Search Results
Found 1 results
510(k) Data Aggregation
(135 days)
Safety blood collection needles with/without needle holder are intended to be used with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against, accidental needle stick injuries.
The Safety blood collection needles with/without needle holder is used in routine venipuncture procedures. That is composed of a bottom sheath, rubber cap, needle hub, connecting base, safety shield, needle tube, upper sheath, and optional needle holder, which are made from PP, PE, ABS, rubber, and SUS materials. The proposed device has various configurations and sizes, differing in various colors for easy recognition by use. The threaded hub is one side that connects with the needle holder, which is used to quide the needle into a vacuum blood collection tube. This end of the needle is shorter and is fitted with a rubber cap and a needle hub. The Safety blood collection needles with /without needle holder are manufactured from tubular stainless steel sharpened at both ends that are attached: - The opposite end of the needle tube is ¾" ~ 1 ½″ for blood collection and is fitted with a protective sleeve. - The needle hub and protective cap protect the needle tube. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The safety feature is easily operated by releasing a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place.
The provided text describes a 510(k) premarket notification for a medical device: "Safety Blood Collection Needles with/without Needle Holder." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not contain information about a clinical study involving human-in-the-loop performance, expert ground truth establishment for a test set in a diagnostic AI context, or MRMC studies.
Therefore, many of the requested details about acceptance criteria, study design, and expert involvement (points 2-5, 7-9) are not applicable or cannot be extracted from this specific document, as it pertains to a physical medical device (blood collection needles) rather than a diagnostic AI or imaging device requiring extensive validation with human readers and expert-adjudicated ground truth.
However, I can extract the acceptance criteria and performance data for the non-clinical tests that were performed.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device, "Safety Blood Collection Needles with/without Needle Holder," was evaluated through non-clinical performance testing against various international standards to demonstrate its safety and effectiveness.
| Standard/Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 7864, needle performance testing | Refer to ISO 7864 clause 4 | Meet performance requirements |
| ISO 9626, needle tube performance testing | Refer to ISO 9626 clause 5 | Meet performance requirements |
| ISO 6009, needle hub color | Refer to ISO 6009 clause 3 | Meet color code requirements |
| ASTM F88, packaging sealing strength testing | Sealing strength >1.5N/15mm | Pass, round 1.8N/15mm |
| ASTM D3078-2, package leakage bubble emission | No bubbles observed attributable to leaks, and no test fluid attributable to a leak is inside a specimen | Pass, no bubbles or fluid observed |
| ASTM F1929, dye penetration testing | No dye penetrates into packaging | Pass, no dye penetrated into package |
| ISO 11737-1/-2, USP <71>, sterility testing – microbiological method | Negative result of micro culture | Negative |
| ISO 10993-7, EO/ECH residual testing | EO <4mg/day; ECH <9mg/day | EO pass; ECH undetectable |
| ISO 10993-4, in-vitro hemolytic testing | No hemolysis | No hemolysis |
| ISO 10993-5, in-vitro cytotoxicity testing | No cytotoxicity | No cytotoxicity |
| ISO 10993-10, irritation and skin sensitization testing | No irritation and no skin sensitization | No irritation and no skin sensitization |
| ISO 10993-11, acute systemic toxicity testing | No acute systemic toxicity | No acute systemic toxicity |
| ISO 10993-11, pyrogens testing | No pyrogens | No evidence of pyrogens |
| USP <85>, endotoxin testing | <20EU/device | Pass |
| USP <788>, residual particles testing | The average number of particles present in the units tested should not exceed 6000 per container equal to or greater than 10 mm and should not exceed 600 per container equal to or greater than 25 mm. | Pass |
| ISO 23908 sharp injury protection – activation and safe mode | Testing items with varying criteria; Refer to ISO 23908 Clause 4.2 and Clause 4.3 | Pass |
| USP 41 <1207> rigid package integrity evaluation | Testing items with varying criteria; Refer to USP <1207.2> | Pass |
| Simulated clinical study | <1% failures under 95% CL | 0% failures. |
| ISO 80369, luer connector | Vary criteria refer to ISO 80369 | Pass |
Regarding the other requested information:
- Sample size used for the test set and the data provenance: The document mentions "Simulated Clinical Use Study" with a result of "0% failures," but it does not specify the sample size used for this simulation. All other tests are non-clinical, involving material property and performance testing on device components/samples rather than a "test set" in the context of an AI algorithm or human subject data. The data provenance is implicitly from laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.) in China, as indicated by the submitter's address. The studies are non-clinical (laboratory).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert readers or ground truth establishment for diagnostic purposes. The "ground truth" for the non-clinical tests is established by adherence to the specified ISO/ASTM standards and their methodologies.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human reader adjudication process is described as this is not a diagnostic AI or imaging study.
- 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: Not applicable. This document does not describe an MRMC study or AI assistance for human readers. This is a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the objective measurements and adherence to the technical specifications and performance requirements detailed in the cited ISO and ASTM standards (e.g., specific force for sealing strength, absence of bubbles for leakage, negativity for sterility, specified chemical residual limits).
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1