(115 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and safety features of a sharps container, with no mention of AI or ML technology.
No
The device is a sharps container, intended for the safe disposal of hazardous sharps, not for treating or diagnosing any medical condition.
No
The device is a sharps container, intended for the safe disposal of hazardous sharps, not for diagnosing medical conditions.
No
The device description clearly states it is an injection molded polypropylene plastic container, which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the safe disposal of hazardous sharps. This is a containment and safety function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the container (puncture resistant, leak resistant, etc.) and its function in holding sharps. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies are all related to the physical integrity and functionality of the container for sharps disposal (puncture resistance, leak resistance, impact resistance, etc.). There are no studies related to diagnostic accuracy or analysis of biological materials.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a container for waste disposal, specifically hazardous sharps waste.
N/A
Intended Use / Indications for Use
Oak Ridge Products Sharps containers are a 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 containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.
The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by health care professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration.
The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The health care facility performs the final assembly on-site by snapping the lid to the base.
The Medium capacity container is offered with two different models. The model 0330-150S has a sliding closure which when fully snapped locks the access opening for final disposal. This configuration is intended for OR areas where a large easy access is required for disposal of sharps objects. The model 0330-150M uses a counter balanced door that is suitable for use with unrestricted patient access. Both devices are free standing or can be wall mounted with a locking wall bracket PN 1030-9904.
The Large container lid design allows for use as a conventional sharps container or disposal of larger sharps. This is accomplished by two closures. The lid is design in two regions which are connected by a large flexible hinge. The lid regions and hinge are molded as a single component.
For use as a standard sharps collector: The entire lid is snapped onto the base. The small opening and closure are used. This provides a high capacity sharps collector for small to moderate sized sharps objects. When the container is full the small closure is closed by pressing down on the three snaps marked on the closure. Once snapped the container is ready for disposal.
For use as a large sharps collector: One half of the lid is snapped onto the base, the other half is folded over leaving the large opening. A small strap and hook which is molded as part of the lid is used to keep the large closure in the open position. This allows one half of the lid to act as a large closure, allowing single hand disposal of large sharps objects. The flexible hinge area is covered on the underside of the lid by a guard that prevents sharps objects from penetrating the thinner hinge area of the lid. When the container is full, the strap is released. Both the large half lid and the small closure are snapped closed the container is ready for disposal.
Both the hinge guard and small aperture closer are installed at the time of manufacture and becomes integral to the lid assembly. The fastening method used is permanent and not removable by the user.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the large capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the fill level line on the product identification label. Carrying handles are molded into the upper rim of the container allowing for fingers to be above the fill level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals / healthcare purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing / product testing was performed.
Puncture Resistance, Leak Resistance of bottom and sides, Overfill detection and Capacity, Needle unwinder and recapper, Impact resistance and safe handling, Sharps access, closure and minimization of aerosolization, Stability, Mounting Brackets usability and stability, Handle Strength were tested. All tests passed. The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products Medium and Large device and the predicate device. The Oak Ridge Products Medium and Large Sharps container has 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Oak Ridge Products LLC C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K141759
Trade/Device Name: Oak Ridge Products Multi-Purpose Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Sharps Container Regulatory Class: II Product Code: MMK Dated: October 9, 2014 Received: October 10, 2014
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.
1
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 tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. Below the words "Oak Ridge" is the word "Products" in black. To the right of the words are three green triangles that appear to be mountains.
