OAK RIDGE PRODUCTS SHARP CONTAINER

K130281 · Oak Ridge Products, LLC · MMK · Jun 21, 2013 · General Hospital

Device Facts

• Record ID: K130281
• Device Name: OAK RIDGE PRODUCTS SHARP CONTAINER
• Applicant: Oak Ridge Products, LLC
• Product Code: MMK · General Hospital
• Decision Date: Jun 21, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is for trained healthcare professionals. The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device. The 5.4 quart is intended to be used with an appropriate mounting device. The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

Device Story

Injection-molded polypropylene sharps containers; single-use; non-sterile; nestable design for storage efficiency. Available in 1 quart, 5.4 quart, and 2 gallon sizes. Features include puncture-resistant walls, leak-resistant bottoms/sides, and locking mechanisms (slide or rotating door) to secure contents. Used in healthcare facilities by trained professionals for safe disposal of hazardous sharps. Visual determination of fill level via translucent material or fill lines. Some models require wall-mounting brackets or cabinets. Benefits include containment of hazardous waste, reduction of sharps injury risk, and compliance with OSHA 1910.1030.

Clinical Evidence

Bench testing only. Compliance demonstrated with ASTM F2132-01 (puncture resistance), ISO 23907:2012 (sharps injury protection, stability, impact resistance, closure, and aerosolization), and OSHA 29 CFR 1910.1030 (leak resistance).

Technological Characteristics

Injection-molded polypropylene; nestable design; non-sterile; manual operation (slide or rotating door); wall-mountable or free-standing; translucent components for fill-level monitoring. Complies with ASTM F2132-01 and ISO 23907.

Indications for Use

Indicated for trained healthcare professionals for the safe disposal of hazardous sharps including hypodermic needles, syringes, lancets, and blood needles in healthcare 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

• B-D Guardian™ Nestable Sharps Collectors (K943575)
• Multi-purpose Sharps Container (K943659)
• SharpSafety™ Phlebotomy Containers (K943660)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '1', '3', '0', 'Z', '8', and '1'. The characters are written in a simple, handwritten style.

Image /page/0/Picture/1 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

JUN 2 1 2013

# 510(k) Summary

Summary Preparation Date: May 15th, 2013

1. Submitted By

(Primary)

2. Contact Information

Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA Establishment Registration #:1419823

Tibor B. Kovari Quality Assurance Manager Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA

[phone]

Contact Information (Secondary)

3. Device identification:

Trade Name: Common Name: Product Code: Classification: CFR Reference: Classification Panel: Conor J. O'Malley Owner Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA [e-mail] [phone]

[e-mail]

Oak Ridge Products Sharps Containers Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880 5570 - Class II General Hospital

Oak Ridge Products Sharps Containers

Revision 5

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Image /page/1/Picture/0 description: The image shows the logo for Oakridge Products. The text "OAKRIDGE" is in large, bold, black letters. Below that, the text "PRODUCTS" is in smaller, bold, black letters. There is a black swoosh above the text.

#### 4. Predicate devices:

Trade Name: Common Name: Product Code: Classification: CFR Reference: Classification Panel: B-D Guardian™ Nestable Sharps Collectors Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880.5570 - Class II General Hospital

| Company | Product | 510(k)# |
|-------------------------------------------------------------------------------|------------------------------------------------|---------|
| Becton Dickinson | B-D Guardian™<br>Nestable Sharps<br>Collectors | K943575 |
| Covidien (originally cleared<br>under Sage Products now<br>owned by Covidien) | Multi-purpose Sharps<br>Container | K943659 |
| Covidien (originally cleared<br>under Sage Products now<br>owned by Covidien) | SharpSafety TM<br>Phlebotomy Containers | K943660 |

# Legally Marketed Equivalent Devices:

# 5. Product Description:

The Oak Ridge Products Sharps Containers are an injection molded polypropylene plastic designed for a single-use. The containers are puncture resistant, leak resistant on the sides and bottom, closable and stable. The products have engraved maximum fill lines on the containers and instructions for locking the container closed. Labels are white with black text and a black bio-hazard symbol printed on an orange-red background. Labels are adhered to the containers at the time of manufacture with the fill line warning matching the engraved fill line on the container.

The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.

