(10 days)
The AutoBand Multiple Band Ligator is used to band esophageal varices or hemorrhoids in the colon. The device is intended for single use only.
The AutoBand Multiple Band Ligator device consists of the applicator unit (including the band barrel, handle, activation wheel, wheel grip, beaded string, interior stainless steel trigger wire, and fixation arm), a fixation strap, and the ligation bands that are mounted on the barrel.
The device is intended for single use and is supplied non-sterile. The ligation bands are intended for endoscopic placement in the esophagus or colon, with the trigger wire introduced through the biopsy port of the endoscope. Each AutoBand barrel is pre-loaded with seven bands. Models are manufactured for compatibility with either gastroscopes or colonoscopes. AutoBand model designations also are differentiated based on compatibility with different endoscope manufacturers.
Here's a breakdown of the acceptance criteria and study information for the AutoBand Ligator, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Safety | Biocompatibility - Sensitization | Passed | Passed |
| Biocompatibility - Irritation | Passed | Passed | |
| Biocompatibility - Cytotoxicity | Not cytotoxic | Cytotoxic | |
| Allergen Testing (ELISA) | Below detection limits | Below detection limits (for allergens clinically relevant to latex allergy) | |
| Functional Performance | Band Deployment Performance | Improved | Improved (due to minor design changes) |
| Substantial Equivalence | Comparison to Predicate Device | Substantially equivalent in: Intended Use, Operating Principle, Performance, Technology, Energy Used, Packaging. | All criteria met for substantial equivalence to predicate device. |
Note on Biocompatibility - Cytotoxicity: The document explicitly states the "Ligation Band material is cytotoxic when tested in accordance with ISO 10993-5:1999." This appears to be a deviation from a typical "passed" acceptance criterion for cytotoxicity in the conventional sense of indicating no cytotoxic effect. However, it's presented in the context of demonstrating substantial equivalence to the predicate device, which also stated its material was cytotoxic. This suggests that for this specific application (ligation bands contacting mucosal membranes for prolonged duration), a certain level of cytotoxicity might be considered acceptable or an inherent characteristic of the material, and the goal was to demonstrate that the new material is no worse than the predicate.
Study Details
The provided document describes non-clinical testing rather than a human clinical study. The device is a modification of an already approved device (K083556), and the submission focuses on demonstrating substantial equivalence.
1. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not explicitly stated for each specific bench test. The document mentions "bench testing of performance" and "laboratory biocompatibility testing."
* Data Provenance: The testing was conducted in a laboratory setting ("laboratory biocompatibility testing"). The country of origin of the data is not specified, but it can be inferred to be within the scope of the manufacturer's (EndoChoice, Inc. in Alpharetta, GA, USA) operations or contracted labs. It is retrospective in the sense that it's testing a finished product modification against established standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This was a non-clinical, laboratory-based study validating material properties and functional performance against technical specifications and international standards (ISO 10993-1, ASTM D6499-07, ASTM D74727-08), not human expert evaluation against a "ground truth" in the clinical imaging sense.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. This was a non-clinical, laboratory-based study.
4. 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:
* No. This is a medical device (ligation band) and not an AI/imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device, not an algorithm. However, the non-clinical functional verification testing can be considered "standalone" as it evaluates the device's intrinsic mechanical and material performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For biocompatibility: International standards (ISO 10993-1, ISO 10993-5:1999) and specific ASTM test methods (ASTM D6499-07, ASTM D74727-08) served as the "ground truth" or reference for evaluating material safety.
* For functional performance: Engineering specifications and expected performance characteristics (e.g., improved band deployment) of the modified components served as the "ground truth."
7. The sample size for the training set:
* Not applicable. This is a non-clinical study for a physical medical device, not an algorithm that requires a training set.
8. How the ground truth for the training set was established:
* Not applicable. There is no training set for this type of device submission.
§ 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.