STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU

K132007 · Stericycle, Inc. · MMK · Dec 27, 2013 · General Hospital

Device Facts

• Record ID: K132007
• Device Name: STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
• Applicant: Stericycle, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Dec 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

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

Device Story

Single-piece, reusable sharps container; injection-molded polypropylene copolymer; 2-gallon and 4-gallon sizes. Used in health care facilities for disposal of syringes and medical sharps. Features gravity-activated, counterbalanced lid design; acts as protective barrier preventing sharps retrieval or accidental contact. Container is puncture-resistant, leakproof, and impact-resistant. Used by healthcare staff to safely contain sharps waste for transport and subsequent disinfection by Stericycle. Benefits include safe containment of hazardous waste, preventing needlestick injuries during disposal and transport.

Clinical Evidence

Bench testing only. Evaluated for vibration resistance (ISTA 3E, 49 CFR 178.608), impact resistance (4 ft drop test, 49 CFR 178.603), leak resistance (24-hour liquid retention), needle puncture resistance (ASTM F2132-01:2008), stacking resistance (49 CFR 178.606), and topple resistance (AS/NZS 4261:1994). All tests passed.

Technological Characteristics

Material: Polypropylene copolymer (0.125" nominal thickness). Design: Single-piece, reusable, gravity-activated counterbalanced lid. Dimensions: 2-gallon (12.3" x 6.9" x 13.9") and 4-gallon (12.3" x 6.9" x 21.9"). Standards: ASTM F2132-01:2008 (puncture resistance), 49 CFR 173.197 (DOT), 29 CFR 1910.1030 (OSHA). Sterilization: Disinfected by provider prior to reuse.

Indications for Use

Indicated for storage and transport for disposal of syringes and other medical sharps waste in health care facilities.

Regulatory Classification

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.

Predicate Devices

• Daniels Sharpsmart™ reusable sharps container (K001337)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

## Contact Person:

Lori Adels, PhD Regulatory Consultant Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: [phone] Fax: [phone]

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

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.

## 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

:

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## 510(k) Summary

| Feature | Stericycle Sharps Management<br>Service Reusable Sharps Container | Daniels Sharpsmarttm<br>reusable sharps container |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K132007 | K001337 |
| Indications for Use | Stericycle Sharps Management Service<br>Reusable Sharps Container is intended<br>for use in health care facilities for the<br>storage and transport for disposal of<br>syringes and other medical sharps waste. | Reusable containers intended to be<br>used for the disposal of<br>contaminated medical sharps in<br>health care facilities. |
| Classification/<br>Product Code | MMK | MMK |
| Regulation Number | 21 CFR§880.5570,<br>Hypodermic single lumen needle | 21 CFR§880.5570,<br>Hypodermic single lumen needle |
| Container<br>Material | Polypropylene copolymer | Polypropylene copolymer |
| Material Thickness | 0.125" (nominal) | Not available |
| Volume<br>(Fill Capacity) | 2 gallons<br>4 gallons | S14: 7.0 quarts (1.8 gallons)<br>S22: 15.5 quarts (3.9 gallons)<br>S32: 25.0 quarts (6.3 gallons) |
| Dimensions<br>(L x W x H) | 2 Gallon: 12.3" x 6.9" x 13.9"<br>4 Gallon: 12.3" x 6.9" x 21.9" | S14: 13.5" x 6.6" x 11.0"<br>S22: 13.5" x 6.6" x 17.3" |
| Intended Location<br>of Use | Health care facilities | Health care facilities |
| Biohazard Waning<br>Label | Labeled as Biohazard in Fluorescent<br>orange or orange-red with lettering in<br>contrasting color | Labeled as Biohazard in Fluorescent<br>orange or orange-red with lettering<br>in contrasting color |
| Sharps access and<br>closure | Gravity-activated | Gravity-activated |
| Closable | Yes | Yes |
| Puncture Resistant | Yes [Test method: ASTM F2132-01<br>(2008)] | Information not available. |
| Leakproof on Sides<br>and Bottom | Yes | Yes |
| Impact Resistant | Yes | Yes |
| Vibration Resistant | Yes | Yes |
| Stacking Resistant | Yes | Yes |
| Capable of<br>maintaining stable,<br>upright position | Yes | Yes |
| No feature to bend,<br>break, or shear<br>needles | No feature | No feature |
| Unwinders | No feature that would recap, remove, or<br>unwind needle of the hub. | No feature that would recap, remove,<br>or unwind needle of the hub. |
| Reusable or<br>Non-reusable | Reusable | Reusable |
| Feature | Stericycle Sharps Management<br>Service Reusable Sharps Container | Daniels Sharpsmart™<br>reusable sharps container |
| Performance<br>Standards | • American Society for Testing and<br>Materials (ASTM) Consensus<br>Standards for Puncture Resistance<br>(ASTM F2132-01:2008) | • Australian/New Zealand Standard<br>for Reusable containers for<br>collection of sharp items<br>(AS/NZS 4261:1994) |
| | • Australian/New Zealand Standard for<br>Reusable containers for collection of<br>sharp items (AS/NZS 4261:1994) | • Department of Transportation<br>(DOT) regulations<br>(49 CFR 173.197) |
| | • Department of Transportation (DOT)<br>regulations (49 CFR 173.197) | • Occupational Safety and Health<br>Administration (OSHA)<br>bloodborne pathogen standards<br>(29 CFR 1910.1030) |
| | • Occupational Safety and Health<br>Administration (OSHA) bloodborne<br>pathogen standards (29 CFR<br>1910.1030) | (29 CFR 1910.1030) |
| Features for safe | • Secure closure and puncture resistance | • Secure closure and puncture |
| transport and<br>re-use | for transport<br>• Container is permanently marked for<br>reuse | resistance for transport<br>• Container is permanently marked<br>for reuse |
| | • Container is disinfected by Stericycle<br>prior to reuse | • Container is disinfected prior to<br>reuse |
| | • Container volume is between 2 and<br>40 gallons in volume (49 CFR<br>173.197) | • Container volume is between 2 and<br>40 gallons in volume (49 CFR<br>173.197) |

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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<br>(each test performed on both<br>2- and 4-gallon Container<br>sizes) | Test Standard / Description | Result |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Life-cycle testing | Subsequent to conditioning of units representative of reprocessing and<br>transport of the 2- and 4-gallon Reusable Sharps Containers, the units<br>were tested and evaluated for the following parameters: | |
| • Vibration Resistance | ISTA 3E | Pass |
| • Impact Resistance | The filled container maintains its integrity<br>when dropped 4 ft. to a concrete surface and<br>retains its solid contents. | Pass |
| • Leak Resistance | The container loses no liquid over a 24-hour<br>period. | 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 [phone] or [phone] 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 [phone] or [phone] 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

・

#### 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'

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