Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

K211329 · Jiangsu Kangbao Medical Equipment Co., Ltd. · MEG · Nov 15, 2021 · General Hospital

Device Facts

• Record ID: K211329
• Device Name: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
• Applicant: Jiangsu Kangbao Medical Equipment Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Nov 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Disposable 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 sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. The Sterile Disposable Safety Needle is intended to be used with a luer slip or 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 sticks. The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

Device Story

Manual, single-use sterile syringes and hypodermic needles; available in luer lock or luer slip configurations. Syringes consist of barrel, plunger, and piston; needles consist of hub, tube, and cap. Safety variants include a manually activated shield to cover the needle post-withdrawal to prevent accidental sticks. Used by clinicians for fluid aspiration and injection. Output is the physical delivery or withdrawal of fluids. Benefits include precise fluid management and reduced risk of sharps injury via safety mechanisms.

Clinical Evidence

No clinical data. Bench testing only. Includes biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogen, thromboresistance), physical/mechanical testing (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-1), and simulated clinical study for safety mechanism performance per ISO 23908.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, hub, cap), Polyisoprene (piston), Stainless Steel 304 (needle tube). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Luer lock/slip. Standards: ISO 7886-1 (syringes), ISO 7864/9626 (needles), ISO 80369-7 (connectors), ISO 10993 (biocompatibility).

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic delivery or fluid withdrawal. No specific patient population contraindications provided.

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

• Syringe with safety needle, Safety needle (K193526)

Submission Summary (Full Text)

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November 15, 2021

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

Re: K211329

Trade/Device Name: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: October 28, 2021 Received: October 29, 2021

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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542 of the Act); 21 CFR 1000-1050.

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-

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 mediation-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,

CAPT Alan Stevens Assistant 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K211329

# Device Name

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

# Indications for Use (Describe)

The Sterile Disposable 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 sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or 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 sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: K211329

- 1. Date of Preparation: 11/03/2021
- 2. Sponsor Identification

# Jiangsu Kangbao Medical Equipment Co., Ltd. 78#, North Suzhong Road Baoying 225800 Yangzhou PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3009742443

Contact Person: Rujun Tang Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (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 Disposable Syringe with Safety Needle

Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle Sterile Disposable Needle

Common Name: Syringes with 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: Piston Syringe Classification: II; Product Code: MEG; Regulation Number: 21 CFR 880. 5860; Review Panel: General Hospital

Indications for use:

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 needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

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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 needle sticks.

The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.

Device Description

The Sterile Disposable Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle.

Syringe volume: 1ml, 2ml, 3ml, 10ml, 20ml, 30ml, 50ml, 60ml

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of The Sterile Disposable Syringe with Safety Needle.

Needle specification: 23G*1/2", 23G*5/8", 23G*1", 23G*1-1/4" and 23G*1-1/2"

Compared with The Sterile Disposable Safety Needle, The Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Compared with The Sterile Disposable Syringe with Safety Needle, The Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism.

The proposed devices are sterilized by Ethylene Oxide a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

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- న్. Identification of Predicate Device
510(k) Number: K193526 Product Name: Syringe with safety needle, Safety needle

#### 6. Non-Clinical Test Conclusion

Nonclinical 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.
- A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- A ISO 10993-4:2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood
- > 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
- A ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- > 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 6009:2016 Hypodermic needles for single use Colour coding for identification A
- > 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 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals
- > 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
- > USP<85> Bacterial Endotoxins Test
- A USP<151> Pyrogen Test
- > USP<788> Particulate Matter in Injections

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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 |
| Color 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 leakage | Clause 6.2 of ISO 80369-7:2016 |
| Stress cracking | Clause 6.3 of ISO 80369-7:2016 |
| Resistance to separation form axial load | Clause 6.4 of ISO 80369-7:2016 |
| Resistance to separation form unscrewing | Clause 6.5 of ISO 80369-7:2016 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7:2016 |

General requirements

Clause 5 of ISO 7886-1:2017

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| 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 |
| Particulate testing | USP <788> |

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 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.

| 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<br>were performed on aging samples to verify the<br>claimed shelf life of the device |

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,
- > Sensitization,
- > Intracutaneous,
- > Acute Systemic Toxicity,
- > Hemolysis,
- A Pyrogen,

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- ア In vivo thromboresistance,
- > Complement activation.

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 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.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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#### 8. Summary of Technology Characteristics

