Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

K190002 · Shanghai Kohope Medical Devices Co., Ltd. · FMF · Sep 12, 2019 · General Hospital

Device Facts

• Record ID: K190002
• Device Name: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
• Applicant: Shanghai Kohope Medical Devices Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Sep 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

Manual, single-use sterile devices for fluid injection/aspiration or insulin delivery. Components include barrel, plunger, piston (isoprene rubber), and needle (stainless steel). Operated manually by medical professionals or patients. Syringes use Luer slip or Luer lock connectors; insulin syringes feature fixed needles. Devices function by manual plunger displacement within the barrel to aspirate or expel fluids. Used in hospital or home settings. Benefits include precise, sterile, single-use delivery of medications or withdrawal of body fluids.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with ISO 7886-1, ISO 7864, ISO 9626, ISO 8537, ISO 594-1/2, ISO 11135, ISO 10993-1/7, USP <85>, USP <788>, ASTM F88/F88M, and ASTM F1929.

Technological Characteristics

Materials: Polypropylene (PP) barrel/plunger/hub, isoprene rubber piston, stainless steel (SUS304) needle, epoxy resin adhesive. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Connectivity: None. Operation: Manual. Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 8537, ISO 594-1/2.

Indications for Use

Indicated for medical professionals, trained caregivers, and patients for manual fluid injection/aspiration or insulin delivery (U-40/U-100) into body tissues.

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, Sterile Insulin Syringe for Single use with Needle (U-40), Sterile Insulin Syringe for Use with Needle (U-100) (K112057)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

September 12, 2019

Shanghai Kohope Medical Devices Co., Ltd % Diana Hong Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn

Re: K190002

Trade/Device Name: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with 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 28, 2019 Received: August 9, 2019

Dear Diana Hong 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.

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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 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 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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## Indications for Use

510(k) Number (if known) K190002

Device Name

Sterile Hypodermic Syringe for Single use, with/without needle

Indications for Use (Describe)

The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Indications for Use

510(k) Number (if known) K190002

Device Name

Sterile Insulin Syringe for Single use, with needle

Indications for Use (Describe)

The sterile Insulin Syringe for Single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.

The sterile Insulin Syringe for Single use with the callbration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin into parts of insulin into parts of insulin into parts of the body below the surface skin.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known)

#### Device Name

Sterile Hypodermic needle for Single use

Indications for Use (Describe)

The sterile Hypodermic needle for Single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# K190002 510(k) Summary

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

- 1. Date of Preparation: 09/11/2019
- 2. Sponsor Identification

### SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD.

Room 1001, No.2 building, Lane 2888, South Qilian Mountains Road, Putuo District, Shanghai, 200331, China

Establishment Registration Number: Not yet registered

Contact Person: Yibing Wang Position: General Manager Tel: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (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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- Subject Device 4.
- Trade Name: Sterile Hypodermic Syringe for Single use, with/without needle a. Classification: II Regulation Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Common Name: Syringe, Piston Product Code: FMF
- b. Trade Name: Sterile Insulin Syringe for Single use, with needle Classification: II Regulation Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Common Name: Syringe, Piston Product Code: FMF
- Trade Name: Sterile Hypodermic needle for Single use c. Classification: II Regulation Name: Hypodermic single lumen needle Regulation Number: 21 CFR 880.5570 Common Name: Needle, Hypodermic, Single Lumen Product Code: FMI
- న్. Identification of Predicate Device 510(k) Number: K112057 Product Name: Sterile Hypodermic Syringe for Single use with/ without Needle, Sterile Hypodermic Needle for Single use, Sterile Insulin Syringe for Single use with Needle (U-40), Sterile Insulin Syringe for Use with Needle (U-100) Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd.

