Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use

K212846 · Jiangsu Jichun Medical Devices Co., Ltd. · FMF · Aug 30, 2022 · General Hospital

Device Facts

• Record ID: K212846
• Device Name: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
• Applicant: Jiangsu Jichun Medical Devices Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Aug 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sterile Hypodermic Syringe for Single Use, with/without needle: The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration and injection of fluids for medical purposes. Sterile Hypodermic Needle for Single use: The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.

Device Story

Manual, single-use sterile hypodermic syringe and needle system; used for aspiration and injection of medical fluids. Components include polypropylene (PP) barrel, plunger, and needle hub; stainless steel needle tube; isoprene rubber plunger stopper; silicone oil lubricant; epoxy resin adhesive. Available in various needle gauges (18G-30G) and syringe volumes (1ml-100ml). Operated manually by clinicians in clinical settings. Device functions via standard piston-syringe mechanics. Benefits include sterile, single-use fluid delivery/aspiration. No software or electronic components.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), sterility (ISO 11135), and mechanical performance testing (ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 80369-20). Package and shelf-life validation (5 years) performed per ASTM and ISO standards.

Technological Characteristics

Materials: PP (barrel, plunger, hub, cap), stainless steel (needle), isoprene rubber (stopper), silicone oil (lubricant), epoxy resin (adhesive). Manual piston-syringe operation. Dimensions: 18G-30G needles, 1ml-100ml syringes. Sterilization: EO (SAL 10^-6). Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 80369-20, ISO 10993-1.

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes using sterile hypodermic syringes and needles. Intended for single use.

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 Hypodermic Syringe for Single use, with/without needle Sterile Hypodermic needle for Single use (K190002)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

August 30, 2022

Jiangsu Jichun Medical Devices Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K212846

Trade/Device Name: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: July 27, 2022 Received: August 2, 2022

Dear Charles Mack:

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 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 M. 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K212846

Device Name

Sterile Hypodermic Syringe for Single Use, with/without needle Sterile Hypodermic Needle for Single use

Indications for Use (Describe)

Sterile Hypodermic Syringe for Single Use, with/without needle:

The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.

Sterile Hypodermic Needle for Single use:

The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Jichun Medical Devices. The logo features the text "Jichun Medical Devices" in a light gray font. To the right of the text is the acronym "JJMD" in a bold, blue font.

# 510(k) Summary (21 CFR §807.92)

Date of Preparation: July 29, 2022

#### Submitter Information: l.

| Submitter Name: | Jiangsu Jichun Medical Devices Co., Ltd. |
|-----------------|---------------------------------------------------------------------------------|
| Address: | NO.98, Baiyang Bridge, Zhenglu Town, Tianning, Changzhou, Jiangsu, China 213111 |
| Contact Person: | Zhu Pingnan/Head of Firm |

### US Agent and Correspondent

Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: [phone] Email: [e-mail]

#### II. Device

| Trade Name: | Sterile Hypodermic Syringe for Single Use, with/without needle |
|-----------------------|----------------------------------------------------------------|
| Common Name: | syringe, piston |
| Regulation Number: | 21 CFR §880.5860 |
| Regulation Name: | Piston syringe |
| Regulatory Class: | II |
| Product Code: | FMF |
| Classification Panel: | General Hospital |

Sterile Hypodermic Needle for Single Use Trade Name: Common Name: needle, hypodermic, single lumen Regulation Number:21 CFR §880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: ll FMI Product Code: Classification Panel: General Hospital

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#### III. Predicate Device Information

| Manufacturer | Predicate Device | 510(k)<br>Number | Submitted Device |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------|
| Shanghai Kohope<br>Medical Devices<br>Co., Ltd | Sterile Hypodermic<br>Syringe for Single use,<br>with/without needle<br>Sterile Hypodermic<br>needle for Single use | K190002 | Sterile Hypodermic<br>Syringe for Single Use,<br>with/without needle,<br>and Sterile Hypodermic<br>Needle for Single Use |

# IV. Device Description:

# Sterile Hypodermic Syringe for Single Use, with/without needle:

The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.

# Sterile Hypodermic Needle for Single use:

The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.

