The Well-life™ Safety Pen Needles and Well-life™ Pen Needles are single use, sterile, disposable medical devices intended to be used with compatible insulin pen injectors. The pen needles are intended for use by adults and pediatrics in a home, clinical, or hospital environment. The devices are sterilized by Ethylene Oxide (EO) to a sterility assurance level of 10 °. The Well-life™ Pen Needles consist of a Needle, Hub, Needle Cap, and Sterile Cap. The Well-life™ Safety Pen Needles consist of a Needle, Hub, Needle Cap, Sterile Cap, Guide, Safety Cap, and Spring. To use the devices, the Needle Hub is screwed onto a compatible pen injector. The Well-life™ Safety Pen Needle (i.e., S type) is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin, the Needle Cap will retract. After the injection is completed and needle is removed from the skin, the safety cap will automatically extend to cover the needle. Once the pen needle is locked out, it can no longer be used.

AI/ML Overview

The provided text describes the 510(k) premarket notification for "Well-life™ Pen Needles" and "Well-life™ Safety Pen Needles." This submission focuses on establishing substantial equivalence to legally marketed predicate devices through performance data (bench testing and biocompatibility) and a comparison of device characteristics.

However, the provided document DOES NOT describe an AI/ML-driven medical device. Therefore, it is not possible to extract information related to:

Acceptance criteria for an AI/ML model
A study proving an AI/ML device meets acceptance criteria
Sample size for a test set or its provenance for an AI/ML model
Number of experts for ground truth establishment for an AI/ML model
Adjudication methods for an AI/ML model's test set
Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance
Standalone performance of an algorithm (AI only)
Type of ground truth used for an AI/ML model
Sample size for the training set of an AI/ML model
How ground truth for the training set was established for an AI/ML model

The document details the physical and biological testing of the pen needles to ensure they meet established standards and are substantially equivalent to the predicate devices. The "performance data" section (page {5}) lists various tests and their requirements, predominantly referencing ISO standards for physical characteristics, material properties, and sterility. The "biocompatibility" section (page {5} - {6}) lists tests related to the device's interaction with the human body. These are physical device performance evaluations, not AI/ML model performance evaluations.

Summary

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Image /page/0/Picture/0 description: The image contains 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 acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

W. L. Med Co., Ltd. % Peter Chung President Plus Global 300. Atwood Street Pittsburgh, Pennsylvania 15213

Re: K210748

Trade/Device Name: Well-life™ Pen Needles, Well-life™ Safety Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: April 25, 2022 Received: April 27, 2022

Dear Peter Chung:

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 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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210748

Device Name Well-life™ Safety Pen Needles Well-life™ Pen Needles

Indications for Use (Describe) This device is intended for use with pen injector devices for the subcutaneous injection of insulin.

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)

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510(k) Summary K210748

1. Applicant

1. Company : W. L. MED Co., Ltd.
Address : 246, Geumgwangosan-ro, Geumgwang-yeon, Anseong-si, Gyeonggi-do, Korea 2)
1. Tel : 82-31-8057-2162
1. Fax : 82-31-8057-2163
Prepared date : Feb 26, 2021 ട്)
Contact person : Peter Chung, 412-512-8802 ()
Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 7)
1. Submission date : May. 20, 2022

2. Device Information

1. Trade name : Well-life™ Safety Pen Needles and Well-life™ Pen Needles
Common name : Hypodermic single lumen needle 2)
Regulation name : Needle, hypodermic, Single Lumen 3)
1. Product code : FMI
Regulation number : 880.5570 5)
ର) Class of device : Class II
Panel : General Hospital 7)
1. Model Types

G-type
G2904	G2905	G2906	G2908	G2910	G2912	G3004	G3005
G3006	G3008	G3010	G3012	G3104	G3105	G3106	G3108
G3110	G3112	G3204	G3205	G3206	G3208	G3210	G3304
G3305	G3306	G3308	G3310	G3404	G3405	G3406	G3408
P-type
P2904	P2905	P2906	P2908	P2910	P2912	P3004	P3005
P3006	P3008	P3010	P3012	P3104	P3105	P3106	P3108
P3110	P3112	P3204	P3205	P3206	P3208	P3210	P3304
P3305	P3306	P3308	P3310	P3404	P3405	P3406	P3408
S-type
S2904	S2905	S2906	S2908	S2910	S2912	S3004	S3005
S3006	S3008	S3010	S3012	S3104	S3105	S3106	S3108
S3110	S3112	S3204	S3205	S3206	S3208	S3210	S3304
S3305	S3306	S3308	S3310	S3404	S3405	S3406	S3408

3. The legally marketed device to which we are claiming equivalence

Predicate Device #1: K113186, ShinaPen / SHINA CORPORATION

Predicate Device #2: K172095, Autokeeper / MedExel Co., Ltd.

