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510(k) Data Aggregation
(178 days)
Omnican fine is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.
The Omnican fine is a pen needle device that is a sterile, individually packaged, single use, hypodermic single lumen needle; intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products. Omnican fine is a double-ended needle consisting of a tri-beveled tip, hollow steel cannula, and needle hub packaged in a hard plastic sealed container. Specific versions contain an inner needle shield. The Omnican fine provides a fluid path from a drug container to subcutaneous tissue.
The provided text describes a 510(k) premarket notification for a medical device, specifically a hypodermic single lumen needle called "Omnican fine." The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials. Therefore, the "study" referred to will be a collection of non-clinical performance tests and comparisons.
Here's a breakdown of the acceptance criteria and the "study" details based on the document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document outlines acceptance criteria indirectly through the "Summary of nonclinical performance tests" and lists the intended performance of the "Proposed Device Omnican fine."
| Feature/Test | Acceptance Criteria (Predicate/Omnican Fine) | Reported Device Performance (Omnican fine) |
|---|---|---|
| Functional Performance | ||
| Measurement of needle tube length: Injector end | 6.15 +0.5/-0.3 mm | 6.15 +0.5/-0.3 mm |
| Measurement of needle tube length: Patient End | 12 +1.1/-0.8 mm (for 12mm size)8 +1.1/-0.8 mm (for 8mm size)6 +1.1/-0.8 mm (for 6mm size)4 + 1.25/-0.0 mm (for 4mm size) | 12 +1.1/-0.8 mm8 +1.1/-0.8 mm6 +1.1/-0.8 mm4 + 1.25/-0.0 mm |
| Dislocation of measuring point at patient end | ≤ 1.1 mm (for 12mm needle)≤ 0.9 mm (for 8mm needle)≤ 0.7 mm (for 6mm needle)≤ 0.6 mm (for 4mm needle) | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Bond between needle hub and needle tube | Withstand a 22 N force applied axially for 5 seconds. | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Unscrewing torque of the needle | < 0.1 Nm | < 0.1 Nm |
| Flow Rate | According to product specification (specific values not provided but implied as meeting a standard)Blockage/Patency of inner lumen | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Tube Tips (Patient end and Cartridge end) | Freedom from damages and defects (implied by standard ISO 7864 and general quality expectations) | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Lubricants (Siliconizing needle tube patient/cartridge end) | Adequate lubrication for intended use (implied by general quality expectations and functional testing without explicit numerical criteria) | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Compatibility with NIS (Torque on/off) | Function correctly with declared compatible NIS (specific torque values not provided, but implies smooth and secure attachment/detachment) | Met criteria (implied by "Omnican fine met all established acceptance criteria" and "Comparison of Technological Characteristics" stating compatibility) |
| Compatibility with NIS (Dose accuracy) | Not specified as a direct acceptance criterion for the needle itself, but typically assessed as part of the overall injection system performance. The needle's design must not negatively impact the NIS's dose accuracy. | Met criteria (implied by "Omnican fine met all established acceptance criteria" in conjunction with NIS compatibility) |
| Ease of assembly/disassembly | Easy and intuitive assembly/disassembly (implied by functional testing) | Met criteria (implied by "Omnican fine met all established acceptance criteria") |
| Biocompatibility | Meet requirements per ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Rabbit Pyrogen - for Externally Communicating Device, Tissue/Bone/Dentin, Limited Contact Duration <24 hrs) | Met requirements (stated as "Meets the requirements per ISO 10993-1") |
| Sterilization | Ethylene Oxide, SAL 10-6, validated according to ISO 11135:2014(E) | EtO, SAL 10-6, validated (stated as "The sterilization process is the same and has been validated according to the same procedures" and "Ethylene Oxide, SAL 10-6") |
| Shelf Life | 5 years (demonstrated through accelerated aging) | 5 years (stated as "5 years" and "Accelerated ageing was conducted to prove a shelf life of 5 years") |
| Physical Characteristics (Dimensional) | Corresponds to specified OD/ID, Gauge sizes, and absence of an inner needle shield for Pencylcap. | Omnican fine: OD: 0.33 mm; 0.25 mm; ID: 0.19 ± 0.01 mm; 0.125 + 0.035 mm; Gauge sizes: 29 Gauge; 31 Gauge (these are the differences from predicate, but they are tested to ensure they meet the functional criteria of the device as a whole, matching relevant standards) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes (number of units) for each non-clinical test. It lists the types of tests performed (e.g., Dimensions, Flow Rate, Connection of needle hub to the needle tube, etc.) and refers to compliance with ISO standards (e.g., ISO 7864:2016(E), ISO 9626:2016(E), ISO 11608-2:2012(E)). These standards often specify minimum sample sizes for material and performance testing.
- Data Provenance: The testing was conducted by B. Braun Medical Inc. ("assessed by B. Braun" and "conducted along with the same indications for use..."). This would be internal company data. The document does not specify country of origin for the data or whether the test samples were retrospective or prospectively manufactured for the submission. Given it's a premarket submission, the test samples would be representative of the intended manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a medical device (needle) 510(k) submission, not an AI/Software as a Medical Device (SaMD) submission. As such:
- No expert ground truth establishment: The "ground truth" for this device's performance is established by adhering to recognized international and national standards for medical devices (e.g., ISO for needles, biocompatibility, sterilization). The performance is measured directly against physical and functional specifications.
- No specific experts mentioned: The testing would be performed by qualified engineers, technicians, and laboratory personnel experienced in medical device testing, quality control, and compliance with the referenced ISO standards. There is no mention of "experts" in the sense of clinicians establishing 'diagnoses' or 'interpretations'.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This type of adjudication method is used in studies where human interpretation (e.g., radiology reads) forms the basis of ground truth, typically for AI/SaMD or diagnostic imaging devices. For a hypodermic needle, performance is determined by meeting objective, measurable physical and functional criteria per established 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:
Not applicable. This is a physical medical device (a needle), not an AI-assisted diagnostic or therapeutic system. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this submission.
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. Its performance is entirely mechanical and material-based.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for hypodermic needles is established by:
- Compliance with recognized international standards: Such as ISO 7864 (hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 10993 (biocompatibility), ISO 11135 (sterilization), and ISO 11608-2 (Needle-based injection systems). These standards define test methods and acceptable performance limits.
- Engineering specifications and design verification: The device is tested against its own design specifications, which are themselves derived from clinical need and regulatory requirements (e.g., specific lengths, diameters, bonding strength).
- Comparison to a predicate device: A key aspect of a 510(k) is demonstrating that the new device is substantially equivalent to a predicate, meaning it performs similarly and presents similar safety and effectiveness profiles. The predicate device's established safe and effective use serves as a benchmark for the "ground truth" of performance for this device type.
8. The sample size for the training set:
Not applicable. There is no AI component or machine learning in this device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for machine learning, there is no ground truth established for one.
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