CPL Insulin Pen Needle

K151090 · Cpl Co., Ltd. · FMI · Sep 21, 2016 · General Hospital

Device Facts

• Record ID: K151090
• Device Name: CPL Insulin Pen Needle
• Applicant: Cpl Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Sep 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This is a single use sterile insulin pen-injector needle to be used by diabetic patients for the purpose of injecting insulin.

Device Story

Single-use sterile insulin pen-injector needle; consists of hub, needle, needle cap, sterile cap, and blister paper. Connects to various pen-type insulin syringes/injectors. Used by diabetic patients for self-administration of insulin. Needle cannula penetrates skin for subcutaneous delivery; withdrawn immediately after injection. Device ensures sterile delivery of medication; protects user via needle cap. Benefits include safe, effective insulin administration for diabetes management.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemolysis). Performance testing per ISO 11608-2, ISO 7864, and ISO 9626 included dimension, draw, elasticity, flexural rigidity, flow rate, bond strength, and needle dose accuracy. Results demonstrate substantial equivalence to predicate.

Technological Characteristics

Single lumen hypodermic needle; stainless steel 304 cannula; polypropylene hub; polyethylene needle cap. EO gas sterilization. Available in 29G, 30G, 31G, and 32G. Complies with ISO 11608-2, ISO 7864, ISO 9626, and ISO 10993-1 standards.

Indications for Use

Indicated for diabetic patients requiring subcutaneous insulin injection via pen-injector systems.

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

• Feel Fine Insulin Pen Needle (K080904)

Submission Summary (Full Text)

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

September 21, 2016

CPL Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K151090

Trade/Device Name: CPL Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 16, 2016 Received: August 23, 2016

Dear Mr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address

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

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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

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

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## Indications for Use

510(k) Number (if known) K151090

Device Name

CPL Insulin Pen Needle

Indications for Use (Describe)

This is a single use sterile insulin pen-injector need by diabetic patients for the purpose of injecting insulin.

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

الص Prescription Use (Part 21 CFR 801 Subpart D)

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

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Expiration Date: January 31, 2017

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# 510(k) Summary

# [as required by 807.92(c)] K151090

## 1. Applicant

- 1) Company : CPL Co.,Ltd.
- 2) Address : 36, Yongteurim-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
- 3) Tel : [phone]
- 4) Fax : [phone]
- 5) Contact person : Peter Chung, 412-687-3976
- 6) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
- 7) Date prepared : September 16, 2016

## 2. Device Information

- 1) Trade Name : CPL Insulin Pen Needle
- 2) Common Name : Hypodermic single lumen needle
- 3) Classification Name : Needle, Hypodermic, Single Lumen
- 4) Product Code : FMI
- 5) Regulation Number : 880.5570
- 6) Class of device : Class II
- 7) Panel : General Hospital

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

K080904 Feel Fine Insulin Pen Needle (Company : Feel Tech)

### 4. Device description

CPL insulin pen needle consist of a sterile cap, needle, hub and blister paper. The sterile cap and blister paper function to sustain sterilization of the product. The hub can be connected with pen type insulin syringe. The needle cap protects the needle. This device is single use.

| | Model | Needle length (mm) : | |
|----------------------------|--------------|------------------------|---------------------------|
| Patient-side tip | CPLPN-29 | 8mm, 10mm, 12mm | |
| | CPLPN-30 | 5mm, 8mm, 10mm, 12 mm | |
| | CPLPN-31 | 4mm, 5mm, 6mm, 8mm | |
| | CPLPN-32 | 4mm, 5mm, 6mm, 8mm | |
| Cartridge-side tip | CPLPN-29 | | |
| | CPLPN-30 | 5mm, | |
| | CPLPN-31 | | |
| | CPLPN-32 | | |
| Needle taper | | 3.5mm | |
| Wall type<br>(Thin-walled) | Needle gauge | Range of out diameters | Inside diameter of tubing |
| | CPLPN-29 | 29G(0.324mm~0.351mm) | 29G (0.190) |
| | CPLPN-30 | 30G (0.298mm~0.320mm) | 30G (0.165) |
| | CPLPN-31 | 31G (0.254mm~0.267mm) | 31G (0.125) |
| | CPLPN-32 | 32G (0.229mm~0.241mm) | 32G (0.105) |

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### 5. Intended Use :

This is a single use sterile insulin pen-injector needle to be used by diabetic patients for the purpose of injecting insulin.

### 6. Performance data:

In accordance with ISO 10993-1, CPL Insulin Pen Needle is classified as : Externally Communicating Device, Blood Path Indirect, Shor Term (<24 hours) Use, as the cannula is immediately withdrawn after injection into the body. This classification was chosen as "worst case scenario."

PER ISO 10993-1, the following tests were performed for this classification:

- 1. Cytotoxicity
- 2. Sensitization
- 3. Intracutaneous reactivity (Acute)
- 4. Systemic toxicity (Acute)
- 5. Pyrogenicity
- 6. Hemolysis

Bench tests relating to the performance of the "CPL Insulin Pen Needle" were conducted. The principal device demonstrated equivalent performance to the predicate devices during bench testing. Bench testing consisted of:

| Inner/outside and structure | |
|---------------------------------------------------|---------------|
| Dimension | |
| Draw test | |
| Elasticity test | |
| Flexual rigidity | |
| Inner and outside of needle | |
| Size designation | |
| Elasticity of the needle tube | |
| Pull | Test standard |
| Lubricant | |
| Limits for acidity and alkalinity | ISO 11608-2 |
| Stiffness | |
| Resistance to breakage | ISO 7864 |
| Resistance to corrosion | |
| Determination of flow rate through the needle | ISO 9626 |
| Bond between hub and needle tube | |
| Freedom from defects | |
| Penetration resistance | |
| Cap-hub fitting strength | |
| Dislocation of measuring point at patient end | |
| Needle dose accuracy test | |
| Needle hub torque removal | |
| Ease of assembly and disassembly test | |
| Compatibility with needle-based injection systems | |

The performance tests demonstrated that CPL Insulin Pen Needle is performes in a substantially equivalent manner to the predicate device.

