Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use

K201284 · Set Medikal Sanayi VE Ticaret Anonim Sirketi · FMF · Dec 14, 2020 · General Hospital

Device Facts

• Record ID: K201284
• Device Name: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
• Applicant: Set Medikal Sanayi VE Ticaret Anonim Sirketi
• Product Code: FMF · General Hospital
• Decision Date: Dec 14, 2020
• Decision: SESE
• Submission Type: Abbreviated
• 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 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 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 hypodermic syringes, insulin syringes, and hypodermic needles. Syringes consist of barrel, plunger, and piston; needles feature hub and cannula. Operated manually by medical professionals, caregivers, or patients to aspirate or inject fluids. Insulin syringes include specific U-100 or U-40 calibration. Devices facilitate medication delivery or fluid withdrawal. Benefit: provides sterile, reliable means for fluid administration/aspiration. No electronic or automated components.

Clinical Evidence

Bench testing only. Conformance demonstrated with ISO 7886-1 (syringes), ISO 7864/9626 (needles), ISO 8537 (insulin syringes), and ISO 10993 series (biocompatibility: cytotoxicity, irritation, sensitization, systemic toxicity, hemocompatibility). Sterilization validated per ISO 11135.

Technological Characteristics

Materials: PP (barrel/hub/cap), PE (plunger), Isoprene Rubber (piston), SUS304 (needle), Epoxy resin (adhesive). EO sterilized (SAL 10^-6). Manual operation. Syringe volumes 0.3ml-60ml. Needle sizes 14G-30G. Complies with ISO 7886-1, ISO 7864, ISO 9626, ISO 8537.

Indications for Use

Indicated for medical professionals, trained caregivers, or patients requiring manual fluid aspiration or injection into body tissues. Includes hypodermic syringes (with/without needles) for general fluid injection/aspiration and insulin syringes (U-100/U-40) for subcutaneous insulin delivery.

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

• Shanghai Kohope Medical Devices Co., Ltd (K190002)

Submission Summary (Full Text)

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Build Correspondence

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December 14, 2020

Set Medikal Sanayi Ve Ticaret Anonim Sirketi % Mehmet Fatih Ormeci Consultant Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, 06830 Turkey

Re: K201284

Trade/Device Name: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, 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: November 11, 2020

Received: November 16, 2020

Dear Mehmet Fatih Ormeci:

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,

Rumi Young Acting 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)

Device Name

Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock

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)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Indications for Use

510(k) Number (if known)

Device Name

Sterile Insulin Syringe for Single use, with needle

Indications for Use (Describe)

The sterile insulin syringe for single use 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 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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 [e-mail]

"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 [e-mail]

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Image /page/5/Picture/0 description: The image contains the logo for "SET MEDIKAL". The logo consists of a blue square with a stylized "S" inside it on the left, followed by the text "SET MEDIKAL" in a gray, sans-serif font. The "S" in the square is also stylized, with a gap in the middle.

# K201284 510(k) Summary

| 510(k) Submitter Name | SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter Address | Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No:18 Esenyurt<br>İstanbul/TURKEY |
| 510(k) Submitter Telephone No | [phone] |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant)<br>[phone]<br>[e-mail]<br>Fax Number: [phone] |
| Summary Preparation Date | 11/24/2020 |

| Trade Or Proprietary Name | Sterile Hypodermic Syringe for Single use, with/without needle;<br>luer/luer-lock |
|---------------------------|-----------------------------------------------------------------------------------|
| | Sterile Insulin Syringe for Single use, with needle |
| | Sterile Hypodermic needle for Single use |
| Common Name | Hypodermic Syringe |
| | Insulin Syringe |
| | Hypodermic needle |
| Classification Name | Piston Syringe |
| | Piston Syringe |
| | Hypodermic Single Lumen Needle |
| Regulation Number | 21 CFR 880.5860 |
| | 21 CFR 880.5860 |
| | 21 CFR 880.5570 |
| Product Code | FMF |
| | FMF |
| | FMI |

| | Subject Device 510k No | Predicate Device 510k<br>No | Predicate Device<br>Manufacturer |
|-----------------------------------------------------------------------------------------|------------------------|-----------------------------|------------------------------------------------|
| Sterile Hypodermic<br>Syringe for Single use,<br>with/without needle;<br>luer/luer-lock | K201284 | K190002 | Shanghai Kohope<br>Medical Devices Co.,<br>Ltd |
| Sterile Insulin Syringe<br>for Single use, with<br>needle | K201284 | K190002 | Shanghai Kohope<br>Medical Devices Co.,<br>Ltd |
| Sterile Hypodermic<br>needle for Single use | K201284 | K190002 | Shanghai Kohope<br>Medical Devices Co.,<br>Ltd |

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Image /page/6/Picture/0 description: The image contains the logo for SER Medikal. The logo features a blue diamond shape with a stylized "S" inside. To the right of the diamond is the text "SER medikal" in a gray, sans-serif font. The text is all lowercase and has a modern, slightly futuristic appearance.

