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510(k) Data Aggregation
(753 days)
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs
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.
The document describes the acceptance criteria and study results for the Pikdare Insupen Pen Needle, Insupen ORIGINAL Pen Needle, and Insupen ADVANCED pen needle.
1. Table of acceptance criteria and the reported device performance:
| Test Parameter | Acceptance Criteria (Requirement – ISO 11608-2:2012) | Reported Device Performance (Subject Device) |
|---|---|---|
| Materials | The needle shall be made of tubing materials specified in ISO 9626. | Requirement met |
| Dimensions | The tubing features used in the needles shall meet the requirements of ISO 9626. For G34 needle, the limits of stiffness have 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 |
| 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 |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Requirement met |
| Needle points | Needle points shall appear sharp and free from featheredges, burrs and hocks when examined 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 |
| Freedom from defects | The needle tube shall fulfill the requirements of ISO 7864, clause 11.3. | Requirement met |
| 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 surface of the needle tube. | Requirement met |
| 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 |
| Determination of functional compatibility with NIS | Compatibility with any NIS (Needle-based Injection System) shall be claimed only after testing in accordance with Clause 11. | Requirement met |
| 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 |
| Sterility | The needles in its unit packaging is subjected to a validated sterilization process. (SAL = 10^-6) | Requirement met (SAL = 10^-6 achieved) |
| 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 |
| Biocompatibility Tests | ||
| Cytotoxicity Study Using the ISO Elution Method | ISO 10993-5 (Tests for in vitro cytotoxicity) | No evidence of causing cell lysis or toxicity. |
| ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10 (Tests for irritation and skin sensitization) | No evidence of causing delayed dermal contact sensitization; not considered a sensitizer. |
| ISO Intracutaneous Study in Rabbits | ISO 10993-10 (Tests for irritation and skin sensitization) | Met the requirements of the test. |
| ASTM Hemolysis Study | ASTM F756 and ISO 10993-4 (Assessment of Hemolytic Properties of Materials) | Non-hemolytic. |
| ISO Two Week Toxicity Study in the Rat | ISO 10993-11 (Tests for systemic toxicity) | No microscopic changes considered test article related; no systemic toxicity. |
| ISO Systemic Toxicity Study in Mice | ISO 10993-11 (Tests for systemic toxicity) | No mortality or evidence of systemic toxicity. |
| USP Rabbit Pyrogen Study, Material-mediated | ISO 10993-11 (Tests for systemic toxicity) | Total rise of rabbit temperatures within acceptable USP limits; non-pyrogenic. |
| USP Pyrogen Study - Material Mediated | USP, General Chapter , Pyrogen Test as recommended by ISO 10993-11 | Nonpyrogenic. |
| EO Residual Values | Maximum EO residual values after degassing and before product release set at 1 mg per device (ISO 10993-7 limit: 4 mg/day, considering 4 uses/day). | Met (values below 1 mg/device). |
| ECH Residual Values | Maximum ECH residual values after degassing and before product release set at 2.25 mg per device (ISO 10993-7 limit: 9 mg/day, considering 4 uses/day). | Met (values below 2.25 mg/device). |
2. Sample size used for the test set and the data provenance:
The document states that "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)." This implies the testing was done on the actual manufactured products (both the subject device and the predicate device).
- Sample size: Not explicitly stated with a specific number for each test, but it is implied that sufficient samples were used to meet the requirements of the listed ISO standards.
- Data provenance: The predicate device is manufactured in Italy by Pikdare S.p.A. The testing described for both the subject device and the predicate device was presumably performed by or on behalf of Pikdare S.p.A. in Italy. All tests refer to recognized international standards (ISO).
- Retrospective or prospective: The data appears to be prospective, collected specifically for the 510(k) submission to demonstrate compliance with standards and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (pen needle) conformity assessment, not an AI or diagnostic imaging study that relies on expert interpretation for ground truth. The "ground truth" here is defined by meeting the objectively measurable criteria specified in ISO and ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, for the same reason as point 3. The assessment is based on objective measurements against predefined standards.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is defined by the technical specifications and performance requirements established by recognized international standards (e.g., ISO 11608-2, ISO 9626, ISO 10993-1, ISO 7864, ASTM F756, USP General Chapter ). The device performance is objectively measured against these established criteria.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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