Safety Auto-Disable Syrine with Needle (Auto-Lock)

K143497 · Guangdong Intmed Medical Appliance Co., Ltd. · MEG · Nov 4, 2015 · General Hospital

Device Facts

• Record ID: K143497
• Device Name: Safety Auto-Disable Syrine with Needle (Auto-Lock)
• Applicant: Guangdong Intmed Medical Appliance Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Nov 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and a variety of fluid injections below the surface of the skin except phlebotomy. It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the 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.

Device Story

Device is a single-use, sterile, piston-style safety syringe with a detachable needle. Input: manual aspiration of fluids from vials. Operation: user-activated retraction mechanism; upon release of thumb force, an internal spring-loaded mechanism retracts the needle into the plunger rod. Output: needle fully contained within the syringe barrel post-activation. Used in clinical settings by healthcare providers. Benefit: prevents accidental needle sticks during handling and disposal. The device features a dedicated fitting to prevent use with non-compatible components.

Clinical Evidence

Simulated clinical study performed per FDA guidance for sharps injury prevention features. Tested 512 devices with zero failures observed. Statistical analysis indicates 97.5% confidence that the true failure rate is ≤0.7% and 99.5% confidence that it is ≤1.1%. Bench testing included sterility, bacterial endotoxin, residual EO, needle point strength, piston fitness, delivery accuracy, dead space, and leakage tests. Biocompatibility testing (ISO 10993) included cytotoxicity, irritation, sensitization, hemolysis, and acute systemic toxicity.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, needle hub), Isoprene rubber (piston), Stainless steel (needle), PDMS (lubricant), Silicone rubber (O-ring). Sensing/Actuation: Manual activation of spring-loaded retraction mechanism. Dimensions: 1ml to 10ml volumes; 21G-28G needle gauges. Connectivity: None. Sterilization: Ethylene Oxide (EO) per ISO 11135. Standards: ISO 7886-1, ISO 7886-4, ISO 7864, ISO 10993-1, ISO 11607-1/-2.

Indications for Use

Indicated for aspiration of fluids from vials and fluid injections below the skin surface, excluding phlebotomy. Intended for use by clinicians.

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

• WTF Secura Safety Syringe (with Needle) (K132120)

Reference Devices

• BD Spring Based Syringe (K011103)
• BD Integra 1ml Syringe (K023752)

Submission Summary (Full Text)

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

November 4, 2015

Guangdong Intmed Medical Appliance Co., Ltd. Mr. Sanfei Wang Management Representative 1# South Shunhe Road Europe Industry Park Shunde District, Foshan Guangdong 528300 CHINA

Re: K143497

Trade/Device Name: Safety Auto-Disable Syringe with Needle (Auto-Lock) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: September 23, 2015 Received: October 5, 2015

Dear Mr. Wang:

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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang-S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K143497

Device Name

Safety Auto-Disable Syringe with Needle (Auto-Lock)

Indications for Use (Describe)

The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and a variety of fluid injections below the surface of the skin except phlebotomy.

It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## K143497

# 510(k) Summary

| Submitter: | Guangdong Intmed Medical<br>Application Co., Ltd<br>1# South Shunhe Road Europe Industry Park, Shunde<br>District, Foshan, Guangdong, P.R. China, 528300 | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Mr. Wang, Sanfei Management<br>Representative<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Date Prepared: | Sep. 23, 2015 | | |
| Device Trade Name: | Safety Auto-Disable Syringe with Needle (Auto-Lock) | | |
| Device Common Name: | Safety Syringe (with Needle) | | |
| Class: | II | | |
| Classification Name: | 880.5860 Piston Syringe | | |
| Product Code: | MEG, FMI, FMF | | |

## 1. Predicate Device (Primary Predicate Device):

| Device | Company | Product Code | 510(k) Number |
|--------------------------------------------|--------------------------------------------------|----------------------|---------------|
| WTF Secura Safety<br>Syringe (with Needle) | Beijing WanTeFu<br>Medical Apparatus Co.,<br>Ltd | MEG, FMF,<br>and FMI | K132120 |

## 2. Reference Predicate Devices:

| Device | Company | Product Code | 510(k) Number |
|----------------------------|---------------------|----------------|---------------|
| BD Spring Based<br>Syringe | BD Medical | MEG and<br>FMF | K011103 |
| BD Integra 1ml<br>Syringe | BD Medical Surgical | MEG and<br>FMF | K023752 |

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## 3. Indications for Use:

The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the 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.

