(274 days)
The SafetyTip™ Multi-Sample Needle and SafetyTing Blood Collection The Sarely In -- Mun-Sample thood collection. The safety sheath helps to System is to be used for vehous blood conceasing the needle before and after use.
The Multi-Sample needle consists of a Cannula, Hub, Safety Sheath, Rubber Sleeve, and lower cover. The Multi-Sample needle consists of a hypodermic needle in sizes 18 Gauge to 22 gauge with lengths of 1" to 3 ½". It has a hinged cover/sheath that is pulled open by the user by pinching the sides to expose the needle. When closing there are two levels, first. Close the sheath over the needle by pressing the needle down against any hard surface. At this noint the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permare rot lock. The SafetyTip™ Blood Collection System consists of a Cannula, Hub, Safety Sheath, Medical Surgical Grade Rubber Sleeve Holder and The Tube Holder. This is a "safety" device in that by using the permanent-locking feature, It may prevent accidental needlesticks. Its one-handed loosing motion is in compliance with the CAL-OSHA standards. When cloning the Safety Tip™ Blood Collection System there are two levels, first. close the sheath over the needle by pressing the needle down against any hard surface. At this point the needle may be re-opened by using the normal technique. To use the permanent locking system, close the sheath over the needle by pressing the needle down against any hard surface then, pressing the tip of the sheath with more force until the needle is lodged between the locking tabs, creating a permanent lock.
The provided 510(k) summary for K993125, concerning the SafetyTip™ Multi-Sample Needle and SafetyTip™ Blood Collection System, explicitly states that the determination of substantial equivalence is NOT based on an assessment of clinical performance data.
Therefore, there is no study described within this document that proves the device meets any specific acceptance criteria related to its clinical performance. The submission relies solely on non-clinical data and comparison of device features, materials, and intended use to predicate devices already on the market.
Here's a breakdown based on your requested information, highlighting the absence of clinical study data:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None defined in the document for clinical performance. | No clinical performance data reported. |
| (The submission focuses on substantial equivalence to predicate devices based on design and intended use, not on specific performance metrics.) | (The document states: "The determination of substantial equivalence is not based on a assessment of clinical performance data.") |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No clinical test set was used for performance assessment.
- Data Provenance: Not applicable. No clinical data was used for performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth established by experts was used.
4. Adjudication method for the test set:
- Not applicable. No clinical test set required adjudication.
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:
- No. An MRMC comparative effectiveness study was not done. The device is a blood collection needle and tube holder system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. The device is a physical medical device (needle and tube holder), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth based on clinical data was used for performance assessment. The "ground truth" for showing substantial equivalence would be the established safety and effectiveness of the legally marketed predicate devices, inferred from their market history and regulatory clearance.
8. The sample size for the training set:
- Not applicable. No training set was used as this is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
In summary: K993125 is a 510(k) submission that seeks clearance based on substantial equivalence to existing predicate devices, primarily through a comparison of design, materials, and intended use. The document explicitly states that clinical performance data was not used to determine substantial equivalence. The "safety" aspect is highlighted through the inclusion of a safety sheath to prevent needlesticks, aligning with the safety features of some predicate devices. The study proving the device meets acceptance criteria, in this context, refers to the demonstration of substantial equivalence to predicate devices based on non-clinical assessment, rather than a clinical performance study with defined acceptance criteria and collected data.
§ 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).