(30 days)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.
However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).
| Acceptance Criteria (Implied by Standards & Testing) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with ISO 6009:2016 for needle color coding. | "Color system is in accordance with ISO 6009 requirement." |
| Compliance with ISO 8536-4:2019 for infusion sets (gravity feed). | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 9626:2016 for stainless steel needle tubing. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 23908:2011 for sharps injury protection. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. The device's "safety mechanism" is a key feature and its function is maintained. |
| Model RBC visual inspections for correct labeling. | "Visual inspections were conducted on unit packaging to ensure RBC labeling is correct." |
| Full performance testing (appearance, dimension, safety mechanism, labeling) for new needle sizes, colors, and schematic diagrams. | "Full performance was tested, including appearance, dimension, safety mechanism, labeling, etc. and found to comply with drawing requirements." |
| Biocompatibility of new material (PP for safety protective mechanism in RBC model). | "Material of RBC is PP which it is only contact intact skin as limited exposure (A), does not introduce new risks about biocompatibility safety." It also references K230715's biocompatibility testing per ISO 10993-1 (External communicating device, in contact with circulating blood with prolonged exposure B) to support this change, including In vitro cytotoxicity testing in accordance with ISO 10993-5:2009. |
| Overall device safety and effectiveness equal to predicate. | "All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
- Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.
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 as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).
8. The sample size for the training set
This is not applicable as there is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).