(37 days)
The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation.
The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes.
Here's an analysis of the provided text, focusing on acceptance criteria and study details. Please note that the document is a 510(k) summary from 1997 for a medical device (Bard Flexible Endoscopy Injection System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial data with acceptance criteria in the modern sense. Therefore, some of the requested information (like specific performance metrics, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, and large-scale training sets) is not present in this type of submission.
Summary of Findings from the Document:
The provided document describes a Bard Flexible Endoscopy Injection System as an accessory for endoscopes, used to deliver injectable materials into tissues in the urinary bladder and lower urinary tract. The primary goal of the 510(k) submission is to demonstrate that this new device is substantially equivalent to a previously cleared predicate device, the Bard Endoscopic Injection System (#K933815).
The acceptance criteria in this context are not explicitly stated as quantitative performance targets with thresholds (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied through the comparison of the new device's technological characteristics to those of the predicate device, aiming to show that the differences do not raise new questions of safety or effectiveness. The "study" proving acceptance is the comparison to the predicate device through a detailed feature analysis rather than a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, the acceptance criteria are not in a traditional quantitative format for AI/software, but rather a demonstration of similarity to a predicate device.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Bard® Flexible Endoscopy Injection System) |
|---|---|
| **Injection Needle | |
| Luer Lock Hub Material** | USP Class VI Polymer (Identical to Predicate) |
| **Injection Needle | |
| Strain Relief Material** | USP Class VI Polymer (Identical to Predicate) |
| **Injection Needle | |
| Catheter Shaft Dimensions** | 5 Fr., 26" USP Class VI Polymer (Predicate: 5 Fr., 13.14" USF Class VI Polymer) |
| (Difference in length noted, but implied as not raising new safety concerns) | |
| **Injection Needle | |
| Needle Gauge/Length/Material** | 23 Gauge 0.25" Stainless Steel (304 grade) Non-Coring Needle (Predicate: 23 Gauge 0.5" Stainless Steel (304 grade) Non-Coring Needle) |
| (Difference in length noted, but implied as not raising new safety concerns) | |
| Endoscopic Stabilizer Design/Material | 304 Stainless Steel Tube fitting over an 18 Fr. (max.) flexible endoscope and through a preplaced 20 Fr. percutaneous introducer (Predicate: USP Class VI Polymer tube with positive stop fitting inside endoscopes accommodating 7 Fr. instrumentation) |
| (Significant design difference, analysis presumably showed equivalence in function/safety) | |
| Stabilizer Affixation Method | Medical tape for securing stabilizer sheath to flexible endoscope shaft (Predicate: Working channel cap fitting over positive stop of stabilizer) |
| (Design difference, but implied as not raising new safety concerns) | |
| Endoscopic Working Channel Protector (Presence) | USP Class VI Polymer tube used as a protective sheath for insertion of the injection needle (Predicate: None) |
| (Added feature, implied as enhancing safety) | |
| Overall Safety and Effectiveness | Deemed substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense for this type of submission. There is no mention of a "test set" of specific cases or patients for evaluating performance metrics. The "test" is the comparison of technical specifications to the predicate device.
- Data Provenance: Not applicable. The data is a comparison of design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The "ground truth" here is the established safety and effectiveness of the predicate device, and the comparison is based on engineering specifications rather than expert consensus on a test set.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring expert adjudication.
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 MRMC study was done. This document is for a mechanical medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" used for this submission is implicitly the established safety and effectiveness profile of the predicate device (#K933815 Bard® Endoscopic Injection System), which had presumably undergone its own regulatory clearance based on testing and/or comparison to even earlier devices. The new device's compliance with material standards (e.g., USP Class VI Polymer) also serves as a form of ground 'truth' for material safety.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.