(23 days)
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.
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.
The provided text is a 510(k) summary for a medical device (Verifine® Pen Needles). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets acceptance criteria through a clinical or performance study that quantifies specific metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.
The context of your request (acceptance criteria, effect size, MRMC studies, ground truth) is typical for the evaluation of AI/ML-enabled medical devices, especially those involving image analysis or diagnostic support. The provided document describes a physical medical device (hypodermic needle) where the primary concerns are mechanical performance, biocompatibility, and compatibility with existing pen injectors. Therefore, information related to AI/ML device evaluation criteria is largely not applicable to this document.
Here's a breakdown of why many of your excellent questions cannot be answered by this document, followed by what can be extracted:
Why most questions are not applicable:
- AI/ML Device Evaluation: The document does not describe an AI/ML device. It's a pen needle. Therefore, concepts like "effect size of human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts for ground truth," "adjudication method," "sample size for training set," or "data provenance" (in the context of image data) are irrelevant.
- Clinical Performance Data: The summary explicitly states: "No clinical data was necessary to determine the substantial equivalence of this device." This means there was no human-centric clinical study (like an MRMC study) performed to evaluate the diagnostic or treatment benefits in a clinical setting against a "ground truth" established by experts.
What can be extracted or inferred from the document regarding acceptance criteria and device performance for this physical device:
The "acceptance criteria" here are implied by the standards and bench testing performed to demonstrate substantial equivalence to the predicate device and compliance with relevant ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating that changes to the device (new models, sizes, material change, labeling updates) do not raise new questions of safety or effectiveness and that the modified device still meets the performance attributes of the predicate and relevant standards.
| Acceptance Criterion (Implied) | Reported Device Performance (as stated or inferred) |
|---|---|
| Mechanical/Dimensional Compliance | |
| - Conformance to drawing requirements for needle dimensions | "The needle's dimensions, including the container, shield, and hub, were measured, and found to comply with drawing requirements." |
| Performance (Functional) | |
| - Dose Accuracy (per ISO 11608-2) | "The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2." |
| - Needle Removal Torque (per ISO 11608-2) | "The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2." |
| Biocompatibility | |
| - Non-toxicity of needle shield material (PE) (per ISO 10993-1) | "The new material [PE] was tested and found to be biocompatible and non-toxic as per ISO 10993-1.""Results confirmed that the material is non-toxic and safe for use." |
| - Non-cytotoxicity (PE) | Tested for cytotoxicity, results confirmed non-toxic. |
| - Non-skin irritation (PE) | Tested for skin irritation, results confirmed non-toxic. |
| - Non-intracutaneous reactivity (PE) | Tested for intracutaneous reactivity, results confirmed non-toxic. |
| - Non-sensitization (PE) | Tested for sensitization, results confirmed non-toxic. |
| Sterility | "Maintain a Sterility Assurance Level (SAL) of 10-6." (Stated in Device Description as a characteristic). |
| Labeling Compliance | |
| - Metric size labeling compliance on unit packaging (per ISO 11608-2) | "Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 11608-2." |
| - Updated indications for use, warnings, directions, compatible pens | "These changes are meeting for requirement of ISO 11608-2:2022." |
| General Safety & Effectiveness | "The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" as one would for an AI/ML model or a clinical trial. However, non-clinical performance and biocompatibility testing were conducted. The sample size for these specific engineering tests (e.g., how many needles were tested for dose accuracy) is not detailed in this summary.
- Data Provenance: The tests were "completed by Promisemed Hangzhou Meditech Co., Ltd." (China). The data origin is thus the manufacturer's testing facilities. The tests are "non-clinical" (benchtop/lab-based), not from patients. It's not retrospective or prospective in the sense of clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the AI/ML sense (e.g., expert consensus on clinical images), is not relevant here. Performance is measured against engineering specifications and international standards (ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for expert review of data is mentioned or relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was NOT done. This type of study is specifically for evaluating diagnostic performance of AI/ML systems with human readers. The device is a physical pen needle, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm or software being evaluated for standalone performance. Performance tests are against ISO standards for the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this device, the "ground truth" or reference for performance is established by international standards (e.g., ISO 11608-2 for pen needles, ISO 10993-1 for biocompatibility) and the manufacturer's engineering specifications/drawing requirements. It is not clinical diagnostic ground truth.
8. The sample size for the training set:
- Not Applicable. The concept of a "training set" is for AI/ML models. This is a physical device.
9. How the ground truth for the training set was established:
- Not Applicable. Same as above.
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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).
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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).
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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
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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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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.
