Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

K203792 · Pikdare Spa · FMI · Jan 20, 2023 · General Hospital

Device Facts

• Record ID: K203792
• Device Name: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
• Applicant: Pikdare Spa
• Product Code: FMI · General Hospital
• Decision Date: Jan 20, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs

Device Story

Insupen Pen Needles are sterile, single-use, double-ended cannulae assembled into injection-molded hubs. Used with pen injector devices for subcutaneous drug delivery (insulin, peptic hormones, glucagon-like-1, osteoporosis treatments). Operated manually by patients, caregivers, or healthcare professionals in home or clinical settings. The hub threads onto the injector; the cartridge-end cannula pierces the cartridge septum; the patient-end cannula delivers the drug. Lubricated with silicone for ease of injection. Protected by an inner needle shield and sealed medical paper. Benefits include safe, reliable subcutaneous drug administration. MR unsafe.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including ISO 11608-2 (flow rate, bond strength, needle point sharpness, functional compatibility), ISO 9626 (tubing dimensions/stiffness), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Double-ended stainless steel cannula (AISI 304L/305) bonded to polypropylene hub with UV-cured adhesive. Silicone lubricant. Dimensions: 3.5mm-12mm length; 29G-34G gauge. Sterilized via ETO (SAL 10^-6). Manual operation. Compliant with ISO 11608-2, ISO 9626, ISO 10993-1.

Indications for Use

Indicated for subcutaneous injection of drugs using pen injector devices in patients from newborn to elderly. Intended for use in domestic and professional environments.

Regulatory Classification

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.

Predicate Devices

• DROPLET® PEN NEEDLE 34G (K192082)

Reference Devices

• Insupen pen needle (K051783)

Submission Summary (Full Text)

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January 20, 2023

Pikdare S.p.A Roberta Zanoni Official Correspondent Via Saldarini Catelli 10 Casnate con Bernate, COMO 22070 Italy

Re: K203792

Trade/Device Name: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 19, 2022 Received: December 22, 2022

Dear Roberta Zanoni:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Alan M.
Stevens -
S3

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: 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) K203792

Device Name Insupen Pen Needle Insupen ORIGINAL pen needle Insupen ADVANCED pen needle

Indications for Use (Describe)

Sterile, single use needles intended for use with pen injector devices 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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# 510(k) Summary

As required by the Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a).

# Summary [807.92 (a)(1,2)]

Date Prepared: January 20, 2023 Submitted By: Pikdare S.p.A Via Saldarini Catelli 10 22070 Casnate con Bernate - COMO - Italy

Primary Contact: Roberta Zanoni - Market Access Phone: [phone] [e-mail]

Secondary Contact: Marco De Nardi Regulatory Affairs Phone: [phone] [e-mail]

Trade Name: Insupen Pen Needle Insupen ORIGINAL Pen needle Insupen ADVANCED Pen Needle

Device models: Insupen® Pen Needles 12 mm x 29G Insupen®Pen Needles 8 mm x 30G Insupen®Pen Needles 5 mm x 31G Insupen®Pen Needles 6 mm x 31G Insupen®Pen Needles 8 mm x 31G Insupen®Pen Needles 4 mm x 32G Insupen®Pen Needles 6 mm x 32G Insupen®Pen Needles 8 mm x 32G Insupen®Pen Needles 4 mm x 33G Insupen®Pen Needles 3,5 mm x 34G Insupen Original® Pen Needles 12 mm x 29G Insupen Original ®Pen Needles 8 mm x 30G Insupen Original ®Pen Needles 5 mm x 31G Insupen Original ®Pen Needles 6 mm x 31G Insupen Original ®Pen Needles 8 mm x 31G Insupen Original ®Pen Needles 4 mm x 32G Insupen Original ®Pen Needles 6 mm x 32G Insupen Original ®Pen Needles 8 mm x 32G Insupen Original®Pen Needles 4 mm x 33G Insupen Advanced®Pen Needles 5 mm x 31G Insupen Advanced®Pen Needles 4 mm x 32G Insupen Advanced®Pen Needles 6 mm x 32G Insupen Advanced®Pen Needles 4 mm x 33G Insupen Advanced®Pen Needles 3,5 mm x 34G

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Common Name: Pen Needle for drugs subcoutaneous injection Regulation Number: 21 CFR § 880.5570 Product Code: FMI Device Classification: II Review Panel: 80 General Hospital Predicate Device [807.92(a)(3)]

