(77 days)
Not Found
No
The device description focuses on mechanical safety features and does not mention any computational or learning capabilities.
No.
The device is a pen needle, which is an accessory used with a pen injector to administer fluids, including medication. It does not independently perform a therapeutic function but rather facilitates the delivery of therapeutic substances.
No
Explanation: The device is a pen needle used for injecting fluids like insulin. Its purpose is for administration of substances, not for diagnosing conditions or diseases.
No
The device description clearly details a physical pen needle with a safety shield mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of fluids (like insulin and exenatide) using pen injector devices. This is a therapeutic application, delivering medication into the body.
- Device Description: The description details a needle designed for administering fluids and features to prevent needle sticks during injection. This aligns with a device used for drug delivery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing blood, urine, tissue, etc.
Therefore, the Clickfine AutoProtect Pen Needle is a device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Clickfine AutoProtect Pen Needle for use with pen injector devices for the injection of fluids, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
Product codes
FMI
Device Description
The pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of fluids. Each needle is individually packaged in a sealed protective container with a peel tab.
The pen needle is used by peeling back the peel tab and snapping or screwing the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the skin, the safety shield glides into the housing enabling the needle to penetrate the skin barrier and the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism is activated. The pen-injector delivers the medicinal product through the needle.
After the injection, in order to remove the needle from the skin, the user withdraws the pen injector from the skin. As the pen and needle is withdrawn from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (providing passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
The Clickfine AutoProtect 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 -. 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
- ISO 23908:2011 Sharps injury protection - Requirements and test methods
| Test | Requirement | Result |
|---|---|---|
| Needle assembly attachment shall fit and function with needle based injection systems specified in ISO 11608-1 | Clause 4.2.1 of ISO 11608-2; The pen needles were tested for compatibility with needle based injection system as specified in ISO 11608-1 | Pass |
| Tubing dimensions | Clause 4.2.2, Table 1 of ISO 11608-2; Length of patient end: +/- 1.25 mm; Length of cartridge end: 5.7 – 7.0 mm | Pass |
| Flow rate | Clause 4.3 of ISO 11608-2: Measurement of flow rate in accordance with Annex A. | Pass |
| Bond between hub and needle tube | Clause 9 of ISO 11608-2 and clause 13.1 of ISO 7864; The union of the hub and needle tube shall not break for at least 5 sec. while a force of at least 22 N is applied | Pass |
| Needle points | Clause 4.5 of ISO 11608-2; Visually sharp at a 2.5x magnification; designed to minimize coring and fragmentation | Pass |
| Lubrication | Clause 4.7 of ISO 11608-2; No visible droplets on the outside surface of the needle tube. | Pass |
| Dislocation of measuring point at the patient-end | Clause 8 of ISO 11608-2: maximum allowable dislocation acc. Clause 4.8, Table 2 for 5mm: 0.65mm and for 8mm: 0.9mm | Pass |
| Functional compatibility with needle based injection systems | Clause 11 of ISO 11608-2: Needle assembly torque: 0.07 +/- 0.01 Nm; Needle hub removal: less than 0.100 Nm; Dose 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. | Pass |
| 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 ISO 9626/A1. | Pass |
| Tubing diameters | Table 2 of ISO 9626/A1; Tubing dimensions meet outer and inner diameter requirements as defined in table 2 of ISO 9626/A1. | Pass |
| Stiffness | Clause 9 of ISO 9626: When tested in accordance with annex C of ISO 9626 the tubing shall show a deflection not greater than the relevant value given in table 3 of ISO 9626/A1. | Pass |
| Resistance to breakage | Clause 10 of ISO 9626: When tested in accordance with annex D of ISO 9626 and Table 4 of ISO 9626/A1 the tubing shall not break | Pass |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626; Tested in accordance with annex A and extract preparation of the tubing in accordance with Annex B: correction for the volume of titrant required for the control fluid shall not be more than 0.04 ml NaOH or 0.12 ml HCl to reach the end-point titration. | Pass |
| Resistance to corrosion | Clause 11 of ISO 9626: When tested in accordance with annex E, the immersed half of the tubing shall show no evidence of corrosion resulting from the test. | Pass |
