(683 days)
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
The balloon dilatation catheter is a nylon balloon mounted on a double lumen catheter. Proximately the device is fitted with either one or two luer fittings. The balloon dilatation catheters with balloon diameters larger than 12 millimeters have only one luer fitting that allows for balloon inflation. Balloon dilatation catheters with balloon diameters smaller than 12 millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.
The provided document is a 510(k) summary for a medical device (Medi-Globe Balloon Dilatation Catheter) seeking substantial equivalence to existing devices. It focuses on device description, intended use, and comparison to predicate devices, and refers to biological and bench testing.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner as one might find for diagnostic accuracy. Instead, it demonstrates equivalence to predicate devices and safety through testing. The reported performance is primarily focused on physical characteristics and safety margins.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar intended use, design, and materials to predicate devices (Boston Scientific K974788 and K973113). | Intended Use: Endoscopic dilation of biliary tract, esophageal, or sphincter stenosis (identical to predicates). |
| Design: Nylon balloon mounted on double lumen catheter with luer fittings. | |
| Materials: Primarily similar, except for balloon material (Nylon 11 vs. Polyurethane). | |
| Specifications: Diameters, lengths, and max recommended pressures are within ranges comparable to or overlapping with predicates. | |
| Biocompatibility/Safety: Materials must be safe for intended use. | Biologic Testing: Independent toxicology, chemical analysis, and cytotoxicity testing performed on the completed catheter (including balloon) found all material to be safe (Attachment E). |
| Mechanical Integrity/Safety: Balloon must withstand pressures significantly higher than recommended clinical use. | Bench Testing: Balloon's burst pressure is significantly higher than the maximum recommended balloon pressures provided to clinicians (Attachment G). |
| Sterility & Packaging: Sterile, single-patient use, individually packed. | Sterilization: Sterile Packed, Single Patient Use. |
| Packaging: Individual Packed, Peel-open Pouches (Same as predicates). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study or a "test set" in the context of device performance evaluation against a gold standard for accuracy or diagnostic capability. The "testing" mentioned refers to:
- Biologic testing: on materials for safety.
- Bench testing: on the device (balloon) for mechanical integrity (burst pressure).
Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context, as there isn't a patient-centric "test set" described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no "test set" evaluated against a ground truth in the context of diagnostic accuracy, this information is not applicable. The safety and mechanical testing would have been conducted by qualified laboratory personnel, but not "experts" establishing a clinical ground truth for a test set.
4. Adjudication Method for the Test Set
This is not applicable as there is no clinical "test set" or adjudication process described.
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
This is not applicable. The device is a balloon dilatation catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance effect size are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The concept of "ground truth" as typically used for diagnostic or screening devices is not applicable here. The "ground truth" for this device's evaluation is based on:
- Predicate device characteristics: Demonstrating similar physical and functional properties to already approved devices.
- Biocompatibility standards: Evaluating material safety against established biological safety standards.
- Mechanical engineering principles: Testing burst pressure against design specifications and safety margins.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" for an algorithm or a dataset in the context of this physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.