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 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.

AI/ML Overview

This document describes the Med-Tainer Single Deposit Container (SDC), a device for the safe collection and transport of medical sharps. The bulk of the provided text details various performance tests conducted on the device to prove it meets certain acceptance criteria.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Reported Device Performance
Life Span Processing Simulation (per CAN/CSA Z316.6-14 BA.8.3.1) - 780 processing cycles without damage	All containers successfully completed 780 processing simulation cycles without damage.
Life Span Transport Simulation (per CAN/CSA Z316.6-14 BA.8.3.2) - 780 transport cycles without damage	All containers completed transportation without damage.
Leak Resistance Test (per Health Devices, August - September 1993, ECRI, Vol. 22 Nos. 8-9 pgs. 383-384) - No loss of fluid after 24 hours	Passed (containers processed 780 times were filled with water and checked after 24 hours for loss of fluid).
Container Stability Test (per ISO 23907) - Does not topple over on a 15° incline	Passed (containers processed 780 times were filled with material of density 0.20 ± 0.01kg/l and placed on an incline with a minimum angle of 15°, repeated for each side).
Strength of Handles (per ISO 23907) - No breakage or detachment when suspended for an hour with 150% maximum gross mass	Passed (containers processed 780 times were filled with a mass equivalent to 150% of the manufacturer's maximum gross mass, closed, suspended by handles for an hour at 23 ± 5℃, and examined).
Resistance to Damage and Leakage after Dropping (per ISO 23907) - No leakage or loss of integrity after 1-meter drop	Passed (containers processed 780 times, filled with liquid and sharps, closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity).
Resistance to Damage and Leakage after Dropping (modified) (per ISO 23907) - No leakage or loss of integrity after 1-meter drop with heavier fill	Passed (containers filled with liquid, sharps, glass, and stainless steel (40.1 lbs), closed, and dropped 1 meter on bottom, side wall, and adjacent side wall; inspected for leakage and/or loss of integrity).
Puncture Resistance (per ASTM F2132-01) - Average ≥ 3.4 lbf (15 N), no value < 2.8 lbf (12.5 N)	Passed (12 thinnest areas of each side tested with a 21 gauge hypodermic needle).
Puncture Resistance (processed) (per ASTM F2132-01) - Average ≥ 3.4 lbf (15 N), no value < 2.8 lbf (12.5 N) after 780 cycles	Passed (12 thinnest areas of each side of containers processed 780 times tested with a 21 gauge hypodermic needle).
Drop Test (per 49 CFR 178.603) - No loss of contents after 1.2-meter drop	Passed (containers filled, closed, conditioned, and dropped 1.2 meters on top, bottom, end, side, and top corner; examined for loss of contents).
Stack Test (per 49 CFR 178.606) - No deformation or release of contents after 28 days at 104°F with 130 lbs stacked	Passed (containers subjected to 104°F for 28 days with 130 pounds stacked on top; examined for deformation or release of contents).
Vibration Testing (per 49 CFR 178.608) - No deterioration or loss of contents after 60 minutes of vibration	Passed (containers placed on a vertical linear vibration table at 1-inch amplitude and 4.25 Hz for 60 minutes; inspected for deterioration or loss of contents).
Cleaning Validation (per FDA Guidance) - Met or surpassed performance criteria	All containers successfully met or surpassed performance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for each test (e.g., how many individual containers were subjected to each test). However, it consistently refers to "containers" in plural, implying more than one.

The data provenance is from prospective testing conducted by the manufacturer, Snyder Industries, Inc., to demonstrate the device's performance against established industry standards (CAN/CSA, ECRI, ISO, ASTM, 49 CFR, FDA Guidance). No country of origin for the data is explicitly mentioned beyond the US-based company and FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the Med-Tainer SDC, the "ground truth" is not established by human expert consensus on diagnostic images or similar. Instead, the ground truth is defined by the objective pass/fail criteria of the various engineering and performance tests based on the referenced standards. No human experts were used to establish the ground truth in the traditional sense of medical image interpretation. The "experts" in this context are the engineers and technicians who conducted the tests and interpreted the results against the predefined quantitative criteria in the standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are either objective measurements (e.g., force to penetrate, fluid loss, toppling) or visual inspections against defined criteria by the testing personnel. There is no mention of a formal adjudication process (like 2+1 or 3+1 consensus) as typically seen in clinical studies involving interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a physical sharps container, not an AI-powered diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) study was done

No, this question is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is objective engineering and performance test criteria defined by various national and international standards (CAN/CSA Z316.6-14, Health Devices by ECRI, ISO 23907, ASTM F2132-01, 49 CFR 178.603, 49 CFR 178.606, 49 CFR 178.608) and FDA Guidance. This includes quantitative measurements (e.g., average penetration force, presence/absence of leakage, toppling) and visual inspection against specified conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a training set as would be used for a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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 (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

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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
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

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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.6940 O Street, Suite 100Lincoln, NE 68510Telephone: +1 (402) 467-5221Fax: +1 (402) 465-1220
Official Contact	Herbert H. SpannEngineering Manager
Representative/Consultant	Claudia H. FellPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: 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

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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
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

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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.Med-Tainer Single DepositContainer	Rehrig Pacific CompanySharps Tank Reusable SharpsContainerK111085
Indications for Use	Med-Tainer Single DepositContainers are intended for the safecollection and transport of medicalsharps. The reusable 10 gallon and17 gallon containers are to be usedin supervised areas of healthcareinstitutions such as hospitals, clinics,veterinary offices and laboratories.The Med-Tainer Single DepositContainer is available in Kellygreen, Ascent blue, teal, red andyellow.	Rehrig Healthcare Systems reusable17 gallon sharps container isintended to be used for the collectionand transportation of used medicalsharps. The container is intended tobe used in hospitals and clinics,operating rooms, and laboratories bytechnicians, doctors, dentists, andveterinarians. The device is onlyintended for use in areas with nounsupervised patient access.Empty Weight: 9.4 lbsColor: Red with contrastingBiohazard Symbol Dimensions:20.00"L x 12.50"W x 25.8"HOpening 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-lidhave temporary and final closures.Temporary closures are intended toallow opening and closing of thecontainer by the user and to protectagainst spillage if toppled. The finalclosure is designed to secure thecontainer 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 9.75Restrictive Lid opening: 13.7 x 4.2	Main lid opening: 18.00 x 10.7Sub-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.

Regulation Number and Section

§ 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).