| Freedom of defects | Clause 11.3 in ISO 7864: When examined by normal or corrected-to-normal vision, the needle shall appear straight and of regular cross-section and wall thickness | Pass |
| Limits for extractable metals | Clause 6 of ISO 7864: When tested with a recognized method the content of lead, tin, zinc and iron shall be less than 5mg/l. The cadmium content shall be lower than 0.1 mg/l. | Pass |
| Freedom of defects | Clause 11.3 of ISO 7864: When examined by normal or corrected vision, the needle lube shall appear straight and of regular cross-section and wall thickness. | Pass |
| Activation of the sharps injury protection | In accordance with ISO 23908 clause 5.2 the sharps injury protection feature shall be able to be activated by an appropriate force that eases actuation and avoids unintended actuation. An appropriate force was determined using a risk-based approach in accordance with ISO 14971. | Pass |
| Verification of safety feature activation | In accordance with ISO 23908, clause 5.3, needles were tested to provide evidence that once the safety feature was activated, they resist axial and lateral forces so as to prevent unintended exposure to the sharps. | Pass |
| Device design verification for needle tip protection after activation | In accordance to clause 5.4 of ISO 23908 it was demonstrated that a sphere of 6mm radius did not come into contact with the tip of the cannula, either before or immediately after triggering the safety mechanism | Pass |
The 5 mm Clickfine AutoProtect Pen Needles were tested, and met all acceptance criteria, for all the requirements as provided above. Based on the results Ypsomed concluded that the device performance is acceptable for the product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2015
Ypsomed AG Mr. Stephan Affolter Head of Quality System & Regulatory Affairs Brunnmattstrasse 6, CH- 3401 Burgdorf SWITZERLAND
Re: K152514
Trade/Device Name: Clickfine AutoProtect Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: October 20, 2015 Received: October 22, 2015
Dear Mr. Affolter:
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 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/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 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,
Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang". There is a large, looping signature to the left of the name. Below the name, there is a small "-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
Enclosure
2
Indications for Use
510(k) Number (if known) K152514
Device Name Clickfine AutoProtect Pen Needle
Indications for Use (Describe)
The Clickfine AutoProtect Pen Needle for use with pen injector devices for the injection of fluids, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
| 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.
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3
8 510(k) Summary for K152514
| Submitted By/
Contact Person: | Stephan Affolter
Head of Quality System & Regulatory Affairs
Ypsomed AG
Brunnmattstrasse 6
CH - 3401 Burgdorf
Switzerland
Tel. 0041-34 424 3382
Fax 0041-34 424 4122
E-mail: stephan.affolter@ypsomed.com |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Lee Leichter
President
P/L Biomedical
10882 Stonington Avenue
Fort Myers, FL 33913
USA
Tel. (239) 244-1448
Fax. (815) 550-0162
E-mail: leichter@plbiomedical.com |
| Date Prepared: | September 23, 2015 |
| 8.1 Trade/Proprietary Name: | Clickfine AutoProtect Pen Needle |
Injection Pen Needle
8.3 Classification Name:
II 1 . . 1 1
8.3 Classification Name:
8.2 Common/Usual Name:
Hypodermic single lumen needle
8.4 Classification: Regulation 21 CFR Part 880.5570 - Hypodermic single lumen needle was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification, classifying Hypodermic single lumen needles in Class II.
Panel: 80 Procode: FMI
8.5 Predicate Device: K131123 Clickfine AutoProtect Pen Needle
8.6 Purpose of Submission: To widen the range of the needle lengths and include a 5 mm Clickfine AutoProtect pen needle.
4
8.7 Device Description
The pen needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of fluids. Each needle is individually packaged in a sealed protective container with a peel tab.
The pen needle is used by peeling back the peel tab and snapping or screwing the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the skin, the safety shield glides into the housing enabling the needle to penetrate the skin barrier and the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism is activated. The pen-injector delivers the medicinal product through the needle.
After the injection, in order to remove the needle from the skin, the user withdraws the pen injector from the skin. As the pen and needle is withdrawn from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (providing passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect Pen Needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used.
