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Found 214 results
510(k) Data Aggregation
(227 days)
18901
Re: K251402
Trade/Device Name: LIA-1 Catheter (542-1)
Regulation Number: 21 CFR 874.4680
Classification Code: KTI
Predicate Device: ViziShot 2 FLEX: 510(k) K193517
Regulation: 874.4680
| The regulation (874.4680) does not put limitations on what type of imaging can be utilized to guide a |
|---|
| Regulation Product Code |
| KTI |
| Intended Use |
The LIA-1 Catheter is intended for use through a compatible bronchoscope in the tracheobronchial tree for Optical Coherence Tomography (OCT) guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) of endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console.
Do not use this device for any purpose other than its intended use. This device is intended to provide an image of tissue microstructure in the tracheobronchial tree and parenchyma. The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
LIA-1 Catheter is a sterile, single-use, Optical Coherence Tomography (OCT) image-guided biopsy needle which is an assembly consisting of a Handle, Outer Sheath, Needle, and Imaging Stylet (iStylet). The Outer Sheath and Needle are attached to Actuation Handle and the iStylet is located within the Needle.
Outer Sheath: The LIA-1 Catheter Outer Sheath consists of a clear tube attached to the Handle.
Handle: The LIA-1 Catheter Handle allows the user to actuate the needle from the distal tip of the Outer Sheath, and to actuate the iStylet into or out of the Needle tip, or to be retracted for biopsy collection, as necessary.
Needle: The 21G stainless-steel Needle has a beveled, sharpened tip for puncture and tissue collection.
Imaging Stylet: The iStylet consists of a shaft and imaging core serving as an optical imaging probe. It provides real-time imaging for its intended use.
The LIA-1 Catheter is intended to be used only in conjunction with the LIA Console in order to function as intended.
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(266 days)
: K250863**
Trade/Device Name: FUJIFILM Ultrasonic Endoscope EB-710US
Regulation Number: 21 CFR 874.4680
and accessories |
| Classification Name | Bronchoscope (Flexible Or Rigid) |
| Regulation Number | 874.4680
This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians.
This product is not intended for use on children and infants.
EB-710US (referred to as 'the device') is a medical ultrasonic electronic endoscope. The device is inserted into a lumen, a coelom, body cavity, or inside of a body, and provides images for observation, diagnosis, photographing, or treatment. It is also used for ultrasonography by visualizing the shape, the characteristic, or the dynamics of the inside of the body.
This product is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, a channel, a complementary metal-oxide semiconductor (CMOS) image sensor and a ultrasonic transducer in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channel in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor.
This product is used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. And the device drives ultrasonic transducer installed in the distal end of the device by being connected with a ultrasonic processor.
The driven ultrasonic transducer emits ultrasound into the body, and receives the reflected ultrasonic signal from the body. The ultrasonic processor connected to the device performs image processing using the received signal. The electric signal of the image processing is converted into video signal, and it is output to the monitor as a ultrasonic image.
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(182 days)
STORZ Flexible Intubation Video Endoscope - Sterile (FIVE-S) (0916612)
Regulation Number: 21 CFR 874.4680
The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile (FIVE-S) is sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor (when using the Image1 S CCU), where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into the compatible CCU (Camera Control Unit) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
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(28 days)
Name:** Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Regulation Number: 21 CFR 874.4680
Name:** Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Regulation Number: 21 CFR 874.4680
Accessory
Regulatory Class: Class II
Product Code: KTI
Regulation Number: 21 CFR 874.4680
The Compass Steerable Needle is a steerable transbronchial biopsy needle intended to be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Compass Steerable Needle include two model numbers, Model CSN1001 and Model CSN1002. Model CSN1001 includes two accessory adapters for attachment to bronchoscopes.
The subject of this 510(k) is the addition of two new adapters to Model CSN1002. Adapter SRA-1-01 connects the Model CSN1002 to the Ion™ Endoluminal System, and Adapter SRA-2-01 connects the Model CSN1002 to the Monarch™ Platform or Galaxy System™.
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(14 days)
: K252921**
Trade/Device Name: Radial Jaw™ 4 Pulmonary Biopsy Forceps
Regulation Number: 21 CFR 874.4680
Classification Name:** | Bronchoscope (flexible or rigid) and accessories |
| Regulation Number: | 874.4680
Classification Name:** | Bronchoscope (flexible or rigid) and accessories |
| Regulation Number: | 874.4680
These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.
The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) is a sterile, single-use device. The RJ4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8 mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0 mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length, and are offered in Box 5 and Box 20 packaging configurations.
To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
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(85 days)
94086
Re: K252045
Trade/Device Name: Ion Endoluminal System (IF1000)
Regulation Number: 21 CFR 874.4680
Common Name:** Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
Common Name:** Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
Common Name:** Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
Subject DeviceIon™ Endoluminal System, Model IF1000 |
|---|---|---|
| Regulation Number | 21 CFR §874.4680
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint Software, a System Cart with System Software, a Controller, Instruments, and Accessories.
