(58 days)
The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.
The KSEA Clearvision® is a microprocessor-controlled pump device. The device provides irrigation to clean the objective lens of scope, and removes residual solution on the lens. It is used in conjunction with an irrigation sheath.
This 510(k) summary does not contain the information required to answer your request.
Here's why:
- Acceptance Criteria and Device Performance: The document does not describe specific performance-based acceptance criteria (e.g., a certain flow rate, cleaning effectiveness percentage) or present data from a study demonstrating the device meets such criteria. Instead, it focuses on substantial equivalence to a predicate device based on features and intended use.
- Study Details (Sample Size, Provenance, Ground Truth, Training Set): There is no mention of a study involving a test set, training set, or the establishment of ground truth. The submission is a regulatory comparison against a predicate device, not a performance study.
- Expert Review/Adjudication: Since no performance study (like a clinical trial or algorithm evaluation) is presented, there's no information about experts used for ground truth, their qualifications, or adjudication methods.
- MRMC or Standalone Studies: The document does not discuss multi-reader multi-case comparative effectiveness studies or standalone performance studies. The KSEA Clearvision is a physical pump device, not an AI or imaging-based diagnostic tool that would typically undergo such studies.
In summary, this 510(k) pertains to a medical device's regulatory clearance based on substantial equivalence, rather than a detailed performance study with acceptance criteria.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.