8.8 Intended Use
The intended use of the modified device remains the same as the predicate device Clickfine AutoProtect Pen Needles K131123:
The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
- 8.9 Technological Characteristics and Substantial Equivalence discussion For the 5 mm Clickfine AutoProtect, except for the material of the needle shield, all of the material, processes and operating principles are identical to the currently marketed pen needles.
5
| Characteristic | Current Ypsomed Clickfine AutoProtect
Injection Pen Needle 8 and 6 mm | Modified Ypsomed
Clickfine AutoProtect
Injection Pen Needle
5 mm |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 510(k) | K131123
The Clickfine AutoProtect Pen Needle is
intended for use with pen injector devices for
the injection of fluids, including insulin and
exenatide. | N/A |
| Indications for
use | Additionally, the attached safety shield
automatically locks in place and reduces the
occurrence of accidental needle sticks from
the patient end of the needle. The shield also
serves to hide the needle before and after
injection. | Unchanged |
| OTC | OTC | Unchanged |
| Needle length | 6 and 8 mm | 5, 6 and 8 mm |
| Needle gauge | 31, 30 and 29 gauge | Unchanged |
| Needle outer
diameter | 0.25, 0.3 and 0.33 mm | Unchanged |
| | Normal walled needle:
$\ge$ 0.114, $\ge$ 0.133 and
$\ge$ 0.133 mm | Unchanged |
| Needle inner
diameter | Thin walled needle:
$\ge$ 0.125, 0.165 and
$\ge$ 0.190 mm | Unchanged |
| Needle grind | Front and back bevel | Unchanged |
| Needle tip: | 3-bevel | Unchanged |
| Method of
attachment to
pen | "Snap-on" & "Twist-on” attachment and
Twist-off removal | Unchanged |
| Needle
material | Stainless steel | Unchanged |
| Needle/hub
bond | Adhesive bonded | Unchanged |
| Hub material | PP | Unchanged |
| Housing | White colored PP | Unchanged |
| Needle shield | Blue colored MBS, using the Zylar 530
granulate | Blue colored MBS,
using the Zylar 550
granulate |
| Safety lock
indicator | Red colored PP | Unchanged |
| Spring | Stainless steel | Unchanged |
| Characteristic | Current Ypsomed Clickfine AutoProtect
Injection Pen Needle 8 and 6 mm | Modified Ypsomed
Clickfine AutoProtect
Injection Pen Needle
5 mm |
| Outer
protective
container
material | Blue colored PP | Unchanged |
| Peel tab | PET | Unchanged |
| Sterilization
method | Gamma irradiation | Unchanged |
| Sterilization
conditions | 25 kGy | 17.5 kGy |
| IFU | Leaflet | Unchanged |
Comparison to Predicate Device
6
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.
The Clickfine AutoProtect 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 -. 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
- . ISO 23908:2011 Sharps injury protection - Requirements and test methods
| Test | Requirement | Result |
|---|---|---|
| Needle assembly | ||
| attachment shall | ||
| fit and function | ||
| with needle | ||
| based injection | ||
| systems | ||
| specified in | ||
| ISO 11608-1 | Clause 4.2.1 of ISO 11608-2 | |
| The pen needles were tested for compatibility with | ||
| needle based injection system as specified in ISO | ||
| 11608-1 | Pass | |
| Tubing | ||
| dimensions | Clause 4.2.2, Table 1 of ISO 11608-2 | |
| Length of patient end: +/- 1.25 mm | ||
| Length of cartridge end: 5.7 – 7.0 mm | Pass | |
| Test | Requirement | Result |
| Flow rate | Clause 4.3 of ISO 11608-2: | |
| Measurement of flow rate in accordance with | ||
| Annex A. | Pass | |
| Bond between | ||
| hub and needle | ||
| tube | Clause 9 of ISO 11608-2 and clause 13.1 of ISO | |
| 7864 | ||
| The union of the hub and needle tube shall not | ||
| break for at least 5 sec. while a force of at least 22 | ||
| N is applied | Pass | |
| Needle points | Clause 4.5 of ISO 11608-2 | |
| Visually sharp at a 2.5x magnification; designed to | ||
| minimize coring and fragmentation | Pass | |
| Lubrication | Clause 4.7 of ISO 11608-2 | |
| No visible droplets on the outside surface of the | ||
| needle tube. | Pass | |
| Dislocation of | ||
| measuring point | ||