4. Device description

The Well-life™ Pen Needles consist of a Needle, Hub, Needle Cap, and Sterile Cap. The Well-life™ Safety Pen Needles consist of a Needle, Hub, Needle Cap, Sterile Cap, Guide, Safety Cap, and Spring. To use the devices, the Needle Hub is screwed onto a compatible pen injector.

The Well-life™ Safety Pen Needle (i.e., S type) is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds

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with inserting the needle into the skin, the Needle Cap will retract. After the injection is completed and needle is removed from the skin, the safety cap will automatically extend to cover the needle. Once the pen needle is locked out, it can no longer be used.

Model	Gauge	Length	Wall Type	Model	Gauge	Length	Wall Type
G2904		4		P2904		4
G2905	29G	5		P2905	29G	5
G2906		6	RW	P2906		6	RW
G2908		8		P2908		8
G2910		10		P2910		10
G2912		12.7		P2912		12.7
G3004		4		P3004		4
G3005	30G	5		P3005	30G	5
G3006		6		P3006		6
G3008		8		P3008		8
G3010		10		P3010		10
G3012		12.7		P3012		12.7
G3104		4		P3104		4
G3105	31G	5		P3105	31G	5
G3106		6		P3106		6
G3108		8		P3108		8
G3110		10		P3110		10
G3112		12.7		P3112		12.7
G3204	32G	4	TW	P3204	32G	4	TW
G3205		5		P3205		5
G3206		6		P3206		6
G3208		8		P3208		8
G3210		10		P3210		10
G3304		4		P3304		4
G3305		5		P3305		5
G3306	33G	6		P3306	33G	6
G3308		8		P3308		8
G3310		10		P3310		10
G3404		4		P3404		4
G3405	34G	5		P3405	34G	5
G3406		6		P3406		6
G3408		8		P3408		8
S2904		4		S3110	31G	10
S2905	29G	5		S3112		12.7
S2906		6	RW	S3204		4
S2908		8		S3205		5	TW
S2910		10		S3206	32G	6
S2912		12.7		S3208		8
S3004	30G	4	TW	S3210			10

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S3005	5	S3304	4
S3006	6	S3305	5
S3008	8	S3306	33G 6
S3010	10	S3308	8
S3012	12.7	S3310	10
S3104	4	S3404	4
S3105	31G 5	S3405	34G 5
S3106	6	S3406	6
S3108	8	S3408	8

5. Intended Use

This device is intended for use with pen injector devices for the subcutaneous injection of insulin.

6. Performance data:

Bench testing was performed for the Well-life™ Safety Pen Needle and Well-life™ Pen Needle. The tests, shown 1) below, demonstrated that the device performs in a substantially equivalent manner to the predicate device.

Test item	Requirements
Dimension	ISO 11608-2:2012 Dimension, General, Dimension for needles
Flow rate	ISO 11608-2:2012 Determination of flow rate through the needle
Bond between hub and needle tube	ISO 11608-2:2012 Bond between hub and needle tube
Needle point freedom from defectslubrication test	ISO 11608-2:2012 Needle point, Freedom from defects, Lubrication
Dislocation of measuring point atpatient end	ISO 11608-2:2012 Dislocation of measuring point at patient end
Compatibility of needles and injectorsystem	ISO 11608-2:2012 Determination of functional compatibility with needle-basedinjection systems
Ease of assembly and disassembly	ISO 11608-2:2012 Ease of assembly and disassembly
Materials	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Surface finish and visual appearance	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Cleanliness	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Limits for acidity and alkalinity	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Size Designation	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Dimension	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Stiffness	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Resistance to breakage	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Resistance to corrosion	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
Simulated Clinical Use test	Referenced with ISO23908:2011
Elasticity	MFDS Notification No 2020-20 "Needle, aspiration/injection, single-use"
Flexural rigidity test	MFDS Notification No 2020-20 "Needle, aspiration/injection, single-use"
Draw test	Over 11N
Safety device operation test	The Safety cap should work after injection
Extraction test	MFDS Notification No 2020-20 "Needle, aspiration/injection, single-use"
Sterility	Korean Pharmacopeia / General Requirements for tests and assays / Sterility test
EO gas residuals	ISO 10993-7:2008 Ethylene oxide sterilization residuals

