ENVIRO SHARP SOLUTIONS 3

K083511 · Industrial Water Solutions, Inc. · MMK · Mar 3, 2009 · General Hospital

Device Facts

• Record ID: K083511
• Device Name: ENVIRO SHARP SOLUTIONS 3
• Applicant: Industrial Water Solutions, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Mar 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Enviro Sharp Solutions 3 reusable container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles, sharps waste and other infectious waste are generated. The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and materials as to withstand emptying, unloading washing and disinfecting for reuse according to 49 CFR 178.603, 173.44655(d), 173465(e) and 178.608.

Device Story

Enviro Sharp Solutions 3 is a reusable plastic sharps disposal container; features mail-drop, torturous path tumbler lid for horizontal syringe disposal. Syringes deposit automatically into container; tumbler indicates when full. Once full, locking tabs secure container for transport. Sci-Med Waste employees empty, sanitize, and return unit to facility. Used in healthcare settings (hospitals, clinics, labs) by healthcare providers. Durable high-density polyethylene (HDPE) construction ensures leakproof, puncture-resistant, and stable performance. Reusable design offers environmentally friendly, cost-effective alternative to disposable containers. Meets OSHA Bloodborne Pathogens Standard requirements.

Clinical Evidence

Bench testing only. Simulated life-use testing (emptying, filling, washing, sanitizing) performed over two days showed no visible signs of failure. Device passed puncture resistance (Health Devices 22), leak resistance (24-hour water test), vibration (1-hour repetition bounce), free fall drop (5 drops at 3.9 feet), and stacking (24 hours under 65 lbs) tests per 49 CFR standards.

Technological Characteristics

Reusable sharps container; high-density polyethylene (HDPE) construction; wall thickness 0.125" ± 0.002". Features mail-drop, torturous path tumbler lid. Mechanical operation; no energy source. Complies with 49 CFR 178.603, 173.44655(d), 173.465(e), 178.608, and OSHA Bloodborne Pathogens Standard.

Indications for Use

Indicated for healthcare providers in hospitals, laboratories, medical clinics, and veterinary clinics to safely contain sharps waste, including needles, prior to removal, transport, and 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

• Bemis Sharp Sentinal (K953797)
• SteriSharp 3 Gallon RSDC (K020664)

Submission Summary (Full Text)

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## FDA 510(k) Premarket Notification

K083SII

Industrial Water Solutions, Inc. October 28, 2008

### 807.92(a)(1)

:

1.0.00

COMPANY NAME:

COMPANY ADDRESS:

TELEPHONE NUMBER: FACSIMILE NUMBER:

CONTACT PERSON:

SUMMARY PREPARATION DATE:

807.92(a)(2)

TRADE or PROPRIET ARY NAME:

COMMON NAME:

CLASSIFICATION:

807.92(a)(3)

EQUIVALENT DEVICE #1:

CONTAINER LID:

EQUIVALENT IDEVICE #2:

CONTAINER BASE:

#### 807.92(a)(4)

DESCRIPTION:

510(k) SUMMARY

Industriul Willer Solinions, Inc.

2692 Willowlawn Street Rounoke, Virginia 24018

340/772-0599 540/772-7944

Thomas P. Stewart

November 24, 2008

Enviro Sharp Solutions 3

Reusable Sharps Disposal Container

Class II - Accessory Device

Bernis Sharp Schringlos

The Bornis Sharp Sentinal@ container lid ("lid") is used on the top of the Enviro Sharp Solutions 3 container. This Remis Sharp Sentinato container lid has been upproved under 510(k) #K953797.

SteriSharp™ 3 Gallon RSDC (510(k) #K020664

The bottom portion of the unit (the "comminer") is a rensable polychylene cavity with a wall thickness of 0.125" ± 0.002" similar to that of the StoriSharp™ 3. "The SteriSharp™ 3 comainer has been approvod under 510(k) #K020664

The Eaviro Sharp Solutions 3 is a reusable plustic sharps disposal compiner. Il icatures a mail drop, torturous path tumbler lid for Rale and casy disposal of sharps. Simply deposit syringes horizomally into the opening of the lid, and they are deposited automatically into the container. When the container is full, the tumbler will indicate that it is time to replace the unit. Just insert the locking tobs to secure the container in a closed position and replace it with a clean samilized unit. Using our proprietary equipment, Sci-Med Waste comployees will empry and sanitize the unit and relum it to the facility to use for the next switch out. The durable highdensity polychylone construction of the Enviro Sharp Solutions 3 makes it loakproof, puncture resistant and sinble. It meets or oxcocds all OSTIA recommendations for sharps containers, and because it is rewaible, it is more crivironmentully friendly and less expensive than disposable alternatives.

