(161 days)
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The proposed device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the action of gravity. The proposed device is provided with/without injection needle. It is comprised of protective cap of spike, air vent, air filter, drip chamber, fluid filter, flexible tube, injection site, roller clamp, luer lock connector, protector cap of luer lock connector. The devices are provided sterile and single use.
The provided text is a 510(k) summary for a Sterile Single-use Infusion Set. It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical test conclusions.
Acceptance Criteria and Device Performance for Sterile Single-use Infusion Set
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Infusion Set Performance | |
| Particulate contamination | Contamination index limit is less than 90 (Comply with ISO 8536-4) |
| Leakage | No leakage |
| Tensile strength | Withstand a static tensile force of not less than 15N for 15s |
| Closure piercing device | Comply the dimension of ISO 8536 |
| Air-inlet device | Flow of fluid is reduced less than 20% of that from a freely ventilated container |
| Tubing | Length is not less than 1500mm |
| Fluid filter | Retention of latex particles is not less than 80% |
| Drip chamber and drip tube | 20 drops of distilled water delivered by the drip are equivalence to a volume of (1±0.1)ml(1±0.1)g |
| Flow rate | Deliver not less than 1000ml |
| Injection site | No leakage |
| Construction | The clamps can resist the flow of fluid and air at an applied pressure of 50 kPa when closed. |
| Needle Performance | |
| Cleanliness | Free from particles and extraneous matter (Comply with ISO 7864 and ISO 9626) |
| Needle length | 38mm (Specific to the proposed device; predicate "Unknown") |
| Bond of hub and needle tube | Not broken by the minimum force |
| Stiffness | Deflection is less than 0.50mm |
| Dimensions of needle tubing | 0.8mm (Specific to the proposed device; predicate "Unknown") |
| Resistance to breakage | The tubing is not break |
| Resistance to corrosion | No evidence of corrosion |
| Biocompatibility | |
| Cytotoxicity | No Cytotoxicity (Conform with ISO 10993 requirements) |
| Intracutaneous Reactivity | No Intracutaneous Reactivity (Conform with ISO 10993 requirements) |
| Skin Sensitization | No Skin Sensitization (Conform with ISO 10993 requirements) |
| Acute Systemic Toxicity | No Acute Systemic Toxicity (Conform with ISO 10993 requirements) |
| Hemolysis | No Hemolysis (Conform with ISO 10993 requirements) |
| Pyrogen | No pyrogen (Conform with ISO 10993 requirements) |
| Sterile Barrier Packaging Testing | |
| Seal strength, Internal pressure, Dye Penetration | Tested as per ASTM F88/F88-09, ASTM F1140/F1140M-13, ASTM F 1929-12 respectively. (Implicitly met based on SE conclusion) |
| Sterilization and Shelf Life Testing | |
| EO residue, ECH residue | Tested as per ISO 10993-7:2008 (Implicitly met based on SE conclusion) |
| Bacteria Endotoxin Limit | Tested as per USP 36-NF 31 (Implicitly met based on SE conclusion) |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility Tests performed on accelerated aging samples to verify the claimed shelf life of the device. (Implicitly met based on SE conclusion) |
| Transportation Testing | Performed on the final product to verify its package integrity during transportation. (Implicitly met based on SE conclusion) |
Here's an analysis of the study based on your requested items:
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A table of acceptance criteria and the reported device performance
- See table above. The performance is reported as meeting the specified standards (e.g., ISO, ASTM, USP) or specific numerical/qualitative criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for individual non-clinical tests.
- The tests were conducted by a Chinese manufacturer (Jiangxi Hongda Medical Equipment Group, Ltd. in Nanchang City, Jiangxi Province, China). The data provenance is China.
- These are prospective tests conducted on the manufactured device to demonstrate compliance with standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This document describes non-clinical engineering and biological tests, not an AI or diagnostic study involving human expert interpretation for ground truth. Therefore, this question is not applicable. The "ground truth" for these tests is defined by the technical specifications of international and national standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this is not a study involving human adjudication of results for a diagnostic or AI algorithm.
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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 MRMC or AI-related study was done. This is a 510(k) submission for a physical medical device (infusion set), not an AI algorithm. Therefore, this question is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone AI algorithm performance study was done. This is not an AI device. Therefore, this question is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on established international and national standards (e.g., ISO 8536-4, ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ASTM F88, ASTM F1140, ASTM F1929, ISO 10993-7, USP 36-NF 31). These standards define the acceptable performance limits and methodologies for testing.
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The sample size for the training set
- Not applicable. This is not an AI device or a machine learning study.
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How the ground truth for the training set was established
- Not applicable. This is not an AI device or a machine learning study.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.