STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G

K991612 · Sterilogic Waste Systems, Inc. · MMK · May 28, 1999 · General Hospital

Device Facts

• Record ID: K991612
• Device Name: STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
• Applicant: Sterilogic Waste Systems, Inc.
• Product Code: MMK · General Hospital
• Decision Date: May 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

Device Story

SteriSharp 2.5-Gallon RSDC is a reusable sharps disposal container; consists of a plastic mail-drop, torturous path tumbler lid and a rotationally molded linear low-density polyethylene bottom container. Used in healthcare facilities (hospitals, clinics, labs) to safely store sharps waste; container designed to withstand emptying, washing, and disinfecting for reuse. Device provides a secure, leak-proof environment for sharps; prevents dispersal of contents during transport. Healthcare providers insert sharps through the lid; container is periodically emptied and cleaned by facility staff. Benefits include safe containment of infectious waste and reusability.

Clinical Evidence

Bench testing only. Device passed puncture resistance (Health Devices 22), vibration testing (49 CFR 178.608), free fall drop testing (49 CFR 178.603), stacking tests (49 CFR 178.606), and penetration testing (49 CFR 178.609(h)(1)).

Technological Characteristics

Material: Linear low-density polyethylene (0.125" thickness). Construction: Rotationally molded. Design: Two-component system (mail-drop torturous path tumbler lid and container base). Dimensions: 2.5-gallon capacity. Compliance: Meets 49 CFR Sections 178.603, 173.4465(d), 173.465(e), and 178.608 for transport and reuse. Sterilization: Designed for washing and disinfecting.

Indications for Use

Indicated for use by healthcare providers in hospitals, laboratories, medical clinics, and veterinary clinics to safely contain needles, sharps waste, and infectious waste prior to disposal.

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

• Graphics Controls - Point-of-Use II Sharps-A-Gator Mail-Drop Torturous Path Tumbler Lid (K964387)
• Rotonics Manufacturing, Inc. (RMI) Rotationally Molded Plastic Reusable Sharps Container (K964026)

Submission Summary (Full Text)

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MAY 28 1900

0

Tel [phone]
Fax [phone]
Post Office Box 84
Kempton, PA 19529,
Toll Free 888.756.3003 www.sterilogic.com

99116.12

STERILOGIC
WASTE SYSTEMS INC

## 510(k) SUMMARY

807.92(1)

COMPANY NAME:

COMPANY ADDRESS:

TELEPHONE: FAX:

[phone] [phone]

CONTACT PERSON: CALVIN A. ODHNER, V.P.

SUMMARY PREPARATION DATE: May 6, 1999

807.92(2)

STERISHARP™ 2.5-GALLON RSDC TRADE OR PROPRIETARY NAME:

REUSABLE SHARPS DISPOSAL CONTAINER COMMON NAME:

CLASSIFICATION:

807.92(3)

EQUIVALENT DEVICE (A):

GRAPHICS CONTROLS - POINT-OF-USE II SHARPS-A-GATOR MAIL-DROP TORTUROUS PATH TUMBLER LID (510[k] #K964387)

CLASS II -- ACCESSORY DEVICE

STERILOGIC WASTE SYSTEMS, INC.

KEMPTON, PA 19529-0084

9948 KISTLER VALLEY ROAD, SUITE 102

EQUIVALENT DEVICE (B):

ROTONICS MANUFACTURING, INC. (RMI) ROTATIONALLY MOLDED PLASTIC REUSABLE SHARPS CONTAINER (510[k] #K964026)

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### 807.92(4) DESCRIPTION:

REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned.

# 807.92(5)

INTENDED USE:

Reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

#### 807.92(6) LID:

The Graphics Controls' lid will be used on the top of the container. This lid is approved in 510(k) #K964387.

The bottom portion of the unit has the same technological characteristics and a CONTAINER: similar design to the Rotonics Manufacturing Sharps Plus 5-Gallon Reusable Sharps Container, being made of the same process, material, densities and thickness. The only comparable changes are (1) the size of the container (reduced from 5 gallons to 2.5 gallons) and (2) the lid receiving channel, which was increased from 5/16" to 9/16" to accommodate the slightly larger rim that is present on the Graphic Controls lid.

> The container is made from linear low-density polyethylene with a thickness of 0.125", rotationally molded (by building up layers of plastic).

The SteriSharp™ 2.5 Gallon RSDC meets and exceeds the primary design 807.92(6)(b) characteristics needed to comply with the OSHA Bloodborne Pathogens Standard. Data for the following tests have been provided and are as follows:

| Puncture | Health Devices 22 | Needle penetration force | Pass |
|----------------|----------------------|--------------------------|------|
| Vibration | 49 CFR 178.608 | 1 hour repetitive bounce | Pass |
| Free Fall Drop | 49 CFR 178.603 | -18° C 5 drops 1.2 meter | Pass |
| Stacking | 49 CFR 178.606 | 24 hrs. under 30 kg | Pass |
| Penetration | 49 CFR 178.609(h)(1) | 7 kg steel rod - 1 meter | Pass |

"The package, as submitted and tested, visually appears to satisfy the test criteria and be capable of preventing the loss or dispersal of the contents for conditions normal to transport." (Container Testing Laboratory, Inc.)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1999

Mr. Calvin A. Odhner Vice President Sterilogic Waste Systems, Incorporated 9948 Kistler Valley Road, Suite 102 PO Box 84 Kempton, Pennsylvania 19529

Re : K991612 Trade Name: SteriSharp™ 2.5 Gallon RSDC, Model #RSDC2.5G Regulatory Class: II Product Code: MMK Dated: May 6, 1999 Received: May 10, 1999

Dear Mr. Odhner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Odhner

this response to your premarket notification Please note: r submission does not affect any obligation you might have under Submitblor. acob ough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborizone in formalence of your device to a legally rinding of bubbeandad on results in a classification for your markets produce, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): K 991612 Device Name: STECLSHARP™ 2.5 GALLEN

Indications For Use:

The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.1(19) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital ኝ 1 በሀk) Number