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 lengths (4mm, 5mm, 6mm, and 12.7mm). 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 Needles to include colored inner needle shields to distinguish the needle length.

It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™.

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

AI/ML Overview

This document describes a 510(k) submission for an insulin pen needle, which is a medical device, not an AI/ML powered medical device. Therefore, the information typically requested for AI/ML device studies, such as specific acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material, design, manufacturing, and intended use. The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests to ensure the device's safety and effectiveness.

Here's a breakdown of the available information based on your request, highlighting where the AI/ML specific criteria do not apply:

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

Acceptance Criteria (Non-Clinical Performance Tests)	Reported Device Performance
Cytotoxicity (Per ISO 10993-5)	Performed
Sensitization (Per ISO 10993-10)	Performed
Intracutaneous Reactivity (Per ISO 10993-10)	Performed
Acute Toxicity (Per ISO 10993-11)	Performed
Hemocompatibility (Per ISO 10993-4, ASTM F756-8)	Performed
Needle Shield Assembly Strength (Internal Test Method)	Performed

Note: The document states that "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." Specific numerical results or detailed performance metrics for each test are not provided in this summary, only that they were performed and met the criteria for substantial equivalence.

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

Not Applicable: This is a physical medical device. The "test set" in this context refers to the samples of the device used for the non-clinical performance tests listed above (e.g., biocompatibility testing of materials, mechanical strength testing). The document does not specify the number of individual devices or material samples used for each test. Data provenance in the sense of patient data is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: Ground truth for AI/ML devices typically refers to expert-labeled data. For this physical device, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) for biocompatibility and mechanical testing, performed by qualified testing personnel in accredited laboratories. The document does not specify the number or qualifications of these testing personnel, as it's assumed to be part of standard quality system practices for medical device manufacturing.

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

Not Applicable: Adjudication methods are relevant for subjective expert review of data (e.g., imaging in AI/ML studies). For objective non-clinical tests, the results are typically interpreted against pre-defined criteria in the test standard, rather than through an adjudication process.

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. MRMC studies and the concept of human reader improvement with AI assistance are specific to AI/ML powered devices.

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.

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

Not Applicable (in the AI/ML sense): For this device, "ground truth" is established by the results of standardized non-clinical tests (e.g., cytotoxicity assays, sensitization tests, strength tests) as interpreted against the specified criteria within relevant ISO and ASTM standards. The ultimate "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate device, demonstrating equivalent safety and effectiveness based on these tests and design comparisons.

8. The sample size for the training set:

Not Applicable: This is a physical medical device. There is no concept of a "training set" for an algorithm.

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

Not Applicable: This is a physical medical device. There is no training set or associated ground truth establishment.

Summary of the Study:

The central "study" presented here is a Special 510(k) submission designed to demonstrate substantial equivalence of a modified insulin pen needle (CareFine™ Pen Needle with colored inner needle shields and new bevel geometries: QuintaPoint™ and SuperPoint™) to its predicate device (CareFine™ Pen Needle, K133100). The changes are described as "non-significant" and primarily relate to aesthetic features (colored shields for length distinction) and minor modifications to the cannula point bevel geometry.

The primary evidence presented to meet acceptance criteria is:

Design Equivalency: Explicitly stating that the modified device has the same indication for use, does not alter fundamental scientific technology, incorporates the same basic design, uses the same operating principles, is manufactured from the same materials, is sterilized identically, and uses the same packaging.
Non-Clinical Performance Data: A list of biocompatibility and mechanical tests performed (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility, Needle Shield Assembly Strength) in accordance with relevant ISO and ASTM standards. The document states these tests were "performed" and "demonstrated equivalent performance to the predicate device during testing." This implies the results met the acceptance criteria defined by these standards.
Clinical Data: The submission explicitly states "Clinical data is not required," further emphasizing the non-AI/ML nature of the review and reliance on substantial equivalence through non-clinical means.

In essence, the study is a regulatory submission that leverages existing predicate device data and specified non-clinical testing to affirm that minor modifications do not compromise the device's safety or effectiveness, thereby meeting the "acceptance criteria" for 510(k) clearance by demonstrating substantial equivalence.

Summary

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K140568

510(k) Summary

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:	March 3, 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 with 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

ジ

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

The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length.

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

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Special 510(k) for CareFine™ Pen Needle Family Including QuintaPoint™ and SuperPoint™ Submitted Under 21 CFR § 807.87

[(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.

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

The CareFine™ Pen Needle with colored needle shields is identical in composition to the CareFine™ Pen Needle. The only differences are the needle point and colorant additive to the inner needle shield to distinguish needle length.

The CareFine™ Pen Needle with 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 10°, 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 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 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.

રૂદ

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Special 510(k) for CareFine™ Pen Needle Family Including QuintaPoint™ and SuperPoint™ Submitted Under 21 CFR § 807.87

Based upon the risk analysis the following tests were performed.
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 10993-4ASTM F756-8
Needle Shield Assembly Strength	Internal Test Method

Based upon the risk analysis the following tests were performed:

[(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 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

Confidential and Proprietary Copyright @ 2014 Facet Technologies, LLC

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Public Health Service

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

May 13, 2014

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

Re: K140568

Trade/Device Name: Carel"ine™ Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 15, 2014 Received: April 17, 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 cither 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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Page 2 - Ms. 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 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" (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 yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140568

Device Name CareFine™ Pen Needle

Indications for Use (Describe)

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

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

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.

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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).