Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 time 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." {3}------------------------------------------------ # 8. 510(k) Summary | | Submitted By/ | | | | |----------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Contact Person: | Stephan Affolter<br>Ypsomed AG<br>Brunnmattstrasse 6<br>3401 Burgdorf<br>Switzerland<br>Tel. 0041-34 424 3382<br>Fax 0041-34 424 4122 | Head of Quality System & Regulatory Affairs<br>E-mail: stephan.affolter@ypsomed.com | | | Alternative Contact: | | Lee Leichter<br>President<br>P/L Biomedical<br>10882 Stonington Avenue<br>Fort Myers, FL 33913<br>USA<br>Tel. (239) 244-1448<br>Fax. (815) 550-0162<br>E-mail: leichter@plbiomedical.com | | | | | Date Prepared: | May 07, 2015 | | | | 8.1 | Trade/Proprietary Name: | | Clickfine Pen Needle<br>Penfine 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 II<br>according to 21 CFR 880.5570. Final Order was published in the Federal Register on<br>October 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. {4}------------------------------------------------ ### 8.7 Device Description 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. - 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 - {5}------------------------------------------------ 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 assembly<br>attachment shall fit and<br>function with needle based<br>injection systems specified<br>in ISO 11608-1 | Clause 4.2.1 of ISO 11608-2<br>The subject device pen needles were tested on<br>compatibility with needle based injection system as<br>specified in ISO 11608-1 | | Tubing dimensions | Clause 4.2.2, Table 1 of ISO 11608-2<br>Length of patient end: +/- 1.25 mm<br>Length of cartridge end: 5.7 – 7.0 mm | | Flow rate | Clause 4.3 of ISO 11608-2:<br>Measurement of flow rate in accordance with Annex<br>A. | | Bond between hub and<br>needle tube | Clause 9 of ISO 11608-2 and clause 13.1 of ISO<br>7864<br>The union of the hub and needle tube shall not break<br>for at least 5 sec. while a force of at least 22 N is<br>applied | | Needle points | Clause 4.5 of ISO 11608-2<br>Visually sharp at a 2.5x magnification; designed to<br>minimize coring and fragmentation | | Lubrication | Clause 4.7 of ISO 11608-2<br>No visible droplets on the outside surface of the<br>needle tube. | | Dislocation of measuring<br>point at the patient-end | Clause 8 of ISO 11608-2:<br>4, 6, 8, 10mm +/- 0.9mm, 12mm +/- 1.1mm | | Functional compatibility<br>with needle based<br>injection systems | Clause 11 of ISO 11608-2:<br>Needle assembly torque: 0.07 +/- 0.01 Nm<br>Needle hub removal: less than 0.100 Nm<br>Dose accuracy:<br>for doses ≤ 20 ml the calculated values were within ±<br>0.01 ml of the targeted dose;<br>for doses > 20 ml the calculated values were within<br>± 5% of the targeted dose. | | Tubing characteristics | Table 1 of ISO 9626/A1:<br>The tubing is made of austenitic stainless steel acc.<br>one of the designated types given in Table 1 of ISO<br>9626/A1. | | Tubing diameters | Table 2 of ISO 9626/A1 | | Test | Section of Standard | | | Tubing dimensions meet outer and inner diameter<br>requirement as defined in table 2 of ISO 9626/A1. | | Stiffness | Clause 9 of ISO 9626:<br>When tested in accordance with annex C of ISO 9626<br>the tubing shall show a deflection not greater than the<br>relevant value given in table 3 of ISO 9626/A1. | | Resistance to breakage | Clause 10 of ISO 9626:<br>When tested in accordance with annex D of ISO<br>9626 and Table 4 if ISO 9626/A1 the tubing shall not<br>break. | | Limits for acidity and<br>alkalinity | Clause 6 of ISO 9626<br>Tested in accordance with annex A and extract<br>preparation of the tubing in accordance with Annex<br>B: correction for the volume of titrant required for<br>the control fluid shall not be more than 0.04 ml<br>NaOH or 0.12 ml HCl to reach the end-point<br>titration. | | Resistance to corrosion | Clause 11 of ISO 9626:<br>When tested in accordance with annex E, the<br>immersed half of the tubing shall show no evidence<br>of corrosion resulting from the test. | | Patency of lumen | Clause 13.2 of ISO 7864<br>A stylet, having a diameter equivalent to 80% ±2%<br>of lumen inner diameter must pass through freely | | Freedom of defects | Clause 11.3 in ISO 7864:<br>When examined by normal or corrected-to-normal<br>vision, the needle shall appear straight and of regular<br>cross-section and wall thickness | | Limits for extractable<br>metals | Clause 6 of ISO 7864:<br>When tested with a recognized method the content of<br>lead, tin, zinc and iron shall be less than 5mg/l. The<br>cadmium content shall be lower than 0.1 mg/l. | | Freedom of defects | Clause 11.3 of ISO 7864:<br>When examined by normal or corrected vision, the<br>needle lube shall appear straight and of regular cross-<br>section and wall thickness | {6}------------------------------------------------ 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.