CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and the blue needle shield will be offered in 8mm length. CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic.

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.

An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length.

The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.

The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needle family to include blue colored inner needle shield to distinguish the 8mm needle length.

The intended use for the modified device remains the same as the predicate device.

AI/ML Overview

This document describes a Special 510(k) submission for a modification to an insulin pen needle, specifically the addition of a blue colored inner needle shield to distinguish an 8mm needle length. It is not a study that proves the device meets acceptance criteria in the typical sense of a clinical trial for efficacy or diagnostic performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

For this specific submission (K141749), which is a Special 510(k) for a color change, the "acceptance criteria" are primarily related to proving that the modification does not raise new issues of safety or effectiveness and that the device remains substantially equivalent to the predicate. The performance data presented are for the original CareFine™ Pen Needle (K133100), not specifically for the blue shield modification.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Reference to K133100 and K140568)
Similar Indication for Use	Identical indication for use: "The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin."
No Labeling Changes Affecting Intended Use	No labeling changes that affect the intended use of the device.
No Alteration to Fundamental Scientific Technology	Does not alter the fundamental scientific technology.
Same Basic Design	Incorporates the same basic design.
Same Operating Principles	Uses the same operating principles.
Manufactured from Same Materials (except for color additive)	Manufactured from the same materials (the only difference is the blue color additive to the inner needle shield).
Sterilized with Same SAL	Sterilized with a resulting SAL of 10^-6 (EtO terminal sterilization).
Same Unit and Case Materials for Packaging	Packaged using same unit and case materials.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility)	Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4.
Needle Shield Assembly Strength	Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ASTM F756-8 and an internal test method.
Conformance with Applicable Standards & GMP	Manufactured in accordance with the requirements of current Good Manufacturing Practices (21 CFR Subpart C "Design Controls"). All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards (referenced for K133100).
No new safety/effectiveness issues	Based on comparisons, the blue colored inner needle shields "do not raise any new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a separate "test set" sample size for the color change modification. The referenced non-clinical performance data (biocompatibility, needle shield strength) was performed for the original CareFine™ Pen Needle (K133100). The sample sizes for those specific tests are not provided in this summary.
Data Provenance: Not explicitly stated for specific test cases, but the tests performed are standard biocompatibility and mechanical tests for medical devices, generally conducted in controlled laboratory environments. The manufacturer is Facet Technologies, LLC, located in Kennesaw, GA, USA, suggesting the data would likely originate domestically or from certified testing labs. The data is retrospective relative to this Special 510(k), as it refers to data submitted with the earlier Traditional 510(k) (K133100).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis). For this device, which is a physical medical device (insulin pen needle) with a minor aesthetic modification, "ground truth" is established through objective engineering and biocompatibility testing against defined specifications and recognized international standards (e.g., ISO 10993, ASTM F756-8). Therefore, the concept of "experts establishing ground truth" in the way described for AI/diagnostic studies does not apply here. The "experts" would be the certified lab technicians and engineers performing these tests, and the regulatory bodies approving the test methods and results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and submission. Adjudication methods are typically used in clinical trials or studies where subjective assessments or discrepancies in expert opinion need to be resolved. This document focuses on objective performance and equivalence to a predicate device.

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

Not applicable. This is a physical medical device (pen needle), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating the safety and effectiveness of the original pen needle (K133100) was established through objective laboratory testing against recognized standards (ISO, ASTM) and internal test methods to demonstrate physical integrity, sterility, and biocompatibility. For this Special 510(k), the "ground truth" is the demonstrated substantial equivalence to previously cleared devices based on the technical characteristics and the determination that the color change does not impact safety or effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI/ML model is involved.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Facet Technologies. The logo consists of a four-pointed star-like shape on the left, followed by the word "FACET" in large, sans-serif font. Below "FACET" is the word "TECHNOLOGIES" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company name.

