Search Results
Found 1 results
510(k) Data Aggregation
(60 days)
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to provide ultrasonic images. For ultrasound procedure, EB-530US can be used with a single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.
Here's a breakdown of the acceptance criteria and study information for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US, based on the provided 510(k) summary:
This device did not conduct clinical testing to prove its performance against acceptance criteria. Instead, it demonstrated substantial equivalence to a legally marketed predicate device (OLYMPUS BF type UC160F-OL8, K042140) by comparing technical features and conforming to relevant safety and performance standards.
Therefore, many of the requested fields related to clinical study design and performance metrics will be marked as "Not Applicable (N/A)" or "Not Reported" because the submission relies on a different pathway for clearance.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Since no clinical testing was conducted to establish performance metrics against specific acceptance criteria for diagnostic accuracy, the acceptance criteria here are derived from the device's conformance to recognized standards and its equivalence to a predicate device. The "Reported Device Performance" refers to the technical specifications of the proposed device.
| Acceptance Criterion (Implicit) | Reported Device Performance (Technical Specification) |
|---|---|
| Conformance to IEC 60601-1 (General safety) | Device conforms to IEC 60601-1 |
| Conformance to IEC 60601-1-1 (System safety) | Device conforms to IEC 60601-1-1 |
| Conformance to IEC 60601-1-2 (EMC) | Device conforms to IEC 60601-1-2 |
| Conformance to IEC 60601-2-18 (Endoscopic equipment safety) | Device conforms to IEC 60601-2-18 |
| Conformance to IEC 60601-2-37 (Ultrasonic equipment safety) | Device conforms to IEC 60601-2-37 |
| Conformance to ISO 10993-1 (Biological evaluation) | Device conforms to ISO 10993-1 |
| Sterility of balloon (B20BU) | Balloon conforms to applicable internal and international IEC testing requirements for Sterility |
| Validated Reprocessing Instructions | Reprocessing instructions were validated |
| Substantial Equivalence to Predicate Device (K042140) | Technical specifications are comparable (e.g., viewing direction, observation range, field of view, diameters, bending capabilities, working length, scanning method) and materials are the same as previously-cleared Fujinon/Fujifilm endoscopes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not Applicable (No clinical performance or diagnostic accuracy study reported for this device in the 510(k) summary).
- Data Provenance: Not Applicable (No clinical data set used for performance evaluation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not Applicable (No clinical performance or diagnostic accuracy study reported).
- Qualifications of Experts: Not Applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not Applicable (No clinical performance or diagnostic accuracy study reported).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study Done: No.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not Applicable (No AI component, no MRMC study).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Standalone Study Done: No. This device is an endoscope, not an algorithmic device requiring standalone performance evaluation in the context of AI. The performance is assessed through its physical and electrical specifications and safety standards.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not Applicable. For this 510(k) pathway, the "ground truth" for substantial equivalence is derived from compliance with recognized consensus standards and direct comparison of design and technological characteristics to a legally marketed predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not Applicable (No AI/machine learning component requiring a training set was reported for this device).
9. How the Ground Truth for the Training Set was Established
- How Ground Truth was Established: Not Applicable (No AI/machine learning component, therefore no training set or associated ground truth for such a set).
Ask a specific question about this device
Page 1 of 1