(103 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a pen needle, with no mention of AI or ML.
No.
This device is a pen needle, which facilitates the delivery of therapeutic fluids but is not itself a therapeutic device that performs a therapeutic function on the body.
No
The device description clearly states its purpose is for subcutaneous injection of fluids, not for diagnosing medical conditions. It delivers fluid, it does not acquire information about the body to determine a diagnosis.
No
The device description clearly outlines physical components (needles, hubs, caps, packaging) and manufacturing processes (sterilization), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "subcutaneous injection of fluids, including insulin and exenatide." This describes a device used for delivering substances into the body, not for testing samples from the body.
- Device Description: The description details a needle designed to puncture the skin and deliver fluid from a pen injector. This is a delivery mechanism, not a diagnostic tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The device described is a medical device used for drug delivery, specifically a pen needle.
N/A
Intended Use / Indications for Use
The Clickfine and Penfine Classic Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
Product codes
FMI
Device Description
The subject devices are sterile, non-pyrogenic, single use pen needles designed to be used with commercially available pen-injectors. The back end of the needle punctures the rubber injection port of the drug reservoir in the pen. When the injection is needed, the needle is inserted into the chosen site and the pen-injector delivers the fluid through the needle.
The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.
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)
All Subject Device Pen Needles have met the requirements of the relevant sections of the following standards recognized by FDA:
- a) ISO 11608-2:2012 Needle based injection systems for medical use Requirements and test methods - Part 2: Needles
- b) ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- c) ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods
The following risks were adequately addressed through design controls:
- Device Modification: Larger inner diameter of needle on 31 Gauge and 32 Gauge needles
- Risks: Breakage of needle
- Verification Activity: Testing for resistance to breakage was conducted acc. ISO 9626:2016
- Acceptance Criteria: When tested acc. Annex C of ISO 9626:2016, the tubing shall not show visible breakage when examined by normal or corrected vision after testing.
- Results of Verification: All samples tested met the acceptance criteria for resistance to breakage acc. ISO 9626:2016.
- Device Modification: Larger inner diameter of needle on 31 Gauge and 32 Gauge needles
- Risks: Bending of needle
- Verification Activity: Testing for stiffness was conducted acc. ISO 9626:2016
- Acceptance Criteria: The tubing shall show a maximum defined deflection when tested in accordance with annex B of ISO 9626:2016: max. deflection 0.22 mm for 32 G and max. 0.21 mm for 31 G
- Results of Verification: All samples tested met the acceptance criteria for stiffness acc. ISO 9626:2016.
- Device Modification: Change in labeling to add information regarding increased inner diameter
- Risks: None
- Verification Activity: None Required. Changes do not impact the safe or effective use of the product
- Acceptance Criteria: N/A
- Results of Verification: N/A
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
510(k) Summary - File # K171984
8.1. Date prepared September 19, 2017
8.2. Submitter's information
| Company Name: | Ypsomed AG |
|---|---|
| Company Address: | Brunnmattstrasse 6 |
| CH - 3401 Burgdorf, Switzerland | |
| Contact Person: | Stephan Affolter |
| Head of Quality System & Regulatory Affairs | |
| Phone number: | 0041-34 424 3382 |
| Fax number: | 0041-34 424 4122 |
| Email: | stephan.affolter@ypsomed.com |
Alternative contact
| Company Name: | P/L Biomedical |
|---|---|
| Company Address: | 10882 Stonington Avenue |
| Fort Myers, FL 33913, USA | |
| Contact Person: | Lee Leichter |
| Phone number: | (239) 244-1448 |
| Fax number: | (815) 550-0162 |
| Email: | leichter@plbiomedical.com |
8.3. Trade Name, Common Name, Classification
| Trade Name: | Clickfine Pen Needle and
Penfine Classic Pen Needle |
|----------------------|--------------------------------------------------------|
| Common Name: | Injection Pen Needle |
| Classification Name: | Hypodermic single lumen needle |
| Regulation Number: | 21 CFR 880.5570 |
| Regulatory Class: | Class II |
| Product Code | FMI |
8.4. Identification of predicate Device(s)
| The identified predicate device within this submission are as follows: | |
|---|---|
| Manufacturer: | Ypsomed AG |
| Trade Name: | Clickfine Pen Needle and |
| Penfine Classic Pen Needle | |
| Common Name: | Injection Pen Needle |
| Classification Name: | Hypodermic single lumen needle |
| Regulation Number: | 21 CFR 880.5570 |
| Regulatory Class: | Class II |
| Product Code | FMI |
| FDA 510(k) #: | K150662 |
1
8.5. Comparison with Predicate Devices:
The subject device has the same materials, fundamental scientific technology and device performance as the predicate device (K150662). The only difference is that the subject devices of the same gauge (outer diameter) will now have a larger inner diameter, i.e. extra thin walled needles according to ISO 9626:2016.
