Sterile Hypodermic Safety Syringes for Single Use

K163162 · Jiangxi Hongda Medical Equipment Group , Ltd. · MEG · Mar 20, 2017 · General Hospital

Device Facts

• Record ID: K163162
• Device Name: Sterile Hypodermic Safety Syringes for Single Use
• Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Mar 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.

Device Story

Sterile hypodermic safety syringe for single use; manual operation; used to inject or withdraw fluids. Features integrated anti-needlestick mechanism activated manually post-injection. Available in various needle gauges (21G-23G) and lengths (1"-1.5"); Luer Lock connector. Intended for clinical use by healthcare professionals. Benefits include reduction of accidental needle stick injuries during fluid administration or withdrawal.

Clinical Evidence

No clinical study included. Evidence consists of bench testing (physical, mechanical, chemical) per ISO 9626, ISO 7886, ISO 594, and ISO 7864, plus biocompatibility testing per ISO 10993. A simulated clinical study was performed per FDA guidance to evaluate the safety mechanism, demonstrating the device met pre-established criteria.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, hub, cap), Polyisoprene (piston), Stainless Steel SUS304 (needle tube). Manual operation; Luer Lock connector. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 9626, ISO 7886, ISO 594, ISO 7864, ISO 10993, ASTM F88, ASTM F1140.

Indications for Use

Indicated for medical use to inject fluids into or withdraw fluids from the body, incorporating a manual anti-needlestick feature to prevent accidental injuries.

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

• Retractable Auto-Disable Syringe for single use, with/without needle (K072739)

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

March 20, 2017

JiangXi HongDa Medical Equipment Group Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K163162

Trade/Device Name: Sterile Hypodermic Safety Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMI Dated: February 14, 2017 Received: February 15, 2017

Dear Ms. Diana Hong:

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. Isting 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/ResourcesforYou/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, Tina Kiang -S

Tina Kiang, Ph.D. Acting 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) K163162

Device Name

Sterile Hypodermic Safety Syringes for Single Use

Indications for Use (Describe)

The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.

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

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------|
| <span></span> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163162

- 1. Date of Preparation: 03/15/2017
- 2. Sponsor Identification

## JiangXi HongDa Medical Equipment Group Ltd.

No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China

Establishment Registration Number: Not yet registered

Contact Person: Yang Xiaohua Position: Vice-general Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

# Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Sterile Hypodermic Safety Syringes for Single Use Common Name: Piston Syringe with Needle

Regulatory Information Classification Name: Syringe Antistick Classification: II Product Code: MEG Subsequent Product Code: FMI Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

### Indication for Use:

The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.

# Device Description

The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.

#### 5. Identification of Predicate Device

510(k) Number: K072739 Product Name: Retractable Auto-Disable Syringe for single use, with/without needle

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include:

Physical, Mechanical and Chemical Tests performed on the proposed device

| Materials | Clause 3 of ISO 9626:1991/AMD-1:200 |
|----------------|-------------------------------------|
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:200 |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:200 |

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| Limits for acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 |
|-----------------------------------|---------------------------------------|
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 |

### Cleanliness

- Limits for acidity or alkalinity Limits for extractable metals Size designation Colour coding Needle hub Sheath Needle tube Needle point Performance
### Cleanliness

| Limits for acidity or alkalinity | Clause 6 of ISO 7886:1993 |
|----------------------------------|----------------------------|
| Limits for extractable metals | Clause 7 of ISO 7886:1993 |
| Lubricant | Clause 8 of ISO 7886:1993 |
| Tolerance on graduated capacity | Clause 9 of ISO 7886:1993 |
| Graduated scale | Clause 10 of ISO 7886:1993 |
| Barrel | Clause 11 of ISO 7886:1993 |
| Piston/plunger assembly | Clause 12 of ISO 7886:1993 |
| Nozzle | Clause 13 of ISO 7886:1993 |
| Performance | Clause 14 of ISO 7886:1993 |

Dimension Gauging Liquid leakage Air leakage Separation force Stress cracking

Gauging Clause 4.1 of ISO 594-2:1998 Leakage Clause 4.2 of ISO 594-2:1998 Separation force Clause 4.3 of ISO 594-2:1998 Unscrewing torque Clause 4.4 of ISO 594-2:1998

