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.

AI/ML Overview

The document describes a 510(k) premarket notification for the "CPL Insulin Pen Needle" and its substantial equivalence to a predicate device. It details performance data to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical or categorical targets followed by "reported device performance" in the format typically used for AI/ML device evaluations. Instead, it lists various tests performed and states that the device "demonstrated equivalent performance to the predicate devices" or "is substantially equivalent" to the predicate.

However, we can infer the acceptance criteria and performance from the tests conducted against international standards (ISO).

Acceptance Criteria (Inferred Standard Compliance)	Reported Device Performance
Biocompatibility (ISO 10993-1 series)
Cytotoxicity	Performed and suitable
Sensitization	Performed and suitable
Intracutaneous reactivity (Acute)	Performed and suitable
Systemic toxicity (Acute)	Performed and suitable
Pyrogenicity	Performed and suitable
Hemolysis	Performed and suitable
Physical/Mechanical Performance (ISO 11608-2 & ISO 9626)
Inner/outside and structure	Performed and demonstrated equivalent performance
Dimension	Performed and demonstrated equivalent performance
Draw test	Performed and demonstrated equivalent performance
Elasticity test	Performed and demonstrated equivalent performance
Flexural rigidity	Performed and demonstrated equivalent performance
Inner and outside of needle	Performed and demonstrated equivalent performance
Size designation	Performed and demonstrated equivalent performance
Elasticity of the needle tube	Performed and demonstrated equivalent performance
Pull	Performed and demonstrated equivalent performance
Lubricant	Performed and demonstrated equivalent performance
Limits for acidity and alkalinity	Performed and demonstrated equivalent performance
Stiffness	Performed and demonstrated equivalent performance
Resistance to breakage (ISO 7864)	Performed and demonstrated equivalent performance
Resistance to corrosion	Performed and demonstrated equivalent performance
Determination of flow rate through the needle (ISO 9626)	Performed and demonstrated equivalent performance
Bond between hub and needle tube	Performed and demonstrated equivalent performance
Freedom from defects	Performed and demonstrated equivalent performance
Penetration resistance	Performed and demonstrated equivalent performance
Cap-hub fitting strength	Performed and demonstrated equivalent performance
Dislocation of measuring point at patient end	Performed and demonstrated equivalent performance
Needle dose accuracy test	Performed and demonstrated equivalent performance
Needle hub torque removal	Performed and demonstrated equivalent performance
Ease of assembly and disassembly test	Performed and demonstrated equivalent performance
Compatibility with needle-based injection systems	Performed and demonstrated equivalent performance and a list of compatible pens is provided
Sterilization effectiveness	EO Gas sterilization, stated as "Same" as predicate
Packaging integrity	Sterile cap(PP)+sterile paper, stated as "Similar"

The key acceptance criterion is that the "CPL Insulin Pen Needle" demonstrates substantially equivalent performance to the predicate device (K080904 Feel Fine Insulin Pen Needle) based on compliance with relevant ISO standards and a series of bench tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the bench tests. It also does not specify the data provenance (e.g., country of origin or whether the data was retrospective or prospective) for these performance tests. The tests are described as "bench tests," implying laboratory testing of the physical devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable in the context of this 510(k) submission. The CPL Insulin Pen Needle is a physical medical device, not an AI/ML diagnostic or predictive algorithm where expert ground truth for a test set would be established. The "ground truth" here is defined by the technical specifications and performance requirements outlined in the ISO standards and the comparative performance against the predicate device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in cases of subjective interpretation (e.g., medical image reading), not for objective physical device performance testing against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The CPL Insulin Pen Needle is a physical medical device (an insulin pen needle), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study related to human readers improving with AI assistance would not be performed for this type of device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. As explained for point 5, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established by international standards (e.g., ISO 10993-1, ISO 11608-2, ISO 7864, ISO 9626) and the demonstrated performance of the legally marketed predicate device (K080904 Feel Fine Insulin Pen Needle). The product's performance is compared against these objective benchmarks and the predicate device's established performance to determine substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning. The device's design, manufacturing, and quality control processes are informed by engineering principles and compliance with standards, not by AI model training.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Form Approved: OMB No. 0910-0120

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.
1. Address : 36, Yongteurim-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
1. Tel : 82-31-483-7301
1. Fax : 82-31-483-7351
1. Contact person : Peter Chung, 412-687-3976
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Date prepared : September 16, 2016

2. Device Information

1. Trade Name : CPL Insulin Pen Needle
1. Common Name : Hypodermic single lumen needle
1. Classification Name : Needle, Hypodermic, Single Lumen
1. Product Code : FMI
1. Regulation Number : 880.5570
1. Class of device : Class II
1. 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

	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(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
1. Sensitization
1. Intracutaneous reactivity (Acute)
1. Systemic toxicity (Acute)
1. Pyrogenicity
1. 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 sterileinsulin pen-injector needle to beused by diabetic patients for thepurpose of injecting insulin.		These disposable sterile insulin penneedles are intended forsubcutaneous injection of insulin inthe 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,CPLPN-32		Feel Fine Insulin Pen Needle-29Feel Fine Insulin Pen Needle-30Feel Fine Insulin Pen Needle-31	N/A
Appearance	Image: CPL Insulin Pen Needle		Image: Feel Fine Insulin Pen Needle	Similar design
Productconfiguration	HubNeedle capSterile capNeedleSterile paper		HubNeedle capSterile capNeedleSterile paper	Similar devicecomponenets
Material	Sterile cap : PolypropyleneNeedle cap : PolyethyleneNeedle : Stainless steel 304Hub : Polypropylene		Sterile cap : PolypropyleneNeedle cap : PolyethyleneNeedle : Stainless steel 304Hub : Polypropylene	Similar material
Length of parts (mm)
Total length ofassembly	29.8		28.8
Side length ofassembly(max)	15.2		15.5	Similar dimensions
Inner diameter ofsterile cap	11.2		12.95
Gauge	29G	30G	31G	32G	29, 30, 31G	Similar
Length of needle	8 mm10 mm12 mm	5 mm8 mm10 mm12 mm	4 mm5 mm6 mm8 mm	4 mm5 mm6 mm8 mm	5 mm8 mm12.7 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.

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).