(139 days)
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.
The provided document (K231363) is a 510(k) summary for Hantech Pre-filled 0.9% Normal Saline Flush Syringes. This type of device is a sterile medical product, not an AI/ML-driven diagnostic or image analysis tool.
Therefore, the concepts of acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets do not apply in the context of this device and the information provided in the 510(k) summary.
The document describes non-clinical bench testing to demonstrate the substantial equivalence of the Hantech Pre-filled 0.9% Normal Saline Flush Syringes to a legally marketed predicate device. The "acceptance criteria" here refer to the predefined standards and limits for the physical, chemical, and biological properties of the syringe and its contents, as well as the sterilization process, which are based on recognized international and national standards (e.g., ISO, USP).
Here's an interpretation of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table summarizing the non-clinical testing performed. The "Acceptance criteria" column lists the standards/criteria the device must meet, and the "Conclusion" column indicates "Pass" for all tests, meaning the device met these criteria.
| NO. | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO7886-1, ISO80369-7 | ISO7886-1, ISO80369-7 (specific parameters for appearance, scale, sliding, dimension, dead space, acidity/alkalinity, chemical performance) | Pass |
| 2 | Sodium Chloride Injection, USP Testing | USP40-, USP-, USP, USP6-471, USP40-, USP, USP | pH: 4.5-7.0, Positive identification for Sodium/Chlorine, 95% ~ 105% content, limits for oxidizable substances, iron, ammonium salt, calcium salt, carbonate, sulfate, and extractable metals (Cd≤2 μg/L, Pb≤5 μg/L, As≤15 μg/L, Hg≤3 μg/L) | Pass |
| 3 | Particulate matter | USP | ≥10um, ≤6000; ≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | ISO10993-11, ISO10993-10, ISO10993-5, ISO10993-4, ASTM F756-17 | No systemic toxicity, Non-irritant, Non-pyrogen, Non-sensitizer, Non-cytotoxic, Non-hemolytic | Pass |
| 5 | Sterilization | USP, USP31- | Bacterial endotoxins ≤0.5EU/mL, Sterility (conformance to USP31-) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "Summary of clinical Testing: N/A," meaning no clinical trials were conducted. The testing described is bench testing (laboratory-based, non-human, non-animal testing) of the physical product, its components, and its contents. The sample sizes for each specific test (e.g., how many syringes were tested for dimensions, or how many batches for chemical composition) are not provided in this summary document. Data provenance would be the manufacturer's internal testing facilities in China. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set:
This question is not applicable. The "ground truth" for a medical device like a syringe is established by validated measurement methods and recognized standards, not by expert consensus on clinical findings. For example, the pH of the saline is measured by a pH meter against a standard, not by an expert's opinion.
4. Adjudication Method for the Test Set:
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, like image reading, not for objective bench testing of a physical product.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where the performance of human readers, with and without AI assistance, is compared. This device is a pre-filled saline syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this concept is entirely irrelevant for a medical device such as a pre-filled saline syringe. This applies to AI/ML algorithms.
7. The Type of Ground Truth Used:
The "ground truth" (or more accurately, the reference standard) for this device's performance is based on:
- Recognized consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series)
- United States Pharmacopeia (USP) monographs and general chapters: (e.g., USP for pH, USP for identification tests, USP for particulate matter, USP for Bacterial Endotoxins, USP31- for Sterility tests, USP monographs for Sodium Chloride Injection)
- Manufacturer's internal specifications: Which must meet or exceed these recognized standards.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm 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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).