(86 days)
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source.
The provided 510(k) summary does not include specific acceptance criteria or an explicit study detailing how the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and technological characteristics.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new patient-contacting materials | All patient-contacting materials are cleared by previous 510(k) submissions. |
| Compliance with voluntary safety standards | Designed, manufactured, and tested in compliance with IEC 60601-1 and IEC 60601-2-18. |
| Equivalence in safety and efficacy for electrosurgical applications (compared to predicate devices) | Expected to present no differences in safety or efficacy for electrosurgical applications compared to predicate devices, despite being a flexible endoscope where rigid endoscopes were historically used. |
| Intended Use as a pleuravideoscope | Designed for endoscopic diagnosis and surgery within the thoracic and abdominal cavities, with an Olympus video system, light source, documentation equipment, video monitor, endo-therapy accessories, and other ancillary equipment. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission does not describe a test set or clinical study with a sample size for performance evaluation. The device gained clearance based on substantial equivalence to predicate devices and compliance with safety standards, not through a direct performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as there was no test set or clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or mentioned in the summary. The clearance was based on substantial equivalence to existing devices, not on demonstrating an improvement in human reader performance with AI assistance (as this is not an AI device).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is not an algorithm or AI system, so a standalone performance study in that context is irrelevant. The LTF-240 Pleuravideoscope is a medical instrument.
7. Type of Ground Truth Used
Not applicable. The clearance was based on demonstrating substantial equivalence to predicate devices and compliance with recognized safety standards, not on a ground truth established through expert consensus, pathology, or outcomes data from a performance study.
8. Sample Size for the Training Set
Not applicable. This device is a medical instrument and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this device is a medical instrument and not an AI/ML algorithm, it does not have a training set or associated ground truth.
§ 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.