Section 4 Indications for Use
510(k) Number (if known): K141759
Device Name: Oak Ridge Products Multi-purpose Sharps Containers
Model Numbers:
| Multi-purpose sharps containers | ||||||
|---|---|---|---|---|---|---|
| Oak Ridge | ||||||
| Part | ||||||
| Number | Product | |||||
| Description and | ||||||
| closure type | Access | |||||
| opening size | Overall | |||||
| Size | ||||||
| L x W x H | Weight | |||||
| (grams) | ||||||
| empty | Total | |||||
| Capacity | Capacity at | |||||
| full line | ||||||
| Mounting | ||||||
| 0330-150S | Medium Red | |||||
| Sharps container – | ||||||
| Sliding door | 2.5 x 2.5 | |||||
| inches | 12.5 x 6 x | |||||
| 13.5 | ||||||
| inches | 525 grams | 2.9 gallons | 2.4 gallons | |||
| Free | ||||||
| Standing | ||||||
| or Bracket | ||||||
| 0330-150M | Medium Red | |||||
| Sharps container– | ||||||
| Counter balanced | ||||||
| door | 8.5 x 1.75 | |||||
| inches | 12.5 x 6 x | |||||
| 16.0 | ||||||
| inches | 586 grams | 2.9 gallons | 2.4 gallons | |||
| Free | ||||||
| Standing | ||||||
| or Bracket | ||||||
| 0370-1500 | Large Red Sharps | |||||
| container – with | ||||||
| two hinged doors | 13.75 x 4.75 | |||||
| inches (Major) | ||||||
| 8.75 x 1.75 | ||||||
| inches (Minor) | 15.5 x 12 | |||||
| x 13.75 | ||||||
| inches | 1228 grams | 7.6 gallons | 6.1 gallons | |||
| Free | ||||||
| Standing |
Indications for Use:
Oak Ridge Products Sharps containers are a 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 containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.
The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Oak Ridge Products Sharps Containers
3
Image /page/3/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. Underneath the words "Oak Ridge" is the word "Products" in black. To the right of the words "Oak Ridge" are two green triangles that look like mountains.
510(k) Summary
Summary Preparation Date: October 6th, 2014
- Oak Ridge Products L.L.C. 1. Submitted By 4612 Century Court McHenry, Illinois, 60050 USA Establishment Registration #:1419823 Tibor B. Kovari 2. Contact Information Quality Assurance Manager (Primary) Oak Ridge Products L.L.C. 4612 Century Court McHenry, Illinois, 60050 USA (815) 363-4700 tkovari@oakridgeproducts.com
Conor J. O'Malley Contact Information Owner (Secondary) Oak Ridge Products L.L.C. 4612 Century Court
3. Device identification:
Trade Name:
- Common Name: Product Code: Classification: CFR Reference: Classification Panel:
4. Predicate devices:
Trade Name: Common Name: Product Code: Classification: CFR Reference: Classification Panel: Oak Ridge Products Multi-purpose Sharps Container Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880.5570 - Class II General Hospital
McHenry, Illinois, 60050 USA comalley@oakridgeproducts.com
(815) 363-4700
Oak Ridge Products - Sharps Container Sharps Container MMK Accessory to hypodermic single lumen needles 21 CFR 880.5570 - Class II General Hospital
Legally Marketed Equivalent Device:
| Company | Product | 510(k)# |
|---|---|---|
| Oak Ridge Products | 1 quart Phlebotomy | |
| Sharps Container | K130281 | |
| Oak Ridge Products | 2 Gallon Sharps Container | K130281 |
4
Image /page/4/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. The word "Products" is in a smaller font below the words "Oak Ridge". To the right of the word "Ridge" are two green triangles that resemble mountains.
5. Product Description:
The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by health care professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration.
The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The health care facility performs the final assembly on-site by snapping the lid to the base.
| Multi-purpose sharps containers | |||||||
|---|---|---|---|---|---|---|---|
| Oak Ridge | |||||||
| Part | |||||||
| Number | Product | ||||||
| Description and | |||||||
| closure type | Access | ||||||
| opening size | Overall | ||||||
| Size | |||||||
| L x W x H | Weight | ||||||
| (grams) | |||||||
| empty | Total | ||||||
| Capacity | Capacity at | ||||||
| full line | Mounting | ||||||
| 0330-150S | Medium Red | ||||||
| Sharps container – | |||||||
| Sliding door | 2.5 x 2.5 | ||||||
| inches | 12.5 x 6 x | ||||||
| 13.5 | |||||||
| inches | 525 grams | 2.9 gallons | 2.4 gallons | Free | |||
| Standing | |||||||
| or Bracket | |||||||
| 0330-150M | Medium Red | ||||||
| Sharps container– | |||||||
| Counter balanced | |||||||
| door | 8.5 x 1.75 | ||||||
| inches | 12.5 x 6 x | ||||||
| 16.0 | |||||||
| inches | 586 grams | 2.9 gallons | 2.4 gallons | Free | |||
| Standing | |||||||
| or Bracket | |||||||
| 0370-1500 | Large Red Sharps | ||||||
| container – with | |||||||
| two hinged doors | 13.75 x 4.75 | ||||||
| inches (Major) | |||||||
| 8.75 x 1.75 | |||||||
| inches (Minor) | 15.5 x 12 | ||||||
| x 13.75 | |||||||
| inches | 1228 grams | 7.6 gallons | 6.1 gallons | Free | |||
| Standing |
General Specifications:
The Medium capacity container is offered with two different models. The model 0330-150S has a sliding closure which when fully snapped locks the access opening for final disposal. This configuration is intended for OR areas where a large easy access is required for disposal of sharps objects. The model 0330-150M uses a counter balanced door that is suitable for use with unrestricted patient access. Both devices are free standing or can be wall mounted with a locking wall bracket PN 1030-9904.
