The Clickfine 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 pen needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. 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 insulin 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 removed, safely discarded and replaced with a new needle.

AI/ML Overview

This submission (K131125) is an administrative change to revise the Indications for Use for the Clickfine Pen Needle to align with predicate devices, allowing for Over-the-Counter (OTC) marketing for all compatible injection pens. As such, no new performance data was required or submitted to demonstrate safety and effectiveness. The FDA concluded substantial equivalence based on the administrative nature of the change and the existing clearance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this was an administrative submission and no new performance and safety data were required or submitted, there are no specific acceptance criteria or reported device performance metrics in this document. The device did not undergo a new study to establish performance against new criteria.

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

Not applicable. No new performance studies were conducted.

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

Not applicable. No new performance studies were conducted.

4. Adjudication Method for the Test Set:

Not applicable. No new performance studies were conducted.

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

No. This was an administrative change, not a comparative effectiveness study.

6. If a Standalone Performance Study Was Done:

No. This submission did not involve a standalone performance study. The substantial equivalence was based on existing predicate devices.

7. The Type of Ground Truth Used:

Not applicable. No new performance studies were conducted. The "ground truth" for this submission was the existing clearances and intended uses of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No new studies involving training sets were conducted.

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

Not applicable. No new studies involving training sets were conducted.

Summary

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K13 1125

6. Summary of Safety and Effectiveness

"510(K) SUMMARY"

Submitted By/ Contact Person:

Dr. Benjamin Reinmann Vice President Ouality Management & Regulatory Affairs Yosomed AG Brunnmattstrasse 6 CH - 3401 Burgdorf Switzerland Tel. 0041-344244117 Fax 0041-344243460 E-mail: benjamin.reinmann@ypsomed.com

April 19, 2013 Date Prepared:

7.1 Trade/Proprietary Name:
7.2 Common/Usual Name:

Hypodermic single lumen needle

Clickfine Pen Needle

Injection Pen Needle

7.3 Classification Name:
Classification: FDA has classified Hypodermic single lumen needles in Class II. Final 7.4 Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.

Procode: FMI Panel: 80

Purpose of Submission: To make an administrative change to revise the Indications for 7.5 Use to be consistent with the BD Injection Pen Needles so that the needles can be marketed Over the Counter (OTC) for all compatible injection pens.
Substantial Equivalence: The Clickfine Pen Needle is substantially equivalent to the 7.6 Clickfine Pen Needles (K122969 and K122971) and the BD Pen Needles (K110105, K100005 and K051899).
Device Description 7.7

JUL 5 2013

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the needle until the insulin 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 removed, safely discarded and replaced with a new needle.

7.8 Intended Use
The intended use of the device has been modified to combine the Indications cleared for the Clickfine Pen Needle (K122969 and K122971) with the wording in the predicate device BD Pen Needle (K110105, K100005 and K051899):

The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

7.9 Technological Characteristics The technological characteristics have not changed.

Performance and Safety Data 7.10

As this was an administrative change, no performance and safety data were required to be submitted in support of the change.

7.11 Conclusion
Y psomed AG concludes based on the information presented that the product is substantially equivalent to the current products legally marketed in the USA.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 5, 2013

Ypsomed AG Dr. Benjamin Reinmann Vice President Quality Management & Regulatory Affairs Brunnmattstrasse 6 Burgdorf SWITZERLAND CH-3401

Re: K131125

Trade/Device Name: Clickfine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 19, 2013 Received: April 22, 2013

Dear Dr. Reinmann:

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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Page 2 - Dr. Reinmann

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/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 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,

Kwame O. Ulmer -S - - -

Kwame Ulmer M.S. Acting Division 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): K13112 S

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Device Name:

Clickfine Pen Needle

Indications For Use:

and the state of the states of the comments of the

The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard
2013.0
-04'00'

Richard C. Chapman 2013.07.01 14:15:30

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K131125

page 20 of 22

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).