(143 days)
No
The device description and performance studies focus on the mechanical safety features of a syringe and do not mention any computational or data-driven components indicative of AI/ML.
No
A therapeutic device is used to treat a disease or condition. This device is a syringe used to inject or withdraw fluids, and its primary purpose, beyond fluid handling, is to prevent needle stick injuries, which is a safety mechanism rather than a therapeutic action.
No
The device, a syringe, is used for injecting or withdrawing fluids and preventing needle stick injuries, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a needle, barrel, and plunger, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from the body." This describes a device used for direct interaction with the patient's body for therapeutic or diagnostic purposes (like administering medication or drawing blood).
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The description details the physical components of a syringe, which is a tool for administering or withdrawing substances from the body.
- Lack of IVD Indicators: There is no mention of analyzing specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.
Product codes
MEG
Device Description
The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.
The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components:
- Cap - Covers the needle until the syringe is to be used
- Needle - The needle penetrates the patient's skin to inject/withdraw fluid from the body
- Needle house - a plastic part, as a assembly part with needle to fasten together with epoxy glues
- Hub - a plastic part for minimizes the risk of leakage around the needle assembly
- Barrel - The barrel has a scale showing the capacity of the syringe , in addition ,the top of the barrel has a airproof ring lock fitting for minimize risk of leakage around the Hub
- Gasket - A TPE (Thermoplastic Elastomer) molding part. The gasket is to be assembled with plunger for bring plus/minus pressure within barrel when the plunger to be fully depressed/retracted
- Plunger - Once the plunger is fully depressed, it engages the needle assembly, as the plunger is retracted ,the needle assembly is retracted into the barrel, once the plunger is fully retracted and locked in place, the plunger is snapped off leaving the needle in the barrel of the syringe
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
Not Found
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
Simulated Clinical Use Study: Sunwell Biotech Co., Ltd conducted simulated clinical use study of Auto-Disable Sterile Safety Syringe for Single Use, 5ml, in accordance with the FDA Guidance for industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005. The objective was to assess the reliability and usability of the safety feature of that device. Based on the simulated clinical use test recommended in that document, 10 nurses were recruited. They tested a total of 500 Auto-Disable Sterile Safety Syringe for Single Use and 100 samples of a similar products, the Invirosnap Safety Syringe( Which is already marketed in the United States with K092430), and reported their experience with each sample. The safety mechanisms and the user actions of the two devices are similar. Samples of the both syringes were provided by Sunwell Biotech Co., Ltd.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
510(k) Summary
OCT 25 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: June 4, 2012
Company and Correspondent making the submission:
Name - Sunwell Biotech Co., Ltd.
Address - No.9,Yongxing Road, Gangzha Economic Development Zone, Nantong City, Jiangsu, China 226002
Telephone - 86-513-85308888
Fax - 86-513-85308899
Contact - Mr. Charlie Mack
Email - charliemack@irc-us.com
Device :
Trade/proprietary name: Auto-Disable Sterile Safety Syringe For Single Use, 5mL
Common Name
: Antistick Syringe
Classification Name : Piston, Syringe
Predicate Device:
| Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| Invirosnap | |||
| Safety | |||
| Syringe, 1ml | |||
| 2ml 3ml 5ml | |||
| 10ml and | |||
| 20ml | Inviro Medical | ||
| Devices, Inc. | K092430 | Auto-Disable Sterile | |
| Safety Syringe for | |||
| Single Use, 5mL |
Classifications Names & Citations : 21CFR 880.5860, MEG, Anti-Stick Syringe, Class II
1
Description :
General
The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.
The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components:
-
Cap - Covers the needle until the syringe is to be used
-
Needle - The needle penetrates the patient's skin to inject/withdraw fluid from the body
-
Needle house - a plastic part, as a assembly part with needle to fasten together with epoxy glues
-
Hub - a plastic part for minimizes the risk of leakage around the needle assembly
-
Barrel - The barrel has a scale showing the capacity of the syringe , in addition ,the top of the barrel has a airproof ring lock fitting for minimize risk of leakage around the Hub
-
Gasket - A TPE (Thermoplastic Elastomer) molding part. The gasket is to be assembled with plunger for bring plus/minus pressure within barrel when the plunger to be fully depressed/retracted
-
Plunger - Once the plunger is fully depressed, it engages the needle assembly, as the plunger is retracted ,the needle assembly is retracted into the barrel, once the plunger is fully retracted and locked in place, the plunger is snapped off leaving the needle in the barrel of the syringe
Indications For Use
The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.
2
Sterilization:
Sunwell Biotech Co., Ltd., has successfully performed the EO validation according to ISO 11135-1:2007 for Auto-Disable Sterile Safety Syringe for Single Use. All predetermined parameters have been met.