## Device Description

## Table 5.1. Device Description Summary for Hypodermic Syringe

| ITEM | Subject Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock |
| Indications for use | The Sterile Hypodermic Syringe for Single Use with/without needle is<br>intended to be used for medical purposes to inject fluid into or withdraw fluid<br>from body. |
| Configuration | Piston, Plunger, Barrel |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowing<br>the syringe to take in and expel the fluids through the connector to the patient. |
| length | 64-182mm |
| diameter | 6,6mm-31,6mm |
| tip type | luer/ luer lock/catheter/perfusion |
| needle tip configuration | Back bevel needle |
| nozzle type | Luer / Lock, %6 conical, 1,2 mm |
| barrel marking specs | 0,05ml-1ml |
| graduation legibility | Legible |
| needle cover dimensions | L: 35-55mm, D: 6-9mm |
| needle cover color | Transparent |
| lubricant composition | Silicone |
| barrel transparency | Transparent/ UV resistant/ opaque |
| needlecover strength | min. 2N max. 20N |
| hub/ needle bond strength | min. 22-69N |
| Product<br>performance | Complied with ISO 7886-1, ISO 7864, ISO 9626 |
| Volume | 2ml, 2,5ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, 24ml, 50ml and 60 ml |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G |
| Needle Lengths | 4–50 mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP/PE |
| Needle material | PP, SUS304 |
| SAL | $10^{-6}$ |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization<br>Acute Systemic Toxicity. Hemolytical effect) |

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Image /page/7/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with a white "S" inside of it. To the right of the square is the text "SER MEDIKAL" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

## Table 5.2. Device Description Summary for Insulin Syringe

| ITEM | Subject Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Sterile Insulin Syringe for Single use, with needle |
| Indications for use | The sterile insulin syringe for single use with needle, with the calibration unit of<br>insulin for U-100, is a device intended for medical purposes for the manual<br>aspiration of insulin, and for the injection of insulin into parts of the body<br>below the surface skin.<br>The sterile insulin syringe for single use with needle, with the calibration unit of<br>insulin for U-40 is a device intended for medical purposes for the manual<br>aspiration of insulin, and for the injection of insulin into parts of the body<br>below the surface skin. |
| Configuration | Needle Cap, Needle, Piston, Plunger, Barrel, End Cap |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Patient use |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel,<br>allowing the syringe to take in and expel the fluids through the connector to<br>the patient. |
| Product<br>performance | Complied with ISO 8537 |
| Volume | 0.3ml, 0.5ml, 1ml volumes with fixed needle |
| Needle Lengths | 8mm, 13mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |
| Needle material | SUS304 |
| Needle Cap material | PP |
| End Cap material | PP |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization<br>Acute Systemic Toxicity, Subchronic Toxicity, Hemolytic effect) |

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Image /page/8/Picture/0 description: The image contains the logo for SER Medikal. The logo consists of a blue square with a white "S" inside, followed by the text "SER medikal" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

| | | Table 5.3. Device Description Summary for Needle |
|--|--|--------------------------------------------------|
| | | |

| ITEM | Subject Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Sterile Hypodermic needle for Single use |
| 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. |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | For Manual Use Only, For Single Use only |
| Product performance | Complied with ISO 7864, ISO 9626 |
| Sizes | 14G,15G,16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G |
| Needle Lengths | 4–50 mm |
| Protective cap material | PP |
| Adhesive material | Epoxy resin |
| Needle Hub material | PP |
| Needle material | SUS304 |
| SAL material | 10-6 |
| Endotoxin Limit material | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |

# Technological Characteristics

## Table 5.4 Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock Predicate Comparison

| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | | | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| Product name | Sterile Hypodermic Syringe<br>for Single use, with/without<br>needle; luer/luer-lock | Sterile Hypodermic Syringe<br>for Single use, with/without<br>needle | Similar |
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | | | |
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| 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 |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Prescription use | Prescription use | 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 | The plunger of syringe can be<br>pulled and pushed along inside<br>the barrel, allowing the syringe<br>to take in and expel the fluids<br>through the connector to the<br>patient. | The plunger of syringe can be<br>pulled and pushed along<br>inside the barrel, allowing<br>the syringe to take in and<br>expel the fluids through the<br>connector to the patient. | 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 7886-1<br>ISO 7864<br>ISO 9626 | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | Same |
| Volume | 2ml, 2,5ml, 3ml, 5ml, 6ml, 10ml,<br>12ml, 20ml, 24ml, 50ml | 1ml, 3ml, 5ml, 6ml, 10ml,<br>20ml, 30ml, 35ml, 50ml and<br>60 ml | Difference 1 |
| Sizes | 14G,15G,16G,18G,19G,20G,<br>21G,22G,23G,24G,25G,26G,27G,<br>28G,29G,30G | 18G,19G,20G,21G,22G,23G,<br>24G,25G,26G,27G,28G,29G,<br>30G | Difference 2 |
| Needle Lengths | 4-50 mm | 4-38 mm | Difference 3 |
| Patient contact component and material | | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP/PE | PP | Difference 4 |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock | | | |
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

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Image /page/9/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with rounded corners and a white "S" inside. To the right of the square is the text "SER MEDIKAL" in a gray, futuristic-looking font. The logo is simple and modern, and the colors are clean and professional.