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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 onSimilarities/Differences | Safety/EffectivenessStatement | |
|---|---|---|---|---|---|
| Common name | Insulin Pen Needles | No change | N/A | No new concerns. Thecommon name remainsunchanged, ensuringconsistency with the intendeduse. | |
| Trade name | Verifine® Common Type Insulin Pen Needle | IPNFPN, NPN | Verifine® Pen NeedlesVerifine® Plus Pen Needles | It is only for common type penneedle. Only the trade name ischange. | No new concerns. The tradename change does not impactsafety or effectiveness as thedevice's function remains thesame. |
| Classification name | Needle, Hypodermic, Single Lumen (21 CFR 880.5570) | No change | N/A | No new concerns. Theclassification name remainsconsistent. | |
| Device class | Class II | No change | N/A | No new concerns. The deviceremains in Class II, indicatingno change in risk level. | |
| Product Code | FMI | No change | N/A | No new concerns. The productcode remains the same,reflecting no change in devicefunctionality. | |
| General description | The proposed product, insulin pen needle, is manufacturedby Promisemed Hangzhou Meditech Co.,Ltd, which is designed for use with a pen injector for thesubcutaneous injection of insulin.The products have two types, common type and safetytype. Both of the two types are sterile with a SterilityAssurance Level (SAL) of 10-6, non-pyrogenic and single-usedevices. Each type has several models. Different models aredistinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needlecontainer, needle shield, needle tube, needle hub, UV glue | The proposed product, Verifine® Pen Needles, ismanufactured by Promisemed Hangzhou Meditech Co.,Ltd, which is designed for use with a pen injector for thesubcutaneous injection of insulin.The product is common type without safety protectivefeature. It is a sterile with a Sterility Assurance Level (SAL)of 10-6, non-pyrogenic and single-use devices. Each typehas several models. Different models are distinguished byneedle gauge and length.It is consisting of needle container, needle shield, needletube, needle hub, UV glue and silicone oil. UV glue is used | It is only for common type penneedle.Description about common typeis no change. | No new concerns. The changeto a broader intended usedoes not introduce new risksas the fundamental technologyand operation remain thesame. |
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| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| and silicone oil. UV glue is used to glue needle tube andneedle hub and the silicone oil is used to needle tubelubrication.The user proceeds with inserting the needle into the skinmanually.Both the Common Type Insulin Pen Needle and the SafetyType Pen Needle are for OTC use, and they are externalcommunication, blood indirect devices. The contactduration for both subjected devices is within 24h, and theybelong to limited contact device according ISO 10993-1. | to glue needle tube and needle hub and the silicone oil isused to needle tube lubrication.The user proceeds with inserting the needle into the skinmanually.It is intended for OTC use, and they are externalcommunication, blood indirect devices. The contactduration for both subjected devices is within 24h, and theybelong to limited contact device according ISO 10993-1. | |||||||||||
| Principles of operation | The user proceeds with inserting the needle into theskin manually. The patient end and the cartridge end of thetube are lubricated using a silicone based lubricant for easeof injection and rubber septum penetration. | No change | N/A | No new concerns. Theprinciples of operation remainunchanged, ensuringconsistent performance. | ||||||||
| Indication of use | The Common Type Insulin Pen Needle is intended for usewith pen injector device for subcutaneous injection ofinsulin. | Verifine® Pen Needle is intended for use with pen injectordevice for the subcutaneous injection of drugs. | Change in the trade name andfrom specific use (insulin) togeneral use (drugs). | No new concerns. The broaderindication for use does notintroduce new safety oreffectiveness risks as thedevice's mechanism remainsunchanged. | ||||||||
| 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 NPNwere added.Specification code was notdefined that the needle wasidentified through by metric size. | No new concerns. The additionof new models and sizesexpands options withoutaltering the device's safety oreffectiveness. | ||||||||
| 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 additionof new needle sizes does notimpact safety or effectiveness;the new sizes comply withstandard specifications. |
| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | ||
|---|---|---|---|---|---|---|
| Bevel | 3 | Bevel | Model | Needle size | Bevel of needle tip is defined.Addition of 5 bevel design. | No new concerns. Theintroduction of a 5-beveldesign is intended to enhanceuser experience withoutaffecting safety oreffectiveness. |
| 3 bevels | IPN, FPN, NPN | All sizes | ||||
| 5 bevels | IPN, FPN, NPN | All sizes | ||||
