All of the subject device pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The subject device pen needles are used by peeling back the peel tab. The hub of the currently marketed Clickfine Pen Needle is snapping or screwing onto the threaded end of the pen injector. The modified Penfine Classic Pen Needle is attached to pen injectors with only a "screwing" motion. For all needles the back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the fluid is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then unscrewed for the pen injector, discarded and replaced with a new needle before the next injection.

AI/ML Overview

This FDA 510(k) summary describes the "Clickfine Pen Needle" and "Penfine Classic Pen Needle" by Ypsomed AG. The document details the device's intended use and demonstrates its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several tests and associated clauses from international standards (ISO 11608-2, ISO 9626/A1, ISO 7864) which serve as the acceptance criteria. The reported device performance is that "The verifications have shown evidence that the subject device pen needles meet the acceptance criteria of these standards." and "Based on the results it can be concluded that the device performance is acceptable for the product." While the specific quantitative results for all tests are not provided in this summary, the criteria themselves are detailed.

Test / Acceptance Criteria	Reported Device Performance
Needle Assembly Compatibility (ISO 11608-2, Clause 4.2.1) Attachment shall fit and function with needle-based injection systems specified in ISO 11608-1.	Tested on compatibility with needle-based injection systems as specified in ISO 11608-1. (Met Acceptance Criteria)
Tubing Dimensions (ISO 11608-2, Clause 4.2.2, Table 1) Length of patient end: +/- 1.25 mm Length of cartridge end: 5.7 – 7.0 mm	(Met Acceptance Criteria)
Flow Rate (ISO 11608-2, Clause 4.3) Measurement of flow rate in accordance with Annex A.	(Met Acceptance Criteria)
Bond between Hub and Needle Tube (ISO 11608-2, Clause 9 & ISO 7864, Clause 13.1) The union shall not break for at least 5 sec. while a force of at least 22 N is applied.	(Met Acceptance Criteria)
Needle Points (ISO 11608-2, Clause 4.5) Visually sharp at a 2.5x magnification; designed to minimize coring and fragmentation.	(Met Acceptance Criteria)
Lubrication (ISO 11608-2, Clause 4.7) No visible droplets on the outside surface of the needle tube.	(Met Acceptance Criteria)
Dislocation of Measuring Point at Patient-End (ISO 11608-2, Clause 8) 4, 6, 8, 10mm +/- 0.9mm, 12mm +/- 1.1mm	(Met Acceptance Criteria)
Functional Compatibility with Needle Based Injection Systems (ISO 11608-2, Clause 11) Needle assembly torque: 0.07 +/- 0.01 Nm Needle hub removal: less than 0.100 Nm Dose accuracy: for doses ≤ 20 ml, calculated values within ± 0.01 ml of targeted dose; for doses > 20 ml, calculated values within ± 5% of targeted dose.	(Met Acceptance Criteria)
Tubing Characteristics (ISO 9626/A1, Table 1) Made of austenitic stainless steel according to designated types in Table 1.	(Met Acceptance Criteria)
Tubing Diameters (ISO 9626/A1, Table 2) Meet outer and inner diameter requirements as defined in Table 2.	(Met Acceptance Criteria)
Stiffness (ISO 9626, Clause 9) When tested per Annex C, deflection not greater than relevant value in Table 3.	(Met Acceptance Criteria)
Resistance to Breakage (ISO 9626, Clause 10) When tested per Annex D and Table 4, tubing shall not break.	(Met Acceptance Criteria)
Limits for Acidity and Alkalinity (ISO 9626, Clause 6) Correction for volume of titrant required for control fluid not more than 0.04 ml NaOH or 0.12 ml HCl.	(Met Acceptance Criteria)
Resistance to Corrosion (ISO 9626, Clause 11) When tested per Annex E, immersed half of tubing no evidence of corrosion.	(Met Acceptance Criteria)
Patency of Lumen (ISO 7864, Clause 13.2) A stylet, having a diameter equivalent to 80% ±2% of lumen inner diameter, must pass through freely.	(Met Acceptance Criteria)
Freedom of Defects (ISO 7864, Clause 11.3) When examined by normal or corrected-to-normal vision, needle shall appear straight and of regular cross-section and wall thickness.	(Met Acceptance Criteria)
Limits for Extractable Metals (ISO 7864, Clause 6) Content of lead, tin, zinc, iron less than 5mg/l; cadmium content lower than 0.1 mg/l.	(Met Acceptance Criteria)
Freedom of Defects (ISO 7864, Clause 11.3) (Duplicate in text) When examined by normal or corrected vision, the needle tube shall appear straight and of regular cross-section and wall thickness.	(Met Acceptance Criteria)

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "appropriate verification and/or validation activities" were performed.

