Predicate Devices

Reference Devices

K 131358

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and functionality of a pen needle for subcutaneous injection, with no mention of AI or ML.

Therapeutic

No.
This device is a needle intended for the delivery of therapeutic fluids (like insulin), not a therapeutic device itself that treats a condition.

Diagnostic

No

Explanation: The device is described as a "pen needle" intended for "subcutaneous injection of fluids, including insulin and exenatide." Its purpose is to deliver substances into the body, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical medical device (needles) and do not mention any software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the subcutaneous injection of fluids (like insulin and exenatide) using pen injector devices. This is a direct administration of a substance into the body, not a test performed in vitro (outside the body) on a sample from the body.
Device Description: The description clearly states it's an "injection needle intended for use with injection pens." This reinforces its function as a delivery mechanism, not a diagnostic tool.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on the physical and functional characteristics of the needle (dimensions, flow rate, bond strength, compatibility with pens), as well as biocompatibility and sterilization. These are relevant to a device used for injection, not for diagnostic testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication, which is a therapeutic action, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench tests relating to the performance of CareSens Pen Needle and Softip Pen Needle were conducted. Testing to voluntary standards ISO 11608-2 provides additional evidence that the performance of CareSens Pen Needle and Softip Pen Needle demonstrated equivalent performance to the Reference Device.

Performance tests conducted:

Dimension testing: ISO11608-2:2012 (4.2 Dimensions / 4.2.1 General / 4.2.2 Dimensions for needles), meets requirements
Flow rate testing: ISO11608-2:2012 (4.3 Determination of flow rate through the needle), meets requirements
Bond between hub and needle tube testing: ISO11608-2:2012 (4.4 Bond between hub and needle tube), meets requirements
Needle point freedom from defects lubrication test: ISO11608-2:2012 (4.5 Needle point / 4.6 Freedom from defects / 4.7 Lubrication), meets requirements
Dislocation of measuring point at patient end: ISO11608-2:2012 (4.8 Dislocation of measuring point at patient end), meets requirements
Compatibility of needles and injector system test / Ease of assembly and disassembly: ISO11608-2:2012 (4.9 Determination of functional compatibility with needle-based injection systems / 4.10 Ease of assembly and disassembly), meets requirements

Biocompatibility testing:

Cytotoxicity test (ISO 10993-5, Tests for in vitro Cytotoxicity, Test on extracts): Non-Cytotoxic
Intracutaneous (Intradermal) Reactivity Test (ISO 10993-10): Negligible
Sensitization Test (Guinea pig maximization test) (ISO 10993-10): Weak sensitizer
Acute systemic toxicity test (ISO 10993-11): Non-toxic
Pyrogen test (ISO 10993-11, USP Rabbit Pyrogen Test): Non-pyrogenic
Haemolysis test (ISO 10993-4): Non-hemolytic

Sterilization validation (EO gas sterilization, ISO 11135, SAL of 10^-6):

Packaging: PASS (case of injection or outer package should keep clean from microorganism and should not be broken before use. Also needle should be packed one by one.)
Sterility Test-Direct inoculation: PASS (The Korean pharmacopoeia Tenth edition (same as the FDA recognized consensus standard "USP 25 sterility test" are the same in test protocol.))
Ethylene oxide sterilization residuals: PASS (ISO 10993-7, Ethylene oxide sterilization residuals. The Sterilant Residual Limits per ISO 10993-7 for a limited exposure (

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2016

Yidobio Inc. Kyung Hee Yoon Excutive Director #3-1, 59-12, Dong-gil, Hyangnam-eup, Hwaseong-si Gyeonggi-do 18624 KOREA

Re: K160575

Trade/Device Name: CareSens Pen Needle and Softip Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 29, 2016 Received: August 10, 2016

Dear Kyung Hee Yoon:

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. 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.

1

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina
Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160575

Device Name

CareSens Pen Needle and Softip Pen Needle

Indications for Use (Describe)

The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

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

| > 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."

3

Image /page/3/Picture/0 description: The image shows a logo for YIDOBIO. The logo consists of two stylized letters, 'O' and 'B', intertwined together in a calligraphic style. Below the letters, the word "YIDOBIO" is written in a simple, sans-serif font. The color of the logo and the text is a muted gray.

510(k) SUMMARY – K160575

A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

| 1. Prepared by: | Joon Ho Jung
Regulatory Affairs
i-SENS, Inc.
Tel. +82-02-910-0453
Fax. +82-02-942-2514 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| 2. Prepared for: | Owner/Operator
YidoBio Inc.
59-12, Dongo4-gil, Hyangnam-eup
Hwaseong-si, Gyeonggi-do |
| 3. Contact person: | Kyung Hee Yoon
Executive Director
YidoBio Inc.
59-12, Dongo4-gil, Hyangnam-eup
Hwaseong-si, Hyangnam-eup |
| 4. Date Prepared: | February 1, 2016 |
| 5. Subject Device: | |
| Proprietary Name: | CareSens Pen Needle and Softip Pen Needle |
| Common Name: | Insulin Pen Needle |
| Regulation Name: | Needle, Hypodermic, Single Lumen |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Regulatory Class: | Class II |
| 6. Device Description | |

4

Image /page/4/Picture/0 description: The image shows a stylized monogram of the letters 'O' and 'B' in a flowing, intertwined design. The letters are rendered in a muted gray color, giving them a soft and elegant appearance. The design is intricate, with the curves of the letters overlapping and connecting to create a unified and visually appealing emblem. The overall impression is one of sophistication and classic style.