The device is delivered in the following configurations:

| Needle Gauge | 18,19,20,21,22,23,24,25,26,27,28,29,30G |
|----------------|-----------------------------------------|
| Needle Length | 1/6"-1 1/2" |
| Syringe Volume | 1,2,3,5,10,20,30,50,60,100 ml |

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| Needle Gauge | Compatible Needle Length | Compatible Syringe Volume | Compatible Wall Type |
|--------------|-----------------------------|---------------------------|----------------------|
| 18G | 1", 1 1/2" | 50 ml, 60 ml, 100 ml | RW, TW |
| 19G | 1", 1 1/2" | 50 ml, 60 ml, 100 ml | RW, TW |
| 20G | 1", 1 1/2" | 10ml, 20ml, 30ml, 50 ml | RW, TW |
| 21G | 1", 1 1/4", 1 1/2" | 5ml, 10ml, 20ml, 30ml | RW, TW |
| 22G | 1", 1 3/16", 1 1/4", 1 1/2" | 3ml, 5ml, 10ml, 20ml | RW, TW |
| 23G | 1", 1 1/8", 1 1/4", 1 1/2" | 3ml, 5ml, 10ml | RW, TW |
| 24G | 3/4", 1" | 1ml, 2ml, 3ml, 5ml | RW, TW |
| 25G | 5/8", 1", 1 1/2" | 1ml, 2ml, 3ml | RW, TW |
| 26G | 1/2", 1" | 1ml, 2ml | RW, TW |
| 27G | 1/2", 3/4", 1", 1 1/2" | 1ml | RW, TW |
| 28G | 1/3", 1/2" | 1ml | RW, TW |
| 29G | 1/4", 1/2" | 1ml | RW, TW |
| 30G | 1/6", 1/2" | 1ml | RW, TW |

The specifications noted below are available for the subject devices:

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Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:

| Name | Material |
|-----------------|-----------------|
| Needle cap | PP |
| Needle tube | Stainless Steel |
| Needle hub | PP |
| Barrel | PP |
| Plunger stopper | Isoprene rubber |
| Plunger | PP |
| Ink | Black |
| Lubricant | Silicone oil |
| Adhesive | Epoxy resin |
| Colorant | PP masterbatch |

The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours).

## V. Indications for Use

#### Sterile Hypodermic Syringe for Single Use, with/without needle:

The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration and injection of fluids for medical purposes.

#### Sterile Hypodermic Needle for Single use:

The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.

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# VI. Comparison of Technological Characteristics with the Predicate Device Table 1 - Sterile Hypodermic Syringe for Single Use, with/without needle

| Features &<br>Description | Subject Device | Predicate Device | Comparison |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Numbers | K212846 | K190002 | - |
| Device Name | Sterile Hypodermic Syringe for<br>Single Use, with/without Needle | Sterile Hypodermic Syringe for<br>Single Use, with/without needle | - |
| Product Code | FMF | FMF | Identical |
| 21CFR Regulation | 880.5860 | 880.5860 | Identical |
| Class | 2 | 2 | Identical |
| Indication for Use | The sterile hypodermic syringe<br>for single use, with/without<br>needle is intended for use in the<br>aspiration and injection of fluids<br>for medical purposes. | The sterile hypodermic syringe<br>for single use, with/without<br>needle is intended to be used for<br>medical purposes to inject fluid<br>into or withdraw fluid from body. | Identical |
| Configuration | Piston<br>Plunger<br>Barrel | Piston<br>Plunger<br>Barrel | Identical |
| Operation mode | For Manual Use Only, For Single<br>Use only | For Manual Use Only, For Single<br>Use only | Identical |
| Syringe Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,<br>30ml, 50ml, 60ml and 100ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml,<br>30ml, 35ml, 50ml and 60ml | The difference does not raise new<br>questions of safety and effectiveness<br>of the proposed device. The subject<br>devices' syringe volume is different<br>from the predicate device but still<br>conforms to the same applicable<br>performance standards as predicate<br>device. |
| Needle Gauge | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,30G | Identical |
| Needle Length | 4~38 mm (1/6" ~ 1 1/2") | 4~38 mm | Identical |
| Features &<br>Description | Subject Device | Predicate Device | Comparison |
| Material: | | | |
| Barrel | PP | PP | Identical |
| Needle | PP, SUS304 | PP, SUS304 | Identical |
| Plunger | PP | PP | Identical |
| Plunger stopper | Isoprene Rubber | Isoprene Rubber | Identical |
| Performance | ISO 7886-1<br>ISO 7864<br>ISO 9626<br>ISO 80369-7<br>ISO 80369-20 | ISO 7886-1<br>ISO 7864<br>ISO 9626 | Identical |
| Biocompatibility | ISO10993-1 | ISO10993-1 | Identical |
| Sterilization | EO | EO | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Label/labeling | 21 CFR Part 801 | 21 CFR Part 801 | Identical |