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# Compatible pens

| Victoza Liraglutide injection | HumaLog KwikPen |
|--------------------------------------------------|---------------------------------------------|
| Apidra SoloStar | HumaLog Mix 75/25 KwikPen |
| Lantus SoloStar | HumaLog Mix 50/50 KwikPen |
| OptiClik for Lantus and Apidra | Humalog Pen |
| SymlinPen 120 (pramlintide acetate) pen injector | Humalog Mix 75/25 Pen |
| SymlinPen 60 (pramlintide acetate) pen injector | Humalog Mix 50/50 Pen |
| Byetta exenatide injection 10mog | Humulin N Pen |
| Byetta exenatide injection 5mog | Humulin 70/30 Pen |
| Levemir FlexPen | HumaPen LUXURA HD |
| Novolog FlexPen | HumaPen MEMOIR |
| Novolog Mix 70/30 FlexPen | AutoPen |
| NovoPen Junior | Forteo teriparatide (rDNA origin) injection |
| NovoPen 3 | |

# 7. Predicate device comparison table

| Manufacturer | CPL Co.,Ltd. | | Feel Tech | Results | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------|-----------------------|
| 510(k) No. | K151090 | | K080904 | N/A | | |
| Indication for use | This is a single use sterile<br>insulin pen-injector needle to be<br>used by diabetic patients for the<br>purpose of injecting insulin. | | These disposable sterile insulin pen<br>needles are intended for<br>subcutaneous injection of insulin in<br>the treatment of diabetes. | Same intended use | | |
| Product name | Hypodermic single lumen needle | | Hypodermic single lumen needle | Identical | | |
| Trade name | CPL Insulin Pen Needle | | Feel Fine Insulin Pen Needle | N/A | | |
| Model/type | CPLPN-29, CPLPN-30, CPLPN-31,<br>CPLPN-32 | | Feel Fine Insulin Pen Needle-29<br>Feel Fine Insulin Pen Needle-30<br>Feel Fine Insulin Pen Needle-31 | N/A | | |
| Appearance | Image: CPL Insulin Pen Needle | | Image: Feel Fine Insulin Pen Needle | Similar design | | |
| Product<br>configuration | Hub<br>Needle cap<br>Sterile cap<br>Needle<br>Sterile paper | | Hub<br>Needle cap<br>Sterile cap<br>Needle<br>Sterile paper | Similar device<br>componenets | | |
| Material | Sterile cap : Polypropylene<br>Needle cap : Polyethylene<br>Needle : Stainless steel 304<br>Hub : Polypropylene | | Sterile cap : Polypropylene<br>Needle cap : Polyethylene<br>Needle : Stainless steel 304<br>Hub : Polypropylene | Similar material | | |
| Length of parts (mm) | | | | | | |
| Total length of<br>assembly | 29.8 | | 28.8 | | | |
| Side length of<br>assembly(max) | 15.2 | | 15.5 | Similar dimensions | | |
| Inner diameter of<br>sterile cap | 11.2 | | 12.95 | | | |
| Gauge | 29G | 30G | 31G | 32G | 29, 30, 31G | Similar |
| Length of needle | 8 mm<br>10 mm<br>12 mm | 5 mm<br>8 mm<br>10 mm<br>12 mm | 4 mm<br>5 mm<br>6 mm<br>8 mm | 4 mm<br>5 mm<br>6 mm<br>8 mm | 5 mm<br>8 mm<br>12.7 mm | Similar needle length |
| Sterilization | EO Gas sterilization | | EO Gas sterilization | Same | | |
| Packagine | Sterile cap(PP)+sterile paper | | Sterile cap(PP)+sterile paper | Similar | | |
| Performance test | Accordance with ISO 11608-2 | | N/A | Suitable | | |
| Biocompatibility | Accordance with ISO 10993 series | | N/A | Suitable | | |

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The device is investigated for function and effectiveness to compare the operation of function between CPL Co.,Ltd. and Feeltech (K080904). Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device. Therefore, it is concluded that is Insulin pen needle of CPL Co.,Ltd. substantially equivalent to the legally marketed predicate device.

Intended use statement is similar with that of the predicate device. They are both single use only, used for insulin injection and for diabetes treatment. The difference in wording of these intended use does not change the intended use or raise questions of safety and effectiveness per 807.92(a)(5).

The bench tests of Needles with 32G demonstrated conformances to ISO 11608-2 and ISO 7864. Therefore the differences do not raise new concerns to establish substantial equivalence to the predicate.

### 9. Conclusion:

The subject device has been tested according to ISO 11608-2:2012 (Needle-based injection systems for medical use-Requirements and test methods-Part 2:Needles) as well as ISO 9626 (stainless steel tubing for manufacture of medical devices) and test results demonstrated it is substantial equivalent to as the cited predicate device.