(81 days)
Not Found
No
The device description focuses on a mechanical, spring-activated needle retraction mechanism, with no mention of AI or ML.
No
The device is a syringe used for injecting medication, not for therapeutic treatment itself. Its primary function is a delivery mechanism, not a treatment.
No
The device is described as a syringe intended for injecting medication, not for diagnosing conditions.
No
The device description clearly outlines a physical syringe with a barrel, plunger, needle, and a mechanical retraction mechanism, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intramuscular and subcutaneous injection of medication into a patient." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a syringe used for injecting fluids into the body. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe's function is to deliver medication, which is a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and 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 the body.
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.
The plunger rod, barrel, needle hub, needle protector and slider are made from polypropylene. The spring and cannula are made from Stainless steel. The piston is made from isoprene rubber and the piston O-ring is made from silicon dioxide. The components are glued together with acrylic glue. All of these components have been tested to verify biocompatibility.
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
Hospitals, clinics, 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)
Not Found
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
§ 880.5860 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
K113587 page 1 of
..............................................................................................................................................................................
FEB 2 4 2012
8
510(k) Summary
.
| Submitter's References |
|---|
| Shantou Wealy Medical Instrument Co., Ltd. |
| North Jinhuan Road (Near of Qishan Mid-School) |
| Shantou City, Guangdong Province, China |
| Zip: 515064 |
| FDA Registration Number: 3005202235 |
| Owner/Operator Number: 9074040 |
| Tel:+86-754-88218123 |
| Fax:+86-754-82121654 |
| Official Correspondent |
| IRC- Mr. Charles Mack |
| 77325 Joyce Way |
| Echo, Oregon 97826 |
| Ph. 931-625-4938 |
| Fax: 541-376-5063 |
| Email: charliemack@irc-us.com |
| Summary Contents |
| Submitted Device Device Description Statement of Intended Use Substantial Equivalence Safety Effectiveness Conclusions |
1
K113587 page 2 of 8
1. Submitted Device
| Trade Name | Automatically Retractable Safety
Syringe (with fixed needle)
5cc/ml 22×11/4 |
|---------------------|-----------------------------------------------------------------------------------|
| Common Name | Syringe, anti-stick |
| Classification Name | Piston Syringe |
1.1. Predicate/Legally Marketed Device
| Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| Anti-Stick | |||
| Syringe With | |||
| Integral | |||
| Hypodermic | |||
| Needle | |||
| Vanishpoint | |||
| Syringe | Retractable | ||
| Technologies, | |||
| Inc. | K970803 | Automatically | |
| Retractable | |||
| Syringe(with | |||
| needle) | |||
| 5cc/ml 22×11/4 | |||
| Safety fixed |
Proposed Indications 1.2.
The proposed indications for the predicate Anti-stick Vanishpoint and the submitted Automatically Retractable Syringe are the same. The design, intended use and construction are exactly the same.
Both the predicate and the submitted device are single-use, anti-stick piston type syringes. The function of the predicate and the submitted device is to provide a safe and reliable method of injecting medication into a patient. Both devices work like a simple piston syringe except for the syringe's ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.
2
2. Device Description
2.1 Description :
The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and 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 the body.
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.
3
K113587 page 4 of 8
Image /page/3/Figure/1 description: The image shows a diagram of a syringe and a corresponding table that labels the different parts of the syringe. The diagram labels 18 different parts of the syringe with numbers ranging from 1 to 18. The table lists the name of each part, such as 'Leak-proof ring', 'Zero line', 'Capacity graduation', 'Needle', and 'Needle covers', corresponding to the numbers in the diagram.
The plunger rod, barrel, needle hub, needle protector and slider are made from polypropylene. The spring and cannula are made from Stainless steel. The piston is made from isoprene rubber and the piston O-ring is made from silicon dioxide. The components are glued together with acrylic glue. All of these components have been tested to verify biocompatibility.
$\gamma$
20
4
K113587 page 5 of 8
Statement of Intended Use 3.
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
Substantial Equivalence 4.
The submitted Automatically Retractable Safety Syringe is constructed to perform like the predicate Vanishpoint Syringe. Both devices are simple piston syringes with ability to retract the used needle into the body after use. Both devices are single use devices and constructed in the same manner. The submitted device and predicate have undergone similar safety and performance testing and the submitted device has passed these tests.
5. Differences
Please refer to the tables on the following pages for noted differences.
5
| Element of comparison | Company | Subject Device | Claimed SE Device |
|---|---|---|---|
| DA510(K) Number | Shantou Wealy Medical Instrument Co.,Ltd. | Retractable Technologies, Inc. | |
| N/A | K970803 | ||
| Device Name | Automatically Retractable Safety Syringe with Fixed Needle | VanishPoint™ Syringe | |
| Volume | 5ml | 5 ml and 10ml | |
| Needle length | 1-1/4 Inch | 1-1/2 Inch | |
| Available needle gauge sizes | 22G | 20/21/22/25G | |
| Intended Use | Automatically Retractable Safety Syringe (with fixed needle) (5ml/CC 22G×1 1/4") is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. | The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, The syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container. | |
| Principle of operation | The needle is automatically retracted from the patient into the barrel of the syringe when the plunger is fully depressed. Automatically Retractable Safety Syringe reduces the risk of healthcare worker exposure to hazardous drugs during reconstitution, preparation, transport, and disposal. | The needle is automatically retracted from the patient into the barrel of the syringe when the plunger is fully depressed. VanishPoint™ Syringe reduces the risk of healthcare worker exposure to hazardous drugs during reconstitution, preparation, transport, and disposal. | |
| Syringe type | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | |
| Sites of use | Hospitals, clinics, laboratories | Hospitals, clinics, laboratories | |
| Safety Features | Active safety feature, manually activated by users | Active safety feature, manually activated by users | |
| Element of | |||
| comparison | Subject Device | Claimed SE Device | |
| Specific drug use | Conventional drugs | Conventional drugs | |
| Needle tip configuration | Tri-Beveled Tip | Tri-Beveled Tip | |
| Nozzle type | Needle and hub are integral to the syringe, not separable. | Needle and hub are integral to the syringe, not separable. | |
| Barrel marking specs | Scale :conforms to ISO 7886-1:1993/ Corrigendum 1:1995 | Scale :conforms to ISO 7886-1:1993/ Corrigendum 1:1995 | |
| Gradations legibility | 0.2ml | 0.2ml | |
| Needle cover color | colorless | colorless | |
| Lubricant composition | Polydimethylsiloxane (PDMS) | Polydimethylsiloxane (PDMS) | |
| Lubricant amount/cm² |