AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)

K113587 · Shantou Wealy Medical Instrument Co.,Ltd · MEG · Feb 24, 2012 · General Hospital

Device Facts

• Record ID: K113587
• Device Name: AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
• Applicant: Shantou Wealy Medical Instrument Co.,Ltd
• Product Code: MEG · General Hospital
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Automatically Retractable Safety Syringe is a single-use, sterile, piston-type syringe with an integrated fixed needle. Device functions like a conventional syringe for fluid injection; features a user-activated spring-loaded mechanism that retracts the contaminated needle into the barrel immediately following injection. Designed to prevent accidental needle sticks during disposal. Used in hospitals, clinics, and laboratories by healthcare professionals. Needle retraction occurs when the plunger is fully depressed. Benefits include reduced risk of healthcare worker exposure to hazardous drugs and protection from sharps injuries.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through mechanical testing (hub/needle bond strength, needle cover strength, delivery accuracy) and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Piston syringe with integrated fixed needle. Materials: Polypropylene (barrel, plunger, hub), Stainless steel (spring, cannula), Isoprene rubber (piston), Silicon dioxide (O-ring). Components bonded with acrylic glue. Active safety feature: manual spring-activated needle retraction. Conforms to ISO 7886-1:1993 for scale and delivery accuracy. Sterilization: Gamma.

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication into patients.

Regulatory Classification

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.

Predicate Devices

• Vanishpoint Syringe (K970803)

Submission Summary (Full Text)

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K113587 page 1 of

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FEB 2 4 2012

8

# 510(k) Summary

.

| Submitter's References |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shantou Wealy Medical Instrument Co., Ltd.<br>North Jinhuan Road (Near of Qishan Mid-School)<br>Shantou City, Guangdong Province, China<br>Zip: 515064<br>FDA Registration Number: 3005202235<br>Owner/Operator Number: 9074040<br>Tel:[phone]<br>Fax:[phone] |
| Official Correspondent |
| IRC- Mr. Charles Mack<br>77325 Joyce Way<br>Echo, Oregon 97826<br>Ph. 931-625-4938<br>Fax: [phone]<br>Email: [e-mail] |
| Summary Contents |
| Submitted Device Device Description Statement of Intended Use Substantial Equivalence Safety Effectiveness Conclusions |

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### 1. Submitted Device

| Trade Name | Automatically Retractable Safety<br>Syringe (with fixed needle)<br>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<br>Syringe With<br>Integral<br>Hypodermic<br>Needle<br>Vanishpoint<br>Syringe | Retractable<br>Technologies,<br>Inc. | K970803 | Automatically<br>Retractable<br>Syringe(with<br>needle)<br>5cc/ml 22×11/4<br>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.

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## 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.

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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.

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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.

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| 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<br>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 | <0.25mg/cm² | <0.25mg/cm² | |
| Barrel transparency | Clear | Clear | |
| Delivery accuracy | conforms to ISO 7886-1:1993/ Corrigendum 1:1995 | conforms to ISO 7886-1:1993/ Corrigendum 1:1995 | |
| Needle cover strength | <15N | <15N | |
| Hub/needle bond<br>strength | 40N | 40N | |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | |
| omparisor<br>Element of | Subject Device | Claimed SE Device | |
| Materials | Plastic parts : Polypropylene<br>Piston : Isoprene rubber<br>Needle : Stainless steel<br>)-ring: Silicon dioxide | Plastic parts : Polypropylene<br>Piston : Isoprene rubber<br>Needle : Stainless steel<br>O-ring: Silicon dioxide | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Syringe type | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Antistick syringe<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Antistick syringe<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Reuse | lon-reusable | Non-reusable | |
| Sterilization | ______________________________________________________________________________________________________________________________________________________________________________ | Gamma Sterilizatio | |
| | | | |

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A Production Production Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Commen

END

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be a title or heading. The words are capitalized and evenly spaced.

Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure, with three profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

Shantou Wealy Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way Echo, Oregon 97826

FEB 2 4 2012

Re: K113587

Trade/Device Name: Automatically Retractable Safety Syringe (with Fixed Needle) 5ml/CC 22G*1 1/4"

Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 27, 2011 Received: December 7, 2011

Dear Mr. Mack:

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.

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### Page 2 - Mr. Mack

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

Device Name: Automatically Retractable Safety Syringe (with Fixed Needle) 5ml/CC 22G×1 1/4"

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.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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\$\frac{l_{i} \mathbb{N}}{(\mathbb{D}i: \mathbb{C}i} for REC Feb 22, 2012

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K11358 +