(23 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a standard pen needle, with no mention of AI or ML capabilities.
No.
This device is a pen needle, a sterile accessory for injecting drugs subcutaneously, not a device that provides therapy itself.
No
Pen needles are used for administering drugs, not for diagnosing conditions. The description explicitly states their purpose is for "subcutaneous injection of drugs" and "administration of drugs", and performance studies confirm their physical characteristics and safety for this purpose, not diagnostic capabilities.
No
The device description clearly states it is a physical pen needle used for subcutaneous injection of drugs, and the performance studies involve physical testing of the device's dimensions, performance, and biocompatibility. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with pen injector device for the subcutaneous injection of drugs." This describes a device used to administer medication into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a needle designed for drug delivery via a pen injector. It focuses on physical characteristics, materials, and how it's used for injection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (within the body) for drug administration.
N/A
Intended Use / Indications for Use
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.
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)
Non-Clinical Performance Data:
Verification and Validation Activities - Design Changes:
- Needle Sizes: Additional sizes ranging from 0.33mm×12mm to 0.18mm×3.5mm were introduced to meet clinical needs, focusing on reducing outer diameter for increased patient comfort and ensuring safety by minimizing the risk of intramuscular injections.
- Compatible Pens: The pen needle compatibility was expanded to include additional pen models, such as ClikSTAR®, SoloSTAR®, and FlexTouch®, to address the evolving market and clinical requirements.
- Needle Shield Material: The needle shield material was changed from Polypropylene (PP) to Polyethylene (PE) to improve manufacturing efficiency. The new material was tested and found to be biocompatible and non-toxic as per ISO 10993-1.
Testing Performed:
- Labeling and Dimensional Compliance: Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 11608-2. The needle's dimensions, including the container, shield, and hub, were measured, and found to comply with drawing requirements.
- Performance Testing: The pen needles underwent performance testing (reports VR-20230818-02 and VR-20210528-03) to assess dose accuracy and needle removal torque. The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2.
- Biocompatibility Testing: The new Polyethylene (PE) material for the needle shield was tested for cytotoxicity, skin irritation, intracutaneous reactivity, and sensitization according to ISO 10993-1 standards.
Test Results:
All verification and validation tests passed without deviations, confirming that the Verifine® Pen Needles meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.
Conclusion:
Based on the results of the non-clinical verification and validation activities, it can be concluded that the modified Verifine® Pen Needles are substantially equivalent to the predicate device K161950. The changes, including the addition of new needle sizes, compatible pens, and the material change of the needle shield, have been thoroughly evaluated and verified to meet all applicable performance and safety standards. Therefore, the device is as safe and effective as the predicate device for its intended use, and no new risks have been introduced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 26, 2024
Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Founding Member and Senior Consultant MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015
Re: K242632
Trade/Device Name: Verifine® Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 3, 2024 Received: September 3, 2024
Dear John Beasley:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242632
Device Name Verifine® Pen Needles
Indications for Use (Describe)
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.
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)
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4
K242632 510(k) Summary
Verifine® Pen Needles
1. Submission Sponsor
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City Zhejiang 311121 China
Contact: Mr. Zearou Yang
Office Phone: +8657188772985
Email: jim@nemoto-do.co.jp
2. Submission Correspondent
MedTech Review, LLC
257 Garnet Garden Street Henderson NV 89015 United States
Contact: John Beasley
Office Phone: +7027236889
Email:john@medtechreview.com
3. Date Prepared
September 03, 2024
4. Device Identification
| Trade/Proprietary Name: | Verifine® Pen Needles |
|---|---|
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Regulation Number(s): | 880.5570 |
| Product Code(s): | FMI |
| Class: | II |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate Device(s)
Device name: Verifine ® Common Type Insulin Pen Needle and Verifine® Safety Type Insulin Pen Needle
510(k) number: K161950
Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.
5
6. Device Description
Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.
7. Indication for Use Statement
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.
