(30 days)
The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.
Occluder Occlusion Balloon Catheters are designed for use for temporary occlusion of the ureter and applications including renal opacification, dislodgement of calculi and preventative calculi migration. The devices are provided sterile and are intended for single use. The Occluder Occlusion Balloon Catheters are constructed of a soft compliant latex balloon mounted on the tip of a catheter shaft. Catheter shafts are radiopaque, maximizing fluoroscopic visibility. The Occluder Occlusion Balloon Catheters have two lumens that are marked and color-coded. The balloon tubing, marked BALLOON is a balloon inflation lumen. The tubing marked DISTAL, is the essential lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium.
This document describes the Boston Scientific Occluder™ Occlusion Balloon Catheter, which is cleared through the 510(k) pathway as substantially equivalent to a predicate device. As such, the study focuses on demonstrating this substantial equivalence rather than establishing new acceptance criteria or conducting a multi-reader multi-case comparative effectiveness study in the way one might for an AI/ML diagnostic device.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Criterion | Reported Performance (from provided text) |
|---|---|---|
| Substantial Equivalence | The device must demonstrate substantial equivalence to a legally marketed predicate device (Van-Tec Occlusion Balloon Catheter, K841941/A) in terms of intended use, technological characteristics, types of materials, and performance characteristics, demonstrating it is as safe, as effective, and performs as well as the predicate device. | "A direct comparison of key characteristics has been performed and demonstrates that the proposed Occluder Occlusion Balloon Catheter is substantially equivalent to the predicate device in terms of intended use. The proposed device is substantially equivalent to the reference devices in terms of technological characteristics, types of materials and performance characteristics. The proposed Occluder Occlusion Balloon Catheter is as safe, as effective, and performs as well as the predicate device." "The results of the performance testing demonstrate equivalence of the Occluder Catheter to the predicate device. The Occluder Occlusion Balloon Catheter is considered safe and effective for its intended use." |
| Performance Testing | Performance testing (bench evaluation) on samples (aged at T=0 and 7-months Accelerated Aging) to support balloon material and shaft material changes. | "Boston Scientific has conducted performance testing with samples aged at T=0 and 7-months Accelerated Aging in support of the balloon material and shaft material changes. The results of the performance testing demonstrate equivalence of the Occluder Catheter to the predicate device." |
| Intended Use | The device's intended use must align with temporary ureteral occlusion and applications including renal opacification, dislodgment of calculi, and preventative calculi migration. | "The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration." (This is both the stated indication and the demonstration of alignment with the predicate's implied use). |
| Technological Characteristics | The device must have similar technological characteristics and fundamental occlusion balloon catheter design to the predicate device. Minor differences (e.g., packaging) must not raise new questions of safety or effectiveness. | "The Occluder Occlusion Balloon Catheters have the same technological characteristics and fundamental occlusion balloon catheter design as the predicate device. The proposed Occluder Occlusion Balloon Catheters are packed using a thermoformed, multi-product tray and supplied with a stopcock and syringe. A tray lid is applied to help secure the device inside the tray cavities. The lidded tray is then placed into a heal-sealed poly/Tyvek pouch. The pouch is labeled and placed into a labeled shelf carton along with a DFU." |
| Material Changes | Any balloon and shaft material changes must be supported by performance testing demonstrating equivalence. | "Boston Scientific has conducted performance testing with samples aged at T=0 and 7-months Accelerated Aging in support of the balloon material and shaft material changes. The results of the performance testing demonstrate equivalence of the Occluder Catheter to the predicate device." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing mentioned is a bench evaluation.
- Sample Size: The document mentions "samples aged at T=0 and 7-months Accelerated Aging." The specific number of samples tested is not provided.
- Data Provenance: The data is from "Boston Scientific" and is generated through "performance testing (Bench Evaluation)." There is no mention of country of origin of data or whether it is retrospective or prospective, as it does not involve human subjects or historical patient data.
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 to this submission. The "ground truth" for a substantial equivalence claim based on bench testing does not involve expert consensus on clinical findings. Instead, the "truth" is established by direct measurement against engineering specifications and comparison to the predicate device's known performance/specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or when interpreting complex images/data to establish ground truth for diagnostic devices, which is not the case here.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, not for a medical device like an occlusion balloon catheter, especially when seeking 510(k) clearance based on substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on engineering specifications and direct measurements/observations from bench testing. The goal was to show that the new device's physical and functional characteristics (e.g., balloon inflation, shaft properties, radiopacity) meet predetermined criteria and are equivalent to the predicate device. This essentially means the "ground truth" is adherence to design specifications and performance metrics established from the predicate.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.