Search Results

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:

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.

Ask a specific question about this device

The meso-relle needles are intended to inject fluids intradermally.

The meso-relle® needles are single lumen needle intended to inject fluids intradermally. 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. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.

The provided document describes the acceptance criteria and the study conducted for the meso-relle needles (AAL34, AAL36, AM30G), a hypodermic single lumen needle intended to inject fluids intradermally.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a dedicated table format with corresponding numerical performance values. Instead, it states that the meso-relle needles were tested according to specific ISO standards and "met the acceptance criteria." The device's performance is reported indirectly by stating its compliance with these standards and demonstrating substantial equivalence to predicate devices.

However, based on the non-clinical performance data section and the comparison table, we can infer the acceptance criteria are met by conforming to the specified ISO standards and achieving substantial equivalence to the predicate devices in terms of materials, design, and functional characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each non-clinical performance test. It mentions that "tests were performed on the final finished device," suggesting a representative sample was used for each test (biocompatibility, sterility, functional testing).

The data provenance is retrospective, as the tests were conducted on the finished devices to demonstrate compliance with existing standards and equivalence to already marketed predicate devices. The country of origin of the data is not explicitly stated, but the manufacturer (Biotekne S.r.l.) and contact person (Enrico Bisson) are located in ITALY.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The ground truth for hypodermic needles is established by compliance with international engineering and medical device standards (e.g., ISO standards for materials, sterility, and functional performance) and comparison to established predicate devices, not by expert consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology images) where there may be disagreement among experts. This study focuses on objective engineering and performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device (a hypodermic needle).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• International Standards: Compliance with ISO 10993-1 (Biocompatibility), AAMI / ANSI / ISO 11135-1:2007 and UNI EN ISO 10993-7:2008 (Sterility), ISO 7864:2016 (Hypodermic Needles), ISO 9626:2016 (Stainless Steel Needle Tubing), and ISO 594-1:1986 (Luer Taper Fittings).
• Performance of Predicate Devices: The established safe and effective performance of the legally marketed predicate devices (K110606, MV Intradermic Needles and K051783, Artsana Hypodermic Needles). The subject device demonstrates "substantial equivalence" to these predicates.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of validating a physical medical device like a hypodermic needle. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as in point 8.

Ask a specific question about this device

The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).

The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.

The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.

Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.

This document is a 510(k) Premarket Notification for medical devices, specifically pen needles. It is not a study proving an AI/ML medical device meets acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be extracted from this document.

This document focuses on demonstrating substantial equivalence of the Unifine® Pentips® and Unifine® Pentips® Plus pen needles to legally marketed predicate devices, primarily K973899 (Unifine® Pentips®). This is a regulatory pathway for Class II medical devices in the US, where the manufacturer needs to show that their new device is as safe and effective as an already cleared device.

Here's what can be extracted based on the provided text, and where the requested information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these pen needles are primarily defined by adherence to ISO standards and internal performance tests. The document states that the devices meet these standards/criteria.

Note: The document states "The devices comply with the acceptance criteria established based on the specifications of the devices" for internal tests, but does not provide the specific numerical criteria for these tests.

Regarding the study that proves the device meets acceptance criteria (for an AI/ML context):

This document describes a regulatory submission for a physical medical device (pen needles), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC studies" as they apply to AI/ML performance evaluation are not relevant here. The "study" described is a series of non-clinical performance (bench) tests and biocompatibility tests to demonstrate substantial equivalence to existing devices.

Here's why the specific questions are not applicable or cannot be answered from this document:

2. Sample sized used for the test set and the data provenance:

• Not Applicable in AI/ML context: This is a physical device. "Test set" refers to samples tested during bench testing.
• Sample Size: The document does not specify the number of pen needles tested for each performance test. It only states that the tests were performed and results "meet standard" or "meet acceptance criteria."
• Data Provenance: Not applicable in the AI/ML sense. Data is from laboratory bench testing of manufactured pen needles. The manufacturing locations mentioned are the UK (Owen Mumford) and Italy (Artsana S.p.A.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: There is no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for a physical device like a pen needle. The "ground truth" is defined by the objective physical and mechanical properties measured against established ISO standards and internal specifications. Bench testing is typically performed by trained technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: No expert adjudication process as would be used for clinical image interpretation or AI model validation. Bench tests have objective, measurable outcomes.

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:

• Not Applicable: This type of study (MRMC, human readers, AI assistance) is for clinical decision support or diagnostic AI devices. This document is for a mechanical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable in AI/ML context: The "ground truth" for these pen needles is defined by objective physical and mechanical measurements against established ISO standards (e.g., dimensions, flow rate, bond strength) and internal engineering specifications. Biocompatibility is assessed through standardized biological tests.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable: As above, no training set or AI/ML ground truth. The "ground truth" for manufacturing and quality control of pen needles is based on engineering specifications and adherence to international standards for medical devices.

Ask a specific question about this device