8. Substantial Equivalence Discussion
The following table compares the Verifine® Pen Needles to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| SE Comparison |
|---|
| --------------- |
be provides a detailed comparison of the modified device, ensuring that no new concerns regarding safety o effectiveness have been introd
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Insulin Pen Needles | No change | N/A | No new concerns. The
common name remains
unchanged, ensuring
consistency with the intended
use. | |
| Trade name | Verifine® Common Type Insulin Pen Needle | IPN
FPN, NPN | Verifine® Pen Needles
Verifine® Plus Pen Needles | It is only for common type pen
needle. Only the trade name is
change. | No new concerns. The trade
name change does not impact
safety or effectiveness as the
device's function remains the
same. |
| Classification name | Needle, Hypodermic, Single Lumen (21 CFR 880.5570) | No change | N/A | No new concerns. The
classification name remains
consistent. | |
| Device class | Class II | No change | N/A | No new concerns. The device
remains in Class II, indicating
no change in risk level. | |
| Product Code | FMI | No change | N/A | No new concerns. The product
code remains the same,
reflecting no change in device
functionality. | |
| General description | The proposed product, insulin pen needle, is manufactured
by Promisemed Hangzhou Meditech Co.,
Ltd, which is designed for use with a pen injector for the
subcutaneous injection of insulin.
The products have two types, common type and safety
type. Both of the two types are sterile with a Sterility
Assurance Level (SAL) of 10-6, non-pyrogenic and single-use
devices. Each type has several models. Different models are
distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle
container, needle shield, needle tube, needle hub, UV glue | The proposed product, Verifine® Pen Needles, is
manufactured by Promisemed Hangzhou Meditech Co.,
Ltd, which is designed for use with a pen injector for the
subcutaneous injection of insulin.
The product is common type without safety protective
feature. It is a sterile with a Sterility Assurance Level (SAL)
of 10-6, non-pyrogenic and single-use devices. Each type
has several models. Different models are distinguished by
needle gauge and length.
It is consisting of needle container, needle shield, needle
tube, needle hub, UV glue and silicone oil. UV glue is used | It is only for common type pen
needle.
Description about common type
is no change. | No new concerns. The change
to a broader intended use
does not introduce new risks
as the fundamental technology
and operation remain the
same. | |
6
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement | | | | | | | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | and silicone oil. UV glue is used to glue needle tube and
needle hub and the silicone oil is used to needle tube
lubrication.
The user proceeds with inserting the needle into the skin
manually.
Both the Common Type Insulin Pen Needle and the Safety
Type Pen Needle are for OTC use, and they are external
communication, blood indirect devices. The contact
duration for both subjected devices is within 24h, and they
belong to limited contact device according ISO 10993-1. | to glue needle tube and needle hub and the silicone oil is
used to needle tube lubrication.
The user proceeds with inserting the needle into the skin
manually.
It is intended for OTC use, and they are external
communication, blood indirect devices. The contact
duration for both subjected devices is within 24h, and they
belong to limited contact device according ISO 10993-1. | | | | | | | | | | |
| Principles of operation | The user proceeds with inserting the needle into the
skin manually. The patient end and the cartridge end of the
tube are lubricated using a silicone based lubricant for ease
of injection and rubber septum penetration. | No change | N/A | No new concerns. The
principles of operation remain
unchanged, ensuring
consistent performance. | | | | | | | | |
| Indication of use | The Common Type Insulin Pen Needle is intended for use
with pen injector device for subcutaneous injection of
insulin. | Verifine® Pen Needle is intended for use with pen injector
device for the subcutaneous injection of drugs. | Change in the trade name and
from specific use (insulin) to
general use (drugs). | No new concerns. The broader
indication for use does not
introduce new safety or
effectiveness risks as the
device's mechanism remains
unchanged. | | | | | | | | |
| Model | IPN-29-12,
IPN-30-8,
IPN-31-4, IPN-31-5, IPN-31-6, IPN-31-8,
IPN-32-4, IPN-32-5, IPN-32-8,
IPN-33-4 | Model Specification code IPN Not defined. FPN Not defined. NPN Not defined. | | | | | | | | | New two models of FPN and NPN
were added.