The legally marketed device to which substantial equivalence is claimed are:

| | Manufacturer | Trade name | 510K number |
|------------------|-----------------|----------------------------|-------------|
| Reference device | Artsana SpA | Insupen pen needle | K051783 |
| Primary Device | HTL-STREFA S.A. | DROPLET® PEN<br>NEEDLE 34G | K192082 |

In 2019 Artsana SpA has moved the proprietary of its 510K (K051783) to Pikdare S.p.A

# Description of Device: [807.92(a)(4)]

The Insupen Pen Needle/ Insupen ORIGINAL Pen needle/ Insupen ADVANCED Pen Needle are sterile, single use, single patient pen needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals. The intended patients for this device is the population from newborn to elderly. The device can be used both in domestic and professional environment. It is considered MR unsafe. The list of drugs tested and intended to be used with Pikdare's pen needle are Insulin, peptic hormone, peptic glucagon-like-1, and drug for the treatment of osteoporosis. All compatibility is checked following the requirements of ISO 11608-2:2012.

The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub by gluing. The hub has internal threads which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and pen cartridge septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle tip from damage and accidental needle sticks. Each pen needle is protected with a sealed medical paper which together with the primary container provide a sterility barrier. The pen needle is packaged in boxes and sterilized with ETO. It is intended for single patient and single use only. To use a pen needle, the user needs to remove the medical paper, screw the needle onto the pen injector device. Then the user removes both the outer cap and the inner protective cap to expose the needle and make an injection. After the injection, the needle is unscrewed from the pen injector device and disposed in an appropriate container respecting applicable regulations and laws.

# Indications for Use: [807.92(a)(5)]

Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. Technological Characteristics: [807.92(a)(6)]-

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# Predicate Devices: [K051783; K192082]

A comparison of characteristics among Pikdare Pen Needles (New Device) and Predicate Device is shown in the table below, in which it is included the respective Indications for Use

| | New Device | Predicate Device | Conclusion |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Pikdare SpA | HTL-STREFA S.A. | n/a |
| 510(k) Number | Pending | K192082 | n/a |
| Product Code | FMI | FMI | same |
| Proprietary name | Insupen Pen Needle<br>Insupen Original Pen<br>Needle<br>Insupen Advanced<br>Pen needle | Droplet 34G | same |
| Primary<br>Container | Image: Primary Container New Device | Image: Primary Container Predicate Device | same |
| Needle Shield | Image: Needle Shield New Device | Image: Needle Shield Predicate Device | same |
| Needle Tube and<br>Hub | Image: Needle Tube and Hub New Device | Image: Needle Tube and Hub Predicate Device | same |
| Indication for use | Pen Needle for drugs<br>subcutaneous<br>injection | Sterile, single use<br>needles intended for<br>use with pen injector<br>devices for the<br>subcutaneous injection<br>of drugs | Same |
| Intended use | Pen Needle for drugs<br>subcutaneous injection<br>The patients target of<br>this device is the<br>population from<br>newborn to elderly.<br>The device can be<br>used both in domestic<br>and professional<br>environment. MR<br>Unsafe. | Pen Needle for drugs<br>subcutaneous injection | Same |
| Principle of<br>operation | Manual | Manual | same |
| Method of<br>attachment to pen<br>injector | Screw threads | Screw threads | same |
| | New Device | Predicate Device | Conclusion |
| Length | 12mm<br>4mm<br>5mm<br>6mm,<br>8mm<br>(tolerance ±1.25mm)<br><br>3.5mm<br>(tolerance<br>-0.4mm/+0.5mm) | 3.5mm<br>(tolerance<br>-0.4mm /+0.5mm) | See discussion below |
| Gauge | 29G, 30G, 31G, 32G,<br>33G, 34G | 34G | See discussion below |
| Biocompatibility | Conforms to<br>ISO 10993-1:2019 | Conforms to<br>ISO 10993-1:2019 | same |
| Sterility | SAL = $10^{-6}$ | SAL = $10^{-6}$ | same |
| Sterilization<br>method | ETO | ETO | same |
| Shelf Life | 5 years | 5 years | same |
| Unit Packaging | Blister composed by<br>Primary container<br>made of Polyethylene<br>non-toxic for medical<br>use (HDPE2) and<br>seal made of medical<br>grade paper (C/PAP22) | Blister composed by<br>Primary container<br>made of Polyethylene<br>non-toxic for medical<br>use (HDPE2) and seal<br>made of medical grade<br>paper (C/PAP22) | same |
| User Packaging | 100 pcs Cardboard<br>sales box (PAP 21) | Cardboard sales box<br>(PAP 21) | same |
| Transport<br>packaging | 12 cardoboards sales<br>boxes inside a<br>corrugated carton<br>container.(1200 pen<br>needles in total) -<br>(PAP 20) | 12 cardoboards sales<br>boxes inside a<br>corrugated carton<br>container.(1200 pen<br>needles in total) (PAP<br>20 | same |
| Materials | | | |
| Needle Tube | Medical Grade<br>Stainless Steel<br>AISI304L and AISI305 | Medical Grade<br>Stainless Steel<br>AISI 304L | See Discussion |
| Hub | Polypropylene | Polypropylene | same |
| Needle Shield and<br>Primary container | Polyethylene non-toxic<br>for medical use | Polyethylene non-toxic<br>for medical use | same |
| Lubricant | Medical grade silicone | Medical grade silicone | same |
| Glue (for hub and<br>needle tube<br>bonding) | UV glue - non-toxic | UV glue - non-toxic | same |