| ITEM | Proposed Device | Predicate Device | Remark | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------|
| Product | Sterile Disposable Syringe with Safety Needle | Syringe with Safety Needle | / | |
| Product Code | FMF<br>FMI<br>MEG | FMF<br>FMI<br>MEG | SE | |
| Regulation Number | 21 CRF 880.5860<br>21 CRF 880.5570 | 21 CRF 880.5860<br>21 CRF 880.5570 | SE | |
| Class | Class II | Class II | SE | |
| Indication for Use | 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 needle sticks. | 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. | SE | |
| Configuration | Syringe | Syringe<br>Barrel (luer lock) | Analysis 1 | |
| | Barrel (luer lock/luer slip)<br>Plunger<br>Piston<br>Needle<br>Needle hub<br>Needle tube<br>Needle cap<br>Safety mechanism | Plunger<br>Piston<br>Needle hub<br>Needle tube<br>Needle cap<br>Safety shield | | |
| Operation Mode | For manual use only | For manual use only | SE | |
| Sterilized | Yes | Yes | SE | |
| Single Use | Single Use | Single Use | SE | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SE | |
| Syringe Volume | 1ml 2ml 3ml 5ml 10ml | 1ml 3ml 5ml 10ml 20ml 30ml | Analysis 2 | |
| | | 20ml, 30ml, 50ml, 60ml | 60ml | |
| | Connector<br>Type | Luer Lock and Luer Slip | Luer Lock | Analysis 1 |
| Needle | Size | 23G | 16G,18G, 19G, 20G, 21G, 22G,<br>23G, 25G, 26G, 27G, 28G, 29G,<br>30G, 31G | Analysis 3 |
| | Length | 1/2", 5/8", 3/4", 1", 1-1/4",<br>1-1/2" | 13mm(1/2"), 16mm(5/8"),<br>20mm(3/4"), 25mm(1"),<br>32mm(1-1/4"), 38mm(1-1/2") | SE |
| | Syringe Performance | Complied with<br>ISO 7886-1 | Complied with<br>ISO 7886-1 | SE |
| | Needle Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | SE |
| Luer | Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 80369-7 | SE |
| Patient-contact Materials | | | | |
| Barrel | | Polypropylene (PP) | Polypropylene (PP) | Analysis 4 |
| Plunger | | Polypropylene (PP) | Polypropylene (PP) | |
| Piston | | Polyisoprene Rubber | Polyisoprene | |
| Needle hub | | Polypropylene (PP) and blue<br>pigment | Polypropylene (PP) | |
| Needle tube | | Stainless Steel SUS 304 | Stainless Steel 304 | |
| Needle cap | | Polypropylene (PP) | Polypropylene (PP) | |
| Safety mechanism | | Polypropylene (PP) and blue<br>pigment | Polypropylene (PP) | |
| Lubricants | | Silicone oil | Polydimethylsiloxane | |
| Adhesive | | UV adhesive | Epoxy adhesive | |
| Biocompatibility | | | | |
| Cytotoxicity | | No cytotoxicity | Conforms to ISO 10993 series<br>standards | SE |
| Irritation | | No intracutaneous reactivity | | |
| Sensitization | | No sensitization | | |
| Systemic Toxicity | | No systemic toxicity | | |
| Hemolysis | | No Hemolysis | | |
| Pyrogen | | No Pyrogen | | |
| Complement<br>Activation | | Not show potentials to<br>activate complete system | | |
| In vivo<br>Thrombogenicity | | No thrombogenicity | | |
| Sterilization | | | | |
| Method | EO Sterilized | EO Sterilized | SE | |
| SAL | $10^{-6}$ | $10^{-6}$ | SE | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | SE | |
| ITEM | Proposed Device | Predicate Device | Remark | |
| Product | Sterile Disposable Syringe with Needle | Sterile Disposable Syringe with Safety Needle | / | |
| Product Code | FMF<br>FMI | FMF<br>FMI<br>MEG | Analysis 5 | |
| Regulation Number | 21 CRF 880.5860<br>21 CRF 880.5570 | 21 CRF 880.5860<br>21 CRF 880.5570 | Analysis 5 | |
| Class | Class II | Class II | SE | |
| Indication for Use | The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. | 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. | Analysis 6 | |
| Configuration | Syringe<br>Barrel (luer lock/luer slip)<br>Plunger<br>Piston<br>Needle<br>Needle hub<br>Needle tube<br>Needle cap<br>/ | Syringe<br>Barrel (luer lock<br>Plunger<br>Piston<br>Needle<br>Needle hub<br>Needle tube<br>Needle cap<br>Safety Shield | Analysis 7 | |
| Operation Mode | For manual use only | For manual use only | SE | |
| Sterilized | Yes | Yes | SE | |
| Single Use | Single Use | Single Use | SE | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SE | |
| Syringe Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 60ml | Analysis 8 | |
| Connector Type | Luer Lock and Luer Slip | Luer Lock | Analysis 7 | |
| Needle Size | 23G | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G | Analysis 9 | |
| | | | 30G, 31G | |
| | Length | 1/2", 5/8", 3/4", 1", 1-1/4",<br>1-1/2" | 13mm(1/2"),<br>20mm(3/4"),<br>32mm(1-1/4"), 38mm(1-1/2") | 16mm(5/8"),<br>25mm(1"),<br>SE |
| | Syringe Performance | Complied with<br>ISO 7886-1 | Complied with<br>ISO 7886-1 | SE |
| | Needle Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | SE |
| | Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 80369-7 | SE |
| | Patient-contact Materials | | | |
| Barrel | | Polypropylene (PP) | Polypropylene (PP) | Analysis |
| Plunger | | Polypropylene (PP) | Polypropylene (PP) | 10 |
| Piston | | Polyisoprene Rubber | Polyisoprene | |
| Needle hub | | Polypropylene (PP) and blue<br>pigment | Polypropylene (PP) | |
| Needle tube | | Stainless Steel SUS 304 | Stainless Steel 304 | |
| Needle cap | | Polypropylene (PP) | Polypropylene (PP) | |
| Lubricants | | Silicone oil | Polydimethylsiloxane | |
| Adhesive | | UV adhesive | Epoxy adhesive | |
| Biocompatibility | | | | |
| Cytotoxicity | | No cytotoxicity | Conforms to ISO 10993 series<br>standards | SE |
| Irritation |…