(753 days)
No
The device description and performance studies focus on the physical characteristics, materials, and compatibility of a pen needle, with no mention of AI or ML technologies.
No.
The device is a pen needle, which is an accessory used for the subcutaneous injection of drugs. It facilitates drug delivery but does not itself provide a therapeutic effect. The therapeutic effect comes from the drug being injected.
No
Explanation: The device is a pen needle intended for the subcutaneous injection of drugs, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a cannula, hub, inner needle shield, and packaging, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of drugs using pen injector devices. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical needle designed for delivering substances into the body. It does not mention any components or functions related to analyzing samples from the body (like blood, urine, etc.) to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the needle (flow rate, bond strength, sterility, compatibility with pen systems, biocompatibility) which are relevant to its use as an injection device. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This pen needle does not perform any such function.
N/A
Intended Use / Indications for Use
Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
newborn to elderly
Intended User / Care Setting
consumers, caregivers and healthcare professionals. The device can be used both in domestic and professional environment.
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: 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:
- Materials: Requirement met. Both products use tubes specified in ISO 9626.
- Dimensions: Requirement met. Both products comply with the requirements of ISO 9626.
- Determination of flow rate through the needle: Requirement met. Both products have the same flow rate.
- Bond between hub and needletube: Requirement met. Both products pass the breakage test.
- Needle points: Requirement met. Both products accomplish the needle requested features.
- Freedom from defects: Requirement met. Both products fulfill the ISO 7864.
- Lubrication: Requirement met. Both products respect the appropriate quantity of lubrication.
- Dislocation of measuring point at patient end: Requirement met. Both products are compliant with table 2.
- Determination of functional compatibility with needle-based injection systems: Requirement met. Both products are compatible to the same list of pen injector device.
- Ease of assembly and disassembly: Requirement met. Both products are in compliance with clause 11.
- Sterility: Requirement met. Both products are ETO sterilized in the same sterilization place.
- Pre-conditioning of needles: Requirement met. Both products respect ISO 11608-2.
Biocompatibility testing: No adverse biocompatibility effects were observed.
- Biological Risk Assessment/Evaluation: The following end-points have been identified and verified by testing.
- Cytotoxicity Study Using the ISO Elution Method: The test article showed no evidence of causing cell lysis or toxicity.
- ISO Guinea Pig Maximization Sensitization Test: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
- ISO Intracutaneous Study in Rabbits: The test article met the requirements of the test.
- ASTM Hemolysis Study: Both the test article in direct contact with blood and the test article extract were non-hemolytic.
- ISO Two Week Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts: There were no microscopic changes considered to be a test article related response. Parenteral administration of the test article extract did not produce systemic toxicity in rats.
- ISO Systemic Toxicity Study in Mice: There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article met the requirements of the study.
- USP Rabbit Pyrogen Study, Material-mediated: The total rise of rabbit temperatures during the 3 hours observation period was within acceptable USP limits. The test article was judged as non-pyrogenic.
- USP Pyrogen Study - Material Mediated: The test article was judged as nonpyrogenic.
