(147 days)
The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.
The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Performance Data) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993) | Device meets all standards |
| Sterility (ISO 11135) | Device meets all standards |
| Head tip of the distal end | Meets design specifications |
| Connect strength | Meets design specifications |
| Leakage performance | Meets design specifications |
| Balloon fatigue performance | Meets design specifications |
| Balloon position detectability | Meets design specifications |
| Interface compatibility with endoscope | Meets design specifications |
| Compatibility with guide wire | Meets design specifications |
| Compatibility with luer taper | Meets design specifications |
Note on Acceptance Criteria: The document explicitly states "The Balloon Dilatation Catheter meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135)". For the other items listed under "Following tests were conducted in our non-clinical bench test," the document states "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This implies that the acceptance criterion for these tests was to meet their respective design specifications.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical bench tests. It also does not provide information on the provenance of data for these tests (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a Balloon Dilatation Catheter, and the assessment relies on engineering and biological performance standards, not expert interpretation of medical images or clinical outcomes that typically require expert ground truth establishment.
4. Adjudication Method
Not applicable. As noted above, this submission focuses on bench testing against established standards and design specifications, not on subjective clinical assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No Clinical test is included in this submission." Therefore, no MRMC study was conducted.
6. Standalone Performance Study
Yes, a standalone performance study in the form of non-clinical bench testing was conducted to evaluate the device against its design specifications and relevant medical device standards. The "Performance Data" section details the various aspects tested (e.g., head tip, connect strength, leakage, balloon fatigue, etc.).
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation was based on:
- Design specifications: The device's performance was compared against its own pre-defined engineering and functional requirements.
- Relevant medical device standards: Specifically, ISO 10993 for biocompatibility and ISO 11135 for sterility. While not explicitly named for other tests, it's implied that recognized engineering and performance standards would be followed.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device and its performance is evaluated through bench testing and conformance to standards, not through machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning training set for this device.
§ 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.