking Resistance (49 CFR 178.606)	Pass
Other:
• Topple Resistance (AS/NZS 4261:1994, Appendix D)	Pass

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

Sample Size: The document states that each test was performed on "both 2- and 4-gallon Container sizes." It does not specify the number of containers for each size that were tested, meaning the exact sample size is not explicitly provided beyond indicating that both types were included in the evaluation.
Data Provenance: The tests are nonclinical performance tests conducted in a laboratory setting based on established standards. There is no information regarding country of origin or whether the data is retrospective or prospective, as these are not relevant to nonclinical bench testing.

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

This information is not applicable as the evaluation involved nonclinical performance testing against established standards, not interpretation by human experts. The "ground truth" is defined by the objective pass/fail criteria of the specified test standards.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved nonclinical performance testing against established standards, not human judgment or adjudication.

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 diagnostic devices where human readers interpret medical images or data, often with AI assistance. The Stericycle Sharps Management Service Reusable Sharps Container is a physical medical device, and its performance is evaluated through bench testing against engineering standards.

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

This question is not applicable as the device is not an AI algorithm. Its performance is inherent to its physical properties and design, tested directly through nonclinical methods.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation is based on established industry and regulatory standards for sharps containers and transportation, such as:

ISTA 3E (Vibration Resistance)
ASTM F2132-01:2008 (Needle Puncture Resistance)
49 CFR 178.608, 178.603, 178.606 (DOT standards for Vibration, Impact, and Stacking Resistance)
AS/NZS 4261:1994, Appendix D (Topple Resistance)
Internal specifications for impact and leak resistance (e.g., "Retains its solid contents when dropped 4 ft. to a concrete surface," "loses no liquid over a 24-hour period").

These standards define objective and measurable criteria for acceptable performance.

8. The Sample Size for the Training Set

This information is not applicable. The Stericycle Sharps Management Service Reusable Sharps Container is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set or associated ground truth for training.

Summary

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STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION

510(k) Summary

510(k) Notification K132007

GENERAL INFORMATION

Applicant:

Stericycle, Inc. 28161 Keith Drive Lake Forest, IL 60045 U.S.A. Phone: 847-943-6658 FAX: 800-593-5085

Contact Person:

Lori Adels, PhD Regulatory Consultant Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865

Date Prepared: December 27, 2013

DEVICE INFORMATION

Trade Name: Stericycle Sharps Management Service Reusable Sharps Container

Generic/Common Name: Container, Sharps

Classification : 21 CFR§880.5570, Hypodermic single lumen needle. Class II

Product Code: MMK

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510(k) SUMMARY

PREDICATE DEVICE

Daniels Sharpsmart™ reusable sharps container (K001337) .

INTENDED USE

The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities for the storage and transport for disposal of syringes and other medical sharps waste.

The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:

2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color .
4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color

PRODUCT DESCRIPTION

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Stericycle Sharps Management Service Reusable Sharps Container are similar to the predicate device. Performance data are provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The intended use for the predicate device is substantially equivalent to the proposed intended use of the Stericycle Sharps Management Service Reusable Sharps Container. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device. Details are provided in the following table.

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STERICYCLE, INC.

STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER

510(k) PREMARKET NOTIFICATION

510(k) Summary

Feature	Stericycle Sharps ManagementService Reusable Sharps Container	Daniels Sharpsmarttmreusable sharps container
510(k) Number	K132007	K001337
Indications for Use	Stericycle Sharps Management ServiceReusable Sharps Container is intendedfor use in health care facilities for thestorage and transport for disposal ofsyringes and other medical sharps waste.	Reusable containers intended to beused for the disposal ofcontaminated medical sharps inhealth care facilities.
Classification/Product Code	MMK	MMK
Regulation Number	21 CFR§880.5570,Hypodermic single lumen needle	21 CFR§880.5570,Hypodermic single lumen needle
ContainerMaterial	Polypropylene copolymer	Polypropylene copolymer
Material Thickness	0.125" (nominal)	Not available
Volume(Fill Capacity)	2 gallons4 gallons	S14: 7.0 quarts (1.8 gallons)S22: 15.5 quarts (3.9 gallons)S32: 25.0 quarts (6.3 gallons)
Dimensions(L x W x H)	2 Gallon: 12.3" x 6.9" x 13.9"4 Gallon: 12.3" x 6.9" x 21.9"	S14: 13.5" x 6.6" x 11.0"S22: 13.5" x 6.6" x 17.3"
Intended Locationof Use	Health care facilities	Health care facilities
Biohazard WaningLabel	Labeled as Biohazard in Fluorescentorange or orange-red with lettering incontrasting color	Labeled as Biohazard in Fluorescentorange or orange-red with letteringin contrasting color
Sharps access andclosure	Gravity-activated	Gravity-activated
Closable	Yes	Yes
Puncture Resistant	Yes [Test method: ASTM F2132-01(2008)]	Information not available.
Leakproof on Sidesand Bottom	Yes	Yes
Impact Resistant	Yes	Yes
Vibration Resistant	Yes	Yes
Stacking Resistant	Yes	Yes
Capable ofmaintaining stable,upright position	Yes	Yes
No feature to bend,break, or shearneedles	No feature	No feature
Unwinders	No feature that would recap, remove, orunwind needle of the hub.	No feature that would recap, remove,or unwind needle of the hub.
Reusable orNon-reusable	Reusable	Reusable
Feature	Stericycle Sharps ManagementService Reusable Sharps Container	Daniels Sharpsmart™reusable sharps container
PerformanceStandards	• American Society for Testing andMaterials (ASTM) ConsensusStandards for Puncture Resistance(ASTM F2132-01:2008)	• Australian/New Zealand Standardfor Reusable containers forcollection of sharp items(AS/NZS 4261:1994)
	• Australian/New Zealand Standard forReusable containers for collection ofsharp items (AS/NZS 4261:1994)	• Department of Transportation(DOT) regulations(49 CFR 173.197)
	• Department of Transportation (DOT)regulations (49 CFR 173.197)	• Occupational Safety and HealthAdministration (OSHA)bloodborne pathogen standards(29 CFR 1910.1030)
	• Occupational Safety and HealthAdministration (OSHA) bloodbornepathogen standards (29 CFR1910.1030)	(29 CFR 1910.1030)
Features for safe	• Secure closure and puncture resistance	• Secure closure and puncture
transport andre-use	for transport• Container is permanently marked forreuse	resistance for transport• Container is permanently markedfor reuse
	• Container is disinfected by Stericycleprior to reuse	• Container is disinfected prior toreuse
	• Container volume is between 2 and40 gallons in volume (49 CFR173.197)	• Container volume is between 2 and40 gallons in volume (49 CFR173.197)

