(60 days)
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:
- Hemostasis for:
- Mucosal/submucosal defects
The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements)
- Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)
The provided text is a 510(k) Premarket Notification from the FDA for a device called the BARS Set. It describes the device, its indications for use, and a summary of non-clinical tests. However, the document explicitly states "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria from this document alone. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are all related to clinical or performance studies with human data/expert review, which were not submitted for this 510(k).
The document focuses on demonstrating substantial equivalence through bench testing and comparison to predicate and reference devices, rather than a new clinical study.
Here's what I can extract based on the provided text, primarily regarding the non-clinical bench testing:
Non-Clinical Bench Testing Summary (based on the device's substantial equivalence pathway):
-
Acceptance Criteria for Non-Clinical Bench Testing & Reported Device Performance: This information is not presented in a table with specific criteria and results. The document states:
- "Performance bench testing settings investigated key aspects of device safety and effectiveness."
- "The established precedent from these devices were met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing substantial equivalence."
- The tests mentioned for the subject device are:
- Functional capability and robustness
- Endoscope compatibility
- Clip application ring strength
- Space keeper balloon capability and robustness
- Usability
- MRI suitability
- However, specific quantitative acceptance criteria (e.g., "Clip application force > X N") and the numerical results the BARS Set achieved are not detailed in this public summary. The document only confirms that the device "met" these criteria or "the established precedent" set by reference devices.
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Sample Size Used for the Test Set and Data Provenance:
- Not applicable as no clinical test set (i.e., human subject data for performance claims) was submitted. The tests mentioned were bench tests.
- The provenance of any data used for bench testing (e.g., whether conducted in the US, Germany, etc.) is not specified.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable as no clinical test set or expert-adjudicated ground truth was submitted for device performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and physical measurements.
-
Adjudication Method for the Test Set:
- Not applicable as no clinical test set requiring expert adjudication was submitted.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, explicitly stated: "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not an AI/algorithm.
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The Type of Ground Truth Used:
- For the non-clinical bench tests, the "ground truth" would be the engineering specifications and physical properties of the device and its components, and comparison to the performance of legally marketed predicate/reference devices. This is not clinical ground truth (e.g., pathology, outcomes data).
-
The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" of the BARS Set to existing predicate and reference devices through non-clinical bench testing, without the need for new clinical data or human-in-the-loop performance studies like those typically conducted for AI/software devices. The document confirms that the device "met" acceptance criteria related to its physical and functional characteristics based on these bench tests.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.