Med-Tainer Single Deposit Container

K153274 · Snyder Industries, Inc. · MMK · Aug 4, 2016 · General Hospital

Device Facts

• Record ID: K153274
• Device Name: Med-Tainer Single Deposit Container
• Applicant: Snyder Industries, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.

Device Story

Med-Tainer Single Deposit Container (SDC) is a reusable, rotationally molded, low-density polyethylene container for medical sharps collection. Available in 10 and 17-gallon sizes with various lid configurations (locking transport, lab, restrictive). Used in supervised healthcare areas; operated by healthcare staff. Containers are supplied to waste management companies for transport, decanting, decontamination, and destruction. Reusable up to 780 cycles. Provides safe containment of sharps to prevent injury during disposal and transport.

Clinical Evidence

Bench testing only. Performance validated through 780-cycle life span simulation, transport vibration, leak resistance, container stability, handle strength, drop testing (1m), puncture resistance (ASTM F2132-01), stack testing, and cleaning validation per FDA guidance.

Technological Characteristics

Rotationally molded linear low-density polyethylene. 10 and 17-gallon capacities. Reusable (up to 780 cycles). Various lid types (locking, lab, restrictive). Tested per ISO 23907, ASTM F2132-01, and 49 CFR 178.603/606/608.

Indications for Use

Indicated for safe collection and transport of medical sharps in supervised healthcare settings (hospitals, clinics, veterinary offices, laboratories).

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

• Sharps Tank Reusable Sharps Container (K111085)

Submission Summary (Full Text)

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

August 4, 2016

Snyder Industries, Inc. % Claudia Fell Regulatory Affairs Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K153274

Trade/Device Name: Med-tainer Single Deposit Container (SDC) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: July 6, 2016 Received: July 7, 2016

Dear Claudia Fell:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Tina Kiang 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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# Indications for Use

510(k) Number (if known)

K153274 Device Name

Med-Tainer Single Deposit Container (SDC)

#### Indications for Use (Describe)

Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.

| Med-Tainer Single Deposit Containers | | | |
|-----------------------------------------------------|-----------------------------------|---------------------------|--------------------------------------------------------------------------|
| Med-Tainer Single Deposit Container (SDC) 10 Gallon | | | |
| Model Number | Description | Approximate Size (inches) | |
| 780300E74100 | Med-Tainer SDC, 10 gallon, Red | 18 L x 13 W x 16 H | |
| 780300E74200 | Med-Tainer SDC, 10 gallon, Teal | 18 L x 13 W x 16 H | |
| 780300E74300 | Med-Tainer SDC, 10 gallon, Yellow | 18 L x 13 W x 16 H | |
| 780300E74400 | Med-Tainer SDC, 10 gallon, Blue | 18 L x 13 W x 16 H | |
| 780300E74500 | Med-Tainer SDC, 10 gallon, Green | 18 L x 13 W x 16 H | |
| Med-Tainer Single Deposit Container (SDC) 17 Gallon | | | |
| Model Number | Description | Approximate Size (inches) | |
| 780310E74100 | Med-Tainer SDC, 17 gallon, Red | 18 L x 13 W x 25 H | |
| 780310E74200 | Med-Tainer SDC, 17 gallon, Teal | 18 L x 13 W x 25 H | |
| 780310E74300 | Med-Tainer SDC, 17 gallon, Yellow | 18 L x 13 W x 25 H | |
| 780310E74400 | Med-Tainer SDC, 17 gallon, Blue | 18 L x 13 W x 25 H | |
| 780310E74500 | Med-Tainer SDC, 17 gallon, Green | 18 L x 13 W x 25 H | |
| Med-Tainer Single Deposit Container Lids | | | |
| Model Number | Description | Approximate Size (Inches) | Aperture (inches) |
| 34300474 | Locking Transport Lid, Black | 17 L x 11 W | No opening - use to seal container for transport |
| 34300476 | Large Lab Lid, Black | 17 L x 11 W | 5.75 x 9.75 - use only in areas that have no unsupervised patient access |
| 34300477 | Small Lab Lid, Black | 13 L x 9 W | No opening - use to cover large lab lid when not in use |
| 78033300E74101 | Restrictive Lid, Red | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74201 | Restrictive Lid, Teal | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74301 | Restrictive Lid, Yellow | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74401 | Restrictive Lid, Blue | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74501 | Restrictive Lid, Green | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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# 510(k) Summary

