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510(k) Data Aggregation
(181 days)
Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only.
The provided text describes the acceptance criteria and the summary of testing for the "BAIXIN™ Intravascular Administration Set". However, it does not detail a study in the context of AI/ML devices or clinical trials that would typically involve a "test set," "training set," "ground truth experts," or "MRMC comparative effectiveness studies." The document is a 510(k) summary for a medical device that conforms to recognized consensus standards, specifically ISO 8536-4-2007.
Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and review process described.
Here's the information that can be extracted or inferred:
Acceptance Criteria and Reported Device Performance
| Test Items | Requirements | Reported Device Performance |
|---|---|---|
| Sterility | No evidence of growth of BI | Conforms (Implied) |
| Pyrogenicity | Free from pyrogenicity (Bacterial endotoxin test) | Conforms (Implied) |
| Haemolysis | The infusion set shall be free from haemolytic reactions | Conforms (Implied) |
| Toxicity | Free from toxicity | Conforms (Implied) |
| Reducing (oxidizable) matter | The total amount of potassium permanganate solution used [c(KMnO4)=0.002mol/l] shall not exceed 2.0ml | Conforms (Implied) |
| Metal ions | The extract shall not contain in total more than 1µg/ml of cadmium, chromium, copper, lead and tin. Not more than 0.1µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or equivalent method. | Conforms (Implied) |
| Titration acidity or alkalinity | Not more than 1ml of either standard volumetric solution shall be required for the indicator to change to the colour grey. | Conforms (Implied) |
| Residue on evaporation | The total amount of dry residue shall not exceed 5 mg. | Conforms (Implied) |
| UV absorption of extract solution | The extract solution S, shall not show absorption greater than 0.1. | Conforms (Implied) |
| EO residue | Less than 0.5mg/set | Conforms (Implied) |
| Particulate contamination | Contamination index < 90 | Conforms (Implied) |
| Leakage | Immerse the infusion set, with one end blocked, in water at 20°C to 30°C and apply an internal air pressure of 50kPa above atmospheric pressure for 15s. Examine the infusion set for air leakage. Apply an internal excess pressure of -20kPa at (23±1) °C and (40±1) °C for 15s. Inspect whether air enters the infusion set. | Conforms (Implied) |
| Tensile strength | Withstand a static tensile force of not less than 15N for 15s. | Conforms (Implied) |
| Closure-piercing device | The closure-piercing device shall be capable of piercing and penetrating the closure without prepiercing. No coring should occur during this procedure. | Conforms (Implied) |
| Air-inlet device | The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container. Air went through rate ≥ 90%. The air-inlet device shall be separate from, or integral with, the closure-piercing device. The air admitted into the container shall not become entrained in the liquid outflow. The flow rate of fluid is not reduced by more than 20% of that from a freely ventilated container. | Conforms (Implied) |
| Tubing | The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. The tubing length distal to the drip chamber shall be not less than 1500mm in length. | Conforms (Implied) |
| Fluid filter | The retention of latex particles on the filter shall be not less than 80%. | Conforms (Implied) |
| Dimensions of the drip chamber | There shall be a distance of not less than 40mm between the drip tube and fluid filter. The wall of the drip chamber shall not be closer than 5mm to the end of the drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at: 23±2°C and at a flow rate of 60 drops/min±10drops/min deliver a volume of 1ml±0.1ml (1g±0.1g). | Conforms (Implied) |
| Flow regulator | The flow regulator shall adjust the flow of the infusion solution between zero and maximum. The regulation length should be no less than 30mm. | Conforms (Implied) |
| Flow rate | 20 drops, 10min > 1000ml | Conforms (Implied) |
| Injection port | There shall be no leakage of more than one falling drop of water. | Conforms (Implied) |
| Male conical fitting | In accordance with ISO594-1 or ISO594-2 | Conforms (Implied) |
| Protective cap | The protective caps shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set. | Conforms (Implied) |
| Individual package | The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner. | Conforms (Implied) |
| No flattened portions and kinks | The infusion set and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use. | Conforms (Implied) |
Note on Reported Device Performance: The document states, "Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes conform to the FDA recognized consensus standard, ISO 8536-4-2007, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd." The "Summary of Testing" lists the requirements, implying that the device met these requirements without explicitly providing numerical results for each test within this summary. Therefore, "Conforms (Implied)" is used as the reported performance.
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "All materials used in the fabrication... were evaluated," but does not give a specific sample size for each test.
- Data Provenance: Not explicitly stated, but the manufacturer is Anhui Kangda Medical Products Co., Ltd. in P. R. China. The testing was conducted to conform to ISO 8536-4-2007. The tests are likely performed by the manufacturer or a contracted lab in China.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and submission. The "ground truth" for this device is defined by the technical specifications and performance criteria outlined in the ISO standard, and demonstrated through physical, chemical, and biological testing, rather than expert interpretation of medical images or data.
3. Adjudication method for the test set:
- Not applicable. This concept relates to disagreement resolution among experts in medical image interpretation or clinical diagnosis, which is not relevant for the conformance testing of an intravascular administration set.
4. 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 was not done. MRMC studies are used for evaluating diagnostic or screening devices, particularly those involving human readers (e.g., radiologists) and potentially AI assistance. This device is a fluid administration set, not an AI/ML diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
6. The type of ground truth used:
- The "ground truth" for this device is established by technical specifications, chemical analysis, physical testing, and biological assays (e.g., sterility, pyrogenicity, toxicity, dimensional correctness) as defined by the international consensus standard ISO 8536-4-2007.
7. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
8. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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