(91 days)
VACU-MED® Blood Collection Needles are designed for use in venous blood collection.
VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity. VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").
This document is a 510(k) Premarket Notification for the SHINA CORPORATION VACU-MED® Blood Collection Needles. It does not contain the level of detail typically found in a clinical study report for evaluating AI/ML-based medical devices.
The information provided focuses on demonstrating substantial equivalence to a predicate device based on descriptive data and compliance with standards, rather than a detailed performance study with acceptance criteria in the way you've outlined for AI/ML devices.
Therefore, many of your requested items cannot be directly extracted from this document, as they are not applicable to a 510(k) submission for a non-AI/ML medical device like blood collection needles.
Here's an analysis based on the provided text, addressing what can be inferred and explicitly stating when information is not present:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria or reported device performance in the format of a clinical study with numerical metrics like sensitivity, specificity, or accuracy.
Instead, the "acceptance criteria" are implied by compliance with established international standards for medical devices of this type, and the device's technological characteristics being similar to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 7864 (Sterile Hypodermic Needles for Single Use) | Stated as compliant with the standard. |
| Compliance with ISO 7886-1 (Sterile Hypodermic Syringes for Single Use) | Stated as compliant with the standard. (Note: While for syringes, needles are part of the system). |
| Compliance with ISO 9626 (Stainless Steel Needle Tubing for Medical Devices) | Stated as compliant with the standard. Materials are "made from the same materials (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the Greiner VACUETTE® blood collection needles." |
| Compliance with ISO 6009 (Hypodermic Needles - Colour Coding) | Stated as compliant with the standard. |
| Substantially equivalent in intended use, function, and basic composition to predicate device. | Stated: "The VACU-MED® Blood Collection Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Greiner VACUETTE®..." |
| Non-toxic and non-pyrogenic. | Stated: "The needles are non-toxic and non-pyrogenic." |
| Sterile single-use disposable product. | Stated: "VACU-MED® Blood Collection Needles are a sterile single-use disposable product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on descriptive data and compliance with standards, not on a specific clinical "test set" or patient data.
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 information is not applicable and therefore not provided. This is a submission for a physical medical device (blood collection needles), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system requiring adjudication of interpretations.
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 information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international performance standards (ISO) for hypodermic needles and the demonstrable equivalence of its physical and material properties to a legally marketed predicate device. There is no biological or diagnostic "ground truth" derived from patient data involved in this type of submission.
8. The sample size for the training set
This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.
Summary of the Study Proving Acceptance Criteria:
The "study" in this context is the comparison against the predicate device (Greiner VACUETTE®) and compliance with relevant international standards.
- Methodology: The manufacturer (SHINA CORPORATION) submitted descriptive data comparing their VACU-MED® Blood Collection Needles to the predicate device. They asserted that their device has "similar technological characteristics" and is "made from the same materials" (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the predicate.
- Standards Compliance: The submission explicitly states that the VACU-MED® Blood Collection Needles meet the following device-specific standards:
- ISO 7864 (Sterile Hypodermic Needles for Single Use)
- ISO 7886-1 (Sterile Hypodermic Syringes for Single Use)
- ISO 9626 (Stainless Steel Needle Tubing for Manufacture of Medical Devices)
- ISO 6009 (Hypodermic Needles for Single Use - Colour Coding for Identification)
- Conclusion: Based on this descriptive data and compliance with standards, the manufacturer concluded that the VACU-MED® Blood Collection Needles are "substantially equivalent" to the predicate devices. The FDA concurred with this finding, indicating that the device meets the regulatory requirements for market clearance without requiring a full-scale clinical trial typical for more novel or higher-risk devices.
§ 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).