Clinical Performance Data: Clinical data are not required.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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: +39 031 7297757 roberta.zanoni@pikdare.com
Secondary Contact: Marco De Nardi Regulatory Affairs Phone: +39 031 7297832 marco.denardi@pikdare.com
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 | |
| 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 | ||
| Insupen Original Pen | |||
| Needle | |||
| Insupen Advanced | |||
| Pen needle | Droplet 34G | same | |
| Primary | |||
| 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 | |||
| Hub | Image: Needle Tube and Hub New Device | Image: Needle Tube and Hub Predicate Device | same |
| Indication for use | Pen Needle for drugs | ||
| subcutaneous | |||
| injection | Sterile, single use | ||
| needles intended for | |||
| use with pen injector | |||
| devices for the | |||
| subcutaneous injection | |||
| of drugs | Same | ||
| Intended use | Pen Needle for drugs | ||
| subcutaneous injection | |||
| The patients target of | |||
| this device is the | |||
| population from | |||
| newborn to elderly. | |||
| The device can be | |||
| used both in domestic | |||
| and professional | |||
| environment. MR | |||
| Unsafe. | Pen Needle for drugs | ||
| subcutaneous injection | Same | ||
| Principle of | |||
| operation | Manual | Manual | same |
| Method of | |||
| attachment to pen | |||
| injector | Screw threads | Screw threads | same |
| New Device | Predicate Device | Conclusion | |
| Length | 12mm | ||
| 4mm | |||
| 5mm | |||
| 6mm, | |||
| 8mm | |||
| (tolerance ±1.25mm) |
3.5mm
(tolerance
-0.4mm/+0.5mm) | 3.5mm
(tolerance
-0.4mm /+0.5mm) | See discussion below |
| Gauge | 29G, 30G, 31G, 32G,
33G, 34G | 34G | See discussion below |
| Biocompatibility | Conforms to
ISO 10993-1:2019 | Conforms to
ISO 10993-1:2019 | same |
| Sterility | SAL = $10^{-6}$ | SAL = $10^{-6}$ | same |
| Sterilization
method | ETO | ETO | same |
| Shelf Life | 5 years | 5 years | same |
| Unit Packaging | Blister composed by
Primary container
made of Polyethylene
non-toxic for medical
use (HDPE2) and
seal made of medical
grade paper (C/PAP22) | Blister composed by
Primary container
made of Polyethylene
non-toxic for medical
use (HDPE2) and seal
made of medical grade
paper (C/PAP22) | same |
| User Packaging | 100 pcs Cardboard
sales box (PAP 21) | Cardboard sales box
(PAP 21) | same |
| Transport
packaging | 12 cardoboards sales
boxes inside a
corrugated carton
container.(1200 pen
needles in total) -
(PAP 20) | 12 cardoboards sales
boxes inside a
corrugated carton
container.(1200 pen
needles in total) (PAP
20 | same |
| Materials | | | |
| Needle Tube | Medical Grade
Stainless Steel
AISI304L and AISI305 | Medical Grade
Stainless Steel
AISI 304L | See Discussion |
| Hub | Polypropylene | Polypropylene | same |
| Needle Shield and
Primary container | Polyethylene non-toxic
for medical use | Polyethylene non-toxic
for medical use | same |
| Lubricant | Medical grade silicone | Medical grade silicone | same |
| Glue (for hub and
needle tube
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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Image /page/7/Picture/0 description: The image shows the logo for PIKDARE. The logo is in blue and gray. The word "PIKDARE" is written in blue, with the first letter "P" being partially gray. The gray part of the "P" is a square with a line extending from the top and left sides.
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
K192082
(HTL-S.A.) | | | Wall type | | | |
|--------|--------|--------------|----------------------------|---------|--|-----------|--------------|----------------------------|------------------|--|--------------|------------------|--|------------|-------------------------------------------|--|--|-----------|---|-----------|----|
| G29 | 12mm | X | AISI 304L | | | RW | X | AISI 304L | | | X | AISI 304
L | | RW | | | | - | | | |
| G30 | 8mm | X | AISI 304L | | | RW | X | AISI 304L | | | - | | | - | | | | - | | | |
| | 5mm | X | AISI 304L
&
AISI 305 | | | ETW | X | AISI 304L
&
AISI 305 | | | - | | | - | | | | UTW | | | |
| G31 | 6mm | X | AISI 304L
&
AISI 305 | | | ETW | X | AISI 304L
&
AISI 305 | | | X | AISI
304L | | ETW
(1) | | | | - | | | |
| | 8mm | X | AISI 304L
&
AISI 305 | | | ETW | X | AISI 304L
&
AISI 305 | | | X | AISI
304L | | ETW
(1) | | | | - | | | |
| | 4mm | X | AISI 304L
&
AISI 305 | | | ETW | X | AISI 304L
&
AISI 305 | | | - | | | - | | | | UTW | | | |
| G32 | 6mm | X | AISI 304L
&
AISI 305 | | | TW | X | AISI 304L
&
AISI 305 | | | - | | | - | | | | ETW | | | |
| | 8mm | X | AISI 304L
&
AISI 305 | | | TW | X | AISI 304L
&
AISI 305 | | | - | | | - | | | | - | | | |
| G33 | 4mm | X | AISI 304L
&
AISI 305 | | | TW | X | AISI 304L
&
AISI 305 | | | - | | | - | | | | ETW | | | |
| G34 | 3,5mm | X | AISI 304L
&
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:
-
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.