## 3. Product Description:

It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the 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.

The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.

| Specification | | | | | | | | |
|------------------------|--------------------|-------------------|--------------------|-------------------|--------------------|-------------------|-------------------|-------------------|
| Size<br>Volume | 28G<br>(0.36x12mm) | 27G<br>(0.4x12mm) | 26G<br>(0.45x16mm) | 25G<br>(0.5x16mm) | 24G<br>(0.55x25mm) | 23G<br>(0.6x32mm) | 22G<br>(0.7x38mm) | 21G<br>(0.8x38mm) |
| 1ml | ● | ● | ● | ● | | | | |
| 3ml | | | | ● | ● | ● | ● | |
| 5ml | | | | ● | | ● | ● | ● |
| 10ml | | | | | | ● | ● | ● |
| Color of<br>needle hub | Blue-Green | Gray | Brown | Orange | Purple | Blue | Black | Green |

### Product Specification

Note: the part of size include both external diameter and needle length and in unit of mm

### 4. Summary of Technology Characteristics and Performance Testing:

The intended use and technology characteristics of the proposed Safety Auto-Disable Syringe with Needle (Auto-Lock), and the substantial equivalence to the predicate device have been demonstrated via data collected in design verifications, clinical simulation investigation and clinical investigation performed in China per the requirements of China FDA. The results of these tests and clinical report provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new performance issues were raised during the testing. All materials used in the proposed device meet the requirements of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process, same as predicate devices.

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Guangdong Intmed Medical Application Co., Ltd

| Bench Testing | Bench Testing(continued) | Biocompatibility/In vivo testing |
|-----------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------|
| Sterile test | Needle point piecing strength test | In vitro cytotoxicity (ISO Elution) |
| Bacterial Endotoxin test | Piston in barrel fitness test | Irritation (Intracutaneous Reaction) |
| Residual of EO test | Tolerance on graduated capacity(delivery accuracy) test | Sensitization (ISO Guinea Pig Maximization) |
| Springe holder<br>deactivating test | Dead space test | Hemolysis in vitro |
| Auto-disable part<br>activating strength test | Binding strength between<br>Needle hub & Sheath | Acute systemic toxicity |
| Auto-disable part<br>resisting force test | Freedom from leakage at<br>needle hub & syringe nozzle | |
| Binding strength<br>between auto-disable<br>part and needle tube test | Liquid and air leakage past<br>piston | |
| Force to unplug push<br>button test | Nozzle conical fitting tests | |

Also we have packaging testing non-clinical performance data including packaging sealing strength test, and package integrity test.

The subject product, Safety Auto-Disable Syringe with Needle, was compared with the primary predicate device, WTF Secura Syringe (with needle) K132120, and reference predicate devices, BD Spring Based Syringe K011103, and BD Integra 1ml Syringe K023752, using following criteria following the suggestion from "Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes'':