YIDOBIO

CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.

7. Predicate Device

The legally marketed device(s) to which substantial equivalence is claimed is/are:

K063466 TopFine® Insulin Pen, ● Manufactured by Daejin Tech Medical Manufacturing Co., Ltd., Korea

Regulation Name:	Needle, Hypodermic, Single Lumen
Regulation Number:	21 CFR 880.5570
Product Code:	FMI
Regulatory Class:	Class II

7.1 Reference device

K 131358 BD 31G and 32G Extra Thin Wall (XTM) Pen Needles with PentaPoint, manufactured by Becton, Dickinson and Company, New Jersey.

Regulation Name:	Needle, Hypodermic, Single Lumen
Regulation Number:	21 CFR 880.5570
Product Code:	FMI
Regulatory Class:	Class II

8. Reason for 510(K) Submission

This 510(k) is submitted to demonstrate substantial equivalence to the predicate device. CareSens Pen Needle and Softip Pen Needle. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.

The specifications of the product are as follows:

No.	Gauge (Outer diameter of Needle)	Length of needle	Weight
-----	----------------------------------	------------------	--------

5

Image /page/5/Picture/0 description: The image shows a stylized monogram consisting of the letters 'O' and 'B'. The letters are intertwined and feature elegant, flowing lines with flourishes, giving the monogram a sophisticated and decorative appearance. The color of the monogram is a muted gray, which adds to its subtle and refined aesthetic. The overall design suggests a logo or emblem, possibly for a brand or personal use.

		(mm) l	(g)
1	30G (0.298mm ~ 0.320mm)	8mm(5/16")
2	31G (0.254mm ~ 0.267mm)	5mm(3/16")
3		6mm(1/4")
4		8mm(5/16")	1.22
5	32G (0.229mm ~ 0.241mm)	4mm(5/32")
6		5mm(3/16")
7		6mm(1/4")
8	33G (0.204mm ~ 0.215mm)	4mm(5/32")

9. Indication For Use

The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

10. Technological Characteristics

Comparison with Predicate Device (K063466 TopFine Insulin Pen Needle)

The subject device, CareSens Pen Needle and Softip Pen Needle are similar in its intended use, principle of operation, design construction, sizes, material, and sterilization method. The subject device and predicate device both completed biocompatibility and sterility testing with similar results.

The subject device and the predicate device are classified under 21 CFR 880.5570. which states: "A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." The proposed device and the predicate device use statements similar in that they both are used with pen injector devices for subcutaneous injection of fluids, including insulin. The subject device is also used to inject exenatide.

Similarities between the Subject Devices and the Predicate Device
Item	Topfine Insulin Pen Needle
(K063466, Predicate device)	CareSens Pen Needle and
Softip Pen Needle
(subject device)
Intended use	Intended for subcutaneous
injection of insulin in the
treatment of diabetes.	Intended for use with pen
injector devices for
subcutaneous injection of fluids,
including insulin and exenatide.
Operation Principle	To be used with pen
injectors/Single use	Same

6

Image /page/6/Picture/0 description: The image shows a stylized monogram of the letters 'O' and 'B' intertwined. The letters are rendered in a soft gray color and feature flowing, calligraphic lines. The 'O' is positioned to the left and slightly above the 'B', with the curves of the letters overlapping to create a unified design. The overall effect is elegant and decorative.

YIDOBIO

| Design/Construction | • Needle assembly (cannula,
needle hub, protector cap) | Same |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Material | • Outer cap - Polypropylene
• Inner Cap - Polyethylene
• Needle – 304 Stainless
• Needle Silicone -
Polydimethylsiloxane
• Needle Hub – Polypropylene | Same |
| Gauges/
length of needle | 30G 8mm, 31G 5mm, 31G 6mm,
31G 8mm, 32G 4mm, 32G 5mm,
32G 6mm, 33G 4mm | Same |
| Sterilization | EO Gas sterilization | Same |
| Biocompatibility | In accordance to ISO 10993 | Same |

Comparison with the Reference Device (K131358 BD 31G and 32G Extra Thin Wall (XTM) Pen Needles with PentaPoint)

The reference device is used in comparison for performance bench testing in accordance to ISO 11608-2. The reference device is also indicated for use of the injection of both insulin and exenatide.

