(74 days)
Not Found
No
The description focuses on the mechanical safety features of a pen needle and does not mention any computational or learning capabilities.
No.
The device is a pen needle intended for use with pen injector devices for the injection of fluids, such as insulin. While it facilitates the delivery of therapeutic substances, it is a delivery device accessory, not a therapeutic device itself.
No
The device is described as a "Pen Needle" intended for "injection of fluids" (e.g., insulin) and "administration of prescribed fluids." Its function is to deliver medication, not to diagnose a condition.
No
The device description clearly describes a physical pen needle with a safety shield mechanism, not a software application.
Based on the provided text, 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) into the body using a pen injector. This is a therapeutic delivery method, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a needle designed for subcutaneous injection and a safety mechanism to prevent needle sticks. This aligns with a device used for administering medication, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly designed for the delivery of medication into the body, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI
Device Description
The Clickfine AutoProtect 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 needle is used by peeling back the peel tab and snapping 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 safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be 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 moves the pen injector away from the skin. As the pen and needle is moved away 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 (provide 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
As this was an administrative change, no performance and safety data were required to be submitted in support of the change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K131123
7. Summary of Safety and Effectiveness
JUL 5 2013
"510(K) SUMMARY"
Submitted By/ Contact Person:
Dr. Benjamin Reinmann Vice President Quality 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:
Trade/Proprietary Name: 7.1
Classification Name:
Clickfine AutoProtect Pen Needle
- Common/Usual Name: 7.2
7.3
Hypodermic single lumen needle
Injection Pen Needle
- 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.
Panel: 80
Procode: FMI
- Purpose of Submission: To make an administrative change to revise the Indications for 7.5 Use to be consistent with the BD AutoShield Pen Needle so that the needles can be marketed Over the Counter (OTC) for all compatible injection pens.
- Substantial Equivalence: The Clickfine AutoProtect Pen Needle is substantially 7.6 equivalent to the Clickfine AutoProtect Pen Needles (K110312) and the BD AutoShield Pen Needles (K060007).
7.7 Device Description
The Clickfine AutoProtect 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 needle is used by peeling back the peel tab and snapping 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
1
the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be 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 moves the pen injector away from the skin. As the pen and needle is moved away 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 (provide 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.
- 7.8 Intended Use
The intended use of the device has been modified to combine the Indications cleared for the Clickfine AutoProtect Pen Needle (K110312) with the wording in the predicate device BD AutoShield Pen Needle (K060007):
The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for injections 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.
- Technological Characteristics 7.9 The technological characteristics have not changed.
7.10 Performance and Safety Data As this was an administrative change, no performance and safety data were required to be submitted in support of the change.
- 7.11 Conclusion
Yosomed 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
July 5, 2013
Yosomed AG Dr. Benjamin Reinmann Vice President Quality Management & Regulatory Affairs Brunnmattstrasse 6 Burgdorf SWITZERLAND CH-3401
Re: K131123
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: 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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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" (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,
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
4
Indications for Use
510(k) Number (if known): K | 31123
Device Name:
Indications For Use:
Clickfine AutoProtect Pen Needle
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.
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)
Image /page/4/Picture/12 description: The image shows the letters FDA in a stylized font. The letters are made up of small, pixelated squares, giving them a blocky appearance. The letters are arranged horizontally, with the F on the left, the D in the middle, and the A on the right.
Richard C. Chapman 2013.07.01 14:24:38 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
page 21 of 23
510(k) Number: 131123