2) Biocompatibility

#	Test item	Test method / Test criteria
1	Cytotoxicity	ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
2	Acute systemic toxicity test	ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity
3	Pyrogen test	ISO 10993-11 Test for systemic toxicity, pyrogen test
4	Sensitization test	ISO 10993-10 (2010)

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5	Hemolytic test	ISO 10993-4:2017, ASTM F756-17
6	Intracutaneous reactivity test	ISO 10993-10 (2010)
7	Endotoxin test	ISO 10993-11 Tests for systemic toxicity

The performance tests demonstrated that the subject device performs in a substantially equivalent manner to the predicate device.

7. Predicate device comparison table Well-life™ Pen Needle

Device Name	Subject Device	Predicate Device #1	Remark	Device Name	Subject Device	Predicate Device #2	Remark
Manufacturer	W.L. MED	SHINA CORPORATION	N/A	Manufacturer	W.L. MED	MedExel	N/A
510(k) Number	N/A	K113186	N/A	510(k) Number	N/A	K172095	N/A
Product Code	FMI	FMI	Same	Product Code	FMI	FMI	Same
Design	Sterile Cap	Image: Sterile Cap Subject Device	Image: Sterile Cap Predicate Device	Similar	Design	Primary container	Image: Primary container of Subject Device	Image: Primary container of Predicate Device #2	Similar
	Needle Cap	Image: Needle Cap Subject Device	Image: Needle Cap Predicate Device	Similar		Intended Use	The Well-life safety pen needle is designed for use with a pen injector for the subcutaneous injection of insulin.	The MedExel Autokeeper is intended for use with insulin pens for the subcutaneous injection of insulin.Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks form the patient end of the needle. The shield also serves to hide the needle before and after injection.	Similar
	Needle And Hub	Image: Needle and Hub Subject Device	Image: Needle and Hub Predicate Device	Similar		Length	4mm, 5mm, 6mm, 8mm, 10 mm , 12.7mm	4mm, 5mm, 6mm, 8mm	Same
Intended Use	The Well-life pen needle is designed for use with a pen injector for the subcutaneous injection of insulin.	The ShinaPen® is designed for use with a pen injector for the subcutaneous injection of insulin.	Similar		Gauge	29G 30G 31G 32G, 33G, 34G	29G, 30G, 31G, 32G, 33G, 34G	Similar
Length	4mm, 5mm, 6mm, 8mm, 10 mm , 12.7mm	4mm, 6mm, 8mm, 12.7mm	Different		Biocompatibility	Conform ISO 10993-1	Conform ISO 10993-1	Same
Gauge	29G 30G 31G 32G, 33G, 34G	29G 30G 31G 32G	Different	Materials	Needle tube	STS304	STS304	Same
Biocompatibility	Conform ISO 10993-1	Conform ISO 10993-1	Same		Hub	1-Propene polymer with ethene	Polypropylene	Different
Materials	Needle	STS304	STS304		Same	Primary container	Polyethylene	Polyethylene	Same
	Hub	1-Propene polymer with ethene	Polypropylene		Same	Silicon	Poly di-methyl siloxane	Poly di-methyl siloxane	Same
	Needle cap	Polypropylene	Polyethylene	Different		Sterility	Sterilized by ethyleneoxide gas SAL = 10-6	Sterilized by ethyleneoxide gas SAL = 10-6	Same
	Silicon	Poly di-methyl siloxane	Poly di-methyl siloxane	Same
Sterility		Sterilized by ethylene	Sterilized by ethylene	Same
		oxide gasSAL = 10-6	oxide gasSAL = 10-6
Type of use	Single use, Disposable	Single use, Disposable	Same

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The subject device and predicate device outlined above consist of the same materials for each component. The difference in needle length does not impact substantial equivalence as the subject devices needle lengths are in range of the predicate. The difference in needle gauge does not impact substantial equivalence based on the performed bench testing. The difference in Hub material does not impact substantial equivalence based on performed biocompatibility testing.

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Well-life™ Safety Pen Needle

8. Conclusion

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate devices. Therefore, it is concluded that Well-life™ Pen Needles and Well-life™ Safety Pen Needles are substantially equivalent to the legally marketed predicate devices.

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).