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

This type of information is not relevant or applicable for the device described (hypodermic single lumen needles). The performance is assessed against engineering and material standards, not against expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective measurements against established engineering and material standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for a medical device like a pen needle, which is evaluated based on its physical and functional properties against technical standards. MRMC studies are typically used for diagnostic devices that involve human interpretation of images or other data.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The studies performed were "standalone" in the sense that they evaluated the device itself against established engineering and material standards. There is no "algorithm" or "human-in-the-loop" aspect for a hypodermic needle's performance. The tests described are laboratory-based assessments of the physical and mechanical properties of the needles.

7. The Type of Ground Truth Used

The ground truth for this device is based on established international engineering and material standards (ISO 11608-2, ISO 9626/A1, ISO 7864). These standards define objective, measurable criteria for the performance, dimensions, and material properties of hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-based system that requires "training data." Its performance is evaluated through physical tests and measurements.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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

June 9, 2015

Ypsomed AG c/o Mr. Lee Leichter P/L Biomedical 10882 Stonington Avenue Fort Myers, FL 33913

Re: K150662

Trade/Device Name: Clickfine Pen Needle and Penfine Classic Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 7, 2015 Received: May 11, 2015

Dear Mr. Leichter:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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

for 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

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Indications for Use

510(k) Number (if known) K150662

Device Name

Clickfine Pen Needle and Penfine Classic Pen Needle

Indications for Use (Describe)

The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

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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8. 510(k) Summary

	Submitted By/
	Contact Person:	Stephan AffolterYpsomed AGBrunnmattstrasse 63401 BurgdorfSwitzerlandTel. 0041-34 424 3382Fax 0041-34 424 4122	Head of Quality System & Regulatory AffairsE-mail: stephan.affolter@ypsomed.com
Alternative Contact:		Lee LeichterPresidentP/L Biomedical10882 Stonington AvenueFort Myers, FL 33913USATel. (239) 244-1448Fax. (815) 550-0162E-mail: leichter@plbiomedical.com
	Date Prepared:	May 07, 2015
8.1	Trade/Proprietary Name:		Clickfine Pen NeedlePenfine Classic Pen Needle
8.2	Common/Usual Name:		Injection Pen Needle
8.3	Classification Name:		Hypodermic single lumen needle
8.4	Classification Panel.		Classification: FDA has classified Hypodermic single lumen needles in Class IIaccording to 21 CFR 880.5570. Final Order was published in the Federal Register onOctober 21, 1980 after review by the General Hospital and Personal Use Devices
		Panel: 80	Procode: FMI

8.5 Predicate Device: K131125 Clickfine Pen Needles

Purpose of Submission: To add a second product line of needles (Penfine Classic Pen 8.6 Needles) that are attached to pens by using only a "classic" screwing or twisting action in addition to the existing Clickfine Pen Needle line that can also be "clicked" or "snapped" onto the pen. The submission also includes other minor changes to both product lines, including the addition of needle point geometry with 6-bevels (in addition to the existing 3-bevel geometry), changes to the needle hub, labeling and sterilization cycle.

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8.7 Device Description

8.8 Intended Use
The intended use of the modified device remains the same as the predicate device -Clickfine Pen Needles (K131125):

The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

8.9 Technological Characteristics and Substantial Equivalence Discussion The technological characteristics have not changed. All of the materials, processes and operating principles of the modified needles are identical to the currently marketed needles. The Penfine Classic Pen Needle has a modified interface to only allow attachment to compatible cartridge holders through a twisting or screwing motion, while the current device can be snapped, or "clicked" onto the cartridge holder. The only other change is a different grinding of the needle point to produce six, rather than three surfaces. Otherwise the needles have the same design and intended use as the currently marketed product and are compatible with the same injection pens. As such, the subject needles are substantially equivalent to the predicate Clickfine Pen Needles (K131125).