Clause 4 of ISO 7864:1993 Clause 5 of ISO 7864:1993 Clause 6 of ISO 7864:1993 Clause 7 of ISO 7864:1993

Clause 8 of ISO 7864:1993 Clause 9 of ISO 7864:1993 Clause 10 of ISO 7864:1993 Clause 11 of ISO 7864:1993 Clause 12 of ISO 7864:1993 Clause 13 of ISO 7864:1993

Clause 5 of ISO 7886:1993

ISO 7886:1993 ISO 7886:1993 ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 Clause 3 of ISO 594-1:1986 Clause 4.1 of ISO 594-1:1986 Clause 4.2 of ISO 594-1:1986

Clause 4.3 of ISO 594-1:1986 Clause 4.4 of ISO 594-1:1986 Clause 4.5 of ISO 594-1:1986

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| Ease of assembly | Clause 4.5 of ISO 594-2:1998 |
|--------------------------|------------------------------|
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 |

Sterile Barrier Packaging Testing performed on the proposed device:

| Seal strength | ASTM F88/F88-09 |
|-------------------|----------------------|
| Internal pressure | ASTM F1140/F1140M-13 |

Sterilization and Shelf Life Testing performed on the proposed device:

| EO residue | ISO 10993-7:2008 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ECH residue | ISO 10993-7:2008 |
| Sterility test | ISO 11737-2: 2009 |
| Bacteria Endotoxin Limit | USP 36-NF 31<85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility<br>Tests were performed on real time aging samples to<br>verify the claimed shelf life of the device |

### Biocompatibility Testing

The patient-contact materials of Sterile Hypodermic Safety Syringes for Single Use are identified and biocompatibility testing is performed according to ISO 10993 standards

# Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

### Safety Feature Test

The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that the proposed device did not show a significant difference from predicate device.

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#### 7. Clinical Test Conclusion

No clinical study is included in this submission.

#### Substantially Equivalent (SE) Comparison 8.

# Table 1 Comparison of Technology Characteristics

| Item | Proposed Device | Predicate Device<br>K072739 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------|
| Product Code | MEG | Same | |
| Regulation Number | 21 CFR 880.5860 | Same | |
| Class | II | Same | |
| Indication for Use | The Sterile Hypodermic Safety Syringes for<br>Single Use is intended to be used for medical<br>purpose to inject fluids into or withdraw fluids<br>from the body. After injection, the<br>anti-needlestick feature is manually activated to<br>aid in the prevention of accidental needle stick<br>injuries. | Similar | |
| Configuration<br>and material | Barrel | Polypropylene (PP) | Same |
| | Plunger | Polypropylene (PP) | |
| | Piston | Polyisoprene | |
| | Needle hub | Polypropylene (PP) | |
| | Needle cap | Polypropylene (PP) | |
| | Needle tube | Stainless Steel, SUS304 | |
| Operation Mode | For manual use only | | Same |
| Syringe Volume | 5ml | | 3ml, 5ml, 10ml |
| Connector Type | Luer Lock | | Same |
| Needle Gauge and<br>Length | Gauge:21G, 22G, 23G<br>Length: 1", 1 1/4", 1 1/2" | | Similar |
| Biocompatibility | Cytotoxicity | No cytotoxicity | Same |
| | Irritation | No intracutaneous reactivity | |
| | Sensitization | No skin sensitization | |
| | Systemic Toxicity | No systemic toxicity | |
| | Hemolysis | No Hemolysis | |
| | Pyrogen | No Pyrogen | |
| Sterilization | EO Sterilization | | Same |
| SAL | $10^{-6}$ | | Same |
| Single Use | Yes | Same | |
| Label/Labeling | Complied with 21 CFR part 801 | Same | |

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The Sterile Hypodermic Safety Syringe for Single Use is similar to the predicate device in device design, Indications for use, materials, sterilization, method of operation and technological characteristics. The differences are in needle lengths/gauges and barrel sizes. The predicate device submission K072739 also includes insulin syringes and non-safety svringes but the subject device is claiming substantial equivalence to the predicates safety syringe. Through performance testing comparison the subject device and predicate device have demonstrated substantial equivalence.

#### 9. Substantially Equivalent (SE) Conclusion

Based on the bench performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.