#### Oak Ridge Products Sharps Containers

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Image /page/2/Picture/0 description: The image shows the logo for OakRidge Products. The logo has the word "OAKRIDGE" in large, bold, black letters. Below that is the word "PRODUCTS" in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

#### General Specifications Table

| Part<br>Number | Product<br>Description | Access<br>opening<br>size | Access<br>opening<br>and<br>Closure | Overall Size<br>L x W x H<br>(inches) | Weight<br>(grams) | Capacity<br>at full<br>line |
|----------------|---------------------------------|---------------------------|-------------------------------------|---------------------------------------|-------------------|-----------------------------|
| 0310-<br>1500 | 1 Quart<br>Phlebotomy<br>RED | 2.0" x<br>1.5" | Slide | 4.5x4.5x7.5 | 115<br>grams | .8 quarts |
| 0354-<br>1100 | 5.4 quart<br>Universal<br>Clear | 8" x 1.4" | Rotating<br>Door | 11x4.5x10.5 | 340<br>grams | 4.3<br>quarts |
| 0354-<br>1500 | 5.4 quart<br>Universal<br>RED | 8" x 1.4" | Rotating<br>Door | 11x4.5x10.5 | 340<br>grams | 4.3<br>quarts |
| 0320-<br>1500 | 2 Gallon<br>Nestable<br>RED | 5.6" x<br>2.3" | Slide | 10.3x7x710.1 | 363<br>grams | 7.2<br>quarts |

#### Accessories

Oak Ridge Products offers a mountable locking bracket for the 1 quart Phlebotomy container. Oak Ridge Products part number #1010-9904.

Oak Ridge Products also offers several wall mountable locking accessories for the 5.4 quart container.

| Manufacture | Part Number |
|--------------------|---------------------------------------------------------------|
| Oak Ridge Products | "Press and Click" Locking Wall Bracket<br>with Key #1054-1300 |
| Oak Ridge Products | "Swing Arm" Locking Wall Bracket #1054-<br>7300 |
| Oak Ridge Products | Locking Wall Cabinet #1054-5300 |

All of the Oak Ridge Products Sharps Containers conform to the recognized standard ASTM F2132-01(2008) for needle puncture resistance. These also meet or exceed the OSHA 1910.1030 recommendations for sharps containers.

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Image /page/3/Picture/0 description: The image shows the logo for Oakridge Products. The logo features the word "OAKRIDGE" in a bold, sans-serif font, with the word "PRODUCTS" in a smaller font underneath. A curved line extends from the left side of the word "OAKRIDGE" and arches over the top of the word.

### 6. Indications for Use:

| Part<br>Number | Product<br>Description | Access<br>opening<br>size | Access<br>opening<br>and<br>Closure | Length<br>(in) | Width<br>(in) | Height<br>(in) | Mounting |
|----------------|------------------------------|---------------------------|-------------------------------------|----------------|---------------|----------------|---------------------|
| 0310-<br>1500 | 1 Quart<br>Phlebotomy RED | 2.0" x 1.5" | Slide | 4.5" | 4.5" | 7.5" | Bracket required |
| 0354-<br>1100 | 5.4 quart<br>Universal Clear | 8" x 1.4" | Rotating<br>Door | 11" | 4.5" | 10.5" | Bracket<br>required |
| 0354-<br>1500 | 5.4 quart<br>Universal RED | 8" x 1.4" | Rotating<br>Door | 11" | 4.5" | 10.5" | Bracket<br>required |
| 0320-<br>1500 | 2 Gallon<br>Nestable RED | 5.6" x 2.3" | Slide | 10.3" | 7.0" | 10.1" | Free Standing |

Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is for trained healthcare professionals.

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

#### 7. Comparison to Predicate Devices:

| Manufacturer | Oak Ridge Products | Becton Dickson® | Covidien® | Covidien® |
|--------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Trade Name | Oak Ridge Products<br>Sharps Containers | B-D.Guardian™ Nestable<br>Sharps Collectors | SharpsSafety<br>'PHLEBOTOMY<br>SHARPS<br>DISPOSAL<br>CONTAINERS' | Multi-purpose<br>Sharps<br>Container<br>'ANCILLARY<br>AND LARGE<br>VOLUME<br>SHARPS<br>DISPOSAL<br>CONTAINERS' |
| 510(k) number | K130281 | K943575 | K943660 | K943659 |
| Indication for use | Oak Ridge sharps<br>containers are<br>intended to be used<br>for the safe disposal<br>of hazardous sharps | B-D sharps containers are<br>intended to be used for the<br>safe disposal of hazardous<br>sharps | containers are<br>intended to be used<br>for the safe disposal<br>of hazardous sharps | containers are<br>intended to be<br>used for the safe<br>disposal of<br>hazardous sharps |
| Target Population | Healthcare<br>professional | Healthcare professional | Healthcare<br>professional | Healthcare<br>professional |
| Where used | Healthcare facilities | Healthcare facilities | Healthcare facilities | Healthcare<br>facilities |
| Material | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| Sharps access | Sharps inserted<br>through the top | Sharps inserted through the<br>top | Sharps inserted<br>through the top | Sharps inserted<br>through the top |

