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510(k) Data Aggregation
(254 days)
Anhui Tianyang Pharmaceutical Co., Ltd.
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
The provided document is a 510(k) summary for a medical device called "Pre-Filled Normal Saline Flush Syringe." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not describe a study involving an AI/CADe device or human readers. Therefore, I cannot provide information regarding acceptance criteria and studies typical for AI/CADe devices, such as those related to multi-reader multi-case studies, effect size of AI assistance, expert qualifications, or ground truth establishment for training and test sets in an AI context.
However, I can extract the acceptance criteria and performance data for the non-clinical (bench) tests conducted on the Pre-Filled Normal Saline Flush Syringe to demonstrate its safety and effectiveness.
Here's the information based on the provided text, specifically from Section VII "Summary of Non-clinical Testing (Bench)":
1. Table of Acceptance Criteria and the Reported Device Performance
| ID# | Test | Method | Acceptance Criteria | Conclusion (Reported Device Performance) |
|---|---|---|---|---|
| 1.1 | Lubricant | ISO7886-1 | ISO7886-1 | Pass |
| 1.2 | Dead Space | ISO7886-1 | ISO7886-1 | Pass |
| 1.3 | Limits for acidity or alkalinity | ISO7886-1 | ISO7886-1 | Pass |
| 1.4 | Syringe Luer Performance | ISO 80369-7 | ISO 80369-7 | Pass |
| 1.5 | Sealing performance | ISO7886-1 | ISO7886-1 | Pass |
| 2.1 | pH value (Sodium Chloride Injection, USP) | USP | PH: 4.5-7.0 | Pass |
| 2.2 | Oxidizable substance test | USP6-471 | USP6-471 | Pass |
| 2.3 | Carbonate (Sodium Chloride Injection, USP) | USP | USP | Pass |
| 2.4 | Sulfate (Sodium Chloride Injection, USP) | USP | USP | Pass |
| 2.5 | Calcium (Sodium Chloride Injection, USP) | USP | USP | Pass |
| 2.6 | Ammonium (Sodium Chloride Injection, USP) | USP | USP | Pass |
| 2.7 | Iron test (Sodium Chloride Injection, USP) | USP | , USP | USP, USP |
| 3 | Particulate Contamination | AAMI TIR42:2021 | ≥10μm, ≤6000; ≥25μm, ≤600 | ≥10μm, ≤361.5; ≥25μm, ≤0.0 |
| 4.1 | Bacterial Endotoxins Test | USP 43 | Bacterial endotoxins ≤ 0.5EU/mL | Pass |
| 4.2 | In Vitro Cytotoxicity | ISO 10995-5:2009 (should be ISO 10993-5) | Non-cytotoxic | Pass |
| 4.3 | Intracutaneous Reactivity Test | ISO 10995-23:2021 (should be ISO 10993-23) | Non-irritant | Pass |
| 4.4 | Skin Sensitization Test | ISO 10993-10:2021 | Non-sensitizer | Pass |
| 4.5 | Acute Systemic Toxicity Test | ISO 10993-11:2017 | No systemic toxicity | Pass |
| 4.6 | Pyrogen Test | ISO 10993-11:2017 | Non-pyrogen | Pass |
| 4.7 | In Vitro Hemolysis Test | ISO 10993-4:2017 | Non-hemolytic | Pass |
Note on ISO standards in the table: There appears to be a typo for test IDs 4.2 and 4.3 in the provided document (ISO 10995 instead of ISO 10993 for biocompatibility tests). I have kept the text as written but noted the likely correct standard.
2. Sample size used for the test set and the data provenance
- Sample Size: "Real time aged samples from three non-consecutive lots were tested for all performance criteria."
- Data Provenance: The document does not specify the country of origin for the test samples or explicitly state if the study was retrospective or prospective. It implies prospective testing of manufactured lots.
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 non-clinical, bench testing study for a physical medical device, not an AI/CADe device requiring expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is bench testing. The results are based on objective measurements against established standard criteria.
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, an MRMC comparative effectiveness study was not done. This device is not an AI/CADe device, and the study did not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "device" in this context is the physical syringe. The performance tests conducted are standalone tests of the device itself (its materials, chemical contents, physical properties, and biocompatibility), without specific human-in-the-loop performance measurement beyond standard laboratory procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by internationally recognized consensus standards (e.g., ISO, USP, AAMI TIR) which define the acceptable limits and test methodologies for the physical, chemical, and biological properties of the device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.
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