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| ELEMENT OF<br>COMPARISON | SUBJECT DEVICE | (Primary) Predicate Device<br>K132120 | Reference Predicate Devices | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | WTF Secura Syringe (with<br>needle) | Device 1 (K011103) | Device 2 (K023752) |
| Indications for Use | The Safety Auto-<br>Disable Syringe with<br>Needle (Auto-Lock)<br>is used for aspiration<br>of fluids from vials<br>and ampoules and a<br>variety of fluid<br>injections below the<br>surface of the skin<br>except phlebotomy.<br>It has a detachable<br>needle with a<br>dedicated fitting.<br>The Safety Auto-<br>Disable Syringe with<br>Needle (Auto-Lock)<br>contains an inner<br>mechanism used to<br>allow the needle to<br>be retracted inside<br>the plunger rod of<br>the syringe after the<br>operator's thumb<br>force released. After<br>activation the needle<br>is fully contained<br>inside the syringe<br>guarding against<br>accidental needle<br>sticks during normal<br>handling and<br>disposal of the used<br>needle/syringe<br>combination. | The WTF Secura<br>Syringe (with needle) is<br>used for aspiration of<br>fluids from vials and<br>ampoules and a variety<br>of fluid injections below<br>the surface of the skin.<br>The WTF Secura<br>Syringe( with needle)<br>has a manually attached<br>WTF Secura Retracting<br>Needle. The WTF<br>Secura Syringe (with<br>needle) contains an<br>inner mechanism used<br>to allow the WTF<br>Secura Retracting<br>Neelde to be retracted<br>inside the plunger rod of<br>the syringe when<br>operator's thumb force<br>released. After<br>activation the needle is<br>fully contained inside<br>the syringe guarding<br>against accidental<br>needle sticks during<br>normal handling and<br>disposal of the used<br>needle/ syringe<br>combination | BD Spring Based<br>Syringe is used for<br>general purpose<br>injection and<br>aspiration of fluid from<br>vials, ampoules and<br>part of the body below<br>the surface of the skin<br>except phlebotomy.<br>The BD Spring Based<br>Syringe has a<br>detachable needle<br>with a dedicated<br>fitting. The dedicated<br>interface prevents<br>clinician from<br>attaching BD Spring<br>Based Syringe<br>components to a<br>standard syringe or<br>needle.<br>The BD Spring Based<br>Syringe contains a<br>tool used to cut<br>through the stopper<br>and inner hub allowing<br>the needle is fully<br>contained inside the<br>syringe guarding<br>against accidental<br>needle sticks during<br>normal handling and<br>disposal of the used<br>needle / syringe<br>combination. | The BD Integra™<br>Syringe is used for<br>aspiration of fluids<br>from vials and<br>ampoules and a<br>variety of fluid<br>injections below the<br>surface of the skin. It<br>is not intended to be<br>used for phlebotomy.<br>The insulin syringe<br>has scale lines in<br>insulin units and is<br>used for insulin<br>injections. The<br>tuberculin syringe can<br>be used for any of the<br>3 types of common<br>injections (intra-<br>dermal, intra-muscular<br>or subcutaneous).<br>The BD Integra™ Iml<br>Syringe has a<br>permanently attached<br>needle. The BD<br>Integra™ 1 nil Syringe<br>contains a tool used to<br>cut through the hub<br>and stopper allowing<br>the needle to become<br>retracted inside the<br>plunger rod of the<br>syringe after use.<br>After activation the<br>needle is fully<br>contained inside the<br>syringe guarding<br>against accidental<br>needle sticks during<br>normal handling and<br>disposal of the used<br>needle/syringe<br>combination. |
| Brief Summary: The subject device has smaller intended application scope compare to | | | | |
| WTF Secura Safety Syringe since subject device is not used for phlebotomy, and<br>smaller intended application scope compare to BD Integra 1m syringe since subject | | | | |
| device is not used for insulin injection. | | | | |
| ELEMENT OF | SUBJECT DEVICE | (Primary) Predicate Device Reference Predicate Devices | | |
| COMPARISON | | K132120 | Device 1 (K011103) | Device 2 (K023752) |
| | | WTF Secura Syringe (with needle) | BD Spring Based Syringe | The BD IntegraTM Syringe |
| syringe type | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle |
| | Active safety | Active safety feature, | Active safety feature, | Active safety feature, |
| Safety Features | feature, manually activated by user | manually activated by user | manually activated by user | manually activated by user |
| tip type | Tri-Beveled Tip | Tri-Beveled Tip | Tri-Beveled Tip | Tri-Beveled Tip |
| volume | 1 / 3/ 5 / 10 ml | 1/ 2.5/ 3 /5 /10 ml | 3 ~10 ml | 1 ml |
| needle length | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 |
| needle gauge | 21G~28G | 21/ 22/ 23/25/30 G | 18G ~ 25 G | 25G ~ 30 G |
| needle tip configuration | 15 oC regular point | 15 oC regular point | 15 oC regular point | 15 oC regular point |
| nozzle type | Needle hub Luer connector; Needle & syringe separable | Needle hub Luer connector; Needle & syringe separable | Needle hub Locking-fit; Needle & syringe separable | Needle hub Locking-fit; Needle & syringe not separable |
| barrel marking specs | Scales as required by ISO 7886-1…