(115 days)
This device is intended for the observation, diagnosis, and endoscopic treatment of the frachea and bronchial tree.
Fulinon/Fuilfilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchial tree. The Fujinon/Fujifilm EB-530 Series Bronchoscopes are used in combination with the Fujinon/Fujifilm's video endoscope processors, light source, monitor, cart, foot switch, endoscopic accessories, other peripheral devices (e.g. printer, keyboard, etc.), and the legally marketed electrosurgical instruments.
There are three models included in this submission:
- EB-530S Standard Type
- EB-530T Treatment Type (includes 2.8mm forceps channel)
- EB-530H Super Image Type (High resolution)
The provided text describes a 510(k) submission for the Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T, and EB-530H). This submission demonstrates substantial equivalence to a legally marketed predicate device, the Fujinon G5 Bronchoscope (K050907), rather than proving that the device meets specific acceptance criteria through a clinical study.
The submission focuses on engineering and performance validation against recognized medical device standards. There is no information provided about a clinical study with acceptance criteria, human readers, ground truth establishment, or training sets as requested in the prompt.
Here's a breakdown of the information that can be extracted based on the provided text, and where information is missing:
No information regarding a study proving acceptance criteria through clinical performance is available in the provided document.
The document details a 510(k) submission that demonstrates substantial equivalence to a predicate device, focusing on engineering performance and safety standards, rather than clinical efficacy measured against acceptance criteria.
Information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The device was evaluated for compliance with several international and industry standards, which serve as performance "acceptance criteria" for safety and basic non-clinical performance. The "reported device performance" is that it "passed" these requirements.
| Standard / Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| IEC 60601-1 | General requirements for safety | Passed |
| IEC 60601-1-1 | Safety requirements for medical electrical systems | Passed |
| IEC 60601-1-2 | Electromagnetic Compatibility - Requirements and tests | Passed |
| IEC 60601-2-18 | Requirements for the safety of endoscopic equipment | Passed |
| ISO 10993-1 | Biological evaluation of medical devices | Passed |
| Pre-sterilized suction button SB-602 | Conforms to applicable internal and international ISO testing requirements for Sterility | Conforms |
| Reprocessing instructions | Validated reprocessing instructions | Updated and validated |
- Substantial Equivalence Comparison Table (Functional/Physical Characteristics): This table compares the proposed device models to the predicate device. While not "acceptance criteria" in the sense of clinical performance, it shows how the new device performs against a device already cleared by the FDA.
| Characteristic | Predicate Fujinon G5 Bronchoscope (EB-470S, K050907) | Proposed Device Model EB-530S | Proposed Device Model EB-530T | Proposed Device Model EB-530H |
|---|---|---|---|---|
| Viewing direction | Forward/0 degree | Forward/0 degree | Forward/0 degree | Forward/0 degree |
| Observation range | 3-100mm | 3-100mm | 3-100mm | 3-100mm |
| Field of view | 120 degrees | 120 degrees | 120 degrees | 140 degrees |
| Distal end diameter | 4.9mm | 4.9mm | 5.8mm | 5.4mm |
| Flexible portion diameter | 4.9mm | 4.9mm | 5.9mm | 4.9mm |
| Bending capability (Up) | 180 degrees | 180 degrees | 180 degrees | 180 degrees |
| Bending capability (Down) | 130 degrees | 130 degrees | 130 degrees | 130 degrees |
| Forceps channel diameter | 2.0mm | 2.0mm | 2.8mm | 2.0mm |
| Working length | 600 mm | 600 mm | 600 mm | 600 mm |
| Total length | 870mm | 870mm | 870mm | 870mm |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- None provided. The submission explicitly states: "No clinical testing was conducted." The "test set" here refers to physical devices tested against engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- None provided. No clinical ground truth was established as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None provided. Not applicable as no clinical study was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a bronchoscope, a physical medical instrument for direct observation and intervention, not an AI-assisted diagnostic or imaging interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical bronchoscope, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for this submission are the established engineering standards (IEC, ISO) and the characteristics of the predicate device.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm was used.
Summary: The provided document is a 510(k) summary for a medical device (bronchoscopes) seeking market clearance based on substantial equivalence to a predicate device and compliance with recognized safety and performance standards. It explicitly states that "No clinical testing was conducted." Therefore, the specific types of studies and criteria related to clinical performance, expert consensus, and AI-driven analysis requested in the prompt are not applicable to this submission.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.