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The subject device and the Predicate devices are classified under 21 CFR 880.5570, which states: "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."

There are no differences in the main design, intended use (see details in the table above), principle of operation, method of attachment to pen injector devices, biocompatibility (see details in the table above), sterilization method, materials (see details in the table above), between the Pikdare pen needle device and the Predicate devices. Thus as detailed above the substantial equivalence is demonstrated

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The Pikdare pen needle differs from the predicate device as shown in the table below:

| GAUGES | LENGTH | Availability | Stainless Steel | INSUPEN | | Wall type | Availability | Stainless Steel | INSUPEN ORIGINAL | | Availability | INSUPEN ADVANCED | | Wall type | PREDICATE DEVICE<br>K192082<br>(HTL-S.A.) | | | Wall type | | | |
|--------|--------|--------------|----------------------------|---------|--|-----------|--------------|----------------------------|------------------|--|--------------|------------------|--|------------|-------------------------------------------|--|--|-----------|---|-----------|----|
| G29 | 12mm | X | AISI 304L | | | RW | X | AISI 304L | | | X | AISI 304<br>L | | RW | | | | - | | | |
| G30 | 8mm | X | AISI 304L | | | RW | X | AISI 304L | | | - | | | - | | | | - | | | |
| | 5mm | X | AISI 304L<br>&<br>AISI 305 | | | ETW | X | AISI 304L<br>&<br>AISI 305 | | | - | | | - | | | | UTW | | | |
| G31 | 6mm | X | AISI 304L<br>&<br>AISI 305 | | | ETW | X | AISI 304L<br>&<br>AISI 305 | | | X | AISI<br>304L | | ETW<br>(1) | | | | - | | | |
| | 8mm | X | AISI 304L<br>&<br>AISI 305 | | | ETW | X | AISI 304L<br>&<br>AISI 305 | | | X | AISI<br>304L | | ETW<br>(1) | | | | - | | | |
| | 4mm | X | AISI 304L<br>&<br>AISI 305 | | | ETW | X | AISI 304L<br>&<br>AISI 305 | | | - | | | - | | | | UTW | | | |
| G32 | 6mm | X | AISI 304L<br>&<br>AISI 305 | | | TW | X | AISI 304L<br>&<br>AISI 305 | | | - | | | - | | | | ETW | | | |
| | 8mm | X | AISI 304L<br>&<br>AISI 305 | | | TW | X | AISI 304L<br>&<br>AISI 305 | | | - | | | - | | | | - | | | |
| G33 | 4mm | X | AISI 304L<br>&<br>AISI 305 | | | TW | X | AISI 304L<br>&<br>AISI 305 | | | - | | | - | | | | ETW | | | |
| G34 | 3,5mm | X | AISI 304L<br>&<br>AISI 305 | | | TW | - | | | | - | | | - | | | | ETW | X | AISI 304L | TW |

(1) Wall definition are declared based on the current revision of the standard.

In conclusion, analyzing the main differences between the subject device and the Predicate device, below these are the main consideration:

1. Pikdare Pen Needles are manufactured using both AISI304L and AISI 305 while the Predicate devices use AISI 304L only. AISI 305 is mentioned in the ISO 9626:2016 where it is stated that "tubing shall be made in the stainless steels listed in the ISO 15510" and our material is included in the standard, therefore there is no new impact on safety and performances.