Biocompatibility:
The biocompatibility study has been conducted for Auto-Disable Sterile Safety Syringe for Single Use 5ml according to the below applicable standards:
In Vitro Cytotoxicity (ISO 10993-5:2009) Delayed Contact Sensitization Study in the Guinea Pig (ISO10993-10:2010) Intracutaneous Test (ISO10993-10:2010) Systemic Toxicity (Acute) (ISO10993-11:2006) Hemolysis Test (ISO 10993-4-2002/Amd. 1:2006) Complement Activity Test (ISO 10993-4-2002/Amd. 1:2006) Thrombosis Test (ISO 10993-4-2002/Amd. 1:2006)
Package and Shelf Life:
Testing was performed to demonstrate package and shelf life verification. The study shows that the subject sterilization package complies with the applicable standards and support the 3 years shelf life claim. The tests noted below were performed:
Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07) Sterilization of medical devices - Microbiological methods (AAMI/ANSI/ISO 11737-2:2009 - Part 2)
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (ASTM D3078-02)
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-98)
Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-09) for terminally sterilized medical devices - Part 1: (AAMI/ANSI/ISO 11607-1:2006/) Sterile hypodermic syringes for single use - Part 1: (ISO 7886-1:1993) Sterile hypodermic needles for single use (ISO 7864 Third edition 1993-05-15) Stainless steel needle tubing for the manufacture of medical devices (ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01)
3
Simulated Clinical Use Study
Sunwell Biotech Co., Ltd conducted simulated clinical use study of Auto-Disable Sterile Safety Syringe for Single Use, 5ml, in accordance with the FDA Guidance for industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005. The objective was to assess the reliability and usability of the safety feature of that device. Based on the simulated clinical use test recommended in that document, 10 nurses were recruited. They tested a total of 500 Auto-Disable Sterile Safety Syringe for Single Use and 100 samples of a similar products, the Invirosnap Safety Syringe( Which is already marketed in the United States with K092430), and reported their experience with each sample. The safety mechanisms and the user actions of the two devices are similar. Samples of the both syringes were provided by Sunwell Biotech Co., Ltd.
Product Picture
Image /page/3/Picture/3 description: The image shows a syringe with a needle. The syringe is made of clear plastic and has a black plunger. The syringe is marked with measurements from 1 to 5 ml. The brand name "Dr. Needl" is printed on the side of the syringe.
Comparison with predicate device :- Please see the next page
4
SE Table
| Element of comparison | Subject Device | Claimed SE Device |
|---|---|---|
| Company | Sunwell Biotech Co., Ltd. | Inviro Medical Devices, Inc. |
| FDA510(K) Number | N/A | K092430 |
| Device Name | Auto-Disable Sterile Safety Syringe for Single Use | Invirosnap Safety Syringe |
| Model Number | 5ml | 1ml 2ml 3ml 5ml 10ml and 20ml |
| Intended Use | The Auto-Disable Sterile Safety Syringe for Single Use | |
| is used to inject fluids into, or withdraw fluids from the | ||
| body. In addition, the retractable needle of the syringe | ||
| goes into the barrel after use. It is designed to | ||
| aid in the prevention of needle stick injuries | The InviroSnap Safety Syringe is used to inject fluids into, or | |
| withdraw fluids from, the body. In addition, the InviroSnap | ||
| Safety Syringe is designed to aid in the prevention of needle | ||
| stick injuries. | ||
| Principle of operation | Identical | After use, the health care professional fully depresses the |
| plunger to engage the luer assembly. Once the luer | ||
| assembly is engaged, pulling back the plunger causes the | ||
| Adapter and the attached needle to be withdrawn into the | ||
| safety of the barrel. In this position against the flange, lateral | ||
| pressure on the plunger results in a controlled fracture of | ||
| the plunger. Both the syringe and plunger are discarded in a | ||
| sharps container. | ||
| Safety feature | Identical | Manually retractable safety syringe with permanent disable |
| Specific drug use | Identical | Conventional drugs |
| Sterilization | Identical | Sterilized by ethylene oxide gas |
| Needle length | Identical | 1 1/4 Inch |
| Needle gauge | 22G | 21/22/23G |
| Needle tip configuration | Identical | Tri-Beveled Tip |
| Wall type | Identical | Regular wall |
| Nozzle type | Identical | Needle and hub are integral to the syringe, not separable. |
| Barrel marking specs | identical | conforms to ISO 7886-1:1993/ Corrigendum 1:1995 |
| Gradations legibility | identical | 0.2ml |
| Needle cover color | identical | clarity |
| Lubricant composition | identical | Polydimethylsiloxane oil (PDMS) |
| Lubricant amount/cm² | Identical |