(57 days)
The SELFSHIELD HN™ Self Sheathing Hypodermic Needle is indicated for non patient contacting and non-skin penetrating applications such as fluid transfer from a drug vial or ampoule to an IV administration set injection site (Y-site) or an IV catheter intermittent injection cap (heparin lock).
The SelfShield HN™ device incorporates a standard hypodermic needle which adapts to piston syringe standard luer fittings. The device embodies a spring loaded needle shield which automatically covers the needle tip prior to and after each use. It helps reduce the occurrence of accidental needlesticks to healthcare workers when the product is used as directed. The user activates the device by placing the tip of the shield against a rubber injection site, clockwise rotating the device by at least 40° and pushing the shield back until the needle tip penetrates into and beyond the injection site rubber plug. Once fluid, drug, agent or blood is drawn, the unit is removed from the injection site. The needle shield automatically advances covering and protecting the sharp tip for transport. The device is reactivated again against another injection site until disposed in an approved sharps container. The device is supplied sterile in a peelable Tyvek-nylon blister package.
The provided text describes the SelfShield HN™ Self Sheathing Hypodermic Needle and its acceptance criteria, along with a study supporting its performance.
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sharps Injury Prevention | Meeting the test requirements of the FDA guidance document on devices with sharps injury prevention features, specifically regarding the absence of sharps injuries and proper shield activation. | The device performed as indicated in its labeling 548 times without any sharps injuries reported or failure of the shield activation feature. This directly meets the test requirements of the FDA guidance document. |
| User Effectiveness Rating | Rated as "very effective" (score = 10) by a significant percentage of user-evaluators. | Rated as "very effective" (score = 10) by 50% of user-evaluators. |
| User Acceptability Rating | Generally rated as "acceptable" (score = 8 and above) by a high percentage of user-evaluators. | Generally rated as "acceptable" (score = 8 and above) by 93% of user-evaluators. |
| User Satisfaction (Safety & Ease of Use) | Positive feedback on safety and ease of use, with indications of repeated aseptic fluid transfer and easy disposal/training. | User-evaluators were positive about the safety and ease of use of the device. They indicated it will repeatedly transfer fluids aseptically until easily disposed of and that users can be easily trained. |
| Usability for Left/Right Handed Users | Effective for both left and right-handed users. | Analysis of the data demonstrates that it can be used effectively by either left or right-handed users. |
| Comparative Usability vs. Predicate Device | Rated as easier and requiring less time to use than the predicate device by a majority of current predicate device users. | Rated as easier and requiring less time to use by the majority of user-evaluators compared to the predicate device for fluid transfer applications. |
| Recommendation for Use vs. Predicate Device | Recommended for use over the predicate device for fluid transfer by a high percentage of current predicate device users. | Recommended 98% of the time over the predicate device for fluid transfer applications by users who currently use the predicate device. |
| Mechanical Strength (Tensile Load) | Tensile loads needed to separate the shield from the unit should be more than adequate to reduce potential for failure by pulling. | Tensile loads needed to separate the shield are more than adequate and "well above the force that can be reasonably applied by hand in a clinical setting." |
| Mechanical Strength (Compressive Load) | Peak compressive load to expose the needle tip should be sufficiently high to prevent accidental override of the lock during transport. | The device's peak compressive load needed to expose the needle tip is approximately 10 times higher than the predicate device while in the temporary locked position, indicating "substantially more force to override the lock." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Simulated Clinical Test: The device was tested "548 times." This refers to 548 uses of the device in a simulated clinical setting.
- Sample Size for User-Evaluators: "User-evaluators" were involved in rating the device, with percentages given for their feedback (50% rated very effective, 93% rated acceptable, majority found it easier to use, 98% recommended it). However, the absolute number of user-evaluators is not explicitly stated.
- Data Provenance: The study was conducted as a "simulated clinical test." The country of origin of the data is not explicitly stated, but given the FDA submission, it is highly probable the data was collected in the United States. The study appears to be prospective as it involves active testing and user evaluation of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The term "experts" here refers to the "experienced users of the predicate device" who participated in the simulated clinical test and provided feedback.
- Number of Experts: The absolute number of "experienced users" is not explicitly stated. However, their collective feedback (e.g., 50% rated very effective, 93% satisfactory, 98% recommended) suggests a group of evaluators.
- Qualifications of Experts: They are described as "experienced users of the predicate device." This implies they are healthcare professionals familiar with the type of device and its application in a clinical setting. Specific certifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
The text does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth from multiple expert opinions. Instead, it relies on aggregate user ratings and reported observations from the simulated clinical test. The "ground truth" regarding safety (no sharps injuries) and shield activation failure was based on direct observation during the 548 uses. User ratings for effectiveness and acceptability were presented as percentages of the user-evaluator group.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The text does not describe a formal MRMC comparative effectiveness study in the typical sense of evaluating diagnostic accuracy with AI vs. without AI. It does, however, contain a comparative user evaluation section:
- The SelfShield HN™ device was compared to the predicate device (Sherwood Monoject® Safety Syringe) in terms of ease of use, time required, and recommendation for fluid transfer applications.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This metric is not applicable here as the device is not an AI-assisted diagnostic tool. Instead, the comparison is between two medical devices with different safety features, and the "human readers" are "user-evaluators" assessing the usability and safety of the devices.
- User perceived ease of use: The SelfShield HN™ device was rated as "easier and requiring less time to use by the majority of user-evaluators" compared to the predicate device.
- Recommendation rate: The SelfShield HN™ device was recommended "98% of the time than the predicate device for fluid transfer applications" by users who currently use the predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the described device is a physical medical device (hypodermic needle with a safety shield), not an algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
The ground truth used is a combination of:
- Observed Outcomes (Safety and Functionality): For the sharps injury prevention aspect, the ground truth was the absence of reported sharps injuries and the successful activation of the shield over 548 uses.
- User Perceptions/Ratings: For effectiveness, acceptability, ease of use, and recommendations, the ground truth was derived from the aggregated responses and ratings of the "experienced users" (user-evaluators).
- Bench Test Results: For mechanical properties like tensile and compressive loads, the ground truth was established through physical measurements in laboratory (bench) tests.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical medical device and not an AI system that requires a "training set" of data. The "training" mentioned refers to training human users on the device's technique, not training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above. There is no training set for an AI algorithm in this context.
§ 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).