The Large container lid design allows for use as a conventional sharps container or disposal of larger sharps. This is accomplished by two closures. The lid is design in two regions which are connected by a large flexible hinge. The lid regions and hinge are molded as a single component.
For use as a standard sharps collector: The entire lid is snapped onto the base. The small opening and closure are used. This provides a high capacity sharps collector for small to moderate sized sharps objects. When the container is full the small closure is closed by pressing down on the three snaps marked on the closure. Once snapped the container is ready for disposal.
For use as a large sharps collector: One half of the lid is snapped onto the base, the other half is folded over leaving the large opening. A small strap and hook which is molded as
5
Image /page/5/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. Below the words "Oak Ridge" is the word "Products" in black. To the right of the words is a green graphic of two mountains.
part of the lid is used to keep the large closure in the open position. This allows one half of the lid to act as a large closure, allowing single hand disposal of large sharps objects. The flexible hinge area is covered on the underside of the lid by a guard that prevents sharps objects from penetrating the thinner hinge area of the lid. When the container is full, the strap is released. Both the large half lid and the small closure are snapped closed the container is ready for disposal.
Both the hinge guard and small aperture closer are installed at the time of manufacture and becomes integral to the lid assembly. The fastening method used is permanent and not removable by the user.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the large capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the fill level line on the product identification label. Carrying handles are molded into the upper rim of the container allowing for fingers to be above the fill level.
The both the Oak Ridge Products Medium and Large Sharps Container 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.
| Multi-purpose sharps containers | |||||||
|---|---|---|---|---|---|---|---|
| Oak Ridge | |||||||
| Part | |||||||
| Number | Product | ||||||
| Description and | |||||||
| closure type | Access | ||||||
| opening size | Overall | ||||||
| Size | |||||||
| L x W x H | Weight | ||||||
| (grams) | |||||||
| empty | Total | ||||||
| Capacity | Capacity at | ||||||
| full line | Mounting | ||||||
| 0330-150S | Medium Red | ||||||
| Sharps container – | |||||||
| Sliding door | 2.5 x 2.5 | ||||||
| inches | 12.5 x 6 x | ||||||
| 13.5 | |||||||
| inches | 525 grams | 2.9 gallons | 2.4 gallons | Free | |||
| Standing | |||||||
| or Bracket | |||||||
| 0330-150M | Medium Red | ||||||
| Sharps container– | |||||||
| Counter balanced | |||||||
| door | 8.5 x 1.75 | ||||||
| inches | 12.5 x 6 x | ||||||
| 16.0 | |||||||
| inches | 586 grams | 2.9 gallons | 2.4 gallons | Free | |||
| Standing | |||||||
| or Bracket | |||||||
| 0370-1500 | Large Red Sharps | ||||||
| container – with | |||||||
| two hinged doors | 13.75 x 4.75 | ||||||
| inches (Major) | |||||||
| 8.75 x 1.75 | |||||||
| inches (Minor) | 15.5 x 12 | ||||||
| x 13.75 | |||||||
| inches | 1228 grams | 7.6 gallons | 6.1 gallons | Free | |||
| Standing |
Indications for Use: 6.
Oak Ridge Products Sharps containers are a 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 containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.
The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
6
Image /page/6/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, the word "Ridge" is in black, and the word "Products" is in black. To the right of the word "Products" are two green triangles that appear to be mountains.
