(119 days)
The LumiLoc™ Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures.
The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath.
The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.
The LumiLoc™ Safety Introducer Needle consist of a stainless steel trocar/needle with a colored translucent hub and a colored translucent safety guard, a sheath attached to a translucent hub having a standard female Luer lock hub connector. The trocar/needle hub has a bevel-up orientation indicator. The sheath hub utilizes a phosphorescent material. The LumiLoc™ Safety Introducer Needle's sheath hub has an integral Seldinger shield. The stainless steel trocars/needles have a specialty coating to enhance percutaneous entry.
The LumiLoc™ Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath and helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip. A visual. tactile, or audible confirmation of the locking component over the trocar/needle confirms lockout of the safety guard over the trocar/needle.
LumiLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile single use devices. Additionally, the device will be placed in Percutaneous Endoscopic Gastrostomy (PEG) procedural trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the procedural tray or kit manufacturer. The LumiLoc™ Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.
The provided text describes the LumiLocTM Safety Introducer Needle and its regulatory submission. It does not contain information about an AI/ML device or its performance characteristics. This device is a physical medical instrument, not a software algorithm. Therefore, many of the requested categories related to AI/ML device evaluations (e.g., sample size for training set, MRMC studies, ground truth establishment, number of experts for ground truth) are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and the study that "proves" it meets them, based on the context of a 510(k) submission for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description (Implied) | Reported Device Performance |
|---|---|---|
| Safety Guard Functionality | The integral safety guard must activate upon removal of the trocar/needle and lock over the tip to reduce needlestick injuries. | 500 LumiLoc™ Safety Introducer Needles were successfully activated. |
| Injury Prevention | The device should prevent sharps injuries (specifically related to the safety guard). | No sharps injuries occurred during the simulated use study. |
| Failure Rate | The integral safety guard should not fail during use. | No failures of the integral safety guard occurred. |
| Successful Insertion | The device should allow for successful insertion into simulated tissue. | 500 LumiLoc™ Safety Introducer Needles were successfully inserted. |
| Substantial Equivalence | The device must perform in a substantially equivalent manner to predicate devices regarding safety and effectiveness for its intended use. | Test results indicate substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 500 LumiLoc™ Safety Introducer Needles.
- Data Provenance: The study was a "simulated use study." This implies a controlled laboratory or clinical simulation environment rather than actual patient data. The country of origin is not specified, but the submission is to the US FDA, so the testing was likely conducted in the US or under US regulatory standards. It's prospective in the sense that the testing was performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated, but the study involved "clinicians" performing the simulated insertions and activations. The exact number of clinicians is not provided.
- Qualifications of Experts: Described as "clinicians." Specific qualifications (e.g., years of experience, specialty) are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not described. This was a direct performance test where the device's physical function (activation, no injuries, no failures) was observed. There isn't a "ground truth" to adjudicate in the typical sense of subjective interpretations. The outcomes (e.g., "no sharps injuries," "no failures") are direct observational results.
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
- MRMC Study: No, this is not an AI/ML device. This type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the objective observation of the device's physical performance during the simulated use study.
- Successful insertion: Observed directly.
- Safety guard activation: Observed directly.
- Lack of sharps injuries: Observed directly.
- Lack of failures: Observed directly.
- The "material testing" mentioned also contributed to proving substantial equivalence, suggesting engineering specifications and quality control data likely formed part of the ground truth for material properties.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML model that requires a training set. The development process would involve iterative design and testing, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.