Syringe with safety needle, Safety needle

K193526 · Jiangsu Caina Medical Co.,Ltd · FMF · Jul 17, 2020 · General Hospital

Device Facts

• Record ID: K193526
• Device Name: Syringe with safety needle, Safety needle
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: FMF · General Hospital
• Decision Date: Jul 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Device Story

Manual syringe and safety needle system; used for aspiration and injection of medical fluids. Device consists of barrel, plunger, piston, needle hub, needle tube, and manually activated safety shield. Operator manually draws fluid into syringe and injects; upon withdrawal from patient, operator manually slides safety shield over needle to prevent accidental sticks. Used in clinical settings by healthcare professionals. Benefits include reduced risk of sharps injury to clinicians. No electronic or automated components.

Clinical Evidence

No clinical study included. Bench testing only. Simulated clinical study performed per FDA guidance for sharps injury prevention features and ISO 23908:2011; results met pre-established criteria. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, pyrogenicity) and physical/mechanical testing (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-1) confirm safety.

Technological Characteristics

Manual piston syringe and hypodermic needle with safety shield. Materials evaluated for biocompatibility per ISO 10993. Sterilization via Ethylene Oxide (EO) to SAL 10^-6. Connectors comply with ISO 80369-7 (luer lock). Needle tubing stainless steel per ISO 9626. Color-coded hubs per ISO 6009. No software or electronic components.

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic needle/syringe use. Intended for use by clinicians to minimize accidental needle stick injuries post-withdrawal.

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

• Sterile Disposable Syringe with Safety Needle (K170651)

Reference Devices

• BD Eclipse™ Hypodermic Needle (K161170)

Submission Summary (Full Text)

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July 17, 2020

Jiangsu Caina Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K193526

Trade/Device Name: Syringe with safety needle, Safety needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FMF, MEG Dated: June 5, 2020 Received: June 23, 2020

Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Alan M. Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193526

Device Name Syringe with Safety Needle Safety Needle

# Indications for Use (Describe)

The Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="display: inline-block;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display: inline-block;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary: K193526

- 1. Date of Preparation: 07/17/2020
- 2. Sponsor Identification

Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jianwei Pan Position: Management Representative Tel: [phone]-8027 Fax: [phone]-8009 Email:[e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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: Syringe with Safety Needle, Safety Needle Common Name: Piston syringe and antistick needle

Regulatory Information Classification Name: Syringe, Piston Classification: II: Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;

Classification Name: Needle, Hypodermic, Single Lumen Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570; Review Panel: General Hospital;

Classification Name: Syringe, Antistick Classification: II; Product Code: MEG: Regulation Number: 21 CFR 880. 5860; Review Panel: General Hospital

5. Identification of Predicate Device and Reference Device

## Predicate Device Information:

510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle (used as predicate device) Sterile Disposable Needle

Regulatory Information Classification Name: Syringe, Piston Classification: II: Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;

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Classification Name: Needle, Hypodermic, Single Lumen Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570; Review Panel: General Hospital;

Classification Name: Syringe, Antistick Classification: II; Product Code: MEG; Regulation Number: 21 CFR 880.5860; Review Panel: General Hospital;

### Reference Device Information:

510(k) Number: K161170 Product Name: BD Eclipse™ Hypodermic Needle

Regulatory Information Classification Name: Needle, Hypodermic, Single Lumen Classification: II; Product Code: FMI: Regulation Number: 21 CFR 880.5570; Review Panel: General Hospital;

#### 6. Indications for Use:

The Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

### 7. Device Description

The proposed devices are provided in two types of configurations; one type is a syringe with safety needle contained in a sterility maintenance package, the other is one safety needle contained in a sterility maintenance package.