Oak Ridge Products Sharps Containers

510(k) Summary Page 4 of 8

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Image /page/4/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above and below the words.

| Manufacturer | Oak Ridge Products | Becton Dickson® | Covidien® | Covidien® |
|------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sharps closure | Closure feature is<br>closed then locked in<br>place for removal | Flaps are closed and locked<br>in place for removal | Closure feature is<br>closed then locked in<br>place for removal | Closure feature is<br>closed then<br>locked in place<br>for removal |
| Impact resistance | Yes | Yes | Yes | Yes |
| Puncture resistance | Yes | Yes | Yes | Yes |
| Leak resistance | Yes | Yes | Yes | Yes |
| Single use | Yes | Yes | Yes | Yes |
| Non-sterile | Yes | Yes | Yes | Yes |
| Capable of<br>maintaining a<br>stable, upright<br>position | Yes | Yes | Yes | Yes |
| No features to<br>bend, break, or<br>shear needle. | No Feature Present | No Feature Present | No Feature Present | No Feature<br>Present |
| Reusable Sharps<br>Containers | Same | Labeling is "Single Use<br>Only" | Labeling is "Single<br>Use Only" | Labeling is<br>"Single Use<br>Only" |
| Overfill Indication | Same | "Do Not Overfill" or "Fill<br>to this Level Only" is<br>Labeled or embossed on the<br>container at the location of<br>the overfill. Labeling<br>includes a "Fill Line". | "Do Not Overfill" or<br>"Fill to this Level<br>Only" is Labeled or<br>embossed on the<br>container at the<br>location of the<br>overfill. Labeling<br>includes a "Fill<br>Line". | "Do Not Overfill"<br>or "Fill to this<br>Level Only" is<br>Labeled or<br>embossed on the<br>container at the<br>location of the<br>overfill. Labeling<br>includes a "Fill<br>Line". |
| Clarity | Same | Each Collector has a<br>minimum of one<br>translucent component.<br>either base or top. | Each Collector has a<br>minimum of one<br>translucent<br>component, either<br>base or top. | Each Collector<br>has a minimum of<br>one translucent<br>component. either<br>base or top. |
| Construction | Same | Injection Molded<br>Containers. Lids and<br>Closure | Injection Molded<br>Containers. Lids and<br>Closure | Injection Molded<br>Containers. Lids<br>and Closure |

# 8. Substantial Equivalence Discussion of Similarities and Differences:

The Oak Ridge Products Sharps Containers are similar to the B-D Guardian™ Nestable Sharps containers in:

- . Intended use
- Target population .
- Materials .
- Design .
- Performance testing .

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Image /page/5/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

#### 9. Intended use comparison:

The intended use of the new Oak Ridge Products Sharps Containers is the same as the predicate device. Oak Ridge Products Sharp Containers are containers intended for the disposal of contaminated medical waste in a healthcare facility.

# 10. Design and Material Comparison:

The design and functional characteristics of the Oak Ridge Products Sharps Containers and the predicate devices are similar. The Oak Ridge Products Sharps Containers parts are nestable and when assembled form a single unit. These units have features to prevent contact between user and the contents and are designed for a visual determination of the maximum capacity. None of the devices have features that bend, break, or shear needles. The devices are designed for a single use by a locking feature in the lids and closure or access door.

They are constructed of polymeric materials which is injection molded. The Oak Ridge Products Sharps Containers are constructed of only polypropylene. Oak Ridge Products Sharps Containers are either natural (uncolored) or colored red with translucent lids that allow for a visual determination of content level.

# 11. Summary of Non-Clinical Performance Bench Testing:

#### 11.1 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."

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

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Image /page/6/Picture/0 description: The image shows the logo for Oakridge Products. The logo is black and white and features the words "OAKRIDGE" in large, bold letters. Below the main text, the word "PRODUCTS" is written in a smaller font. A curved line extends over the top of the word "OAKRIDGE".

Collectors dated October 1993", was used to identify applicable physical and mechanical features of the Oak Ridge Products and predicate devices.

