(106 days)
The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
The Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The safety feature is easily operated by releasing a latch mechanism whereby the user slides a winged cover over the needle removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.
This document is a 510(k) Summary for a medical device called "Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection / Infusion Set (with/without needle holder)". It is a submission to the FDA for market clearance, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets acceptance criteria in the sense of a clinical trial for an AI/ML product.
Therefore, many of the requested items (sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, etc.) are not applicable to this type of regulatory submission for this class of device.
This document focuses on non-clinical performance testing and biocompatibility to show that the new device performs as intended and is as safe and effective as the predicate device.
Here's the information that can be extracted and a breakdown of why some questions are not directly answerable from this document:
1. A table of acceptance criteria and the reported device performance
The document states that "All of the pre-determined acceptance criteria were met" for various categories of non-clinical testing. While it lists the standards to which the device was tested, it does not provide the specific numerical acceptance criteria within those standards or the exact reported performance values (e.g., a specific tensile strength value that passed the ISO 7864 requirement).
However, it does implicitly describe acceptance criteria as compliance with established international standards for similar devices.
| Category of Testing | Specific Standards/Tests | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Performance Testing | ISO 8536-4 (Infusion sets), ISO 9626 (SS needle tubing), ISO 7864 (Sterile hypodermic needles), ISO 80369-7 (Small-bore connectors), ISO 80369-20 (Common test methods), ISO 23908 (Sharps injury protection), ISO 6009 (Colour coding), ISO 2859-1 (Sampling procedures), USP 788 (Particulate Matter), Flowrate and Priming volume of tubing | Compliance with all listed international standards. | "met all requirements of related international standards", "All of the pre-determined acceptance criteria were met." |
| Biocompatibility | ISO10993-1 (General), ISO10993-5 (Cytotoxicity), ISO10993-10 (Skin Sensitization, Intracutaneous Reactivity), ISO10993-11 (Acute Systemic Toxicity), ISO10993-4 (Coagulation, Complement Activity, Hemolytic Properties), ISO10993-3 (Ames Test, Mammalian Chromosome Aberration, Mammalian Erythrocyte Micronucleus) | Compliance with ISO10993-1 and specific substantiating tests. | "The new device complies with the biocompatibility requirement defined in ISO10993-1", "The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1", "All of the pre-determined acceptance criteria were met." |
| Sterility | ISO11135-1 (Ethylene Oxide Sterilization), ISO11737-1 (Microorganisms on product), ISO11737-2 (Tests of sterility), ISO10993-7 (EO Residuals), ANSI/AAMI ST72 (Bacterial endotoxins) | Sterilization validated per ISO11135, achieving a SAL of 10^-6. | "The sterilization was conducted according to the following standards", "achieves the same SAL of 10^-6 as the predicate device", "All of the pre-determined acceptance criteria were met." |
| Package and Shelf Life | AAMI/ANSI/ISO 11137-1 (Radiation), AAMI/ANSI/ISO11737-2 (Sterility), AAMI/ANSI/ISO 11607-1 (Packaging), ASTM F1929 (Dye Penetration), ASTM F1980 (Accelerated Aging), ASTM D3078 (Bubble Emission), ASTM F88/F88M (Seal Strength) | Support the stated shelf life claim, maintaining package integrity and sterility. | "The test result supports the shelf life claim for the subject device from the sterilization date.", "All of the pre-determined acceptance criteria were met." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests beyond general adherence to standards (e.g., ISO 2859-1 for sampling procedures). For medical device clearances like this, testing typically involves a sufficient number of units to demonstrate compliance with the relevant standards for the device type, rather than statistical sampling for clinical performance.
- Data Provenance: The manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in Anhui Province, China. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the underlying data for the standard compliance comes from prospective or retrospective studies, but given it's non-clinical testing, it would be prospective testing of newly manufactured devices.
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)
- N/A. This is a non-clinical device clearance. Ground truth in the context of expert review for medical imaging or AI performance is not relevant here. The "ground truth" for the device's acceptable performance is defined by its adherence to established international engineering, materials, and sterility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert reviews. Non-clinical performance tests have objective, measurable endpoints defined by standards.
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
- N/A. This is a physical medical device (blood collection/infusion set), not an AI/ML product. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness is its compliance with internationally recognized consensus standards (e.g., ISO, ASTM, USP) for the performance, materials, sterility, and biocompatibility of hypodermic needles and infusion sets. These standards define the acceptable physical, chemical, and biological properties.
8. The sample size for the training set
- N/A. This is a physical device, not an AI/ML product that undergoes "training."
9. How the ground truth for the training set was established
- N/A. Not applicable, as it's not an AI/ML product.
§ 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).