The Syringe with Safety Needle is available in various combination of syringe volume and needle size. The proposed device is operated manually. The liquid is aspiration into the syringe by pulling the

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plunger manually and injected into the body by pushing the plunger manually. When the needle is pulled out from the body, push the safety shield to cover the needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10% and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

- Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device | Predicate Device | Referenced Device | Remark |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | K170651 | K161170 | |
| Product | Syringe with Safety Needle | Sterile Disposable Syringe with Safety Needle | BD EclipseTM / Hypodermic Needle | |
| Product Code | FMF<br>FMI<br>MEG | FMF<br>FMI<br>MEG | FMI | Same |
| Regulation Number | 21 CRF 880.5860<br>21 CRF 880.5570 | 21 CRF 880.5860<br>21 CRF 880.5570 | 21 CRF 880.5570 | Same |
| Class | Class II | Class II | Class II | Same |
| Indication for Use | The Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. | The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental | The BD EclipseTM Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes. The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated | Same |

Table 1 General Comparison of Syringe with Safety Needle

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| | | | needle sticks. | | position the needle<br>cover guards against<br>accidental needle<br>sticks during normal<br>handling and disposal<br>of the used needle/<br>syringe combination. | |
|---------------|---------|--------------------------|----------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Configuration | Syringe | Barrel<br>(luer<br>lock) | Syringe | Barrel<br>(luer<br>lock/luer<br>slip) | / | Different |
| | | Plunger | | Plunger | / | |
| | | Piston | | Piston | / | |
| | Needle | hub | Needle | hub | hub | |
| | | Needle tube | | Needle<br>tube | Needle tube | |
| | | Needle cap | | Needle<br>cap | Needle cap | |
| | | Safety shield | | Safety<br>shield | Safety shield | |

# Different-Configuration

The configuration of proposed syringe with safety needle is similar as predicate device, considering the needle may become disengaged from the syringe when activating the safety shield for the syringe with luer-slip connector, therefore the proposed syringe with safety needle doesn't have the configuration of barrel with luer-slip connector. We think the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

| Operation Mode | | | | |
|----------------|---------------------------------------|--------------------------------------------------|-------------------------------|-----------|
| | For manual use only | For manual use only | For manual use only | Same |
| Sterilized | Yes | Yes | Yes | Same |
| Single Use | Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Syringe | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 60ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | / | Different |
| Needle | Connector<br>Type<br>Size | Luer Lock<br>16G,18G, | Luer Lock /Luer Slip / 19G, / | Different |

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| | 19G, 20G,<br>21G, 22G,<br>23G, 25G,<br>26G, 27G,<br>28G, 29G,<br>30G, 31G | 20G, 21G, 22G,<br>23G, 24G, 25G,<br>26G, 27G, 28G,<br>29G, 30G | |
|---------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------|
| Length | 13mm,<br>16mm,<br>20mm,<br>25mm,<br>32mm,<br>38mm | 8mm(5/16"),<br>13mm(1/2"),<br>16mm(5/8"),<br>20mm(3/4"),<br>25mm(1"),<br>32mm(1-1/4"),<br>38mm(1-1/2") | / |
| Needle<br>hub | Color-coded<br>per ISO<br>6009 | Color-coded per<br>ISO 6009 | Same |

# Different- Syringe Volume and Connector Type

The Syringe volume for proposed device is different from the predicate devices. However, this difference is just in dimension. Different volume device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the syringe volume of the proposed syringe with safety needle is covered by the range of the syringe volume of the predicate device. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

# Different-Needle Size and Length

The needle size and length for proposed device is different from the predicate device. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the needle length of the proposed syringe with safety needle is included in the range of the needle length of the predicate device. The needle size of the syringe with safety needle is very close to that of the comparison product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

| Cytotoxicity | No cytotoxicity | No cytotoxicity / | Same |
|-------------------|------------------------------|--------------------------------|------|
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity / | |
| Sensitization | No skin sensitization | No skin sensitization / | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity / | |
| Hemolysis | No Hemolysis | No Hemolysis / | |

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| Pyrogen | No Pyrogen | No Pyrogen | / | |
|-----------------|------------------|------------------|---|------|
| Method | EO Sterilized | EO Sterilized | / | Same |
| SAL | 10-6 | 10-6 | / | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | / | Same |

