(113 days)
The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.
The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.
The Aspire Introducer Needle, a single-use, sterile, non-pyrogenic, disposable product, underwent testing to ensure its reliable design and performance. The device is intended for guidewire introduction during percutaneous gastrointestinal procedures.
Here's a breakdown of the acceptance criteria and the study information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Needle to Hub bond strength | Test results met predetermined criteria. |
| Sheath to Handle bond strength | Test results met predetermined criteria. |
| Sterilization (EO) | Product is EO sterilized (implies successful sterilization). |
| Biocompatibility (ISO 10993-1:2009 series) | All applicable sections of ISO 10993-1:2009 series standards were successfully passed. |
| Verification and validation to product specifications and risk mitigation requirements | Successfully passed with all requirements met, demonstrating safety and effectiveness for intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each performance test (e.g., bond strength, biocompatibility). It generally states that "test articles" were used, implying a sample was taken for each test. The provenance of the data is from internal testing conducted by Aspire Bariatrics, Inc. and is likely prospective in nature as it is part of the premarket notification process for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical instrument, and its performance is evaluated through engineering tests, sterilization validation, and biocompatibility testing, not through expert-established ground truth on a dataset. The "ground truth" here is the adherence to established engineering specifications and regulatory standards.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study data where multiple experts interpret cases. For device performance testing, the results are typically objectively measured against predetermined acceptance criteria.
5. If a multi-reader multicase (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
This information is not applicable. The Aspire Introducer Needle is a physical medical device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of this device is based on established engineering specifications, recognized industry standards (e.g., ISO 10993-1), and regulatory requirements for medical devices. This includes predefined strength limits for bond tests, successful sterilization, and documented biocompatibility.
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 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.