7. Comparison to Predicate Devices:
| Manufacturer | Oak Ridge Products
(New Devices) | Oak Ridge Products
(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Oak Ridge Products Sharps
Containers | Oak Ridge Products Sharps
Containers |
| 510(k) number | K141759 | K130281 |
| Indication for use | Oak Ridge sharps containers are
intended to be used for the safe
disposal of hazardous sharps | Oak Ridge sharps containers are
intended to be used for the safe
disposal of hazardous sharps |
| Target Population | Healthcare professional | Healthcare professional |
| Where used | Healthcare facilities | Healthcare facilities |
| Material | Polypropylene | Polypropylene |
| Sharps access | Sharps inserted through the top | Sharps inserted through the top |
| Sharps closure | Closure feature is closed then
locked in place for removal | Closure feature is closed then locked
in place for removal |
| Impact resistance | Yes | Yes |
| Puncture resistance | Yes | Yes |
| Leak resistance | Yes | Yes |
| Single use | Yes | Yes |
| Non-sterile | Yes | Yes |
| Capable of
maintaining a stable,
upright position | Yes | Yes |
| No features to bend,
break, or shear
needle. | No Feature Present | No Feature Present |
| Reusable Sharps
Containers | Same | Labeling is "Single Use Only" |
| Overfill Indication | Same | "Do Not Overfill" or "Fill to this Level
Only" is Labeled or embossed on the
container at the location of the full
point. Labeling includes a "Fill Line". |
| Clarity | Same | Each Collector has a minimum of one
translucent component, either base or
top. |
| Construction | Same | Injection Molded Containers, Lids and
Closure |
| Unwinder | Feature present only on Large
container | 1 quart Phlebotomy containers have
this feature |
7
Image /page/7/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. The word "Products" is in green and is located below the words "Oak Ridge". There are three green triangles to the right of the word "Ridge".
8. Substantial Equivalence Discussion of Similarities and Differences:
The Oak Ridge Products Multi-Purpose Sharps Containers are similar to the Oak Ridge Products Sharps Containers in:
- Intended use
- . Target population
- Materials ●
- Design ●
- Performance testing
9. Intended use comparison:
The intended use of the new Oak Ridge Products Multi-Purpose Sharps Container is the same as the predicate device. Oak Ridge Products Sharp Containers intended for the disposal of contaminated sharps 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 device are similar. The Oak Ridge Products Multi-Purpose Sharps Container 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 lid and closure or access door.
They are constructed of an injection molded polypropylene. Oak Ridge Products Sharps Containers are colored red with translucent lid that allows 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."
8
Image /page/8/Picture/0 description: The image shows the logo for Oak Ridge Products. The words "Oak Ridge" are in a bold, sans-serif font, with "Oak" in green and "Ridge" in black. Below that, the word "Products" is in a smaller, sans-serif font, also in black. To the right of the text are two green triangles, which appear to be stylized mountains.
- 0 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 Collectors dated October 1993", was used to identify applicable physical and mechanical features of the Oak Ridge Products multi-purpose sharps containers and the predicate device.
All applicable standards have been used to show that the Oak Ridge Products Medium and Large Sharps Container is substantially equivalent to the appropriately listed predicate device.
The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products Medium and Large device and the predicate device. The Oak Ridge Products Medium and Large Sharps container has 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.
11.2 Performance Testing (Bench) - Product Testing
The Oak Ridge Products Medium and Large 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 an 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 present on the large model - Passed
Impact resistance and safe handling - Passed Based on ISO 23907:2012
9
Image /page/9/Picture/0 description: The image shows the logo for Oak Ridge Products. The word "Oak" is in green, and the word "Ridge" is in black. Below the words "Oak Ridge" is the word "Products" in black. To the right of the word "Ridge" are two green triangles that resemble mountains.
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: Applies only to the Medium sharps container. The Large container is a free standing device.
Handle Strength: - Passed Based on ISO 23907:2012
11.3 Performance test summary:
The performance testing summary demonstrates substantial equivalence between the Oak Ridge Products device and the predicate devices. The Oak Ridge Products Medium and Large 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 Medium and Large Sharps Containers introduces no new questions concerning the safety or effectiveness and proves to be substantially equivalent to the respective predicate sharps collectors.