(112 days)
The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.
The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.
The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.
The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.
Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:
1. A table of acceptance criteria and the reported device performance
The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.
Andorate® Disposable Biopsy Valve:
| Acceptance Criteria Category | Reported Device Performance (Tests Conducted) |
|---|---|
| Mechanical Integrity | Assembling Integrity |
| Compatibility | Endoscope Compatibility |
| Leakage Prevention | Vacuum Leak Test |
| Leakage Prevention | Squeegee Leak Test |
Andorate® Disposable Biopsy Irrigator:
| Acceptance Criteria Category | Reported Device Performance (Tests Conducted) |
|---|---|
| Compatibility | Compatibility with irrigation tubing |
| Compatibility | Compatibility with endoscope |
| Functionality | Water Flow Test |
| Leakage Prevention | Vacuum Leak Test |
| Leakage Prevention | Water Leakage Test |
| Leakage Prevention | Squeegee Leak Test |
| Fluid Dynamics | Backflow Performance Test |
General Performance Criteria (Both Devices):
| Acceptance Criteria Category | Reported Device Performance (Tests Conducted) |
|---|---|
| Sterility Assurance | EO sterilization cycle validated to SAL 10⁻⁶ |
| Sterilization Residuals | EO residuals below levels defined in ANSI/AAMI/ISO 10993-7:2008 |
| Shelf Life | Accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test, sterility test, performance test after accelerated aging (results imply maintenance of sterile barrier and intended performance) |
| Biocompatibility | Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin Sensitization, Irritation (results show biocompatibility for mucosal membrane contact |
§ 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.