2. Needle features and wall are confirmed to be compliant with ISO 9626 considering all the possible dimensions defining the wall. So there is no risk about the safety of the subject device With reference to needle's size G34, which is not covered by ISO 9626 requirements for stiffness, Pikdare SpA chooses to characterize the tube of this needle according to thestiffness test limits of G33 TW (as defined in ISO 9626:2016).

3. The Pikdare pen needle will be under OTC as well as the Predicate device K192082,

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4. The Pikdare pen needle intended use is for injection of drugs in general as well as the Predicate device K192082. This feature does not introduce critical differences and new risks (migration and transfer tests has been carried out on needles with both intended uses).

The differences above indicated do not raise new questions of safety and/or functionality for the subject device. Considering that the Predicate device is covering G34 and 3,5mm only, while the Subject device is intended to cover the range of pen needles of G29 - G30 - G31 - G32 - G33 and G34 with lengths varying from 12mm to 3,5mm. we can declare that the products with extended gauges and lengths do not pose any new concerns in terms of safety and performance, since they have been submitted to tests according to the following recognized consensus standards:

-ISO 11608-2 Needle based injection system for medical use - Requirements and test methods - part 2: needles

-ISO 9626 Stainless steel needle tubing for the manufacture of Medical Devices – Requirements and Test Methods

-ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a Risk management Process

and the risk assessment carried out on them hasn't identified further risks not reduced to unacceptable level.

So, Pikdare pen needle product line has been demonstrated not having any impact on functional compatibility related to the combination of the pen needle with the pen injector devices including dose accuracy and limited differences in flow rates directly related to the differences of needle's internal diameter.

Based upon the above comparisons to the Predicate device. Pikdare Pen Needles are substantially equivalent to the Predicate device.

# Non-Clinical Performance Data: [(807.92(b)(1)]

Pikdare pen needles successfully passed all the required non-clinical testing which included the following testing for compliance with the requirements of ISO 11608-2:2012 Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles

| Test Parameter | Requirement – ISO 11608-2:2012 | Result Subject<br>device | Result Predicate<br>device | Conclusion |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------|-----------------------------------------------------------------|
| Materials | The needle shall be made of tubing<br>materials specified in ISO 9626. | Requirement met | Requirement met | Both products use<br>tubes specified in<br>ISO 9626 |
| Dimensions | The tubing features used in the<br>needles shall meet the requirements<br>of ISO 9626. For G34 needle the<br>limits of stiffness has been chosen to<br>comply with the same limits of G33<br>TW needle. The needles shall fit the<br>test apparatus specified in item 7.3 of<br>ISO 11608-2. The dimension shall<br>comply with Table 1 of clause 4.2.2<br>of ISO 11608-2 | Requirement met | Requirement met | Both products<br>comply with the<br>requirements of ISO<br>9626 |
| Determination<br>of flow rate<br>through the<br>needle | The needle was tested in accordance<br>with Annex A to ISO 11608-2 to<br>determine flow rate through the<br>needle. | Requirement met | Requirement met | Both products have<br>the same flow rate |
| Bond between hub<br>and needletube | The union of the hub and needle tube<br>shall not break when tested in<br>accordance with Clause 9 of ISO<br>11608-2. | Requirement met | Requirement met | Both products pass<br>the breakage test |

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| Needle points | Needle points shall appear sharp and<br>free from featheredges, burrs and<br>hocks when examinate under<br>magnification x2,5. The needle<br>point at the cartridge end is designed<br>to minimize coring and<br>fragmentation when penetrating the<br>cartridge set. | Requirement met | Requirement met | Both products<br>accomplish the<br>needle requested<br>features |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|------------------------------------------------------------------------|
| Freedom from<br>defects | The needle tube shall fulfill<br>the requirements of ISO<br>7864,clause11.3. | Requirement met | Requirement met | Both products<br>fulfill the ISO<br>7864 |
| Lubrication | The needle tube should be lubricated<br>at both the patient end and the<br>cartridge end. The lubricant shall not,<br>under normal or corrected-<br>to-normal vision, be visible as<br>droplets of fluid on the outside | Requirement met | Requirement met | Both products<br>respect the<br>appropriate quantity<br>of lubrication |