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| 6. Device Description | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sterile Hypodermic Syringe<br>for Single Use with/without<br>Needle | Sterile Insulin Syringe for<br>single use with Needle | Sterile Hypodermic<br>Needle for single use |
| Intended Use | The Sterile Hypodermic Syringe for Single Use with/without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. | The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.<br>The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration |
| Principle of<br>Operation | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. |
| Operation Mode | For manual use only | For manual use only | For manual use only |
| Configuration | Piston<br>Plunger<br>Barrel<br>(Needle) | Needle cover;<br>Needle;<br>Piston;<br>Barrel;<br>Plunger;<br>End cap | Protective cap;<br>Needle tube;<br>Adhesives;<br>Needle hub; |
| Nozzle | Luer Slip, Luer Lock | Fixed Needle | Luer Slip, Luer Lock |
| Volume/Sizes | Luer slip:<br>1,2,3,5,10,20,30,35,50,60(ml) | 0.3,0.5,1(ml)<br>29G, 30G, 31G | 18G, 19G, 20G, 21G,<br>22G, 23G, 24G, 25G |
| Device Name | Sterile Hypodermic Syringe<br>for Single Use with/without<br>Needle | Sterile Insulin Syringe for<br>single use with Needle | Sterile Hypodermic<br>Needle for single use |
| | Luer Lock:<br>1,2,3,5,10,20,30,35,50,60(ml)<br>18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G,<br>28G, 29G, 30G | | 26G, 27G, 28G, 29G,<br>30G |
| Material | Plunger: polypropylene (PP);<br>Barrel: polypropylene (PP);<br>Piston: isoprene rubber;<br>Hypodermic<br>needle:<br>polypropylene (PP), stainless<br>steel; | Needle cover: polypropylene<br>(PP);<br>Needle: stainless steel (SUS);<br>Piston: isoprene rubber;<br>Barrel: polypropylene (PP);<br>Plunger: polypropylene (PP);<br>End cap: polypropylene (PP); | Protective<br>cap:<br>polypropylene (PP)<br>Needle tube: stainless<br>steel (SUS)<br>Adhesives:<br>epoxy<br>resin:<br>Needle<br>hub:<br>polypropylene (PP) |

#### 6. Device Description

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Detailed specifications of the Sterile Hypodermic Needle for single use:

| Product Specification | Needle Gauge | Needle wall |
|-----------------------|--------------|-------------|
| 1.2 mm TW x38mm | 18G | TW |
| 1.1 mm TWx38mm | 19G | TW |
| 0.9 mm TWx38mm | 20G | TW |
| 0.8 mm TWx50mm | 21G | TW |
| 0.7 mm TWx38mm | 22G | TW |
| 0.6 mm TWx32mm | 23G | TW |
| 0.55 mm TWx25mm | 24G | TW |
| 0.55 mm RWx20mm | 24G | RW |
| 0.5 mm TWx25mm | 25G | TW |
| 0.5 mm RWx20mm | 25G | RW |
| 0.45 mm RWx16mm | 26G | RW |
| 0.4 mm RWx13mm | 27G | RW |
| 0.36 mm RWx8mm | 28G | RW |
| 0.33 mm RWx6mm | 29G | RW |
| 0.3 mm RWx4mm | 30G | RW |

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#### 7. Indications For Use

Sterile Hypodermic Syringe for Single Use, With/without Needle:

The sterile Hypodermic Syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

### Sterile Insulin Syringe for Single use, with Needle:

The sterile Insulin Syringe for Single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The sterile Insulin Syringe for Single use with needle, with the calibration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

Sterile Hypodermic needle for Single Use:

The sterile Hypodermic needle for Single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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

| | | Needle | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ITEM | Subject Device | Predicate Device<br>K112057 | Comparison |
| Product name | Sterile Hypodermic Syringe<br>for Single use, with/without<br>needle | Sterile Hypodermic Syringe<br>for Single use, with/without<br>needle | |
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for use | The Sterile Hypodermic<br>Syringe for Single Use<br>with/without needle is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw fluid<br>from body. | The Sterile Hypodermic<br>Syringe for Single Use<br>with/without needle is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw fluid<br>from body. | Same |
| Configuration | Piston<br>Plunger<br>Barrel | Piston<br>Plunger<br>Barrel | Same |

### Table 1 Comparison of Technology Characteristics of Sterile Hypodermic Syringe for Single Use, with/without

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| Sterility condition | EO Sterilized | EO Sterilized | Same |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Environment of use | Hospital | Hospital | Same |
| Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For Single Use only | For Manual Use Only, For Single Use only | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Product performance | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | Same |
| Volume | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml, 35ml, 50ml and 60 ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml, 35ml and 50ml | Different; the subject<br>device includes a 60 mL<br>model |
| Sizes | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,<br>30G | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,<br>30G | Same |
| Needle Lengths | 4–38 mm | Not provided | Same |
| Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Sterilization | | | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| ITEM | Subject Device | Predicate Device<br>K112057 | Comparison |
| Product name | Sterile Insulin Syringe for<br>Single use, with needle | Sterile Insulin Syringe for<br>Single use, with needle | Same |
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for use | The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-100, is a<br>device intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-100, is a<br>device intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | Same |
| | The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-40 is a device<br>intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | The sterile insulin syringe<br>for single use with needle,<br>with the calibration unit of<br>insulin for U-40 is a device<br>intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | |
| Configuration | Needle Cap | Needle Cap | Same |
| | Needle | Needle | |
| | Piston | Piston | |
| | Barrel | Barrel | |
| | Plunger | Plunger | |
| | End Cap | End Cap | |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment<br>of<br>use | Home use (OTC) | Home use (OTC) | Same |
| Intended users | Patient use | Patient use | Same |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For | For Manual Use Only, For | Same |
| | Single Use only | Single Use only | |
| Label/labeling | Complied with 21 CFR part | Complied with 21 CFR part | Same |
| | 801 | 801 | |
| Product performance | Complied with ISO 8537 | Complied with ISO 8537 | Same |
| Volume | 0.3ml, 0.5ml, 1ml volumes<br>with fixed needle | 0.3ml, 0.5ml, 1ml volumes<br>with fixed needle | Same |
| Needle lengths | 8mm, 13mm | Not provided | Same |
| Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle Cover | PP | PP | Same |
| Needle | Stainless Steel (SUS304) | Stainless Steel (SUS304) | Same |
| End Cap | PP | PP | Same |
| Sterilization | | | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