Specification code was not
defined that the needle was
identified through by metric size. | No new concerns. The addition
of new models and sizes
expands options without
altering the device's safety or
effectiveness. |
| Needle size | IPN
+
0.33mm×12mm,
0.30mm×8mm,
0.25mm×4mm, 0.25mm×5mm, 0.25mm×6mm, 0.25mm×
8mm,
0.23mm×4mm, 0.23mm×5mm, 0.23mm×8mm,
0.20mm× 4mm | IPN, FPN, NPN
+
0.33mm×12mm,
0.30mm×8mm,
0.25mm×4mm, 0.25mm×5mm, 0.25mm×6mm, 0.25mm×
8mm,
0.23mm×4mm, 0.23mm×5mm, 0.23mm×6mm, 0.23mm×
8mm,
0.20mm× 3.5mm, 0.20mm× 4mm, 0.20mm× 5mm,
0.18mm× 3.5mm, 0.18mm× 4mm, 0.18mm× 5mm | Some size was added. | No new concerns. The addition
of new needle sizes does not
impact safety or effectiveness;
the new sizes comply with
standard specifications. | | | | | | | | |
| Item of description | Cleared device | Modified device | | | Comments on
Similarities/Differences | Safety/Effectiveness
Statement |
|----------------------------------|------------------------------------|---------------------------------|---------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bevel | 3 | Bevel | Model | Needle size | Bevel of needle tip is defined.
Addition of 5 bevel design. | No new concerns. The
introduction of a 5-bevel
design is intended to enhance
user experience without
affecting safety or
effectiveness. |
| | | 3 bevels | IPN, FPN, NPN | All sizes | | |
| | | 5 bevels | IPN, FPN, NPN | All sizes | | |
| Needle
Gauge | 29G, 30G, 31G, 32G, 33G | 29G, 30G, 31G, 32G, 33G, 34G | | | Outer diameter of 34G (0.18mm)
was added, per K210059. | No new concerns. The added
dimensions meet regulatory
standards, ensuring safety and
effectiveness. |
| Dimension | Length
4mm, 5mm, 6mm, 8mm, 12mm | 3.5mm, 4mm, 5mm, 6mm, 8mm, 12mm | | | Nominal length of 3.5mm was
added. | |
| Color | Image: Color chart | Not defined. | | | There is no color designated to
each size that metric size is
identified through the gauge and
length, and there is no color
requirement for pen needle in
ISO 11608-2. | No new concerns. The lack of a
defined color does not impact
the safety or effectiveness of
the device. |
| Schematic diagram
and picture | Image: Schematic diagram of IPN | No change | | | There is only the difference about
shape of needle shield and hub
for each model. | No new concerns. The design
variations do not introduce
new safety or effectiveness
risks, as they are minor
adjustments to the device's
form. |
7
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement |
|---------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------|
| / | | FPN
Fig. 2—Schematic representation of FPN
Key
1 Needle container 4 Jointing medium
2 Needle shield 5 Needle hub
3 Needle tube | | |
| / | | NPN
Fig. 3—Schematic representation of NPN
Key
1 Needle container 4 Jointing medium
2 Needle shield 5 Needle hub
3 Needle tube | | |
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement | | |
|---------------------|-----------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------|
| Product picture | / | Image: Side view
Image: Front view | There is only the difference about
shape of needle shield and hub
for each model. | No new concerns. The design
variations do not introduce
new safety or effectiveness
risks, as they are minor
adjustments to the device's
form. | | |
| | / | | | | | |
| Material | Image: IPN symbol IPN | Image: IPN symbol IPN | Material of needle shield is
changed to PE which is only
contact intact skin. | No new concerns. The material
change for the needle shield is
minor and does not affect
safety as it only contacts intact