-
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).
-
The Pikdare pen needle will be under OTC as well as the Predicate device K192082,
8
- 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
device | Result Predicate
device | Conclusion |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------|-----------------------------------------------------------------|
| Materials | The needle shall be made of tubing
materials specified in ISO 9626. | Requirement met | Requirement met | Both products use
tubes specified in
ISO 9626 |
| Dimensions | The tubing features used in the
needles shall meet the requirements
of ISO 9626. For G34 needle the
limits of stiffness has been chosen to
comply with the same limits of G33
TW needle. The needles shall fit the
test apparatus specified in item 7.3 of
ISO 11608-2. The dimension shall
comply with Table 1 of clause 4.2.2
of ISO 11608-2 | Requirement met | Requirement met | Both products
comply with the
requirements of ISO
9626 |
| Determination
of flow rate
through the
needle | The needle was tested in accordance
with Annex A to ISO 11608-2 to
determine flow rate through the
needle. | Requirement met | Requirement met | Both products have
the same flow rate |
| Bond between hub
and needletube | The union of the hub and needle tube
shall not break when tested in
accordance with Clause 9 of ISO
11608-2. | Requirement met | Requirement met | Both products pass
the breakage test |
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| Needle points | Needle points shall appear sharp and
free from featheredges, burrs and
hocks when examinate under
magnification x2,5. The needle
point at the cartridge end is designed
to minimize coring and
fragmentation when penetrating the
cartridge set. | Requirement met | Requirement met | Both products
accomplish the
needle requested
features |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|------------------------------------------------------------------------|
| Freedom from
defects | The needle tube shall fulfill
the requirements of ISO
7864,clause11.3. | Requirement met | Requirement met | Both products
fulfill the ISO
7864 |
| Lubrication | The needle tube should be lubricated
at both the patient end and the
cartridge end. The lubricant shall not,
under normal or corrected-
to-normal vision, be visible as
droplets of fluid on the outside | Requirement met | Requirement met | Both products
respect the
appropriate quantity
of lubrication |
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| surface of the needle tube | ||||
|---|---|---|---|---|
| Dislocation of | ||||
| measuring | ||||
| point at patient | ||||
| end | Dislocation of the cannula point at | |||
| the patient end shall be in | ||||
| accordance with Table 2 when | ||||
| tested in accordance with Clause 8 | ||||
| (of ISO 11608-2). | Requirement met | Requirement met | Both products are | |
| compliant with table |
-
|
| Determination of
functional
compatibility
with needle-
based injection
systems | Compatibility with any NIS
(Needle-based Injection System)
shall be claimed only after testing in
accordance with Clause 11. | Requirement met | Requirement met | Both products are
compatible to the
same list of pen
injector device |
| Ease of
assembly
and
disassembly | Attachment of the needle shall be
possible without removing the
needle from its opened unit
packaging. Compliance is checked
according to the requirements of
Clause 11. | Requirement met | Requirement met | Both products are in
compliance with
clause 11 |
| Sterility | The needles in its unit
packaging is subjected to a
validatedsterilization process | Requirement met | Requirement met | Both products are
ETO sterilized in
the same
sterilization place |
| Pre-conditioning of
needles | The needles satisfy all the
requirements of ISO 11608-2 after
preconditioning according to
clauses 6.1, 6.2 and 6.3 of the same
standard | Requirement met | Requirement met | Both products
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
contact* |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------|---------------------|
