(130 days)
The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.
The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals.
The Blood Collection Needle is 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 ¾" 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 permits identification and acts as a seal integrity.
The Safety Blood Collection Set is delivered sterile and is intended for single use only.
This document describes the premarket notification (510(k)) for the Jiangsu Shenli Medical Production Co., Ltd.'s Safety Blood Collection Set (K163093). The document primarily focuses on establishing substantial equivalence to a predicate device, the Improsafe Blood Collection Set (K123987), rather than a detailed study proving the device meets specific acceptance criteria through a clinical or performance study with human readers or AI.
Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable to this type of submission, which relies on demonstrating equivalence through technical characteristics and compliance with standards.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All of the pre-determined acceptance criteria were met," but it does not provide a table with specific quantitative acceptance criteria alongside corresponding test results. It lists the types of performance tests conducted.
| Test Category | Acceptance Criteria (Not explicitly stated in document, but implied by "pre-determined" and compliance with standards) | Reported Device Performance |
|---|---|---|
| Sterility | Compliance with relevant standards (e.g., ISO 11135 for EO sterilization) | Met |
| Toxin in bacteria | Within acceptable limits (Implied) | Met |
| Reducing Substance | Within acceptable limits (Implied) | Met |
| Metal Ion | Within acceptable limits (Implied) | Met |
| pH Value | Within acceptable range (Implied) | Met |
| Residue after evaporation | Within acceptable limits (Implied) | Met |
| Ultraviolet absorbency degree | Within acceptable limits (Implied) | Met |
| EO gas residue | Below specified maximum levels (e.g., ISO 10993-7) | Met |
| ECH gas residue | Below specified maximum levels (Implied, often part of general residue testing) | Met |
| Particle pollution | Below specified maximum limits (Implied, often referenced in ISO standards for medical devices) | Met |
| Connection firmness | Complying with ISO 7864 (e.g., 21G > 44N) | Met (21G > 44N) |
| Needle Tube | Mechanical properties meet standards (Implied) | Met |
| Lubricant | Performance and safety meet standards (Implied) | Met |
| Needle Handle | Mechanical integrity meets standards (Implied) | Met |
| Rubber Sleeve | Material and function meet standards (Implied) | Met |
| Leakage | No leaks under specified conditions (Implied, often referenced in ISO standards) | Met |
| Flow Rate | Meets specified flow rate (Implied, often crucial for blood collection efficiency) | Met |
| Length of needle tube | Within specified tolerances (Implied) | Met |
| Needle tip | Sharpness and integrity meet standards (Implied) | Met |
| Needle base to connection base | Dimensions and integrity meet standards (Implied) | Met |
| Flexing tube | Flexibility and integrity meet standards (Implied) | Met |
| Protective safety sheath | Functionality of safety mechanism (Implied, e.g., smooth activation, secure locking) | Met |
| Biocompatibility | Complying with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility) | Met |
2. Sample size used for the test set and the data provenance
- Sample Size: This document does not specify the sample sizes used for each of the performance tests listed. For typical device clearance, these would be engineering tests, not clinical studies with human participants.
- Data Provenance: The tests were performed to demonstrate substantial equivalence for a device manufactured by Jiangsu Shenli Medical Production Co., Ltd. (China). The data would therefore originate from testing conducted by or for this company, likely in China or by contracted laboratories. The nature of these tests is retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering standards and design specifications, verified through laboratory testing, not expert interpretation of medical images or conditions.
4. Adjudication method for the test set
This information is not applicable. Adjudication typically refers to the resolution of conflicting expert opinions in clinical studies. For engineering performance tests, results are usually compared against predefined objective 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 information is not applicable. This submission is for a physical medical device (blood collection set), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as the device is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the device's performance is adherence to established national and international standards for medical devices (e.g., ISO 7864 for needles, ISO 10993-1 for biocompatibility) and its own design specifications. This is confirmed through laboratory and engineering testing.
8. The sample size for the training set
This information is not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable, as this is not an AI/machine learning device.
§ 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).