(29 days)
No
The device description and performance studies focus on the mechanical and material properties of a pen needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a pen needle, intended for fluid injection, not for treating a disease or condition itself.
No
Explanation: The device is described as a pen needle intended for the hypodermic injection of fluids, not for diagnosing conditions.
No
The device description clearly describes a physical pen needle, which is a hardware component used for injection. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Clickfine pen needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "hypodermic injection of fluids into the body." This describes a device used for administering substances into a living organism.
- Device Description: The description details a needle designed to be attached to an injection pen for delivering fluids. This is consistent with a device used for direct administration, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. The Clickfine pen needle's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Product codes
FMI
Device Description
The Ypsomed 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 peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug 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.
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
Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices. The Clickfine 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. The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are 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
7. Summary of Safety and Effectiveness
OCT 2 5 2012
"510(K) SUMMARY"
| Submitted By/ Contact Person: | Dr. Benjamin Reinmann
Vice President
Quality Management & Regulatory Affairs
Ypsomed AG
Brunnmattstrasse 6
CH - 3401 Burgdorf
Switzerland
Tel. 0041-344244111
Fax 0041-344244122
E-mail: benjamin.reinmann@ypsomed.com |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 24, 2012 |
| 7.1 | Trade/Proprietary Name: | Clickfine Pen Needle |
|---|---|---|
| 7.2 | Common/Usual Name: | Injection Pen Needle |
| 7.3 | Classification Name: | Hypodermic single lumen needle |
| 7.4 | Classification: FDA has classified Hypodermic single lumen needles in Cla |
-
n Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.
CFR Reference: 880.5570 Procode: FMI -
7.5 Purpose of Submission: To expand the product line to include smaller needles including a 4 mm, 32 gauge needle.
-
7.6 Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Clickfine Pen Needles (K102108). The equivalence is supported by the attached documentation.
-
7.7 Device Description
The Ypsomed 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 peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected. When the injection is
1
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 modified device remains the same as the predicate device Clickfine Pen Needles (K102108):
The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Technological Characteristics 7.9 The technological characteristics have not changed.
- 7.10 Performance and Safety Data
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.
The Clickfine 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 .
The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.
7.11 Conclusion
Y psomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol, 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 symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
2 5 2012
P/L Biomedical Mr. Lee Leichter 10882 Stonigton Avenue Fort Myers, Florida 33913
Re: K122971
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: September 24, 2012 Received: September 26, 2012
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.
3
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Antim V.n
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):
Device Name:
Indications For Use:
K 122971
Clickfine Pen Needle
The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K122971