#### Discussion:

The indications for use statement for the subject device is identical to the predicate device.

The there are no technological differences between the predicate and subject devices for the 1 – 50 mL syringes and the hypodermic needles. This was verified by performance testing per ISO 7886-1, ISO 7864, and ISO 9626. The subject device includes a 60 ml syringe size not included in the predicate. However, performance testing to ISO 7886-1 has been conducted on this model and demonstrates that the 60ml syringe meets the requirements of the standard. The hypodermic needles were shown to comply with ISO 7864 and ISO 9626.

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#### Discussion:

The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the subject and the predicate device. This was verified by performance testing to ISO 8537. The intended use, principle of operation, materials, specification information for the subject device are the same as for the predicate device. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.

| ITEM | Subject Device | Predicate Device | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Sterile Hypodermic needle for Single use | Sterile Hypodermic needle for Single use | |
| Product code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Indications for use | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Same |
| Configuration | Protective cap<br>Needle tube | Protective cap<br>Needle tube | Same |

Table 3 Comparison of Technology Characteristics of Sterile Hypodermic Needle for Single Use

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| | Adhesives<br>Needle hub | Adhesives<br>Needle hub | |
|----------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|------|
| Sterility<br>condition | EO Sterilized | EO Sterilized | Same |
| Environment of<br>use | Hospital | Hospital | Same |
| Intended users | Medical professionals and<br>trained care givers | Medical professionals and<br>trained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For<br>Single Use only | For Manual Use Only, For<br>Single Use only | Same |
| Label/labeling | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | Same |
| Product<br>performance | Complied with:<br>ISO 7864<br>ISO 9626 | Complied with:<br>ISO 7864<br>ISO 9626 | Same |
| Gauges | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,<br>30G | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,<br>30G | Same |
| Needle lengths | 4 – 38 mm | Not provided | Same |
| Patient contact component and material | | | |
| Protective cap | PP | PP | Same |
| Needle tube | Stainless steel (SUS304) | Stainless steel (SUS304) | Same |
| Adhesives | Epoxy resin | Epoxy resin | Same |
| Needle hub | PP | PP | Same |
| Sterilization | | | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

### Discussion:

The indications for use statement for the subject device is identical to the predicate device.

There are no technological differences between the subject and the predicate device. This was verified by performance testing according to ISO 7864 and ISO 9626. The intended use, principle of operation, materials, specifications and sterilization information for the subject device are the same as for the predicate device. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.

#### 9. Non-Clinical Testing

Bench tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

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- For Sterile Hypodermic Syringe for single use, with/without needle a.
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use. ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.

- b. For Sterile Insulin Syringe for single use, with needle
ISO 8537:2016 Sterile single-use syringes, with or without needle. for insulin; ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.

- c. For Sterile Hypodermic Needle for single use
ISO 7864:2017, Sterile Hypodermic Needles for Single Use.

ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

ISO 594-1:1986, Conical Fittings with A 6% (Luer) Taper for Syringes. Needles and Certain Other Medical Equipment - Part 1: General Requirements.

ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.

The following standards are used to evaluate the sterilization and package integrity. The test results show that the proposed device complies with the requirements.

ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices;

ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals;

USP39-NF34 <85> Bacterial Endotoxin Limit

ASTM F88/F88M-15 standard test method for seal strength of flexible barrier materials;

ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration

In addition, accelerated aging testing was conducted to substantiate the 5 year shelf life of the proposed device.

#### Biocompatibility

The devices were tested for biocompatibility per ISO 10993-1 Biological evaluation of medical devices – Part

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1 : Evaluation and testing within a risk management process. The following tests were performed: Cytotoxicity, Irritation, Sensitization, Material Mediated Pyrogenicity, Acute Systemic Toxicity, In addition, the subject devices were tested for particulates per USP <788>.

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

- 11. Substantially Equivalent (SE) Conclusion
The proposed device, Sterile Hypodermic Syringe for single use, with/without needle, Sterile Insulin Syringe for single use with needle and Sterile Hypodermic Needle for single use, were demonstrated to be Substantially Equivalent (SE) to the predicate device K112057.