(252 days)
The ALVUE™ Balloon Dilation System is indicated for patients undergoing surgical procedures requiring tissue retraction including the following procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space. The system is intended to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal, subcutaneous extremity, or thoracic space.
The ALVUE™ Balloon Dilation System is a surgical instrument that consists of an inflatable nylon balloon attached to the distal end of a dilator. ALVUE™ is used to dilate soft tissue to gain access to the surgical site and is available in a variety of sizes to accommodate the anatomical needs of the patient. The system includes accessories for inflation. ALVUE™ is a sterile single use device.
This device is a physical medical device (ALVUE™ Balloon Dilation System) and not an AI/ML powered device, so acceptance criteria and studies are based on mechanical and biocompatibility testing rather than AI model performance metrics. Therefore, many of the requested fields are not applicable.
Here's the relevant information from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Mechanical Testing | Inflation Volume and Pressure (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013) | Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.) |
| Axial Tension (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013) | Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.) | |
| Fatigue (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013) | Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.) | |
| Biocompatibility Testing | According to ISO 10993-1 on patient contacting materials | Performed (Result is implied compliance for substantial equivalence, specific results not detailed in this summary.) |
| Technological Characteristics | Design, intended use, material composition, and function compared to predicate devices. | Similar technological characteristics to predicate devices. Consists of cylindrical balloons that dilate soft tissue. Uses fluid to inflate (predicates use fluid or gas). |
| Intended Use | For patients undergoing surgical procedures requiring tissue retraction (endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space) | The ALVUE™ Balloon Dilation System is indicated for these procedures. (Note: ALVUE™, unlike the predicates, is not indicated for vascular surgery nor laparoscopic surgery requiring a sealed port of access.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary (as these are physical device tests, not clinical data from patients).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is not an AI/ML device relying on expert-established ground truth from clinical data. The "ground truth" for mechanical testing is compliance with established engineering standards (ISO 10555-1, ISO 10555-4) and biocompatibility standards (ISO 10993-1).
4. Adjudication Method:
- Not Applicable. This is not an AI/ML device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/ML device.
6. Standalone (Algorithm Only) Performance Study:
- Not Applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- For mechanical testing: Engineering standards (ISO 10555-1:2013, ISO 10555-4:2013).
- For biocompatibility: Biocompatibility standards (ISO 10993-1).
8. Sample Size for the Training Set:
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is a physical medical 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.