| at the patient- | ||
| end | Clause 8 of ISO 11608-2: | |
| maximum allowable dislocation acc. Clause 4.8, | ||
| Table 2 for 5mm: 0.65mm and for 8mm: 0.9mm | Pass | |
| Functional | ||
| compatibility | ||
| with needle | ||
| based injection | ||
| systems | Clause 11 of ISO 11608-2: | |
| Needle assembly torque: 0.07 +/- 0.01 Nm | ||
| Needle hub removal: less than 0.100 Nm | ||
| Dose 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. | Pass | |
| 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 ISO | ||
| 9626/A1. | Pass | |
| Tubing | ||
| diameters | Table 2 of ISO 9626/A1 | |
| Tubing dimensions meet outer and inner diameter | ||
| requirements as defined in table 2 of ISO 9626/A1. | Pass | |
| Stiffness | Clause 9 of ISO 9626: | |
| When tested in accordance with annex C of ISO | ||
| 9626 the tubing shall show a deflection not greater | ||
| than the relevant value given in table 3 of ISO | ||
| 9626/A1. | Pass | |
| Resistance to | ||
| breakage | Clause 10 of ISO 9626: | |
| When tested in accordance with annex D of ISO | ||
| 9626 and Table 4 of ISO 9626/A1 the tubing shall | ||
| not break | Pass | |
| Test | Requirement | Result |
| Limits for | ||
| acidity and | ||
| alkalinity | Clause 6 of ISO 9626 | |
| Tested in accordance with annex A and extract | ||
| preparation of the tubing in accordance with Annex | ||
| B: correction for the volume of titrant required for | ||
| the control fluid shall not be more than 0.04 ml | ||
| NaOH or 0.12 ml HCl to reach the end-point | ||
| titration. | Pass | |
| Resistance to | ||
| corrosion | Clause 11 of ISO 9626: | |
| When tested in accordance with annex E, the | ||
| immersed half of the tubing shall show no evidence | ||
| of corrosion resulting from the test. | Pass | |
| Freedom of | ||
| defects | Clause 11.3 in ISO 7864: | |
| When examined by normal or corrected-to-normal | ||
| vision, the needle shall appear straight and of | ||
| regular cross-section and wall thickness | Pass | |
| Limits for | ||
| extractable | ||
| metals | Clause 6 of ISO 7864: | |
| When tested with a recognized method the content | ||
| of lead, tin, zinc and iron shall be less than 5mg/l. | ||
| The cadmium content shall be lower than 0.1 mg/l. | Pass | |
| Freedom of | ||
| defects | Clause 11.3 of ISO 7864: | |
| When examined by normal or corrected vision, the | ||
| needle lube shall appear straight and of regular | ||
| cross-section and wall thickness. | Pass | |
| Activation of the | ||
| sharps injury | ||
| protection | In accordance with ISO 23908 clause 5.2 the sharps | |
| injury protection feature shall be able to be | ||
| activated by an appropriate force that eases | ||
| actuation and avoids unintended actuation. An | ||
| appropriate force was determined using a risk-based | ||
| approach in accordance with ISO 14971. | Pass | |
| Verification of | ||
| safety feature | ||
| activation | In accordance with ISO 23908, clause 5.3, needles | |
| were tested to provide evidence that once the safety | ||
| feature was activated, they resist axial and lateral | ||
| forces so as to prevent unintended exposure to the | ||
| sharps. | Pass | |
| Device design | ||
| verification for | ||
| needle tip | ||
| protection after | ||
| activation | In accordance to clause 5.4 of ISO 23908 it was | |
| demonstrated that a sphere of 6mm radius did not | ||
| come into contact with the tip of the cannula, either | ||
| before or immediately after triggering the safety | ||
| mechanism | Pass |
7
8
The 5 mm Clickfine AutoProtect Pen Needles were tested, and met all acceptance criteria, for all the requirements as provided above. Based on the results Y psomed concluded that the device performance is acceptable for the product.
8.11 Clinical Data
9
Clinical Data was not required to establish substantial equivalence for these devices.
- 8.12 Conclusion
Ypsomed AG concludes based on the information presented that the subject device is substantially equivalent to the predicate product legally marketed in the USA.