# Snyder Industries, Inc.

# Med-Tainer Single Deposit Container (SDC)

August 3, 2016

| ADMINISTRATIVE INFORMATION | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name | Snyder Industries, Inc.<br>6940 O Street, Suite 100<br>Lincoln, NE 68510<br>Telephone: [phone]<br>Fax: [phone] |
| Official Contact | Herbert H. Spann<br>Engineering Manager |
| Representative/Consultant | Claudia H. Fell<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Med-Tainer Single Deposit Container (SDC) |
|----------------------------|-------------------------------------------|
| Common Name | Container, Sharps |
| Classification Name | Hypodermic single lumen needle |
| Classification Regulations | 21 CFR 880.5570, Class II |
| Product Code | MMK |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |

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#### PREDICATE DEVICE INFORMATION

### Primary predicate device: K111085, Rehrig Pacific Company, Sharps Tank Reusable Sharps Container

#### INDICATIONS FOR USE

Med-Tainer Single Deposit Containers (SDC) are intended for the safe collection and transport of medical sharps. The reusable 10 gallon and 17 gallon containers are to be used in supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.

| Med-Tainer Single Deposit Containers | | | |
|-----------------------------------------------------|-----------------------------------|---------------------------|--------------------------------------------------------------------------|
| Med-Tainer Single Deposit Container (SDC) 10 Gallon | | | |
| Model Number | Description | Approximate Size (inches) | |
| 780300E74100 | Med-Tainer SDC, 10 gallon, Red | 18 L x 13 W x 16 H | |
| 780300E74200 | Med-Tainer SDC, 10 gallon, Teal | 18 L x 13 W x 16 H | |
| 780300E74300 | Med-Tainer SDC, 10 gallon, Yellow | 18 L x 13 W x 16 H | |
| 780300E74400 | Med-Tainer SDC, 10 gallon, Blue | 18 L x 13 W x 16 H | |
| 780300E74500 | Med-Tainer SDC, 10 gallon, Green | 18 L x 13 W x 16 H | |
| Med-Tainer Single Deposit Container (SDC) 17 Gallon | | | |
| Model Number | Description | Approximate Size (inches) | |
| 780310E74100 | Med-Tainer SDC, 17 gallon, Red | 18 L x 13 W x 25 H | |
| 780310E74200 | Med-Tainer SDC, 17 gallon, Teal | 18 L x 13 W x 25 H | |
| 780310E74300 | Med-Tainer SDC, 17 gallon, Yellow | 18 L x 13 W x 25 H | |
| 780310E74400 | Med-Tainer SDC, 17 gallon, Blue | 18 L x 13 W x 25 H | |
| 780310E74500 | Med-Tainer SDC, 17 gallon, Green | 18 L x 13 W x 25 H | |
| Med-Tainer Single Deposit Container Lids | | | |
| Model Number | Description | Approximate Size (Inches) | Aperture (inches) |
| 34300474 | Locking Transport Lid, Black | 17 L x 11 W | No opening - use to seal container for transport |
| 34300476 | Large Lab Lid, Black | 17 L x 11 W | 5.75 x 9.75 - use only in areas that have no unsupervised patient access |
| 34300477 | Small Lab Lid, Black | 13 L x 9 W | No opening - use to cover large lab lid when not in use |
| 78033300E74101 | Restrictive Lid, Red | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74201 | Restrictive Lid, Teal | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74301 | Restrictive Lid, Yellow | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74401 | Restrictive Lid, Blue | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |
| 78033300E74501 | Restrictive Lid. Green | 18.75 L x 13.5 W x 11.6 H | 3.8 H x 13.8 W |

### DEVICE DESCRIPTION

Med-Tainer Single Deposit Container (SDC) is used to collect medical sharps in supervised areas of healthcare facilities. The containers are rotationally molded and made of low density polyethylene. They are available in 17 gallon and 10 gallon sizes and in five colors: red, teal, yellow, blue and green. Med-Tainer SDC is a reusable container intended to be reprocessed up to 780 times. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The accompanying lids vary by purpose. The black transport lid is used during transport of the filled container. The combination of black large lab lid, with an opening to discard sharps, and the black small lab lid, used to slide across the large lab lid when not in use, allows easy disposal of sharps. The color coordinating restrictive lid with a mail box type opening is intended to prevent hand or finger access.