| NeedleGauge | 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 addeddimensions meet regulatorystandards, ensuring safety andeffectiveness. | ||
| Dimension | Length4mm, 5mm, 6mm, 8mm, 12mm | 3.5mm, 4mm, 5mm, 6mm, 8mm, 12mm | Nominal length of 3.5mm wasadded. | |||
| Color | Image: Color chart | Not defined. | There is no color designated toeach size that metric size isidentified through the gauge andlength, and there is no colorrequirement for pen needle inISO 11608-2. | No new concerns. The lack of adefined color does not impactthe safety or effectiveness ofthe device. | ||
| Schematic diagramand picture | Image: Schematic diagram of IPN | No change | There is only the difference aboutshape of needle shield and hubfor each model. | No new concerns. The designvariations do not introducenew safety or effectivenessrisks, as they are minoradjustments to the device'sform. |
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| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement |
|---|---|---|---|---|
| / | FPNFig. 2—Schematic representation of FPNKey1 Needle container 4 Jointing medium2 Needle shield 5 Needle hub3 Needle tube | |||
| / | NPNFig. 3—Schematic representation of NPNKey1 Needle container 4 Jointing medium2 Needle shield 5 Needle hub3 Needle tube |
| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | ||
|---|---|---|---|---|---|---|
| Product picture | / | Image: Side viewImage: Front view | There is only the difference aboutshape of needle shield and hubfor each model. | No new concerns. The designvariations do not introducenew safety or effectivenessrisks, as they are minoradjustments to the device'sform. | ||
| / | ||||||
| Material | Image: IPN symbol IPN | Image: IPN symbol IPN | Material of needle shield ischanged to PE which is onlycontact intact skin. | No new concerns. The materialchange for the needle shield isminor and does not affectsafety as it only contacts intactskin. | ||
| 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 dialyzingpaper | Dialyzing paper(Seal) | Medical grade glue dialyzingpaper | |||
| Image: FPN symbol FPN | Material of needle shield ischanged to PE which is only | |||||
| Component | Material | contact intact skin. | ||||
| Needle tube | Stainless steel (X5CrNi18-10) |
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| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| / | Needle ShieldNeedle ContainerNeedle HubGlue (Joint medium)LubricantDialyzing paper(Seal) | |||||||||||||||||||
| Needle Shield Polyethylene (PE)Needle Container Polypropylene (PP)Needle Hub Polypropylene (PP)Glue (Joint medium) UV GlueLubricant Silicone oilDialyzing paper Medical grade glue dialyzing paper(Seal) | ||||||||||||||||||||
| NPNComponent 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. | |||||||||||||||||||
| Performancerequirements | Remain no change | No change | N/A | No new concerns.Performance requirementsremain unchanged, ensuringconsistent functionality. | ||||||||||||||||
| Labeling | Unitpackage | Remain no change | No change | N/A | ||||||||||||||||
| Userpackage | Remain no change | Blow contents were changed:1. Indication;2. warning;3. direction for use;4. compatible pens; | These changes are meeting forrequirement of ISO 11608-2:2022. | No new concerns. Labelingupdates meet currentstandards and enhance thedevice's safety and usability. | ||||||||||||||||
| Instructionfor use | Remain no change | Blow contents were changed:1. Indication;2. warning;3. direction for use; | These changes are to be met forrequirement of ISO 11608-2:2022. |
| Item of description | Cleared device | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | |
|---|---|---|---|---|---|
| / | Needle ShieldNeedle ContainerNeedle HubGlue (Joint medium)LubricantDialyzing paper(Seal) | ||||
| Needle Shield Polyethylene (PE)Needle Container Polypropylene (PP)Needle Hub Polypropylene (PP)Glue (Joint medium) UV GlueLubricant Silicone oilDialyzing paper (Seal) Medical grade glue dialyzing paper | |||||
| NPNComponent MaterialNeedle tube Stainless steel (X5CrNi18-10)Needle Shield Polypropylene (PP)Needle Container Polypropylene (PP)Needle Hub Polypropylene (PP)Glue (Joint medium) UV GlueLubricant Silicone oilDialyzing paper (Seal) Medical grade glue dialyzing paper | No change. | ||||
| Performancerequirements | Remain no change | No change | N/A | No new concerns.Performance requirementsremain unchanged, ensuringconsistent functionality. | |
| Labeling | Unitpackage | Remain no change | No change | N/A | No new concerns. Labelingupdates meet current |
| Userpackage | Remain no change | Blow contents were changed:1. Indication;2. warning;3. direction for use;4. compatible pens; | These changes are meeting forrequirement of ISO 11608-2:2022. | standards and enhance thedevice's safety and usability. | |
| Instructionfor use | Remain no change | Blow contents were changed:1. Indication;2. warning;3. direction for use; | These changes are to be met forrequirement 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.
§ 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).