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| | surface of the needle tube | | | |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|-------------------------------------------------------------------------------|
| Dislocation of<br>measuring<br>point at patient<br>end | Dislocation of the cannula point at<br>the patient end shall be in<br>accordance with Table 2 when<br>tested in accordance with Clause 8<br>(of ISO 11608-2). | Requirement met | Requirement met | Both products are<br>compliant with table<br>2. |
| Determination of<br>functional<br>compatibility<br>with needle-<br>based injection<br>systems | Compatibility with any NIS<br>(Needle-based Injection System)<br>shall be claimed only after testing in<br>accordance with Clause 11. | Requirement met | Requirement met | Both products are<br>compatible to the<br>same list of pen<br>injector device |
| Ease of<br>assembly<br>and<br>disassembly | Attachment of the needle shall be<br>possible without removing the<br>needle from its opened unit<br>packaging. Compliance is checked<br>according to the requirements of<br>Clause 11. | Requirement met | Requirement met | Both products are in<br>compliance with<br>clause 11 |
| Sterility | The needles in its unit<br>packaging is subjected to a<br>validatedsterilization process | Requirement met | Requirement met | Both products are<br>ETO sterilized in<br>the same<br>sterilization place |
| Pre-conditioning of<br>needles | The needles satisfy all the<br>requirements of ISO 11608-2 after<br>preconditioning according to<br>clauses 6.1, 6.2 and 6.3 of the same<br>standard | Requirement met | Requirement met | Both products<br>respect ISO 11608-2 |

Based on the comparison table on Non-Clinical Performance Data, we can declare that there is no difference between Subject device and the Predicate device.

Test were performed on both products, the total availability on sample of the fact that the Predicate Device is manufactured in Pikdare factory in Italy (Pikdare is the contract manufacturer of Droplet G34 Pen Needle).

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# Biocompatibility testing:

Based on the test conduction according to ISO 10993-1 the medical device is categorized as follow:

- Nature of the body contact: -
- 0 Category: externally communicating medical device
- 0 Contact: Blood path indirect
- Contact Duration: B - prolonged (>24 h to 30 d)

# List of constituents (extract from the Biological Evaluation Plan)

The list of the device constituents provided by the sponsor is reported in Table 2.

| Component | Material Type Type | Material Trade name | Supplier | Type of<br>contact* |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------|---------------------|
| Primary<br>Container | High Density<br>Polyethylene<br>Copolymer | ERACLENE ® MR 80 U | Versalis | None/Instant |
| | | ERACLENE ® MS 80 U | Versalis | |
| | | RIGIDEX HD5218EA | Ineos | |
| | | RIGIDEX HD5226EA | Ineos | |
| Hub | Homopolymer<br>Polypropylene | Eltex® MED 100-MG25 | Ineos | None/Instant |
| | | HEALTHCARE HPP25G | Repsol | |
| | | PPM H250 or ACESO® PPM<br>H250 | Total | |
| Hub Master<br>batch | Pigment for polymers Remafin Blue PE52080094<br>Pigment for polymers Remafin Yellow PE11078232<br>Pigment for polymers Remafin Grey PE71077043<br>Pigment for polymers Remafin Red PE31079060<br>Pigment for polymers Remafin Red PE31079091<br>Pigment for polymers Remafin Purple PE41076243<br>Pigment for polymers Remafin PP-All colours | | Clariant | None/Instant |
| | Pigment for polymers Sicolen Green 90-0755 SN<br>Pigment for polymers Sicolen Orange 28-5504 | | Basf | None/Instant |
| Cannulae | AISI 305 stainless steel | | Bws | Direct |
| | AISI 305 stainless steel | | Outokumpu | |
| | AISI 304 L stainless steel | | Kobayashi | |
| UV Glue | UV3028 | | Loxeal | Direct |
| | AA3921 | | Loctite | |
| Lubricant | Medical silicon 360 12.500cps<br>Medical silicone MDX4-4159<br>Q7 9180 | | Dow Corning | Direct |
| Shield | High Density<br>Polyethylene<br>Copolymer | ERACLENE ® MR 80 U | Versalis | None/Instant |
| | | ERACLENE ® MS 80 U | Versalis | |
| | | RIGIDEX HD5218EA | Ineos | |
| | | RIGIDEX HD5226EA | Ineos | |
| Medical paper | Grid Coated Paper | 0K08xxxx05x | Amcor | None/Instant |
| Box | Recycled cardboard | | Autajon | None/Instant |
| Master | Carton B wave | | Saica | None/Instant |

