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510(k) Data Aggregation
(251 days)
The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury.
The U&U Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system. It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is not made with Latex.
The provided document is a 510(k) summary for the U&U Blood Collection Sets, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. As such, the "acceptance criteria" and "device performance" are typically defined by demonstrating conformance to recognized standards and through direct comparison with the predicate device, rather than explicit numerical thresholds for diagnostic performance metrics like sensitivity or specificity.
Here's an analysis of the provided information, structured as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Defined by Conformance to Standards & Predicate Comparison) | Reported Device Performance (U&U Blood Collection Sets) |
|---|---|
| Indication for Use | The U&U Blood Collection Sets is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated to cover the needle immediately following blood collection thus preventing accidental needle-stick injury. (Equivalent to Predicate) |
| Regulation Number | 880.5570 (Conforms) |
| Product Codes | FMI & JKA (Conforms) |
| Principle of Operation | Manual (Equivalent to Predicate) |
| Needle Gauges | 19G to 27G (Predicate: 21G to 25G. The subject device offers a wider range, but still meets safety and performance requirements as demonstrated by testing.) |
| Leakage (ISO 594-2) | No Leakage (Conforms, Equivalent to Predicate) |
| Tensile Strength | Withstand a static tensile force of not less than 15N for 15s; (Conforms, Equivalent to Predicate) |
| Tubing Transparency | 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. (Conforms, Equivalent to Predicate) |
| Materials | PVC, HDPE, ABS, RUBBER, SUS 304, PP (Equivalent to Predicate) |
| Force to Attach Connection (Sharps Injury Prevention Features) | < 15N (Conforms, Equivalent to Predicate) |
| Force to Activate (Sharps Injury Prevention Features) | < 15N (Conforms, Equivalent to Predicate) |
| Number of Activations to Failure (Sharps Injury Prevention Features for Subject Device) | Tested 500, Failure 0 (Predicate: Tested 100, Failure 0. The subject device demonstrated superior performance in terms of number of activations tested without failure, exceeding the predicate's tested number. Note: ISO 23908 specifies "500 samples of each gauge size with zero failures" for activation, directly addressed by this test). |
| Force to Deactivate (Sharps Injury Prevention Features) | ≥100N (Conforms, Equivalent to Predicate) |
| Sterilization Method | EtO Gas (Equivalent to Predicate) |
| Method to Retract Needle | Pull back on tubing until needle is locked within the Safety Shield (Equivalent to Predicate) |
| Biocompatibility (ISO 10993) | Conforms to ISO10993 (Acute Systemic Toxicity, Bacterial endotoxins, Cytotoxicity, Haemolysis, Irritation, Skin Sensitization, Pyrogenicity) |
| Ethylene Oxide Residues (ISO 10993-7) | Ethylene oxide & Ethylene Chlorohydrin Residues Test (Conforms) |
| Shelf Life | 5 Years (Predicate: 3 Years. The subject device has a longer shelf life, demonstrating superior or equivalent performance in this aspect.) |
| Labeling | Meet the requirements of 21 CFR Part 801 (Conforms) |
| Conforms to ISO 7864 | Surface Finish and Cleanliness, Needle Freedom from Defects, Bond Between Hub and Needle Tube, Needle Tolerance on Length, Needle Patency of Lumen, Lubricant, Reducing (oxidizable) matter, Metal ions, Titration acidity or alkalinity, Residue on evaporation, UV absorption of extract solution, Pyrogenicity (Conforms) |
| Conforms to ISO 9626 | Physical Performance - Resistance to breakage, Physical Performance - Stiffness, Physical Performance - Resistance to corrosion (Conforms) |
| Conforms to ISO 23908 (Sharps Protection) | Activated the sharps injury prevention feature in 500 samples of each gauge size with zero failures. (Conforms) |
| Conforms to ISO 11607-1 (Packaging) | Seal Strength, Visual Inspection, Dye Penetration, Bubble Emission (Conforms) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing rather than clinical validation with a "test set" in the context of diagnostic algorithms. For the non-clinical tests:
- Sharps Injury Prevention Feature Activation (ISO 23908): "500 samples of each gauge size with zero failures."
- For the predicate comparison: "Tested 500, Failure 0" for the subject device and "Tested 100, Failure 0" for the predicate device in the "number of activations to failure" row. This implies a test size of 500 samples for the subject device.
- Data Provenance: The studies were non-clinical bench tests performed by the manufacturer, U&U Medical Technology Co., Ltd. (China). The data is from laboratory testing of the devices themselves, not human patient data, and is effectively prospective for the purpose of demonstrating device performance against standards.
3. 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 is not applicable to this submission. The device is a physical blood collection set, not a diagnostic algorithm that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering standards and a predicate device through physical and material tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" requiring human adjudication as would be found in AI/ML performance studies. The tests are bench tests with objective measurements against specified 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
This is not applicable. The device is a physical medical instrument (blood collection set), not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical blood collection set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is primarily established by:
- International Standards: Conformance to recognized ISO standards (e.g., ISO 7864, ISO 9626, ISO 23908, ISO 594-2, ISO 11607-1, ISO 10993, ISO 10993-7). These standards define objective, measurable physical, chemical, and biological properties expected of such devices.
- Predicate Device Performance: Direct comparison with the performance characteristics of the legally marketed predicate device (VACUETTE PREMIUM Safety Blood Collection Set, K102010). The predicate's established safety and effectiveness serve as a benchmark.
8. The sample size for the training set
This is not applicable. The device is a physical blood collection set, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device submission.
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