(156 days)
Not Found
No
The description focuses on the mechanical features of a safety syringe and needle retraction mechanism. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a syringe used for fluid aspiration and injection, and its primary function is delivery and removal, not therapeutic treatment of a disease or condition. The safety feature is for user protection, not patient therapy.
No
Explanation: The device is described as a syringe used for aspiration and fluid injections. It does not mention any function related to diagnosing a disease, condition, or state of health. Its primary purpose is drug delivery and fluid removal.
No
The device description clearly details physical components like a barrel, stopper, plunger rod, and needle, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin." This describes a device used for administering substances into or withdrawing substances from the body, which is a typical function of a medical device, not an IVD.
- Device Description: The description details a syringe with a needle, plunger, barrel, and a sharps injury prevention feature. These are components of a device used for injection or aspiration, not for testing samples in vitro (outside the body).
- No mention of testing or analysis: The text does not mention any function related to analyzing biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status. This is the core purpose of an IVD.
- Anatomical Site: The mention of "below the surface of the skin" further reinforces its use for in-body procedures.
In summary, the WTF Secura Syringe (with needle) is a medical device used for administering or withdrawing fluids from the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin.
The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI, MEG
Device Description
The WTF Secura Safety Syringe (with needle) is a sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 1ml, 2.5ml, 3m1, 5ml, and 10ml. and needle sizes: 21-30G. All sizes will be available with a Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a isoamyl stopper, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of needle retracting performance before or after use, allowing for secure encapsulation of the needle point. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe.
Main material of WTF Secura Safety Syringe (with needle) are Polypropylene pellets (PP) , Isoamyl rubber piston, retracting needle made of stainless tube, and its main package material are gumming paper and Medical composite membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Simulated Clinical Study: For this simulated test, there was only one failure among 1000 devices tested. This result is acceptable for confidence and statistical theory.
Product test report information covers Sterile, Pyrogen, Hemolysis, Acute systemic toxicity, Readily oxidizable substance ml, pH value, Heavy metal ug/ml, Residual quantity of ethylene oxide ug/g, Controllable core pin, Self-destruction performance, Body adaptation, Volume tolerance, Piercing force of sword, Rigidity, Toughness, Corrosion resistance, Surface, Cleanliness inside the tube, Appearance, Scale length, Scale volume line, Zero line position, Metering number, Scale printing, Jacket length, Jacket hemming, Handle interval, Piston, Sliding property, Residual capacity, retracting needle, Dimension, Upright connection, Smooth pinhole, Color, Separating force of sheath and Single packing mark. Main indexes of products meet the product standard requirements.
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.
BD Integra 1ml Syringe K023752
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
§ 880.5860 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
Date: 2013-12-11
1. Sponsor
Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, 102200, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961
2. Submission Correspondent
Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961 Email: lightsman@163.com
3. Summary of technological characteristics of proposed Device:
| PRODUCT | SPECIFICATIONS | REF |
|---|---|---|
| Safety Syringe | 1 ml | 110101 |
| 2.5 ml | 110251 | |
| 3 ml | 110301 | |
| 5 ml | 110501 | |
| 10 ml | 111001 | |
| Retracting Needle | 25G 1" | 212551/222551 |
| 23G 1" | 212351 | |
| 22G 1" | 212251 | |
| 21G 1 1/8" | 212161 | |
| 30G 1" | 223051/213051 | |
| 21G 1 1/4" | 212171 | |
| 22G 1 1/4" | 212271 | |
| Filling Needle (Optional) | 18G 1" | 311812 |
DEC 12 2013
1
Niantou Industrial Park, Machikou, Changping District, Belilng, China Tel: 8610-60750950 Fax: 8610-60750961
- Trade Name: WTF Secura Safety Syringe (with Needle) ●
- . Common Name: Safety syringe (with needle)
- . Classification Name: Piston Syringe
- . Review Panel: General Hospital
- Product Code: FMF, FMF, FMI, MEG ●
- . Regulation Number: 880.5860
- Device Class: II .
- Predicate Device Trade name: BD Integra 1ml Syringe K023752 .
- Predicate Device manufacturer: BD Medical Surgical 1 Becton Drive MC226 ♥ Franklin Lakes, NJ
4. Intended use:
The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin.