Table 2 General Comparison of Safety Needle

| ITEM | Proposed Device | Predicate Device | Remark |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | K170651 | |
| Product | Safety Needle | Sterile Disposable Safety Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Safety Needle is intended for use with luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. | The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | Same |
| Configuration | Hub<br>Needle tube<br>Needle cap<br>Safety shield | Hub<br>Needle tube<br>Needle cap<br>Safety shield | Same |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Connector Type | Luer Lock | Luer Lock /Luer Slip | Different |
| Needle Gauge | 31G, 30G, 29G, 28G, 27G, 26G,<br>25G, 23G, 22G, 21G, 20G, 19G,<br>18G, 16G | 16G,18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G, 28G,<br>29G, 30G | Different |
| Needle Length | 13mm, 16mm, 20mm, 25mm,<br>32mm, 38mm | 8mm(5/16"),<br>16mm(5/8"),<br>25mm(1"),<br>38mm(1-1/2")<br>13mm(1/2"),<br>20mm(3/4"),<br>32mm(1-1/4") | |
| Needle Hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same |
| Safety mechanism | Similar safety shield and same<br>manual activated mechanism. | Similar safety shield and same<br>manual activated mechanism. | Same |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | Same |
| Sensitization | No skin sensitization | No skin sensitization | Same |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | Same |
| Hemolysis | No Hemolysis | No Hemolysis | Same |
| Pyrogen | No Pyrogen | No Pyrogen | Same |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

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# Different-Connector type

The connector type of proposed needle is covered by the predicated device. Considering the needle may become disengaged from the syringe when activating the safety shield for the syringe with luer-slip connector, therefore the proposed safety needle is not available in luer-slip connector. Therefore, we think the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.

# Different-Needle Gauge and length

The proposed needle has extra 31G than the predicate device. And the 31G needle is similar the 30G in dimension. The needle gauge and length will be selected by physician per patient's condition. This difference does not affect intended use. Therefore, this difference does not affect substantially equivalence on safety and effectiveness

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#### 9. 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 results demonstrated that the proposed device complies with the following standards:

- > ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
- > ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- > ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- > ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- > ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- > ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- > ISO 9626:2016. Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- > ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
- > ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
- > ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- A USP<788> Particulate Matter in Injections

Physical. Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device meets the requirements of related standards.

| Item | Standard |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Item | Standard |
| Surface finish and appearance | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
| Item | Standard |
| Fluid leakage | Clause 6.1 of ISO 80369-7:2016 |
| Sub-atmospheric pressure air<br>leakage | Clause 6.2 of ISO 80369-7:2016 |
| Stress cracking | Clause 6.3 of ISO 80369-7:2016 |
| Resistance to separation form axial<br>load | Clause 6.4 of ISO 80369-7:2016 |
| Resistance to separation form<br>unscrewing | Clause 6.5 of ISO 80369-7:2016 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7:2016 |
| Item | Standard |
| General requirements | Clause 5 of ISO 7886-1:2017 |
| Extraneous matter | Clause 6 of ISO 7886-1:2017 |
| Lubricant | Clause 7 of ISO 7886-1;2017 |
| Tolerance on graduated capacity | Clause 8 of ISO 7886-1:2017 |
| Graduated scale | Clause 9 of ISO 7886-1:2017 |
| Barrel | Clause 10 of ISO 7886-1:2017 |
| Piston/ plunger assembly | Clause 11 of ISO 7886-1:2017 |
| Nozzle | Clause 12 of ISO 7886-1:2017 |
| Performance | Clause 13 of ISO 7886-1:2017 |
| Item | Standard |
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device |

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Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM

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F1929-15). The test result showed that the device package can maintain its integrity.

Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.

### Biocompatibility testing

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (<24 hours). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

- > Cytotoxicity,
- A Sensitization,
- > Intracutaneous,
- > Acute Systemic Toxicity,
- > Hemolysis.
- > Pyrogen
- > Particulate testing

### Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 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 both the test data of the proposed device is very close to the test data of the predicate device.

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# 10. Clinical Test Conclusion

No clinical study is included in this submission.

- 11. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the legally marketed predicate device