Similarities between the Subject Devices and the Reference Device
Item	CareSens Pen Needle and
Softip Pen Needle
(subject device)	BD 31G and 32G Extra
Thin Wall (XTM) Pen
Needles with PentaPoint
(K131358, Reference Device)
Intended use	CareSens Pen Needle and Softip
Pen Needle are Intended for use
with pen injector devices for
subcutaneous injection of fluids,
including insulin and exenatide.	BD Pen Needle is intended
for use with pen injector
device for subcutaneous
injection of drugs, including
insulin and exenatide.
Operation Principle	To be used with pen
injectors/Single use	Same
Design/Construction	Needle assembly (cannula,
needle hub, protector cap)	Same

7

Image /page/7/Picture/0 description: The image shows a stylized logo with intertwined letters, likely a monogram. The letters appear to be 'C' and 'B', rendered in a flowing, calligraphic style. Below the monogram, there is some text, but it is too blurry to read. The logo is presented in a light gray color against a white background.

| Material | • Outer cap - Polypropylene
• Inner Cap - Polyethylene
• Needle – 304 Stainless
• Needle Silicone –
Polydimethylsiloxane
• Needle Hub – Polypropylene | • Outer cap – Unknown plastic
• Inner Cap – Unknown plastic
• Needle - Stainless steel
• Needle Silicone – Unknown
• Needle Hub – Unknown
plastic |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | EO Gas sterilization | Gamma irradiation |
| Performance Bench | ISO 11608-2 | ISO 11608-2 |

Bench tests relating to the performance of CareSens Pen Needle and Softip Pen Needle were conducted. Testing to voluntary standards ISO 11608-2 provides additional evidence that the performance of CareSens Pen Needle and Softip Pen Needle demonstrated equivalent performance to the Reference Device.

11. Summary of performance tests

Dimension testing	ISO11608-2:2012 (4.2 Dimensions / 4.2.1 General / 4.2.2 Dimensions for needles), meets requirements
Flow rate testing	ISO11608-2:2012 (4.3 Determination of flow rate through the needle), meets requirements
Bond between hub and needle tube testing	ISO11608-2:2012 (4.4 Bond between hub and needle tube), meets requirements
Needle point freedom from defects lubrication test	ISO11608-2:2012 (4.5 Needle point / 4.6 Freedom from defects / 4.7 Lubrication), meets requirements
Dislocation of measuring point at patient end	ISO11608-2:2012 (4.8 Dislocation of measuring point at patient end), meets requirements
Compatibility of needles and injector system test / Ease of assembly and disassembly.	ISO11608-2:2012 (4.9 Determination of functional compatibility with needle-based injection systems / 4.10 Ease of assembly and disassembly), meets requirements

Biocompatibility

Biocompatibility testing of the subject device, Softip Pen Needle and CareSens Pen Needle, were conducted so ensure no physical harm on the human skin. Results of the testing demonstrate that the device is biocompatible. Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained. Results of the testing demonstrate that the device is biocompatible.

No.	Test Items	Test Method	Result
1	Cytotoxicity test	ISO 10993-5, Tests for in vitro Cytotoxicity,	Non-
		Test on extracts	Cytotoxic

8

Image /page/8/Picture/0 description: The image shows a stylized monogram consisting of the letters 'O' and 'B' intertwined. The letters are rendered in a flowing, calligraphic style with delicate curves and flourishes. The color of the monogram is a muted gray, giving it a soft and elegant appearance.

YIDOBIO

| 2 | Intracutaneous
(Intradermal)
Reactivity Test | ISO 10993-10,
Intracutaneous(Intradermal) reactivity test | Negligible |
|---|--------------------------------------------------------|--------------------------------------------------------------|--------------------|
| 3 | Sensitization
Test(Guinea pig
maximization test) | ISO 10993-10, Sensitization(Guinea pig
maximization test) | Weak
sensitizer |
| 4 | Acute systemic
toxicity test | ISO 10993-11, Acute systemic toxicity | Non-toxic |
| 5 | Pyrogen test | ISO 10993-11, USP Rabbit Pyrogen Test | Non-
pyrogenic |
| 6 | Haemolysis test | ISO 10993-4, Haemolysis testing-general
considerations | Non-
hemolytic |

Sterilization

EO gas sterilization method is utilized for assuring sterility of the subject device, Softip Pen Needle and CareSens Pen Needle. The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135. The sterilization validation has provided a Sterility Assurance Level (SAL) of 10°.

No.	Test items	Test Method
1	Packaging	The case of injection or outer package should keep clean
from microorganism and should not be broken before
use. Also needle should be packed one by one.	PASS
2	Sterility Test-Direct
inoculation	The Korean pharmacopoeia Tenth edition
(same as the FDA recognized consensus standard
"USP 25 sterility test" are the same in test
protocol.)	PASS
3	Ethylene oxide
sterilization residuals	If the product is sterilized by EO gas, it should be tested
in accordance with ISO 10993-7, Ethylene oxide
sterilization residuals. The Sterilant Residual Limits per
ISO 10993-7 for a limited exposure (