Well-life TM Pen Needles, Well-life TM Safety Pen Needles
Device Facts
| Record ID | K210748 |
|---|---|
| Device Name | Well-life TM Pen Needles, Well-life TM Safety Pen Needles |
| Applicant | W. L. Med Co., Ltd. |
| Product Code | FMI · General Hospital |
| Decision Date | May 25, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
This device is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Story
Single-use, sterile, disposable pen needles for subcutaneous insulin delivery. Used with compatible pen injectors in home, clinical, or hospital settings by patients or healthcare providers. Subject device includes standard pen needles and safety pen needles. Safety version features a spring-loaded shield that automatically extends to cover the needle after injection to prevent accidental needle sticks. User screws needle hub onto pen injector; needle cap retracts during skin insertion; safety cap locks after removal. Benefits include ease of use and protection against sharps injuries.
Clinical Evidence
Bench testing only. Testing included dimensional analysis, flow rate, bond strength, needle point defects, functional compatibility, and simulated clinical use per ISO 11608-2 and ISO 23908. Biocompatibility testing included cytotoxicity, systemic toxicity, pyrogenicity, sensitization, hemolysis, and intracutaneous reactivity per ISO 10993 series.
Technological Characteristics
Materials: Stainless steel (STS304) needle tubing, 1-Propene polymer with ethene hub. Dimensions: 29G-34G, 4mm-12.7mm lengths. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Mechanical operation: Manual assembly with spring-loaded safety shield mechanism for S-type models.
Indications for Use
Indicated for adults and pediatrics requiring subcutaneous insulin injection via pen injector devices.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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)
- 3) Tel : 82-31-8057-2162
- 4) 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)
- 8) 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)
- 4) Product code : FMI
- Regulation number : 880.5570 5)
- ର) Class of device : Class II
- Panel : General Hospital 7)
- 8) 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™ 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
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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 defects<br>lubrication test | ISO 11608-2:2012 Needle point, Freedom from defects, Lubrication |
| Dislocation of measuring point at<br>patient end | ISO 11608-2:2012 Dislocation of measuring point at patient end |
| Compatibility of needles and injector<br>system | ISO 11608-2:2012 Determination of functional compatibility with needle-based<br>injection 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 in<br>vitro cytotoxicity |
| 2 | Acute systemic toxicity test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for<br>systemic 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.<br>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 ethylene<br>oxide gas SAL = 10-6 | Sterilized by ethylene<br>oxide gas SAL = 10-6 | Same |
| | Silicon | Poly di-methyl siloxane | Poly di-methyl siloxane | Same | | | | | |
| Sterility | | Sterilized by ethylene | Sterilized by ethylene | Same | | | | | |
| | | oxide gas<br>SAL = 10-6 | oxide gas<br>SAL = 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
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.
#### 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.
