(36 days)
The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.
This document is a 510(k) Pre-market Notification for the InScope Precision Balloon Dilator, seeking substantial equivalence to a predicate device. As such, it does not contain acceptance criteria in the traditional sense of a performance study with numerical targets for sensitivity, specificity, etc. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and non-clinical bench testing.
Here's an analysis based on the provided text, addressing the points you requested where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no explicit acceptance criteria with quantitative targets are provided in the document. The "performance" is assessed through comparison to a predicate device and non-clinical bench tests.
| Feature / Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Materials | Substantially equivalent to predicate device (Boston Scientific's CRE Balloon dilatation catheter) | Found to be biocompatible; technological characteristics considered substantially equivalent. |
| Mode of Operation | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Performance Properties | Substantially equivalent to predicate device | Demonstrated via data collected from non-clinical bench type tests and analyses. |
| Biocompatibility | Meets biocompatibility standards | Materials used are found to be biocompatible. |
| Sterilization | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Packaging | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Inflation Pressure/Diameter Relationship | Specific relationship, represented on labeling | Capable of 3 distinct and progressive larger diameters as a function of applied inflation pressure. Specific relationship represented on labeling. |
| Marking Bands | Provide precise centering facilitation | Contains three marking bands on the balloon to facilitate more precise centering within the stricture. (Middle band at center, 5 cm from shaft marker; proximal and distal bands 2.5 cm from center band.) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: This document refers to "non-clinical bench type tests and analyses." It does not specify a sample size for these tests.
- Data Provenance: The document does not specify country of origin for the data, nor whether it was retrospective or prospective. Given it's non-clinical bench testing, these distinctions (retrospective/prospective) are less applicable than for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable or not specified. Bench testing typically relies on predefined physical or engineering standards, not expert clinical interpretation of test results in the same way clinical ground truth is established.
- Qualifications of Experts: Not applicable or not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. For non-clinical bench testing, results are typically determined by measurement against established standards, not through adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This submission is for a device, an esophageal dilator, not an AI/imaging diagnostic tool that would typically involve a multi-reader study. The evaluation focuses on the safety and effectiveness of the device itself, primarily through bench testing and comparison to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is an esophageal dilator, not an algorithm.
7. The Type of Ground Truth Used
- Ground Truth: For non-clinical bench tests, "ground truth" refers to established engineering specifications, physical measurements, and materials science standards. The document states "materials used in the subject device are found to be biocompatible," implying adherence to biocompatibility standards. The functional aspects like "3 distinct and progressive larger diameters as a function of the applied inflation pressure" would be verified against engineering specifications and measured outcomes.
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device (dilator), not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI model is involved.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). 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.