8.10 Performance Data

As part of the Design Control Activities, Ypsomed evaluated the potential risks, hazards or hazardous situations, potential clinical impact on the patient, identified the appropriate risk control measure and acceptability criteria associated with each change in the modified devices. Then, each risk was mitigated through appropriate verification and/or validation activities which were determined to be the testing specified in the following international and internal standards and protocols. This testing confirmed that the subject devices are substantially equivalent to the predicate devices.

All Subject Device Pen Needles have met the requirements of the relevant sections of the following standards:

. ISO 11608-2:2012 Needle based injection systems for medical use -

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Requirements and test methods – Part 2: Needles

. ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices
ISO 7864:1993 Sterile hypodermic needles for single use ●

Test	Section of Standard
Needle assemblyattachment shall fit andfunction with needle basedinjection systems specifiedin ISO 11608-1	Clause 4.2.1 of ISO 11608-2The subject device pen needles were tested oncompatibility with needle based injection system asspecified in ISO 11608-1
Tubing dimensions	Clause 4.2.2, Table 1 of ISO 11608-2Length of patient end: +/- 1.25 mmLength of cartridge end: 5.7 – 7.0 mm
Flow rate	Clause 4.3 of ISO 11608-2:Measurement of flow rate in accordance with AnnexA.
Bond between hub andneedle tube	Clause 9 of ISO 11608-2 and clause 13.1 of ISO7864The union of the hub and needle tube shall not breakfor at least 5 sec. while a force of at least 22 N isapplied
Needle points	Clause 4.5 of ISO 11608-2Visually sharp at a 2.5x magnification; designed tominimize coring and fragmentation
Lubrication	Clause 4.7 of ISO 11608-2No visible droplets on the outside surface of theneedle tube.
Dislocation of measuringpoint at the patient-end	Clause 8 of ISO 11608-2:4, 6, 8, 10mm +/- 0.9mm, 12mm +/- 1.1mm
Functional compatibilitywith needle basedinjection systems	Clause 11 of ISO 11608-2:Needle assembly torque: 0.07 +/- 0.01 NmNeedle hub removal: less than 0.100 NmDose accuracy:for doses ≤ 20 ml the calculated values were within ±0.01 ml of the targeted dose;for doses > 20 ml the calculated values were within± 5% of the targeted dose.
Tubing characteristics	Table 1 of ISO 9626/A1:The tubing is made of austenitic stainless steel acc.one of the designated types given in Table 1 of ISO9626/A1.
Tubing diameters	Table 2 of ISO 9626/A1
Test	Section of Standard
	Tubing dimensions meet outer and inner diameterrequirement as defined in table 2 of ISO 9626/A1.
Stiffness	Clause 9 of ISO 9626:When tested in accordance with annex C of ISO 9626the tubing shall show a deflection not greater than therelevant value given in table 3 of ISO 9626/A1.
Resistance to breakage	Clause 10 of ISO 9626:When tested in accordance with annex D of ISO9626 and Table 4 if ISO 9626/A1 the tubing shall notbreak.
Limits for acidity andalkalinity	Clause 6 of ISO 9626Tested in accordance with annex A and extractpreparation of the tubing in accordance with AnnexB: correction for the volume of titrant required forthe control fluid shall not be more than 0.04 mlNaOH or 0.12 ml HCl to reach the end-pointtitration.
Resistance to corrosion	Clause 11 of ISO 9626:When tested in accordance with annex E, theimmersed half of the tubing shall show no evidenceof corrosion resulting from the test.
Patency of lumen	Clause 13.2 of ISO 7864A stylet, having a diameter equivalent to 80% ±2%of lumen inner diameter must pass through freely
Freedom of defects	Clause 11.3 in ISO 7864:When examined by normal or corrected-to-normalvision, the needle shall appear straight and of regularcross-section and wall thickness
Limits for extractablemetals	Clause 6 of ISO 7864:When tested with a recognized method the content oflead, tin, zinc and iron shall be less than 5mg/l. Thecadmium content shall be lower than 0.1 mg/l.
Freedom of defects	Clause 11.3 of ISO 7864:When examined by normal or corrected vision, theneedle lube shall appear straight and of regular cross-section and wall thickness

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The verifications have shown evidence that the subject device pen needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance is acceptable for the product.

8.11 Conclusion

Y psomed AG concludes based on the information presented that the modified products are substantially equivalent to the current product (Clickfine Pen Needles) legally marketed in the USA.

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).