A label will be attached in the outside of the container specifying the intended use of the container. A sample of this lubel is attached at the end of this document. (Sec Attachment 1)

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## 807.92(n)(5)

INTENDED USE:

The Haviro Sharp Solutions 3 reusable container is intended for use by healthcare providers, such as hospitals, luboratories, medical clinics, versinary clinics und other facilities where needles, sharps waste und other infectious waste are generated. The containers are designed to suffely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and materials as to withstand craptying, unloading washing and disinfecting for reuse according to 49 CFR 55 178,603, 173,44655(d), 173465(e) and 178.608.

## 807.92(a)(6)

The Enviro Sharp Shiple on Inchiner is substantially equivalent to the SteriSharp™ 3, and west the Benting Nectination (510k)/K953797 lid that is a Remi-transpirent nuil drop, 10/voronylene muil drop, 10/0rous path tunbler lid. It is injection molded and varies in thickness from 0.0.5" to 0.07". The base vontainer is similar in design and ergonomic characteriales to the SteriShurp™ 3. While the base of the Starish is manufactured using polypropying, the Enviro Sharines is unit is manufactured viri a thicker wall (0.125" ±0,002" as compared to 0.06" ±0.01") and stronger polymer (HDPE) to help contier reusable qualities.

| COMPARISON TABLE (IIJ) | BEMIS SHARP SENTINAL® | NAME OF YOUR CONTAINER |
|------------------------|----------------------------|------------------------|
| Indications for use | Healthcare Sharps | Same |
| Target population | Healthcare Professionals | Same |
| Design | Torturous path, mail-drop | Same |
| Materials | Polypropylene | Same |
| Performance | Multiple Use | Same |
| Mechanical safety | Mail-drop | Same |
| Where used | Healthcare facilities/labs | Same |
| Standards met | 49 CFR/HD 22 (multi-use) | Same |

The Laviro Shap Solidions 3 reusable contuner is also submantially equivelent to the Steckliner They are Inch a combination of a polypropylane turnhir lid with upolyedrylone hase. The SteriShap™ 3 base is a road continuel motion lower under liner low dersity Polyethylone cavity, while the Enviro Sharp Solutions 3 is a roll, injection nolded high density.

| COMPARISON TABLE (container) | SteriSharp™ 3 | NAME OF YOUR CONTAINER |
|------------------------------|----------------------------|------------------------|
| Indications for use | Healthcare Sharps | Same |
| Target population | Healthcare Professionals | Same |
| Design | Injection mold tapered | Same |
| Materials | HDPE | Same |
| Performance | Multiple Use | Same |
| Where used | Healthcare facilities/labs | Same |
| Standards met | 49 CFR/HD 22 | Same |

#### 807.92(b)(1)

Over a two-day poriod from November 5, 2008 to November 5, 2008, all components of a randon sampling of the Enviro Sharp Solutions 3 container were subjected to a simulated life-use of elming, filling, depositing waste, one in an one in an onlying washing and subtizing. After simulated use, there were no visible signs of Inilure. Containces tested and passed (Scc helow )

# 807.92(b)(2) and (3)

The Enviro Sharp Solutions 3 meets und exceeds the primary design churacteristics neceded to comply with the OSILA Blood borno Pathogens Standard. Date for the following tests have been provided and are as follows:

| Puncture | Health Devices 22 | Needle penetration force | Pass |
|-----------------|-------------------|----------------------------|------|
| Leak Resistance | Health Devices 22 | 24 Hours filled with water | Pass |
| Vibration | 49 CFR 178.608 | 1 hour repetition bounce | Pass |
| Free Fall Drop | 49 CFR 178.603 | 5 drops 3.9 feet | Pass |
| Stacking | 49 CFR 178.606 | 24 hours under 65 lbs | Pass |

"The package, us submitted und tested, visually appents to satisfy the test critchi und is capable of preventing the loss or Ilspersal of the contents for continues normal to transport" (Container Testing Laboratory, Inc.) (See Attischnered 2)

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its wings are angled upwards. The text is in all capital letters and is evenly spaced around the circle.

6 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Stewart Industrial Water Solutions, Incorporated 2692 Willowlawn Street Roanoke, Virginia 24018

Re: K083511

> Trade/Device Name: Enviro Sharp Solution 3 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: January 15, 2009 Received: February 11, 2009

Dear Mr. Stewart:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Stewart

Please be advised that FDA's issuance of a substantial equivalence determination does not rnean 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact: CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Austin for

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K08351)

Device Name: Enviro Sharp Solutions 3

Indication For Use:

The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety

Division Sign-Off Office of In Vitro Diagnostic Device

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083511

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