All applicable standards have been used to show that the Oak Ridge Products Sharps Container Family is substantially equivalent to the appropriately listed predicate device.

The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products devices and the predicate devices. The Oak Ridge Products sharps containers have been tested by appropriate methods with respect to the relevant standards, FDA recognized ASTM standards F 2132-01 and OSHA requlations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the Oak Ridge Products Sharps containers are considered substantially equivalent to its predicate device.

#### 11.2 Performance Testing (Bench) - Product Testing

The Oak Ridge Products Sharps Containers incorporate 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 Based on OSHA Specification 29CFR 1910:1030
Overfill detection and Capacity: - Passed

Needle unwinder and recapper: - Only applicable on 1 quart - Passed

Impact resistance and safe handling - Passed Based on ISO 23907:2012

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Image /page/7/Picture/0 description: The image shows the logo for Oakridge Products. The word "OAKRIDGE" is in large, bold, black letters. Below that, the word "PRODUCTS" is in smaller, black letters. There is a black swoosh above the word "OAKRIDGE".

Sharps access, closure and minimization of aerosolization : - Passed Based on ISO 23907:2012

Stability: - Passed Based on ISO 23907:2012

Mounting Brackets usability and stability: - Passed Based on ISO 23907:2012

#### 11.3 Performance test summary:

The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products devices and the predicate devices. The Oak Ridge Products sharps containers have been tested by appropriate methods with respect to the relevant standards, FDA recognized ASTM standards F 2132-01, OSHA regulations 29 CFR Part 1910:1030 and ISO 23907:2012(e). No new issues of safety and effectiveness were raised with the testing performed, and the Oak Ridge Products Sharps containers are considered substantially equivalent to its predicate device.

#### 12. Conclusion:

The Oak Ridge Products Sharps Containers introduces no new questions concerning the safety or effectiveness and proves to be substantially equivalent to the respective predicate sharps collectors.

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

-BD® is a registered trademark of Becton, Dickinson and Company.

-SharpSafety™ is a trademark of the Covidien Company

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 21, 2013

Oak Ridge Products, Limited Liability Company C/O Mark Job Regulatory Technology Services Limited Liability Company 1394 25th Street, N.W. BUFFALO MN 55313

Re: K130281

Trade/Device Name: Oak Ridge Products Sharps Containers Regulation Number: 21 CFR 880.5570 Regulation Name: Accessory to hypodermic single lumen Regulatory Class: Class II Product Code: MMK Dated: June 13, 2013 Received: June 14, 2013

Dear Mr. Job:

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. Job

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 toll-free 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runner
DOSINA Mary S.
Runner -S

Kwame Ulmer M.S. Acting Division 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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Image /page/10/Picture/0 description: The image shows the logo for Oakridge Products. The logo features the words "OAKRIDGE" in large, bold, sans-serif font, with the word "PRODUCTS" in a smaller font size underneath. There is a decorative oval shape above the word "OAKRIDGE".

#### Traditional 510(k) submission

#### Section 4

#### Indications for Use

510(k) Number (if known): K130281

Device Name: Oak Ridge Products Sharps Containers

Model Numbers:

| Part<br>Number | Product<br>Description | Access<br>opening<br>size | Access<br>opening<br>and<br>Closure | Length<br>(in) | Width<br>(in) | Height(in) | Mounting |
|----------------|------------------------------|---------------------------|-------------------------------------|----------------|---------------|------------|---------------------|
| 0310-<br>1500 | 1 Quart<br>Phlebotomy RED | 2.0" x 1.5" | Slide | 4.5" | 4.5" | 7.5" | Bracket<br>required |
| 0354-<br>1100 | 5.4 quart<br>Universal Clear | 8" x 1.4" | Rotating<br>Door | 11" | 4.5" | 10.5" | Bracket<br>Required |
| 0354-<br>1500 | 5.4 quart<br>Universal RED | 8" x 1.4" | Rotating<br>Door | 11" | 4.5" | 10.5" | Bracket<br>Required |
| 0320-<br>1500 | 2 Gallon<br>Nestable RED | 5.6" x 2.3" | Slide | 10.3" | 7.0" | 10.1" | Free<br>Standing |

Indications for Use:

Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

AND/OR

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 ANOTHER PAGE IF NEEDED)

# Concurrence of Capitzation

2013.06.20

Page 1_ of 1

:Division Sion-Ji) ر

Olvision of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number:

Oak Ridge Products Sharps Containers

Revision 5