The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
5. Product Description:
a. Description of each component:
The WTF Secura Safety Syringe (with needle) is a sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 1ml, 2.5ml, 3m1, 5ml, and 10ml. and needle sizes: 21-30G. All sizes will be available with a Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a isoamyl stopper, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of needle retracting performance before or after use, allowing for secure encapsulation of the needle point. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The
2
Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961
needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe.
| PRODUCT | SPECIFICATIONS | REF |
|---|---|---|
| Safety Syringe | 1 ml | 110101 |
| 2.5 ml | 110251 | |
| 3 ml | 110301 | |
| 5 ml | 110501 | |
| 10 ml | 111001 | |
| Retracting Needle | 25G 1" | 212551/222551 |
| 23G 1" | 212351 | |
| 22G 1" | 212251 | |
| 21G 1 1/8" | 212161 | |
| 30G 1" | 223051/213051 | |
| 21G 1 1/4" | 212171 | |
| 22G 1 1/4" | 212271 | |
| Filling Needle | 18G 1" | 311812 |
- b. Main material of WTF Secura Safety Syringe (with needle) are Polypropylene pellets (PP) , Isoamyl rubber piston, retracting needle made of stainless tube, and its main package material are gumming paper and Medical composite membrane.
- c. Standards applied: EN ISO 13485:2012/AC 2012, EN ISO 14971:2009, EN ISO 11135-1:2007, EN ISO 11607-1:2009, EN ISO 11607-2:2009, EN ISO 10993-1:2009, EN 556-1, EN1041:2008, EN 980:2008, ISO 9626, ISO 594-1,ISO 594-2, ISO 7886-4:2006, ISO ISO 7886-1:1993. ISO 7864:1993. WTF/JS-H-AZS7-A-01-2010
| Parts | Material of the
part | Size | Standards | Component |
|-----------------------|-----------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | polypropylene | K4818
K4912 | 1. The requirements for polyethylene
special material for medical use in
YY/T0242-2007 shall be met.
2. The material meeting YY/T0242-2008
standard cannot be found due to
procurement cause, and it shall be
replaced by other similar materials.
Furthermore, the biological performance
of the used material shall be evaluated
according to the requirements of GB/T
16886.1 (BS EN ISO 10993-1), so as to
ensure that the requirements for safety of
product material are met (the biological
assessment and type inspection have
been performed for the fabricated small
batch of samples). | Sleeve,
Outer core bar,
Limit sheath,
Inner core bar,
Needle base
connector
cover,
Needle base,
Needle base
connector,
Protective
cover,
Protection cap,
Luer adapters,
Filling needle
base |
| injection
moulding | TPE
thermoplastic
elastomer | A805-60
R62
E2000-4
5R92 | Shore hardness: 65
Elongation rate: 270
Biological detection shall be performed
for the first batch of supplied material (or
entrust the third party to perform the
biological detection). The haemolytic
activity shall not exceed 5%; it shall have
no acute systemic toxicity; in vitro
cytotoxic response level shall be no
larger than level 1, and there shall be no
sensitization response. | Stop dog |
| | Color
concentrate | Green,
orange,
blue,
black | tinctorial strength 95-105%:
Chromatic aberration≤0.3 | The
different
colors
correspond to
different
specifications
needle base
and needle
base connector |
3
Beijing WanTeFu Medical Apparatus Co., Ltd.
Niantou Industrial Park, Machikou, Changping District, Beijing, China
Tel: 8610-60750950 Fax: 8610-60750961
4
Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961
| Needle
tube | Filling needle
( bare
needle ) | 0.4(27G)
,0.5(25G
),
0.6(23G
),0.7(22
G),0.8(2
1G),0.9(
20G) | Meet standards of ISO 8764 Sterile
Hypodermic Needle for Single Use and
ISO 9626 Stainless steel needle tubing
for the manufacture of medical devices | Integrated
needle、Filling
needle、Filling
needle tube |
|-------------------------------|--------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| spring | Stainless tube | $¢$ 0.1, $¢$
0.3 | tensile strength≥110kg/mm | |
| O ring | Ø5.0×1.0
5
Ø3.9×1.0
5 | | silicon rubber
Hardness 55~60 | |
| | | | | |
| silica gel or Isoprene rubber | 2.5ml;3m
1; 5ml;
10ml | | 1、Meet YY/T0243-2003 Plunger of
sterile controllable safety syringe for
single use (with detachable needle)
2、Meet WTF/JS-A-AZS3-2-06-2005 | Plunger |
| | | | | |
6. Product Performance Test Summary
I. Product test report information
| Property | ltem | Conclusion |
|---|---|---|
| Sterile | sterile growth | |
| Pyrogen | Non-pyrogen | |
| Biological | ||
| property | Hemolysis | Hemolysis ratio: 1% |
| Compliance with technical | ||
| requirements |