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| Features &<br>Description | Subject Device | Predicate Device | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Numbers | K212846 | K190002 | - |
| Device Name | Sterile Hypodermic Needle for Single Use | Sterile Hypodermic Needle for Single Use | - |
| Product Code | FMI | FMI | Identical |
| 21CFR Regulation | 880.5570 | 880.5570 | Identical |
| Class | 2 | 2 | Identical |
| Indication for Use | The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purpose. | The sterile hypodermic needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Identical |
| Configuration | Protective cap<br>Needle tube<br>Adhesives<br>Needle hub | Protective cap<br>Needle tube<br>Adhesives<br>Needle hub | Identical |
| Operation mode | For Manual Use Only, For Single Use only | For Manual Use Only, For Single Use only | Identical |
| Needle Gauge | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,30G | Identical |
| Needle Length | 4~38 mm (1/6" ~ 1 1/2") | 4~38 mm | Identical |
| Material: | | | |
| Protective cap | PP | PP | Identical |
| Needle tube | Stainless steel (SUS304) | Stainless steel (SUS304) | Identical |
| Needle hub | PP | PP | Identical |
| Adhesives | Epoxy Resin | Epoxy Resin | Identical |
| Performance | ISO 7864<br>ISO 9626<br>ISO 80369-7<br>ISO 80369-20 | ISO 7864<br>ISO 9626 | Identical |
| Biocompatibility | ISO10993-1 | ISO10993-1 | Identical |
| Features &<br>Description | Subject Device | Predicate Device | Comparison |
| Sterilization | EO | EO | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Label/labeling | 21 CFR Part 801 | 21 CFR Part 801 | Identical |

# Table 2 - Sterile Hypodermic Needle for Single use

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#### VII. Performance Data

Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate compliance with the requirements of the consensus standards noted below.

### Non-clinical Testing

### Performance Testing

Performance Testing The subject device meets all performance standards for Sterile Hypodermic Needle: ISO 80369-7, Second edition 2020-12 ISO 80369-20, First edition 2015-05-15 ISO 7886-1 Second edition 2017-05 ISO 7864, Fourth edition 2016-08-01 ISO 9626, Second edition 2016-08-01

For the finished device, it meets the defined performance requirements through bench testing.

# Clinical Study

No clinical testing was performed.

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# Biocompatibility

The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours). The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.

- In Vitro Cytotoxicity Test (ISO10993-5: 2009) -
- Skin Sensitization Test (ISO10993-10: 2010) -
- -Intradermal Reactivity Test (ISO10993-10: 2010)
- Coaqulation test (ISO10993-4: 2002Amd1:2006(E) -
- Complement activity Test (ISO10993-4: 2002 Amd1: 2006(E) -
- Hemolytic Properties Test (ASTM F756-13) -
- Pyrogen Test (ISO 10993-11:2006) -
- USP 788 Particulate Matter in Injections

All of the pre-determined acceptance criteria were met.

# Sterility Information

The devices are EO sterilized. The sterilization conducted according to below standards:

- ISO11135
- ISO11737-1 -
- ISO11737-2 -
- -ISO 10993-7
- -ANSI/AAMI ST72

All of the pre-determined acceptance criteria were met.

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# Package and Shelf Life:

We conducted the package and shelf life verification testing noted below to support the shelf life claim:

- AAMI/ANSI/ISO 11137-1:2006/(R) 2010
- AAMI/ANSI/ISO 11737-2:2009 -
- AAMI/ANSI/ISO 11607-1:2006/(R) 2010 -
- ASTM F1929-98 (2004) -
- ASTM D4169-16 -
- ASTM F1980-07 -
- ASTM D3078-02 (2008) -
- ASTM F88/F88M-09 -

The testing was conducted as noted below:

- Product Performance Inspection (Chemical performance and Physical performance) -
- -Sterile Test
- Vacuum Leak Test -
- Dye penetration test -
- Agar Contact-Attack Test -
- -Tensile Seal Strength Test
- -Accelerated Aging Test

The test result supports the 5 years shelf life claim for the subject device from the sterilization date.

All of the pre-determined acceptance criteria were met.

# Clinical Test:

No clinical study is included in this submission.

# VIII. Conclusions:

Based on the information defined above, we conclude that the subject device is substantially equivalent to the marketed predicate device. Any difference between them does not pose a new question of safety and performance.