3S Safety Syringe with/without Needle

K142435 · Sincere Medical Device Co., Ltd. · MEG · Feb 20, 2015 · General Hospital

Device Facts

• Record ID: K142435
• Device Name: 3S Safety Syringe with/without Needle
• Applicant: Sincere Medical Device Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3S Safety Syringe with/without Needle is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Device Story

Manual retractable safety syringe; used for fluid injection. Device features integrated needle and piston mechanism; allows visualization of injection site. Operation: standard injection technique; plunger withdrawn into barrel; snapped off to secure needle; discarded in sharps container. Used in clinical or home settings by clinicians or patients. Benefits: reduces risk of accidental needle-stick injuries and prevents syringe reuse.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and performance comparisons to predicate device. Device conforms to ISO 7864, ISO 7886, and ISO 10993 for biocompatibility.

Technological Characteristics

Manual retractable piston syringe. Materials: Polypropylene (PP) barrel/plunger/hub/sheath, silicone piston, stainless steel needle. Lubricant: silicone oil. Sizes: 0.5cc to 10cc; needle gauges 20G-28G. Standards: ISO 7864, ISO 7886, ISO 10993. Sterile, single-use.

Indications for Use

Indicated for injection of fluids into the body for patients requiring parenteral administration; intended for use by healthcare professionals or patients to reduce risk of sharps injuries and syringe reuse.

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

• Otter Safety Syringe (K040545)

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

February 20, 2015

Sincere Medical Device Company, Ltd. Mr. Garfield Wang RA Manager Room 218, 2F., No. 183, Zhouzi St. Taipei City, Taipei City 114 TAIWAN (R.O.C)

Re: K142435

Trade/Device Name: 3S Safety Syringe with/without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 15, 2015 Received: January 23, 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 yours,

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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Image /page/2/Picture/0 description: The image shows the logo of Sincere Medical Device Co., Ltd. The logo consists of a green circular emblem with the letter 'S' inside, surrounded by stylized green leaves. To the right of the emblem is the company name, 'Sincere Medical Device Co., Ltd.,' written in a clear, sans-serif font.

510(k) Submission

Rev 0.00 15/08/14

# Section_004 Indications for Use

K142435 510(k) Number (if known):

Device Name: 3S SAFETY SYRINGE WITH/WITHOUT NEEDLE

Indications for Use

[3S Safety Syringe]

The 3S Safety Syringe with/without Needle is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo of Sincere Medical Device Co., Ltd. The logo consists of a green circular emblem with the letter "S" inside, along with the company name written in black text to the right of the emblem. The text is clear and easy to read, and the overall design is simple and professional.

510(k) Submission

Rev 0.02

05/02/15

[3S Safety Syringe]

# Section_005 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date Prepared: 15. 08.2014

# 1. Submitter Name and Address:

| Owner Name: | Sincere Medical Device Co., Ltd. |
|-----------------|-----------------------------------------------------------------------------------|
| Address: | Rm. 218, 2F., No. 183, Zhouzi St., Neihu Dist., Taipei City 114.<br>Taiwan(R.O.C) |
| Contactor Name: | Garfield Wang, Vivian Lu |
| TEL: | [phone] |
| E-mail: | [e-mail] |
| Web: | http://sincere-med.com |
| Fax: | [phone] |

# US Agent:

| US Agent: | Benjamin Lee. |
|-----------|------------------------------------------------------|
| Address: | 8692 9th Street, unit 42, Rancho Cucamonga, ca 91730 |
| TEL: | 1909-985-0648 |

# 2. Submission Devices Information:

Trade/Proprietary Name: 3S Safety Syringe with/without Needle Common Name: Syringe, Antistick Piston Syringe Classification name: Piston Syringe.. Class: 2. Panel: 80. Product codes: MEG Submission Type: 510(k) Requlation Number: 880.5860

#### 3. Predicate Devices Information:

| Trade Name: | Otter Safety Syringe |
|----------------|----------------------|
| 510(K) Number: | K040545 |

# 4. Devices Description:

The 3S Safety Syringe with/without Needle is an integrated needle and piston syringe with an innovative anti-needle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision.

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Image /page/4/Picture/0 description: The image shows the logo of Sincere Medical Device Co., Ltd. The logo consists of a green circular emblem with the letter 'S' inside, accompanied by the company name in a simple, sans-serif font. The text is in a dark gray color, providing a clear contrast against the white background.

510(k) Submission

#### [3S Safety Syringe]

Rev 0.02 05/02/15

The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.5cc/ml + 28G x 1/2" to 20G x 1 1/2") and the largest (10cc/ml)

# 5. Intended Use:

The 3S Safety Syringe with/without Needle is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

# 6. Technological Characteristics:

Through comparisons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

| Element of Comparison | Submission Device | Predicate Device<br>K040545 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The 3S Safety Syringe is an<br>integrated needle and piston<br>syringe with an innovative anti-<br>needle-stick mechanism. The<br>design incorporates the ideal<br>features desired in a safety<br>syringe. No special techniques<br>are required to use the safety<br>mechanism. The mechanism<br>allows clear visualization of the<br>injection site at all times. The<br>mechanism clearly shows that<br>the needle has been crushed<br>within the syringe barrel. After<br>standard techniques for<br>injection, the plunger is<br>withdrawn completely into the<br>barrel. Snap off plunger and<br>discard used syringe in a sharp<br>container per regulatory<br>provision. | The Otter Safety Syringe is an<br>integrated needle and piston<br>syringe with an innovative anti-<br>needle-stick mechanism. The<br>design incorporates the ideal<br>features desired in a safety<br>syringe. No special techniques<br>are required to use the safety<br>mechanism. The mechanism<br>allows clear visualization of the<br>injection site at all times. The<br>mechanism clearly shows that<br>the needle has been crushed<br>within the syringe barrel. After<br>standard techniques for<br>injection, the plunger is<br>withdrawn completely into the<br>barrel. A forward compression<br>of the plunger again and the<br>needle is crushed within the<br>puncture-resistant barrel. This<br>renders the needle unusable<br>and safe from accidental<br>needle sticks. |
| Principle of Operation | Normal | Normal |
| Syringe Capacity | Various Sizes | Various Sizes |
| Nozzle Type | Luer Slip & Luer Lock | Luer Slip & Luer Lock |
| Lubricant for Barrel | Silicone Oil | Silicone Oil |
| Barrel Transparency | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible |

#### Safety Syringe Comparison Table

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Image /page/5/Picture/0 description: The image shows a logo with a green circular design. Inside the circle is a stylized letter 'S' in brown. Below the circle, the words 'SINCERE MEDICAL' are written in a curved fashion, following the shape of the circle. The logo appears to be for a medical organization or company.

Sincere Medical Device Co., Ltd.

510(k) Submission

[3S Safety Syringe]

Rev 0.02 05/02/15

| Materials | | |
|-----------------------------------|------------------------------------------|------------------------------------------|
| Barrel | PP | PP |
| Plunger | PP | PP |
| Piston | SILICONE | SILICONE |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Needle Sheath | PP | PP |
| Needle Gauge and Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Sharps Injury Prevention Features | Manual Retractable | Manual Retractable |
| Performances | Conforms to ISO7864 ISO7886 | Conforms to ISO7864 ISO7886 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |

# 7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.

END