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STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION

510(k) Summary

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510(k) SUMMARY

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

The FDA has not established a performance standard for this product under Section 514. However, the Stericycle Sharps Management Service Reusable Sharps Container complies with criteria identified in FDA guidance documents. Occupational Safety and Health Administration (OSHA) standards on blood borne pathogens, as outlined in 29 CFR 1910.1030, Department of Transportation (DOT) regulations controlling the transport of regulated medical waste as outlined in 49 CFR 173.197, and has passed nonclinical performance testing as summarized in the table below.

Testing Type(each test performed on both2- and 4-gallon Containersizes)	Test Standard / Description	Result
Life-cycle testing	Subsequent to conditioning of units representative of reprocessing andtransport of the 2- and 4-gallon Reusable Sharps Containers, the unitswere tested and evaluated for the following parameters:
• Vibration Resistance	ISTA 3E	Pass
• Impact Resistance	The filled container maintains its integritywhen dropped 4 ft. to a concrete surface andretains its solid contents.	Pass
• Leak Resistance	The container loses no liquid over a 24-hourperiod.	Pass
• Needle Puncture Resistance	ASTM F2132-01:2008	Pass
DOT Vibration Resistance	49 CFR 178.608	Pass
DOT Impact Resistance	49 CFR 178.603	Pass
DOT Stacking Resistance	49 CFR 178.606	Pass
Topple Resistance	AS/NZS 4261:1994, Appendix D	Pass

The collective results of the performance testing demonstrate that the Stericycle Sharps Management Service Reusable Sharps Container meets the established specifications necessary for consistent performance of its intended use throughout its planned lifetime and is substantially equivalent to the predicate device.

CONCLUSION

The Stericycle Sharps Management Service Reusable Sharps Container shares its design and mechanism of action with the identified predicate device. The results of the bench testing confirm that the Stericycle Sharps Management Service Reusable Sharps Container functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a sharps container. The Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device in terms of technological characteristics, intended use, and performance. No new issues of safety or effectiveness are raised by the Stericycle Sharps Management Service Reusable Sharps Container.

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STERICYCLE, INC.

STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION

510(k) Summary

SUMMARY

The Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a symbol that resembles a stylized human figure with outstretched arms.

Public Health Service

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

December 27, 2013

Experien Group, LLC C/O Dr. Ms. Lori Adels Regulatory Consultant Stericycle, Incorporated 755 North Mathilda Avenue, Suite 100 SUNNYVALE CA 94085

Re: K132007

Trade/Device Name: Stericycle Sharps Management Service Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 3, 2013 Received: December 4, 2013

Dear Dr Adels:

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 - Dr. Adels

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/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/ReportalProblem/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/7/Picture/7 description: The image shows the words "Kwame O. Ulmer S.A." in a bold, sans-serif font. The letters are arranged in two lines, with "Kwame" on the top line and "Ulmer" on the bottom line. The letters "O" and "S" are slightly smaller than the other letters. The letters "E.U.L.M.E.R.S.A" are stylized with a dotted pattern.

for

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) K132007

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Device Name

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Stericycle Sharps Management Service Reusable Sharps Container

Indications for Use (Describe)

The Stericy . Sharps Management Service Reusable Sharps Container is intentities for the storage and transport for disposal of syringes and other medical sharps waste.

The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:

· 2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color
· 4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color

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

Prescription Use (Part 21 CFR 801 Subpart D)

X 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)

Sreekanth

Gutala -S

Digitally signed by Sreekanth Gutala -S

DN: c=US, o=U.S. Government,

ou=HHS, ou=FDA, ou=People,

0.9.2342.19200300.100.1.1=200054049

cn=Sreekanth Gutala -S

Date: 2013.12.26 14:48:34 -05'00'

FORM FDA 3881 (9/13)	Page 1 of 4	PSC Publishing Services (301) 443-6740 EF
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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).