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510(k) Data Aggregation
(190 days)
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
The provided text describes the 510(k) premarket notification for the "CareSens Pen Needle and Softip Pen Needle". It focuses on demonstrating substantial equivalence to a predicate device and a reference device, primarily through bench testing and biocompatibility assessments, rather than human clinical studies involving AI.
Therefore, many of the requested categories related to medical AI device studies, such as sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training, are not applicable or cannot be extracted from this document as the device in question is a physical medical needle, not an AI device.
Here's the information that can be extracted related to acceptance criteria and performance, as appropriate for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Performance Bench Tests (ISO 11608-2:2012) | ||
| Dimension testing | ISO 11608-2:2012 (4.2 Dimensions / 4.2.1 General / 4.2.2 Dimensions for needles), meets requirements | Meets requirements |
| Flow rate testing | ISO 11608-2:2012 (4.3 Determination of flow rate through the needle), meets requirements | Meets requirements |
| Bond between hub and needle tube testing | ISO 11608-2:2012 (4.4 Bond between hub and needle tube), meets requirements | Meets requirements |
| Needle point freedom from defects lubrication test | ISO 11608-2:2012 (4.5 Needle point / 4.6 Freedom from defects / 4.7 Lubrication), meets requirements | Meets requirements |
| Dislocation of measuring point at patient end | ISO 11608-2:2012 (4.8 Dislocation of measuring point at patient end), meets requirements | Meets requirements |
| Compatibility of needles and injector system test / Ease of assembly and disassembly | ISO 11608-2:2012 (4.9 Determination of functional compatibility with needle-based injection systems / 4.10 Ease of assembly and disassembly), meets requirements | Meets requirements |
| Biocompatibility Tests (ISO 10993) | ||
| Cytotoxicity test | ISO 10993-5, Tests for in vitro Cytotoxicity, Test on extracts | Non-Cytotoxic |
| Intracutaneous (Intradermal) Reactivity Test | ISO 10993-10, Intracutaneous(Intradermal) reactivity test | Negligible |
| Sensitization Test (Guinea pig maximization test) | ISO 10993-10, Sensitization(Guinea pig maximization test) | Weak sensitizer |
| Acute systemic toxicity test | ISO 10993-11, Acute systemic toxicity | Non-toxic |
| Pyrogen test | ISO 10993-11, USP Rabbit Pyrogen Test | Non-pyrogenic |
| Haemolysis test | ISO 10993-4, Haemolysis testing-general considerations | Non-hemolytic |
| Sterilization Tests | ||
| Packaging | Packaging should keep clean from microorganism and not be broken before use; needle packed one by one. | PASS |
| Sterility Test-Direct inoculation | The Korean pharmacopoeia Tenth edition (same as USP 25<71> sterility test) | PASS |
| Ethylene oxide sterilization residuals | ISO 10993-7: EO ≤4 mg first 24 hrs and ECH ≤9 mg first 24 hrs for limited exposure (<24 hours) | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for each bench test, biocompatibility test, and sterilization test are not provided in the document. The document states that tests were "conducted" and "results demonstrate," implying samples were used as per the standards, but quantities are absent.
- Data Provenance: Not explicitly stated for specific test data, but the manufacturer (YidoBio Inc.) is from Korea, suggesting studies were likely conducted there or by affiliated labs. The document is for an FDA 510(k) submission, indicating adherence to US regulatory standards. The studies described are prospective physical property and biological evaluations.
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 physical medical device (needle), not an AI diagnostic device. Ground truth for its performance is established by objective measurements against international standards (ISO standards, pharmacopoeia) and laboratory tests, not by expert human interpretation of data.
4. Adjudication method for the test set
- Not Applicable. As above, the performance is measured objectively against predefined standards, not through consensus or adjudication of human interpretations.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For performance (dimensions, flow rate, bond, etc.): Objective measurements against defined ISO 11608-2 specifications.
- For biocompatibility: Laboratory test results against ISO 10993 standards.
- For sterility: Laboratory test results against compendial methods (Korean Pharmacopoeia/USP) and ISO 11135 for sterilization validation.
8. The sample size for the training set
- Not Applicable. This is not an AI device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI device, the concept of a training set and its ground truth establishment does not apply.
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