(94 days)
This instrument has been designed to be used with the VIDEOSCOPE XCHF-T160 for endoscopy and endoscopic surgery within the biliary tract.
The single use splinting tube, model ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, and ST-Y0003-H used for assisting procedure of inserting a videoscope into the biliary tract , using with a VIDEOSCOPE XCHF-T160.
The provided 510(k) summary (K091759) for the "Single Use Splinting Tube" does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. The information focuses on device description, intended use, and a comparison of technological characteristics to establish that the new device does not introduce new questions of safety or effectiveness. It is not a clinical performance study report.
Here's a breakdown of why the requested information is not available in the provided text:
- Device Type: The device is a 'Single Use Splinting Tube', which is a manual medical instrument, not a diagnostic AI system or a device that requires performance metrics like sensitivity or specificity.
- 510(k) Process: For this type of device and submission, the FDA's 510(k) pathway primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing design, materials, intended use, and functional characteristics to ensure the new device is as safe and effective as the predicate. It does not typically involve extensive clinical trials or performance studies with specific statistical acceptance criteria for diagnostic accuracy.
Therefore, the following points cannot be addressed with the provided text:
1. A table of acceptance criteria and the reported device performance:
* Not applicable as this is not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy. The "performance" in this context refers to its functional equivalence to the predicate.
2. Sample size used for the test set and the data provenance:
* No test set for performance evaluation (e.g., diagnostic accuracy) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
* Not applicable. Ground truth establishment for diagnostic performance is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable.
8. The sample size for the training set:
* Not applicable. There is no mention of a training set as this is not an algorithm or AI device.
9. How the ground truth for the training set was established:
* Not applicable.
Summary of available information relevant to acceptance and study:
The provided document describes a comparison study against a predicate device (K071254, Single Use Splinting Tube ST-SB-1). The "acceptance criteria" can be inferred as demonstrating substantial equivalence by proving that the subject device (ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H) is similar enough to the predicate device in intended use, specifications, materials, and design, such that it does not raise new questions of safety or effectiveness.
Table 1: Comparison of Specifications (Functionally equivalent as the "demonstration of performance")
| Specifications | Subject Device
ST-Y0002-S, ST-Y0002-H
ST-Y0003-S, ST-Y0003-H | Predicate Device
ST-SB1 | Difference & Implication (Interpretation of "Performance" in this context) |
| :------------------------------ | :--------------------------------------------------------------------------------------------------------------------- | :---------------------------------------------------------------- | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Balloon Outer Diameter | $\phi$ 25 mm | $\phi$ 40mm | Smaller. Implication: The subject device has a smaller balloon. The submission implies this change does not affect safety or effectiveness for its intended use with the VIDEOSCOPE XCHF-T160 within the biliary tract. |
| Length of Balloon | 20mm | 52mm | Shorter. Implication: The subject device has a shorter balloon length. The submission implies this change does not affect safety or effectiveness for its intended use. |
| Tube Outer Diameter | $\phi$ 10 mm | $\phi$ 13.2mm | Smaller. Implication: The subject device has a smaller tube outer diameter. This is a design change that the applicant asserts does not negatively impact safety or effectiveness. |
| Tube Inner Diameter | $\phi$ 7 mm | $\phi$ 11mm | Smaller. Implication: Smaller inner diameter. The applicant attests this is acceptable for the device's function. |
| Total Length | 1200mm | 1400mm | Shorter. Implication: The subject device is shorter overall. This change likely requires operators to be aware of the length difference when using the device. |
| Working Length | 1120mm | 1320mm | Shorter. Implication: Shorter working length, similar to the total length. |
| Side Holes | ST-Y0002-S, ST-Y0002-H: Length: 12 x 6 mm, Shape: Oval, Place: Provided on two places
ST-Y0003-S, ST-Y0003-H: None | None | Presence of Side Holes in some models. Implication: This is a key difference. The applicant must have demonstrated that the addition of side holes in some models (ST-Y0002-S, ST-Y0002-H) does not compromise the device's safety or effectiveness compared to the predicate without side holes or the other subject models without side holes. This would likely have been addressed through bench testing to ensure structural integrity and functional performance (e.g., maintaining inflation pressure, proper fluid/air flow characteristics) or clinical rationale that the side holes aid in the intended purpose without adverse effects. The 510(k) summary does not detail these tests. |
| Air flow lumen cross-section shape | Oval (1.4mm x 1.1 mm) | Rectangle (1.4 mm x 1.0 mm) | Different shape. Implication: A change in the shape of the air flow lumen. The applicant would need to ensure that this change does not negatively impact the ability to inflate/deflate the balloon or any other function dependent on this lumen. |
| Distal tip shape | Rounded shape made of silicone rubber adhesive | Silicone rubber distal tip bonded with silicone rubber adhesive | Minor difference in description. Implication: The wording suggests a functionally similar distal tip, designed to be atraumatic. |
| Sterilization before shipment | Non sterile | Sterile | Non-sterile vs. Sterile. Implication: This is a significant difference. The subject device is shipped non-sterile, meaning it must be sterilized by the user before use. The predicate was shipped sterile. The applicant must have justified that the non-sterile shipment of the subject device is acceptable, presuming there are clear instructions for terminal sterilization by the end-user before clinical use. This is a crucial procedural difference, not a performance metric. |
| Balloon inflation device | Syringe | Balloon Control Unit (OBCU) | Syringe vs. Dedicated Control Unit. Implication: The subject device uses a simpler syringe for balloon inflation, whereas the predicate used a dedicated Balloon Control Unit. The applicant would need to ensure that inflation with a syringe is safe, effective, and controllable to achieve the desired balloon pressure/volume without risk of over-inflation or inadequate inflation for the device's intended function. This change simplifies the accessory required for operation. |
**Conclusion from the 510(k) **
"Whien compared to the predicate device, the Single Use Splinting Tube, model ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, and ST-Y0003-H do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."
This statement is the "study" result in the context of a 510(k) for this type of device; the comparison table and the rationale provided were deemed sufficient by the FDA to demonstrate substantial equivalence, thus "meeting acceptance criteria" for market clearance. The acceptance criteria are "substantial equivalence" as defined by the FDA's regulatory framework. The study is the comparison of technological characteristics.
§ 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.