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Image /page/10/Picture/0 description: The image shows the logo for "SER MEDIKAL". The logo consists of a blue square with a white "S" inside on the left. To the right of the square is the company name, "SER MEDIKAL", in a gray, futuristic-looking font. The logo is simple and modern.

T

Table 5.5. Sterile Insulin Syringe for Single use, with needle Predicate Comparison

| Sterile Insulin Syringe for Single use, with needle | | | |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ITEM | Subject Device | Predicate Device<br>K190002 | 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<br>use | The sterile insulin syringe for single<br>use with needle, with the calibration<br>unit of insulin for U-100, is a device<br>intended for medical purposes for<br>the manual aspiration of insulin, and<br>for the injection of insulin into parts<br>of the body below the surface skin.<br>The sterile insulin syringe for single<br>use with needle, with the calibration<br>unit of insulin for U-40 is a device<br>intended for medical purposes for<br>the manual aspiration of insulin, and<br>for the injection of insulin into parts<br>of the body below the surface skin. | The sterile insulin syringe for single<br>use with needle, with the calibration<br>unit of insulin for U-100, is a device<br>intended for medical purposes for the<br>manual aspiration of insulin, and for<br>the injection of insulin into parts of<br>the body below the surface skin.<br>The sterile insulin syringe for single<br>use with needle, with the calibration<br>unit of insulin for U-40 is a device<br>intended for medical purposes for the<br>manual aspiration of insulin, and for<br>the injection of insulin into parts of<br>the body below the surface skin. | Same |
| Configuration | Needle Cap<br>Needle<br>Piston<br>Plunger<br>Barrel<br>End Cap | Needle Cap<br>Needle<br>Piston<br>Plunger<br>Barrel<br>End Cap | Same |
| Sterility<br>condition | EO Sterilized | EO Sterilized | Same |
| Environment<br>of use | Prescription use | Prescription use | Same |
| Intended users | Patient use | Patient use | Same |
| Single use | Yes | Yes | Same |
| Operation<br>mode | The plunger of syringe can be pulled<br>and pushed along inside the barrel,<br>allowing the syringe to take in and | The plunger of syringe can be pulled<br>and pushed along inside the barrel,<br>allowing the syringe to take in and | Same |

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Image /page/11/Picture/0 description: The image shows the logo for SER Medikal. The logo consists of a blue square with rounded corners and a white "S" inside. To the right of the square is the text "SER MEDIKAL" in a gray, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

T

T

| Sterile Insulin Syringe for Single use, with needle | | | |
|-----------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|------------|
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| | expel the fluids through the<br>connector to the patient. | expel the fluids through the<br>connector to the patient. | |
| Label/labeling | Complied with 21 CFR part<br>801 | Complied with 21 CFR part<br>801 | Same |
| Product<br>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<br>Lengths | 8mm, 13mm | 8mm, 13mm | Same |
| | Patient contact component and material | | |
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | SUS304 | SUS304 | Same |
| Needle Cap | PP | PP | Same |
| End Cap | PP | PP | Same |
| Sterilization | | | |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin<br>Limit | 20 EU per device | 20 EU per device | Same |

## Table 5.6. Sterile Hypodermic needle for Single use Predicate Comparison

| Sterile Hypodermic needle for Single use | | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| Product name | Sterile Hypodermic needle<br>for Single use | Sterile Hypodermic needle<br>for Single use | Same |
| 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<br>use is intended for use with syringes and<br>injection devices for general purpose<br>fluid injection/aspiration. | The Sterile Hypodermic Needle<br>for single use is intended for<br>use with syringes and injection<br>devices for general purpose<br>fluid injection/aspiration. | Same |

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Image /page/12/Picture/0 description: The image contains the logo for SER Medikal. The logo consists of a blue square with a stylized white "S" inside, followed by the text "SER MEDIKAL" in a gray, sans-serif font. The logo appears to be for a medical company.

| Sterile Hypodermic needle for Single use | | | |
|------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------|-----------------|
| ITEM | Subject Device | Predicate Device<br>K190002 | Comparison |
| Configuration | Protective cap<br>Needle<br>Adhesives<br>Needle hub | Protective cap<br>Needle<br>Adhesives<br>Needle hub | Same |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of<br>use | Prescription use | Prescription use | 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>perfo…