(118 days)
The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure.
The device description of the Sure-Lok™ secondary needle kit is as follows.
- Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u
- Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment.
- Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure.
- . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath.
- Individually packaged and sterilized. l
This submission (K021315) for the Sure-Lok™ secondary needle kit is a 510(k) Pre-Market Notification, indicating it's a submission for substantial equivalence to a predicate device. As such, the document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing acceptance criteria and proving the device meets them through a specific study in the same way a novel device might.
The provided text, therefore, does not contain detailed information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Specific ground truth types for performance studies.
- Training set sample size or ground truth establishment for a training set.
Instead, the submission demonstrates substantial equivalence by comparing the Sure-Lok™ device to two predicate devices (NeedleTrap™ [K950098] and Point-Lok™ [K946289]) across various characteristics.
Here's a summary of what is provided regarding the device's characteristics and its comparison to predicate devices, which implicitly serves as the "proof" of meeting the standards set by already approved devices:
1. Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence):
The "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The Sure-Lok™ device is deemed acceptable because it shares the same intended use, technique, safety features, and material properties as the legally marketed predicate devices.
| Characteristic | Predicate Devices (NeedleTrap™ and Point-Lok™ standards) | Sure-Lok™ (Reported Device Performance via Equivalence) |
|---|---|---|
| Intended Use | To protect against accidental needle sticks after needle has been inserted into the device. | Same |
| Technique | Needle is inserted into device with one-hand. | Same |
| Needle Point | After insertion into device, needle tip is sealed to prevent sample contamination and blood spattering. | Same |
| Needle Encapsulation | After insertion into device, the needle is locked into the device and cannot be removed. | Same |
| Base Configuration | Device has a flat base that sits on a flat surface. | Same |
| Color | The device is colored orange / red. | Same |
| Needle Specifications | Can accept needle gage size 12 through 30, 5/8" to 1½" in length, luer slip and luer lock (Point-Lok™). | |
| Can accept needle gage size 20 through 25, 1" in length, luer slip and luer lock (NeedleTrap™) | Same | |
| (needle gage size 20 to | ||
| 25, 5/8" to 1½" in | ||
| length, luer slip and luer | ||
| lock) | ||
| Training | No training is required to use the device. | Same |
| Puncture Resistant | Plastics used to encapsulate needles are puncture resistant. | |
| Polystyrene (NeedleTrap™), Rubber Modified Polystyrene (Point-Lok™). | Same | |
| (Acrylic) | ||
| Point of Use | Device does not interfere with syringe/needle during sampling. | |
| The device encapsulates the needle after it has been used. | Same |
2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on demonstrating substantial equivalence to already approved predicate devices based on design and material comparisons, not a new performance study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device is a mechanical needle safety device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, against which the Sure-Lok™ device is compared. Its compliance with the general controls and regulations for hypodermic single lumen needles, as affirmed by the FDA, serves as validation.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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).