(67 days)
This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.
This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.
This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injures when the device is activated during removal from the patient's vein.
The design of the three previously cleared to market 510(k) devices has not changed except to add the integral antineedle stick protector. The antineedle stick protector is a polymeric device designed to be used integral with the wing and needle and shields the needle when the needle with hub and wing assembly is removed from the patient
The provided text describes a 510(k) submission for "Winged Needle Sets with an Antineedle Stick Protector." This is a medical device and not an AI/ML algorithm, so many of the requested criteria regarding AI model performance, ground truth, and expert evaluation are not applicable.
However, I can extract information related to the device's performance study and acceptance criteria as described for this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Minimize accidental needlestick injuries. | The device design provides a safety feature intended to minimize accidental needle stick injuries when activated during removal. |
| Substantially equivalent to predicate devices (Medisystems Masterguard Sets). | The Antineedle Stick Protector is substantially equivalent to the Medisystems Masterguard Sets. |
| Needle tip protected inside the device after use. | In both devices (subject and predicate), the needle tip is protected inside the device after use. |
| Suitable for intended use. | Kawasumi Laboratories believes the successful simulated use study shows the device is suitable for its intended use. |
| As safe as the predicate device. | The device is as safe as the predicate device. |
| Performs as well as the predicate device. | The device performs as well as the predicate device. |
Explanation of "Acceptance Criteria (Implied)": The document doesn't explicitly list "acceptance criteria" but rather describes the desired function and comparative performance against predicate devices, which serve as the de facto acceptance goals for a 510(k) submission for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "a successful simulated use study," but does not provide the number of units tested or trial participants (if any).
- Data Provenance: Not explicitly stated. The study was conducted by "Kawasumi Laboratories." It is likely an internal study. The document does not specify country of origin or whether it was retrospective or prospective, but a simulated use study would typically be prospective for testing a new device feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a physical medical device, not an AI/ML diagnostic system that requires expert-established ground truth for image or data interpretation. The "ground truth" here is the physical performance and safety of the device.
4. Adjudication Method for the Test Set
Not applicable. This refers to consensus among experts, which is not relevant for a physical device performance test. The "adjudication" would be based on objective performance measurements during the simulated use study.
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
Not applicable. This is not an AI/ML algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance study is primarily its ability to physically prevent accidental needlestick injuries and its functional equivalence to predicate devices. This would be established through:
- Objective Performance Metrics: Measuring the effectiveness of the anti-needlestick protector during simulated use (e.g., successful activation rate, needle encapsulation success).
- Design and Material Conformance: Ensuring the device's design, materials, and manufacturing meet specified standards and are comparable to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
§ 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).