skin. | | |
| | Component | Material | | | Component | Material |
| | Needle tube | Stainless steel (X5CrNi18-10) | | | Needle tube | Stainless steel (X5CrNi18-10) |
| | Needle Shield | Polypropylene (PP) | | | Needle Shield | Polyethylene (PE) |
| | Needle Container | Polypropylene (PP) | | | Needle Container | Polypropylene (PP) |
| | Needle Hub | Polypropylene (PP) | | | Needle Hub | Polypropylene (PP) |
| | Glue (Joint medium) | UV Glue | | | Glue (Joint medium) | UV Glue |
| | Lubricant | Silicone oil | Lubricant | Silicone oil | | |
| | Dialyzing paper
(Seal) | Medical grade glue dialyzing
paper | Dialyzing paper
(Seal) | Medical grade glue dialyzing
paper | | |
| | | Image: FPN symbol FPN | | | Material of needle shield is
changed to PE which is only | |
| | | | Component | Material | contact intact skin. | |
| | | | Needle tube | Stainless steel (X5CrNi18-10) | | |
8
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement | | | | | | | | | | | | | | | | |
|-----------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|------------|--|
| | / | Needle Shield
Needle Container
Needle Hub
Glue (Joint medium)
Lubricant
Dialyzing paper
(Seal) | | | | | | | | | | | | | | | | | | |
| | | Needle Shield Polyethylene (PE)
Needle Container Polypropylene (PP)
Needle Hub Polypropylene (PP)
Glue (Joint medium) UV Glue
Lubricant Silicone oil
Dialyzing paper Medical grade glue dialyzing paper
(Seal) | | | | | | | | | | | | | | | | | | |
| | | NPN
Component Material Needle tube Stainless steel (X5CrNi18-10) Needle Shield Polypropylene (PP) Needle Container Polypropylene (PP) Needle Hub Polypropylene (PP) Glue (Joint medium) UV Glue Lubricant Silicone oil Dialyzing paper (Seal) Medical grade glue dialyzing paper | | | | | | | | | | | | | | | | | No change. | |
| Performance
requirements | Remain no change | No change | N/A | No new concerns.
Performance requirements
remain unchanged, ensuring
consistent functionality. | | | | | | | | | | | | | | | | |
| Labeling | Unit
package | Remain no change | No change | N/A | | | | | | | | | | | | | | | | |
| | User
package | Remain no change | Blow contents were changed:
- Indication;
- warning;
- direction for use;
- compatible pens; | These changes are meeting for
requirement of ISO 11608-
2:2022. | No new concerns. Labeling
updates meet current
standards and enhance the
device's safety and usability. | | | | | | | | | | | | | | | |
| | Instruction
for use | Remain no change | Blow contents were changed: - Indication;
- warning;
- direction for use; | These changes are to be met for
requirement of ISO 11608-
2:2022. | | | | | | | | | | | | | | | | |
| Item of description | Cleared device | Modified device | Comments on
Similarities/Differences | Safety/Effectiveness
Statement | |
|-----------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | / | Needle Shield
Needle Container
Needle Hub
Glue (Joint medium)
Lubricant
Dialyzing paper
(Seal) | | | |
| | | Needle Shield Polyethylene (PE)
Needle Container Polypropylene (PP)
Needle Hub Polypropylene (PP)
Glue (Joint medium) UV Glue
Lubricant Silicone oil
Dialyzing paper (Seal) Medical grade glue dialyzing paper | | | |
| | | NPN
Component Material
Needle tube Stainless steel (X5CrNi18-10)
Needle Shield Polypropylene (PP)
Needle Container Polypropylene (PP)
Needle Hub Polypropylene (PP)
Glue (Joint medium) UV Glue
Lubricant Silicone oil
Dialyzing paper (Seal) Medical grade glue dialyzing paper | No change. | | |
| Performance
requirements | Remain no change | No change | N/A | No new concerns.
