(247 days)
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.
The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope.
The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.
The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.
This FDA 510(k) summary describes the Bronchoscope System (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1). The submission indicates that no clinical studies were performed to demonstrate substantial equivalence. Instead, a series of non-clinical (bench) tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate devices (K231107 and K191828).
Therefore, I will provide the acceptance criteria and performance as reported for the non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are typically compliance with recognized standards or meeting specific performance benchmarks defined in the device's design specifications. The "reported device performance" refers to the results of these tests confirming that the device meets those standards/specifications.
| Acceptance Criteria (from recognized standards or design specifications) | Reported Device Performance (Test Results) |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1:2005+A1:2012+A2:2020 | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014 + A1:2020 / ANSI AAMI IEC 60601-1-2:2014 + A1:2021 | Complies with IEC 60601-1-2 |
| Basic Safety and Essential Performance (Endoscopic Equipment): Compliance with IEC 60601-2-18:2009 | Complies with IEC 60601-2-18 |
| Usability Engineering: Compliance with IEC 60601-1-6:2010 + A1:2020 + A2:2020 | Complies with IEC 60601-1-6 |
| Photobiological Safety: Compliance with IEC 62471:2006 | Complies with IEC 62471 |
| Biocompatibility: | |
| ISO 10993-1:2018 (Evaluation and testing) | Complies with ISO 10993-1 |
| ISO 10993-5:2009 (In vitro cytotoxicity) | Complies with ISO 10993-5 |
| ISO 10993-10:2021 (Skin sensitization) | Complies with ISO 10993-10 |
| ISO 10993-11:2017 (Systemic toxicity) | Complies with ISO 10993-11 |
| ISO 10993-23:2021 (Irritation) | Complies with ISO 10993-23 |
| Sterilization & Shelf Life & Packaging: | |
| ISO 11607-1:2019 (Packaging) | Complies with ISO 11607-1 |
| ISO 11135:2014 (EO Sterilization) | Complies with ISO 11135 |
| ISO 10993-7:2019 (EO Sterilization Residuals) | Complies with ISO 10993-7 |
| System Performance Tests: | |
| Validation of up/down deflection | Tested, results met standard requirements |
| Repeated flexing | Tested, results met standard requirements |
| Water supply system | Tested, results met standard requirements |
| Sealing performance | Tested, results met standard requirements |
| Normal working condition | Tested, results met standard requirements |
| Field of View | Tested, results met standard requirements |
| Direction of View (DOV) | Tested, results met standard requirements |
| Geometric distortion | Tested, results met standard requirements |
| Signal-To-Noise Ratio (SNR) | Tested, results met standard requirements |
| Image Intensity Uniformity (IIU) | Tested, results met standard requirements |
| Color performance | Tested, results met standard requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test performed. However, these tests are typically performed on a statistically representative number of manufactured units according to the applicable standard requirements (e.g., a certain number of devices for electrical safety, biocompatibility batches, etc.).
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human subjects. The manufacturer is Shenzhen Sanping Image Technology Co., Ltd. located in Shenzhen, Guangdong, China. The data would therefore originate from testing facilities associated with the manufacturer or their designated testing laboratories. The data is prospective in the sense that it was generated specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Since no clinical studies were performed, there was no test set requiring expert ground truth establishment for diagnostic or clinical performance. The non-clinical tests relied on validated reference methods and calibrated equipment to assess various physical and performance characteristics against established international standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is not an AI/algorithm-only device. It is a Bronchoscope System, which functions as a direct visualization tool for medical professionals. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" implicitly refers to the specifications defined by the international consensus standards (e.g., IEC, ISO) and the device's own design specifications. The tests verify that the device's physical, electrical, mechanical, and imaging properties meet these predefined engineering and safety benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.