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# PERFORMANCE DATA

#### Life Span Processing Simulation per CAN/CSA Z316.6-14 BA.8.3.1 Sharps injury protection -Requirements and test methods – Sharps containers

Containers were processed 780 times to simulate their intended life cycle: filled with sharps, closed for transport, opened, decanted, rinsed and decontaminated, Results; all containers successfully completed 780 processing simulation cycles without damage.

### Life Span Transport Simulation per CAN/CSA Z316.6-14 BA.8.3.2 Sharps injury protection -Requirements and test methods – Sharps containers

Containers processed 780 times were filled with sharps and vibrated to simulate transportation. Results: all containers completed transportation without damage.

#### Leak Resistance Test per Health Devices, August - September 1993, ECRI, Vol 22 Nos. 8-9 pgs. 383-384

Containers processed 780 times were filled with water and checked after 24 hours for loss of fluid. Results: passed.

# Container Stability Test per ISO 23907 Sharps injury protection - Requirements and test methods – Sharps containers

Containers processed 780 times were filled with a material of density 0.20 ± 0.01kg/l and placed on an incline with a minimum angle of 15°. Testing was repeated for each side of the container. The container failed the criteria if it toppled over. Results: passed.

# Strength of Handles per ISO 23907 Sharps injury protection - Requirements and test methods -Sharps containers

Containers processed 780 times were filled with a mass equivalent to 150% of the manufacturer's maximum gross mass, closed, suspended by the handles for an hour at 23 ± 5℃ and examined for breakage or detachment. Results: passed.

# Resistance to Damage and Leakage after Dropping per ISO 23907 Sharps injury protection -Requirements and test methods – Sharps containers

Containers processed 780 times were conditioned for testing, filled with liquid and sharps, closed, and dropped a distance of 1 meter. The containers were oriented to land on the bottom, side wall and adjacent side wall. After landing they were inspected for leakage and /or loss of integrity. Results: passed.

# Resistance to Damage and Leakage after Dropping per ISO 23907 Sharps injury protection -Requirements and test methods – Sharps containers (modified)

Containers were conditioned for testing, filled with liquid, sharps, glass, and stainless steel. The fill weight of the container was 40.1 lbs. The containers were closed, and dropped a distance of 1 meter. The containers were oriented to land on the bottom, side wall and adjacent side wall. After landing they were inspected for leakage and /or loss of integrity. Results: passed.

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# Puncture Resistance per ASTM F2132-01 Standard Specification of Materials Used in Containers for Discarded Medical Needles and Other Sharps

Each side of the container (bottom, and 4 sides) was overlaid with a 1" x 1" grid. The 12 thinnest areas were tested using a 21 gauge by 1 inch hypodermic needle to measure the force required to penetrate the sample. The criteria to pass the puncture resistance test are an average value not less than 3.4 lbf (15 N) with no value less than 2.8 lbf (12.5 N). Results: passed.

# Puncture Resistance per ASTM F2132-01 Standard Specification of Materials Used in Containers for Discarded Medical Needles and Other Sharps

Each side of the container processed 780 times (lid, bottom, and 4 sides) was overlaid with a 1" x 1" grid. The 12 thinnest areas were tested using a 21 gauge by 1 inch hypodermic needle to measure the force required to penetrate the sample. The criteria to pass the puncture resistance test are an average value not less than 3.4 lbf (15 N) with no value less than 2.8 lbf (12.5 N). Results: passed.