Performance requirements
remain unchanged, ensuring
consistent functionality. | |
| Labeling | Unit
package | Remain no change | No change | N/A | No new concerns. Labeling
updates meet current |
| | User
package | Remain no change | Blow contents were changed:
- Indication;
- warning;
- direction for use;
- compatible pens; | These changes are meeting for
requirement of ISO 11608-
2:2022. | standards and enhance the
device's safety and usability. |
| | Instruction
for use | Remain no change | Blow contents were changed: - Indication;
- warning;
- direction for use; | These changes are to be met for
requirement of ISO 11608-
2:2022 | |
The following changes were identified between the subject and predicate devices:
- Trade Name: Changes in the subject device trade name from the predicate does not raise new or ● different questions of safety and effectiveness as the device's functions remains the same.
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- Indications for Use: The broadened indications for use in the subject device trade name from the predicate does not raise new or different questions of safety and effectiveness as the device's principle of operation remains the same.
- Introduction of FPN and NPN Models and Needle Sizes (dimensions, bevel): The addition of new models and sizes expands options without altering the device's safety or effectiveness when compared to the predicate device. Additionally, the new needle sizes comply with standard specifications. Finally, unlike with the insulin needle in the predicate device, the subject device uses metric size instead of color, as there is no color requirement for pen needles in ISO 11608-2.
- Material: The material of the subject device (IPN and FPN) needle shield has been changed to polyethylene (PE) from polypropylene (PP), which only contacts the skin. Biocompatibility testing was performed in accordance with ISO 10993 to support this change and does not raise new or different questions of safety and effectiveness.
- Labeling: Subject device indications for use, warnings, directions for use, and compatible pens have been updated. This does not raise new or different questions of safety and effectiveness, as they are based on results/ review from the points identified above. That is, the device's functions remain the same.
9. Non-Clinical Performance Data
To support substantial equivalence to the predicate device, Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.
Verification and Validation Activities - Design Changes:
Needle Sizes: Additional sizes ranging from 0.33mm×12mm to 0.18mm×3.5mm were introduced to meet clinical needs, focusing on reducing outer diameter for increased patient comfort and ensuring safety by minimizing the risk of intramuscular injections.
Compatible Pens: The pen needle compatibility was expanded to include additional pen models, such as ClikSTAR®, SoloSTAR®, and FlexTouch®, to address the evolving market and clinical requirements.
Needle Shield Material: The needle shield material was changed from Polypropylene (PP) to Polyethylene (PE) to improve manufacturing efficiency. The new material was tested and found to be biocompatible and non-toxic as per ISO 10993-1.
Testing Performed:
Labeling and Dimensional Compliance: Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 11608-2. The needle's dimensions, including the container, shield, and hub, were measured, and found to comply with drawing requirements.
Performance Testing: The pen needles underwent performance testing (reports VR-20230818-02 and VR-20210528-03) to assess dose accuracy and needle removal torque. The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2.
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Biocompatibility Testing: The new Polyethylene (PE) material for the needle shield was tested for cytotoxicity, skin irritation, intracutaneous reactivity, and sensitization according to ISO 10993-1 standards. The results confirmed that the material is non-toxic and safe for use in its intended application.
Test Results:
All verification and validation tests passed without deviations, confirming that the Verifine® Pen Needles meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.
Conclusions:
Based on the results of the non-clinical verification and validation activities, it can be concluded that the modified Verifine® Pen Needles are substantially equivalent to the predicate device K161950. The changes, including the addition of new needle sizes, compatible pens, and the material change of the needle shield, have been thoroughly evaluated and verified to meet all applicable performance and safety standards. Therefore, the device is as safe and effective as the predicate device for its intended use, and no new risks have been introduced.
10. Clinical Performance Data
No clinical data was necessary to determine the substantial equivalence of this device.
11. Statement of Substantial Equivalence
The Verifine® Pen Needles have the same indications for use as the predicate devices listed above. Any minor differences in the technological characteristics of the subject device when compared to the predicate devices have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, the Verifine® Pen Needles have been determined to be substantially equivalent to the predicate device.