| Primary
Container | High Density
Polyethylene
Copolymer | ERACLENE ® MR 80 U | Versalis | None/Instant |
| | | ERACLENE ® MS 80 U | Versalis | |
| | | RIGIDEX HD5218EA | Ineos | |
| | | RIGIDEX HD5226EA | Ineos | |
| Hub | Homopolymer
Polypropylene | Eltex® MED 100-MG25 | Ineos | None/Instant |
| | | HEALTHCARE HPP25G | Repsol | |
| | | PPM H250 or ACESO® PPM
H250 | Total | |
| Hub Master
batch | Pigment for polymers Remafin Blue PE52080094
Pigment for polymers Remafin Yellow PE11078232
Pigment for polymers Remafin Grey PE71077043
Pigment for polymers Remafin Red PE31079060
Pigment for polymers Remafin Red PE31079091
Pigment for polymers Remafin Purple PE41076243
Pigment for polymers Remafin PP-All colours | | Clariant | None/Instant |
| | Pigment for polymers Sicolen Green 90-0755 SN
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
Medical silicone MDX4-4159
Q7 9180 | | Dow Corning | Direct |
| Shield | High Density
Polyethylene
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 | ||
| AssessmentEvaluation | ISO 10993-1- Biological | |
| evaluation of medical devices - Part 1: | ||
| Evaluation and testing within a risk | ||
| management process | The following end-points have been | |
| identified and verified by testing. | ||
| Cytotoxicity Study | ||
| Using the ISO Elution | ||
| Method | ISO 10993-5 - Biological | |
| evaluation of medical devices - Part 5: | ||
| Tests for in vitro cytotoxicity | The test article showed no evidence | |
| of causing cell lysis or toxicity. | ||
| ISO Guinea Pig | ||
| Maximization Sensitization | ||
| Test | ISO 10993-10 - Biological | |
| evaluation of medical devices -- Part 10: | ||
| Tests for irritation and skin | ||
| sensitization | The test article extracts showed no | |
| evidence of causing delayed dermal | ||
| contact sensitization in the guinea pig. The | ||
| test article was not considered a sensitizer | ||
| in the guinea pig maximization test. | ||
| ISO Intracutaneous | ||
| Study in Rabbits | ISO 10993-10 - Biological | |
| evaluation of medical devices -- Part 10: | ||
| Tests for irritation and | ||
| skin sensitization | The test article met the requirements | |
| of the test. | ||
| ASTM Hemolysis | ||
| Study | ASTM F756, Standard Practice | |
| for Assessment of Hemolytic Properties | ||
| of Materials and ISO | ||
| 10993-4 - Biological evaluation of | ||
| medical devices -- Part 4: | ||
| Selection of tests for interactions with | ||
| blood | Both the test article in direct contact | |
| with blood and the test article extract were | ||
| non-hemolytic | ||
| ISO Two Week | ||
| Toxicity Study in the Rat, | ||
| Repeated | ||
| Parenteral | ||
| Administration of Two | ||
| Extracts | ISO 10993-11 - Biological | |
| evaluation of medical devices -- Part 11: | ||
| Tests for systemic toxicity | There were no microscopic changes | |
| considered to be a test article related | ||
| response. Parenteral | ||
| administration of the test article | ||
| extract did not produce systemic toxicity in | ||
| rats. | ||
| ISO Systemic Toxicity Study | ||
| in Mice | ISO 10993-11 - Biological | |
| evaluation of medical devices -- Part 11: | ||
| Tests for systemic toxicity | There was no mortality or evidence | |
| of systemic toxicity from the extracts | ||
| injected into mice. Each test article met the | ||
| requirements of the study. | ||
| USP Rabbit Pyrogen | ||
| Study, Material- | ||
| mediated | ISO 10993-11 Biological | |
| evaluation of medical devices -- | ||
| Part 11: Tests for systemic toxicity | The total rise of rabbit temperatures | |
| during the 3 hours observation period | ||
| was within acceptable USP limits. | ||
| The test article was judged as non- | ||
| pyrogenic | ||
| USP Pyrogen Study - | ||
| Material Mediated | USP, General Chapter , | |
| Pyrogen Test as recommended by ISO | ||
| 10993-11 Biological | ||
| evaluation of medical devices -- | ||
| Part 11: Tests for systemic toxicity | The test article was judged as | |
| 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.