# Drop Test per 49 CRF 178.603 Specification for Packagings – Subpart M – Testing of Non-Bulk Packagings and Packages

Containers were filled, closed, conditioned, and oriented to land during multiple trials on its top, bottom, end, side and top corner. The containers were dropped 1.2 meters, and examined for loss of contents. Results: passed.

# Stack Test per 49 CFR 178.606 Specification for Packagings – Subpart M – Testing of Non-Bulk Packagings and Packages

Containers were subjected to a temperature of 104°F for 28 days with weights of 130 pounds stacked on top of them. The containers were examined for deformation or release of contents. Results: passed.

# Vibration Testing per 49 CFR 178.608 Specification for Packagings – Subpart M – Testing of Non-Bulk Packagings and Packages

Containers were placed on a vertical linear vibration table operated at an amplitude of 1 inch and a frequency of 4.25 Hz for 60 minutes, and inspected for deterioration or loss of contents. Results: passed.

# Cleaning Validation per FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

A cleaning validation protocol was designed and performed. All containers successfully met or surpassed performance criteria.

# EQUIVALENCE TO MARKETED DEVICE

Snyder Industries, Inc. submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate device:

K111085. Rehrig Pacific Company, Sharps Tank Reusable Sharps Container

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| | Subject Device | Primary Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Snyder Industries, Inc.<br>Med-Tainer Single Deposit<br>Container | Rehrig Pacific Company<br>Sharps Tank Reusable Sharps<br>Container<br>K111085 |
| Indications for Use | Med-Tainer Single Deposit<br>Containers are intended for the safe<br>collection and transport of medical<br>sharps. The reusable 10 gallon and<br>17 gallon containers are to be used<br>in supervised areas of healthcare<br>institutions such as hospitals, clinics,<br>veterinary offices and laboratories.<br>The Med-Tainer Single Deposit<br>Container is available in Kelly<br>green, Ascent blue, teal, red and<br>yellow. | Rehrig Healthcare Systems reusable<br>17 gallon sharps container is<br>intended to be used for the collection<br>and transportation of used medical<br>sharps. The container is intended to<br>be used in hospitals and clinics,<br>operating rooms, and laboratories by<br>technicians, doctors, dentists, and<br>veterinarians. The device is only<br>intended for use in areas with no<br>unsupervised patient access.<br>Empty Weight: 9.4 lbs<br>Color: Red with contrasting<br>Biohazard Symbol Dimensions:<br>20.00"L x 12.50"W x 25.8"H<br>Opening Dimensions:<br>Main lid opening (approximate) -<br>18.00" x 10.7"<br>Sub-lid opening (approximate) - 8.0"<br>x 6.0" Both the main lid and sub-lid<br>have temporary and final closures.<br>Temporary closures are intended to<br>allow opening and closing of the<br>container by the user and to protect<br>against spillage if toppled. The final<br>closure is designed to secure the<br>container during transport. |

| | Subject Device | Primary Predicate Device |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Manufacturing | Rotationally molded | Injection Molded |
| Material | Linear Low density polyethylene | High density polyethylene |
| Approximate Size<br>(inches) | 18 L x 13 W x 16 H (10 gallon)<br>18 L x 13 W x 25 H (17 gallon) | 20 L x 12.5 W x 16 H (10 gallon)<br>20 L x 12.5 W x 26 H (17 gallon) |
| Opening dimensions<br>(length x width, inches) | Large Lab Lid opening: 5.75 x 9.75<br>Restrictive Lid opening: 13.7 x 4.2 | Main lid opening: 18.00 x 10.7<br>Sub-lid opening: 8.0 x 6.0 |
| Thickness (inches) | 0.1 | unavailable |
| Tare Weight (pounds) | 10 gallon with lid: 5.5, 17 gallon with lid: 7 | 10 gallon: unavailable, 17 gallon: 9.4 |
| Color | Red, Teal, Yellow, Blue Green with embossed and inked fill line; contrasting label includes Biohazard symbol | Red with contrasting Biohazard Symbol |

# CONCLUSION

The subject device is substantially equivalent to the predicate device.