(214 days)
The PROTOCO₂L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).
The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC is used to distend the colon with uniform pressure in order to properly present the colon during the given diagnostic procedure.
The PROTOCO2L Touch consists of two (2) components:
(1) the Colon Insufflator, and
(2) the disposable, non-sterile Administration Set.
The provided text describes a 510(k) Premarket Notification for the Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator. This is a submission for a medical device that administers and regulates CO₂ for colon distention during CT Colonography, aiming to demonstrate substantial equivalence to existing predicate devices.
The document does not contain information about:
- Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
- Any details of a study involving a test set, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- A standalone performance study of an algorithm.
- The type of ground truth used (pathology, outcomes data, etc.) for any clinical performance evaluation.
- The sample size for a training set or how ground truth for a training set was established.
Instead, the performance testing described focuses on:
- Sterilization and Shelf-Life: Not applicable as the device is not shipped sterile and has no shelf life.
- Biocompatibility: Verification of patient contact materials within the tubing set against ISO 10993-1: 2009.
- Software Testing: Design and development based on a robust software development process, with verification and validation against internal requirements and FDA guidance documents ("The content of premarket submissions for software contained in medical devices," "General principles of software validation").
- Electrical Safety Testing: Compliance with IEC 60601-1: 2005 and UL 60601-1: 2006.
- Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601-1-2: 2007.
- Performance Testing – Bench: Compliance with internal requirements, IEC 62366: 2007 (usability engineering), and ISTA Procedure 3A – 2008 (packaged-products for parcel delivery).
The conclusion states that these verification and validation activities demonstrate that the device is safe and effective and substantially equivalent to the predicate device.
Therefore, I cannot provide a table of acceptance criteria for diagnostic performance or details about a study evaluating such performance, as the provided text does not contain that information. The "acceptance criteria" and "device performance" in this context refer to engineering, safety, and software validation rather than diagnostic accuracy.
§ 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.