The IF1000 Instruments include the Ion Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
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(95 days)
China
Re: K251894
Trade/Device Name: Himaging Bronchscope System
Regulation Number: 21 CFR 874.4680
Flexible or Rigid)
Classification: II
Product Code: EOQ
Regulation Number: 21 CFR 874.4680
K233671 | Remark |
|---|---|---|---|---|
| Product Code | EOQ | EOQ | EOQ | Same |
| Regulation No. | 874.4680
| 874.4680 | 874.4680 | Same |
| Class | II | II | II | Same |
| Manufacturer | Himaging Technology
The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Himaging bronchoscope system is applicable to hospital environment or medical office environment.
The Himaging bronchoscopes are sterile single-use devices designed for use in adults.
The subject device, Himaging Bronchoscope System, is consisting of a single-use flexible video Bronchoscope and an endoscopic video processor. The subject device has been designed to be used for endoscopy within the airways and tracheobronchial tree.
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(25 days)
K252528**
Trade/Device Name: Ion Endoluminal System (IF1000)
Regulation Number: 21 CFR 874.4680
Common Name:** Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
Common Name:** Bronchoscope (flexible or rigid) and accessories
Classification: Class II 21 CFR 874.4680
-|------------------------------------------------------------------|
| Regulation Number | 21 CFR §874.4680
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.
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(79 days)
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
Regulation Number: 21 CFR 874.4680
accessories |
| Classification Name | Bronchoscope (Flexible Or Rigid) |
| Regulation Number | 874.4680
The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Flexible Bronchoscope is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
The Flexible Bronchoscope (Model: BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is intended to be used with the Portable Video Processor (cleared via K243497). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy, and when used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Bronchoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the video processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the video processor, optical fibers for transmitting illumination from the LED inside the handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).
This document is an FDA 510(k) clearance letter for a Flexible Bronchoscope, indicating substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The provided text focuses on the physical and performance characteristics of the bronchoscope itself, its intended use, technological comparison to a predicate device, and various non-clinical tests (electrical safety, photobiological safety, mechanical/optical performance, biocompatibility, sterilization, shelf life, and package validation).
There is no mention of an AI component, an algorithm, or any study involving human readers, ground truth establishment, or performance metrics like sensitivity, specificity, or AUC. The "device performance" in this context refers to the bronchoscope's mechanical and optical functionality, not the diagnostic accuracy of an AI algorithm.
Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to answer based on the provided text, highlighting what is missing:
1. Table of acceptance criteria and reported device performance
The document does not present a formal table of "acceptance criteria" for a diagnostic algorithm with corresponding "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC). Instead, it states that various non-clinical tests were performed to demonstrate compliance with recognized standards and that the device is "as safe, as effective, and performs as well as the legally marketed device identified above."
Below is a table summarizing the types of tests and the general conclusion, but without specific quantitative acceptance criteria or performance metrics related to diagnostic accuracy.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Electrical Safety | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC/TS 60601-4-2 standards. | In compliance with the specified FDA recognized standards. |
| Photobiological Safety | Compliance with IEC 62471:2006. | Tested according to IEC 62471:2006. |
| Mechanical Performance | Compliance with applicable parts of ISO 8600 (e.g., leakage tightness, bending, deflection endurance, tensile strength). | Tested for leakage tightness, bending, deflection endurance, and tensile strength; implied compliance. |
| Optical Performance (Direct) | Compliance with applicable parts of ISO 8600. | Optical measurements performed according to ISO 8600; implied compliance. |
| Optical Performance (Comparative) | Image quality parameters (direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Distortion, Image intensity uniformity) comparable to reference device K173727 and K243857. | Comparative testing performed, results demonstrated subject device is as safe and effective as predicate. |
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance. Absence of cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity. | Evaluated for Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity; implied compliance. |
| Sterilization & Shelf Life | Validation to ISO 11135:2014; EO/ECH residual test per ISO 10993-7:2008; Shelf life determined by stability study per ASTM F1980-21. | Sterilization method validated; EO/ECH residual test performed; shelf life determined through aging test. |
| Package Validation | Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15, ASTM D4169-22. | Conducted according to specified standards. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not mentioned. This document describes a medical device (bronchoscope) itself, not an AI algorithm performing a diagnostic task on a dataset. The "tests" mentioned are non-clinical engineering and biological safety tests, not tests on a dataset.
- Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no mention of "ground truth" in the context of an AI algorithm's diagnostic performance for which experts would be needed. The "ground truth" for the non-clinical tests would be the established performance specifications and standards for a bronchoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no expert ground truth establishment for a diagnostic AI is mentioned, no adjudication method would be relevant.