The table below provides a side by side comparison of the subject device compared to its predicate.
| Characteristic | Predicate device | Subject device | Comments |
|---|---|---|---|
| Indications for | |||
| use | The Clickfine and Penfine | ||
| Classic Pen Needle are | |||
| intended for use with pen | |||
| injector devices for | |||
| subcutaneous injection of | |||
| fluids, including insulin and | |||
| exenatide. | The Clickfine and Penfine | ||
| Classic Pen Needle are | |||
| intended for use with pen | |||
| injector devices for | |||
| subcutaneous injection of | |||
| fluids, including insulin and | |||
| exenatide. | Unchanged | ||
| Needle length | 4, 4.5, 5, 6, 8, 10, and 12 mm | 4, 4.5, 5, 6, 8, 10, and 12 mm | Unchanged |
| Needle gauge | 32, 31, 30 and 29 gauge | 32, 31, 30 and 29 gauge | Unchanged |
| Needle outer | |||
| diameter | 0.23 mm, 0.25, 0.3 and 0.33 mm | 0.23 mm, 0.25, 0.3 and 0.33 mm | Unchanged |
| Needle inner | |||
| diameter | Normal walled needle: | ||
| ≥ 0.114 mm (31 gauge) | |||
| ≥ 0.133 mm (30 gauge) | |||
| ≥ 0.133 mm (29 gauge) |
Thin walled needle:
≥ 0.105 mm (32 gauge)
≥ 0.125 mm (31 gauge)
≥ 0.165 mm (30 gauge)
≥ 0.190 mm (29 gauge) | Normal walled needle:
≥ 0.114 mm (31 gauge)
≥ 0.133 mm (30 gauge)
≥ 0.133 mm (29 gauge)
Thin walled needle:
≥ 0.105 mm (32 gauge)
≥ 0.125 mm (31 gauge)
≥ 0.165 mm (30 gauge)
≥ 0.190 mm (29 gauge) | Unchanged |
| | n/a | Extra thin walled needle:
≥ 0.146 mm (31 gauge),
≥ 0.125 mm (32 gauge) | The needles have
been modified to
have Extra thin
wall tubing |
8.6. Description of the Device
The subject devices are sterile, non-pyrogenic, single use pen needles designed to be used with commercially available pen-injectors. The back end of the needle punctures the rubber injection port of the drug reservoir in the pen. When the injection is needed, the needle is inserted into the chosen site and the pen-injector delivers the fluid through the needle.
The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same
2
sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.
8.7. Indication for Use
The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
8.8. Technological Characteristics
The predicate device Clickfine and the Penfine Classic pen needle are comprised of a siliconized stainless steel needle encased in a needle hub. An outer protective cap snaps onto the hub over the needle. This assembly fits into a larger outer protective container, which provides the sterile barrier along with the peel foil.
These characteristics remain the same for the proposed devices.
8.9. Substantial Equivalence
Performance testing:
All Subject Device Pen Needles have met the requirements of the relevant sections of the following standards recognized by FDA:
- a) ISO 11608-2:2012 Needle based injection systems for medical use Requirements and test methods - Part 2: Needles
- b) ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- c) ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods
The following risks were adequately addressed through design controls:
| Device
Modification | Risks | Verification
Activity | Acceptance
Criteria | Results of
Verification |
|--------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Larger inner diameter of needle on
31 Gauge and 32 Gauge needles | Breakage of needle | Testing for
resistance to
breakage was
conducted acc. ISO
9626:2016 | When tested acc. Annex C
of ISO 9626:2016, the
tubing shall not show
visible breakage when
examined by normal or
corrected vision after
testing. | All samples tested met the acceptance
criteria for resistance to breakage acc. ISO
9626:2016. |
| | Bending of needle | Testing for stiffness
was conducted acc.
ISO 9626:2016 | The tubing shall show a
maximum defined
deflection when tested in
accordance with annex B
of ISO 9626:2016:
max. deflection 0.22 mm
for 32 G and max. 0.21
mm for 31 G | All samples tested met the acceptance
criteria for stiffness acc. ISO 9626:2016. |
| Change in labeling to add
information regarding increased
inner diameter | None | None Required.
Changes do not
impact the safe or
effective use of the
product | N/A | N/A |
8.10. Conclusion
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 subject device is substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it.
October 11, 2017
Ypsomed AG % Lee Leichter President P/L Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913
Re: K171984
Trade/Device Name: Clickfine Pen Needle, Penfine Classic Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 8, 2017 Received: September 13, 2017
Dear Lee 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.
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 of medical device-related adverse events) (21 CFR 803); good
5
manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) 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,
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure