510k for Syringes

FDA 510k for Syringes

This article provides a detailed overview of syringe types, intended uses, regulatory classifications, and the requirements for FDA 510k for syringes. Syringes are critical medical devices used to administer medications, vaccines, and other fluids into or withdraw from the body. They are essential in various medical settings, from hospitals to home healthcare. The FDA regulates these devices to ensure their safety, efficacy, and quality.

Types of Syringes and 510K

Syringes are categorized based on their design, use, and functionality. Common types include:

General-Purpose Hypodermic Syringes

  • Description: These are standard hypodermic syringes used for general medical purposes, such as administering medications or withdrawing fluids from the body. They consist of a cylindrical barrel, a plunger, and an attached or detachable needle.
  • Applications: Routine injections, blood draws, vaccinations, etc.

Insulin Syringes

  • Description: Syringes specifically designed for the administration of insulin. They have finer needles and are marked in insulin units rather than milliliters.
  • Applications: Self-administration of insulin by diabetic patients.

Tuberculin Syringes

  • Description: These are small-volume syringes used for intradermal injections, commonly for tuberculosis (TB) testing. The barrel is marked in millilitres up to 1 mL.
  • Applications: Tuberculin testing, allergy testing, or other intradermal injections

Luer Lock Syringes

  • Description: Syringes with a Luer lock fitting that allows for a secure connection between the syringe and the needle or other devices.
  • Applications: Intravenous injections, procedures where a secure needle connection is necessary.

 Irrigation Syringes

  • Description: Syringes used for wound irrigation, ear irrigation, or similar non-injection purposes. They typically have a blunt tip or no needle.
  • Applications: Wound cleaning, ear, and nasal irrigation.

Catheter Tip Syringes

  • Description: Syringes with a long, tapered tip designed to attach to catheters or tubing rather than a needle.
  • Applications: Flushing catheters, feeding tubes, wound irrigation.

Safety Syringes

  • Description: Syringes incorporate a safety mechanism to prevent needlestick injuries, such as retractable needles or needle shields.
  • Applications: Administration of medications where needlestick injury prevention is important.

Auto-Disable Syringes

  • Description: Syringes are designed to disable themselves after a single use to prevent reuse, helping to reduce the spread of infectious diseases.
  • Applications: Vaccination campaigns, especially in settings where syringe reuse is a concern

 

The barrel is the main body of the syringe, a cylindrical tube that holds the fluid to be injected or withdrawn. It is usually made from transparent materials such as plastic (e.g., polypropylene) or glass, allowing the user to see the fluid inside. The barrel is marked with graduation lines that indicate the volume of fluid, ensuring accurate dosing.

 

Plunger:

The plunger is a rod that fits tightly within the barrel and is used to draw fluid into or expel fluid from the syringe. It is often made of plastic and has a rubber or silicone tip to create a seal with the barrel. When the plunger is pulled back, it creates a vacuum that draws fluid into the barrel; when pushed forward, it expels the fluid.

Plunger Seal (Piston):

Located at the end of the plunger, the plunger seal, or piston, is typically made of rubber or another flexible material. This component ensures a tight seal with the barrel, preventing leakage of the fluid during use and ensuring smooth movement of the plunger.

Nozzle (Tip):

The nozzle, or tip, is located at the narrow end of the barrel and is designed to attach to a needle, IV line, or other medical apparatus. Syringes can have different types of nozzles, such as Luer Lock (which screws onto the needle for a secure connection) or Luer Slip (where the needle is pushed on). The choice of nozzle type affects the security of the attachment and the intended use of the syringe.

 

Needle (if included):

In many cases, the syringe includes a needle attached to the nozzle. The needle is typically made of stainless steel and varies in length and gauge depending on the application. It is designed for penetrating the skin or other tissues to deliver or withdraw fluids. Some syringes are sold without needles, allowing the user to select and attach the appropriate needle for their needs.

 

Flange:

The flange is the flat, wing-like extension at the open end of the barrel where the plunger is inserted. It provides a surface for the user to press against while operating the syringe, making it easier to push or pull the plunger.