JUL 2 9 2014

510(k) Summary K141749

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, Content and Format of a 510(k) Summary, the following safety and effectiveness information is provided below:

Date Prepared:	June 26, 2014
Submitter:	Facet Technologies, LLC112 Town Park Dr.Suite 300Kennesaw, GA 30144Facility Registration Number: 2082882
Company Contact Person:	Jennifer RegisterSenior Regulatory Affairs SpecialistPhone: (770) 590-6455FAX: (770) 590-6412Email: jennifer_register@facettechnologies.com)
Common Name of Device	Insulin Pen Needle
Proprietary Name	CareFineTM Pen Needle Family including QuintaPointTMand SuperPointTM
Classification Name	Hypodermic Single Lumen Needle
Classification Regulation	21 CFR §880.5570, Class 2
Panel	80 General Hospital
Product Code	FMI

[807.92(a)(3)] Predicate Device:

CareFine™ Pen Needle (K133100) Manufactured by Facet Technologies, LLC

CareFine™ Pen Needle with QuintaPoint™ and SuperPoint™ (K140568) Manufactured by Facet Technologies, LLC .

Confidential and Proprietary Copyright 2014 Facet Technologies, LLC

{1}------------------------------------------------

[(807.92(a)(4)] Description of Device:

The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needle family to include blue colored inner needle shield to distinguish the 8mm needle length.

The intended use for the modified device remains the same as the predicate device.

[(807.92(a)(5)] Intended Use / Indication for Use:

The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.

{2}------------------------------------------------

[(807.92(a)(6)] Technological Characteristics:

The CareFine™ Pen Needle with blue colored needle shield is identical in composition to the CareFine™ Pen Needle family. The only difference is the blue color additive to the inner needle shield to distinguish an 8mm needle length.

The CareFine™ Pen Needle with blue colored inner needle shields are equivalent given that they:

. Have the same indication for use,
Do not have any labeling changes that affect the intended use of the device, .
Do not alter the fundamental scientific technology, .
. Incorporate the same basic design
Use the same operating principles, .
Are manufactured from the same materials, .
Are sterilized with a resulting SAL of 10to, and �
Are packaged using same unit and case materials. ●

Based on the comparisons described above to the predicate comparator device, the CareFine™ Pen Needle with blue colored inner needle shields do not raise any new issues of safety and effectiveness.

[(807.92(b)(1)]

Non-Clinical Performance Data:

Non-clinical performance data was performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100). The CareFine™ Pen Needle with blue colored needle shields is manufactured in accordance with the requirements of the current Good Manufacturing Practices for Medical Devices and follows 21 CFR Subpart C "Design Controls". All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards. The principle device demonstrated equivalent performance to the predicate device during testing.

Cytotoxicity	Per ISO 10993-5
Sensitization	Per ISO 10993-10
Intracutaneous Reactivity	Per ISO 10993-10
Acute Toxicity	Per ISO 10993-11
Hemocompatibility	Per ISO 10993-4
	ASTM F756-8
Needle Shield Assembly Strength	Internal Test Method

Based upon the risk analysis the following tests were nerformed

{3}------------------------------------------------

[(807.92(b)(2)] Clinical Performance Data:

Clinical data is not required.

[(807.92(b)(3)] Conclusion:

Based on the design equivalency and the verification activities performed, Facet Technologies, LLC has determined that CareFine™ Pen Needle family with blue inner needle shields are equivalent to the predicate comparator devices currently cleared for marketing in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

[(807.92(d)] Other Information:

None

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

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

Facet Technologies. LLC Ms. Jennifer Register Senior Regulatory Affairs Specialist 112 Town Park Drive, Suite 300 KENNESAW. GA 30144

July 29, 2014

Re: K141749

Trade/Device Name: CareFine™ Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic. Single Lumen Regulatory Class: Class II Product Code: FMI Dated: June 26, 2014 Received: June 30, 2014

Dear Ms. Register:

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.

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

{5}------------------------------------------------

Page 2 - Ms. Register

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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" (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 vours.

Mary S: Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K141749

Device Name Carefine™ Pen Needle

Indications for Use (Describe)

The CareFine Pen Needle™ is intended for use with a pen injector device for the subculaneous injection of insulin

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

ا_J Prescription Use (Part 21 CFR 801 Subpart D)

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Date: 2014.07.29 10:33:31 -04'00'

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

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman -S

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 ime 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."

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).