Table 2: Constituents list.(") instant contact is referred to the contact with the intact skin in order to use the device, therefore negligible

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Biocompatibility Test Summary – no adverse biocompatibility effects were observed:

| Test method | Compliance with | Result |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biological Risk<br>AssessmentEvaluation | ISO 10993-1- Biological<br>evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk<br>management process | The following end-points have been<br>identified and verified by testing. |
| Cytotoxicity Study<br>Using the ISO Elution<br>Method | ISO 10993-5 - Biological<br>evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity | The test article showed no evidence<br>of causing cell lysis or toxicity. |
| ISO Guinea Pig<br>Maximization Sensitization<br>Test | ISO 10993-10 - Biological<br>evaluation of medical devices -- Part 10:<br>Tests for irritation and skin<br>sensitization | The test article extracts showed no<br>evidence of causing delayed dermal<br>contact sensitization in the guinea pig. The<br>test article was not considered a sensitizer<br>in the guinea pig maximization test. |
| ISO Intracutaneous<br>Study in Rabbits | ISO 10993-10 - Biological<br>evaluation of medical devices -- Part 10:<br>Tests for irritation and<br>skin sensitization | The test article met the requirements<br>of the test. |
| ASTM Hemolysis<br>Study | ASTM F756, Standard Practice<br>for Assessment of Hemolytic Properties<br>of Materials and ISO<br>10993-4 - Biological evaluation of<br>medical devices -- Part 4:<br>Selection of tests for interactions with<br>blood | Both the test article in direct contact<br>with blood and the test article extract were<br>non-hemolytic |
| ISO Two Week<br>Toxicity Study in the Rat,<br>Repeated<br>Parenteral<br>Administration of Two<br>Extracts | ISO 10993-11 - Biological<br>evaluation of medical devices -- Part 11:<br>Tests for systemic toxicity | There were no microscopic changes<br>considered to be a test article related<br>response. Parenteral<br>administration of the test article<br>extract did not produce systemic toxicity in<br>rats. |
| ISO Systemic Toxicity Study<br>in Mice | ISO 10993-11 - Biological<br>evaluation of medical devices -- Part 11:<br>Tests for systemic toxicity | There was no mortality or evidence<br>of systemic toxicity from the extracts<br>injected into mice. Each test article met the<br>requirements of the study. |
| USP Rabbit Pyrogen<br>Study, Material-<br>mediated | ISO 10993-11 Biological<br>evaluation of medical devices --<br>Part 11: Tests for systemic toxicity | The total rise of rabbit temperatures<br>during the 3 hours observation period<br>was within acceptable USP limits.<br>The test article was judged as non-<br>pyrogenic |
| USP Pyrogen Study -<br>Material Mediated | USP, General Chapter <151>,<br>Pyrogen Test as recommended by ISO<br>10993-11 Biological<br>evaluation of medical devices --<br>Part 11: Tests for systemic toxicity | The test article was judged as<br>nonpyrogenic. |

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# Sterilization:

Product is EO sterilized in house by manufacturer. Sterilization process is validated using current standard ISO 11135-1:2014 + ISO 11135:2014/Amd 1:2018.

The sterilization cycle assures a SAL of 10-6.

The maximum EO residual values after the degassing period, and before the product release, have been set at 1 mg for each device (ISO 10993-7 limit: 4 mg/day): these limits are set considering a maximum use of the devices equal to 4 times a day.

The maximum ECH residual values after the degassing period, and before the product release, have been set at 2,25 mg for each device (ISO 10993-7 limit: 9 mg/day): these limits are set considering a maximum use of the devices equal to 4 times a day.

The shelf life of the product, considering the integrity of the sterility and physical properties, is 5 years from the production date. The expiring date and sterilization methods are clearly indicated on the pack. The product shelf life is ensured if the product is stored and transported in compliance with the environmental condition stated on the pack and on the delivery boxes.

# Clinical Performance Data: [(807.92(b)(2)]

Clinical data are not required.

# Conclusion: ](807.92(b)(3)]

Pikdare Pen Needles (Insupen ORIGINAL/ Insupen ADVANCED) are concluded to be substantially equivalent in the intended use, technology/principle of operation, materials and performance to the predicate device.