Cap (Optional):

Some syringes come with a cap that covers the nozzle or needle, maintaining sterility until the syringe is used. The cap is typically made of plastic and can be either a separate component or integrated into the syringe design.

 

Intended Use of Syringes

The intended use of a syringe can vary significantly depending on its type:

  • Medication Administration: Syringes are used to inject medications, vaccines, and other fluids into the body.
  • Fluid Withdrawal: Syringes can be used to withdraw blood or other fluids for diagnostic or therapeutic purposes.
  • Diagnostic Testing: Some syringes are designed for specific diagnostic procedures, such as tuberculosis testing.

FDA 510k for Syringes and Performance Test Requirements

Performance testing is essential to demonstrate that the syringe meets its intended use. The required tests typically include:

ISO 7886-1

  • Freedom from Extraneous Matter
  • Lubricant Quantification
  • Tolerance on Graduations
  • Plunger Stopper Detachment
  • Barrel Flange to Plunger Distance
  • Dead Space
  • Freedom from Leakage
  • Piston Operational Force
  • Plunger Fit

ISO 80369-7

  • Luer Connector
Quick Contact

Device Code and Regulation Number for different type of Syringes

Product Code Device Name and Type Regulation Number Class
MZM
fibrin sealant preparation device Piston syringe
880.5860 2
FMF
syringe, piston Piston syringe
880.5860 2
MEG
syringe, antistick Piston syringe
880.5860 2
NKN
syringe, piston, reprocessed Piston syringe
880.5860 2
NSC
injector, pen Piston syringe
880.5860 2
PQX
epinephrine syringe Piston syringe
880.5860 2
PUR
vacuum syringe Piston syringe
880.5860 2
QBL
piston syringe lever Piston syringe
880.5860 2
QDM
midazolam syringe Piston syringe
880.5860 2
QEH
piston syringe with neuraxial connector – epidural … Piston syringe
880.5860 2
QLF
on-body injector Piston syringe
880.5860 2
QLY
ophthalmic syringe Piston syringe
880.5860 2
QNQ
low dead space piston syringe Piston syringe
880.5860 2
QOG
injection data capture device Piston syringe
880.5860 2
MAV
syringe, balloon inflation Angiographic injector and syringe
870.1650 2
NKU
injector and syringe, angiographic, balloon inflat … Angiographic injector and syringe
870.1650 2
NKW
actuator, syringe, for injector, reprocessed Syringe actuator for an injector
870.1670 2
OEQ
angiography/angioplasty kit Angiographic injector and syringe
870.1650 2
OER
angioscopic valvulotome kit Angiographic injector and syringe
870.1650 2
OFH
digital angiography tray Angiographic injector and syringe
870.1650 2
PTM
syringe, balloon inflation, exempt Angiographic injector and syringe
870.1650 2
PNR
enteral syringes with enteral specific connectors Gastrointestinal tube and accessories
876.5980 2
FIH
pump, infusion or syringe, extra-luminal Hemodialysis system and accessories
876.5820 2
DQF
actuator, syringe, injector type Syringe actuator for an injector
870.1670 2
DXT
injector and syringe, angiographic Angiographic injector and syringe
870.1650 2
IZQ
injector, contrast medium, automatic Angiographic injector and syringe
870.1650 2
NKP
injector, contrast medium, automatic, reprocessed Angiographic injector and syringe
870.1650 2
NKT
injector and syringe, angiographic, reprocessed Angiographic injector and syringe
870.1650 2
KCP
syringe, ent Ear, nose, and throat drug administratio…
874.5220 1
OGQ
ear irrigation kit Irrigating syringe
880.6960 1
KYZ
syringe, irrigating (non-dental) Irrigating syringe
880.6960 1
ECB
unit, syringe, air and/or water Dental hand instrument
872.4565 1
EIB
syringe, irrigating (dental) Dental hand instrument
872.4565 1
EIC
syringe, periodontic, endodontic, irrigating Dental hand instrument
872.4565 1
EID
syringe, restorative and impression material Dental hand instrument
872.4565 1
EJI
syringe, cartridge Cartridge syringe
872.6770 2