(266 days)
Not Found
No
The device is a physical container for medical sharps and the description and performance studies focus on its physical properties and durability, with no mention of software, data processing, or AI/ML capabilities.
No
The device is a container for collecting medical sharps, not a device used to treat or cure a disease or condition.
No
This device is a container for collecting and transporting medical sharps, not a diagnostic device that performs medical diagnoses.
No
The device is a physical container made of low density polyethylene, not software. The performance studies focus on physical properties like strength, leak resistance, and durability.
Based on the provided information, the Med-Tainer Single Deposit Container (SDC) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "safe collection and transport of medical sharps." This is a physical containment and handling function, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The description details a container for collecting sharps, its materials, sizes, colors, and lids. It focuses on the physical characteristics and function of containing hazardous waste.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the physical integrity, safety, and durability of the container (e.g., life span, leak resistance, strength, puncture resistance, drop tests, stack tests, vibration testing, cleaning validation). These are relevant to a container for hazardous waste, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. The Med-Tainer SDC does not perform any such function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MMK
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.
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
supervised areas of healthcare institutions such as hospitals, clinics, veterinary offices and laboratories.
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)
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 degrees. 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 degrees C 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.
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 degrees 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.
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 logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head is formed by the first profile, and its body is formed by the other two profiles.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
510(k) Summary
Snyder Industries, Inc.
Med-Tainer Single Deposit Container (SDC)
August 3, 2016
| ADMINISTRATIVE INFORMATION | |
|---|---|
| Manufacturer Name | Snyder Industries, Inc. |
| 6940 O Street, Suite 100 | |
| Lincoln, NE 68510 | |
| Telephone: +1 (402) 467-5221 | |
| Fax: +1 (402) 465-1220 | |
| Official Contact | Herbert H. Spann |
| Engineering Manager | |
| Representative/Consultant | Claudia H. Fell |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: +1 (858) 792-1235 | |
| Fax: +1 (858) 792-1236 | |
| Email: cfell@paxmed.com |
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 |
4
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.
5
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.
6
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
7
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | Snyder Industries, Inc. | |
| Med-Tainer Single Deposit | ||
| Container | Rehrig Pacific Company | |
| Sharps Tank Reusable Sharps | ||
| Container | ||
| K111085 | ||
| Indications for Use | Med-Tainer Single Deposit | |
| Containers 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. | ||
| The Med-Tainer Single Deposit | ||
| Container is available in Kelly | ||
| green, Ascent blue, teal, red and | ||
| yellow. | Rehrig Healthcare Systems reusable | |
| 17 gallon sharps container is | ||
| intended to be used for the collection | ||
| and transportation of used medical | ||
| sharps. The container is intended to | ||
| be used in hospitals and clinics, | ||
| operating rooms, and laboratories by | ||
| technicians, doctors, dentists, and | ||
| veterinarians. The device is only | ||
| intended for use in areas with no | ||
| unsupervised patient access. | ||
| Empty Weight: 9.4 lbs | ||
| Color: Red with contrasting | ||
| Biohazard Symbol Dimensions: | ||
| 20.00"L x 12.50"W x 25.8"H | ||
| Opening Dimensions: | ||
| Main lid opening (approximate) - | ||
| 18.00" x 10.7" | ||
| Sub-lid opening (approximate) - 8.0" | ||
| x 6.0" Both the main lid and sub-lid | ||
| have temporary and final closures. | ||
| Temporary closures are intended to | ||
| allow opening and closing of the | ||
| container by the user and to protect | ||
| against spillage if toppled. The final | ||
| closure is designed to secure the | ||
| container during transport. |
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Manufacturing | Rotationally molded | Injection Molded |
| Material | Linear Low density polyethylene | High density polyethylene |
| Approximate Size | ||
| (inches) | 18 L x 13 W x 16 H (10 gallon) | |
| 18 L x 13 W x 25 H (17 gallon) | 20 L x 12.5 W x 16 H (10 gallon) | |
| 20 L x 12.5 W x 26 H (17 gallon) | ||
| Opening dimensions | ||
| (length x width, inches) | Large Lab Lid opening: 5.75 x 9.75 | |
| Restrictive Lid opening: 13.7 x 4.2 | Main lid opening: 18.00 x 10.7 | |
| 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.