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. This document describes the clearance of a flexible bronchoscope, a physical medical device. It does not mention any AI component or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no mention of an algorithm in this document that would perform as a standalone device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of diagnostic AI is not mentioned. For the non-clinical tests, the "ground truth" is compliance with established engineering and safety standards.
8. The sample size for the training set
- Not applicable. There is no mention of an AI model or a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of an AI model or a training set.
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(59 days)
UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)
Regulation Number: 21 CFR 874.4680
Name** | Endoscope and accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 874.4680
UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.
UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.
The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.
The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."
The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).
Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.
Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Value/Range) | Reported Device Performance | Comments from Text |
|---|---|---|---|
| Optical Performance | Not provided in the text (but implies compliance with ISO 8600 series) | Complies with ISO 8600 series | Bench testing performed according to ISO 8600. |
| Color Performance | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Color reproduction: compared with the predicate device. |
| Geometric Distortion | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Geometric distortion: compared with the predicate device. |
| Resolution | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Resolution: compared with the predicate device. |
| Depth of Field | 6-50 mm (same as predicate device) | 6-50 mm (same as predicate device) | Depth of view is 6-50 mm. |
| Image Intensity Uniformity | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Image intensity uniformity: compared with the predicate device. |
| Noise | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Noise: compared with the predicate device. |
| Dynamic Range | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Dynamic range: compared with the predicate device. |
| Frame Rate | Not provided in the text (comparison to predicate implied) | Not explicitly reported as a quantitative value/range | Frame rate: compared with the predicate device. |
| Field of View | Not provided in the text (Predicate: 85°) | 90° | Field of view (degree): 90° (subject device) vs 85° (predicate). Deemed "Similar". |
| Deflection Angle | Up: 180°, Down: 180° (for Slim/Regular sizes) | 180° up, 180° down | "Same" as predicate for Slim/Regular, "Similar" for Large (predicate Large is 160° down). |
| Insertion Tube Outer Diameter | Matches predicate (Slim: 3.8mm, Regular: 5.0mm, Large: 5.8mm) | EBS-380C: 3.8 mm, EBS-500C: 5.0 mm, EBS-600C: 5.8 mm | "Same". |
| Insertion Portion Maximum Diameter | Equivalent to predicate (Slim: 4.3mm, Regular: 5.5mm, Large: 6.3mm) | EBS-380C: 4.4 mm, EBS-500C: 5.5 mm, EBS-600C: 6.5 mm | "Equivalent". |
| Minimum Working Channel Diameter | Equivalent to predicate (Slim: 1.2mm, Regular: 2.0mm, Large: 2.6mm) | EBS-380C: 1.15 mm, EBS-500C: 2.15 mm, EBS-600C: 2.75 mm | "Equivalent". |
| Average Working Channel Diameter | Matches predicate (Slim: 1.2mm, Regular: 2.2mm, Large: 2.8mm) | EBS-380C: 1.2 mm, EBS-500C: 2.2 mm, EBS-600C: 2.8 mm | "Same". |
| Minimum ETT Inner Diameter Size | Matches predicate (Slim: 5.0mm, Regular: 6.0mm, Large: 7.0mm) | EBS-380C: 5.0 mm, EBS-500C: 6.0 mm, EBS-600C: 7.0 mm | "Same". |
| Minimum DLT Inner Diameter Size | Similar to predicate (Slim: 35 Fr, Regular: 41 Fr, Large: N/A) | EBS-380C: 35 Fr, EBS-500C: N/A, EBS-600C: N/A | "Similar". |
| Biocompatibility | Compliance with ISO 10993-1 | Evaluated and in accordance with ISO 10993-1 and FDA guidance. | Biocompatibility testing performed. |
| Sterilization Process | Compliance with ISO 11135:2014 | Validated in accordance with ISO 11135:2014. | Sterilization and shelf life testing performed. |
| EO/ECH Residual | Compliance with ISO 10993-7 | Test performed according to ISO 10993-7. | Sterilization and shelf life testing performed. |
| Shelf Life | 3 years (based on accelerated aging) | 3 years | Shelf life determined by accelerated aging (ASTM F1980). |
| Package Validation | Compliance with ISO 11607-1 and ISO 11607-2 | Conducted according to ISO 11607-1 and ISO 11607-2. | Package validation performed. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-18 | System complies with IEC 60601-1 and IEC 60601-2-18. | Electrical safety and EMC testing performed. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | System complies with IEC 60601-1-2. | Electrical safety and EMC testing performed. |
| Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" | Conducted and documentation provided as recommended by FDA guidance. | Software V&V testing performed. |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.
4. Adjudication method for the test set
Not applicable, as no clinical study involving expert interpretation or adjudication is mentioned.
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. The document explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.
7. The type of ground truth used
For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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