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Fujifilm 600 Series Endoscope EC-600WL: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Fujifilm 600 Series Endoscope EG-600WR: The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Fujifilm 600 Series (Water Tank, WT-4): This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The proposed EG-600WR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum, this is similar to K042043.

The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels, and a complementary metal-oxide-semiconductor (CMOS) image sensor. 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 endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and light source.

The proposed models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).

The intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.

The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.

The provided document describes the 510(k) premarket notification for Fujifilm 600 Series Endoscopes and the Water Tank WT-4, seeking substantial equivalence to previously cleared devices. It outlines the device description, indications for use, and the studies conducted to demonstrate safety and performance. However, this document does not contain information about a study that proves the device meets specific acceptance criteria related to a diagnostic algorithm or a specific performance metric like sensitivity or specificity. Instead, the studies presented are focused on demonstrating safety and compliance with recognized standards for medical devices.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not present:

Acceptance Criteria and Device Performance Study for Fujifilm 600 Series Endoscopes and Water Tank WT-4

1. Table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria (e.g., specific diagnostic accuracy thresholds, image quality metrics with acceptance levels) for the endoscopes or water tank. Instead, it lists safety and performance requirements (standards) to which the devices were evaluated and passed. The "reported device performance" is implicitly that the devices met these safety and performance standards.

2. Sample size used for the test set and the data provenance

The document clearly states: "No clinical testing was conducted." Therefore, there was no "test set" in the context of clinical or diagnostic performance evaluation with a sample size or data provenance. The evaluations were based on engineering, bench, and biocompatibility testing against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical testing was conducted and no "test set" for diagnostic performance was used, there were no experts involved in establishing ground truth for such a purpose. The ground truth for the engineering and safety tests would have been the specifications of the standards themselves, verified by testing laboratories and engineers.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. No MRMC study was mentioned, nor is this device an AI-assisted diagnostic tool. It is an endoscope and water tank.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm or an AI system; it is a medical hardware device (endoscope and accessory).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the evaluations conducted (safety, biocompatibility, performance against technical specifications), the "ground truth" was defined by the requirements and methodologies outlined in the referenced international standards (e.g., IEC, ISO, ANSI/AAMI) that the device was tested against. For example, for biocompatibility testing, the ground truth would be the defined acceptable levels of cytotoxicity or irritation according to ISO 10993. For mechanical and electrical tests, it would be the published limits and methodologies in the respective IEC/ANSI/AAMI standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML device.

Summary of the Study and Device Justification:

The studies performed for the Fujifilm 600 Series Endoscopes and Water Tank WT-4 were primarily bench testing, engineering verification, and biocompatibility evaluations to demonstrate compliance with recognized international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600 series).

The primary method for "proving the device meets acceptance criteria" in this context was demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon Colonoscopes EC-530HL2 and EC-530LS2, Fujinon G5 Gastroscope EG-450WR5, and Water Tank WT-2). The modifications were described as "minor modifications... for the purpose of overall product enhancement and general technological advancement." The lack of clinical testing further supports that the modifications were considered minor enough not to raise new questions of safety or effectiveness from a performance standpoint, allowing reliance on the predicate devices' established performance.

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The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is:
(1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
(2) to be used for single-patient reuse in the home environment.

The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B WillowTM is a prescription device supplied non-sterile.

This document describes the 3B Willow™ Nasal Mask and its substantial equivalence to predicate devices, focusing on technological characteristics and performance bench testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ResMed Mirage Swift II), rather than establishing novel acceptance criteria for a new device type. The "acceptance criteria" are implicitly defined by the reported performance of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "To verify the substantial equivalence claim, the Willow™ was performance bench tested against the ResMed Mirage Swift (K042043)."

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench testing. It refers to general "performance bench testing." For this type of device (nasal mask), this typically involves testing a small number of production units.
• Data Provenance: The data is generated from bench testing performed on the 3B Willow™ Nasal Mask and compared against the specifications of the ResMed Mirage Swift II. There is no indication of human subject data, country of origin, or retrospective/prospective nature as this is a physical device performance comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is a bench test comparing physical performance characteristics of a medical device against a predicate device's specifications. It does not involve expert review or ground truth establishment in the clinical diagnostic sense. The "ground truth" here is the established and publicly available performance specifications of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. As this is bench testing of physical properties against technical specifications, there is no need for adjudication by experts. The measurements are objective.

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:

Not applicable. This is a physical medical device (nasal mask) and not an AI/software as a medical device (SaMD) that would involve human readers or AI in diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for comparison is the published performance specifications and characteristics of the predicate device, ResMed Mirage Swift II (K042403), derived from its 510(k) submission and/or product documentation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for a training set.

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The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The EG-530N consists of the following portions / parts:

• Control portion to provide grip for holding the endoscope and for the operation of the endoscope.
• LG Flexible Portion - Contains the light guide, air/water supply tube, suction tube, and cables.
• Bending Portion
• Distal End - Contains objective lens, air/water nozzles, forceps channel.

The EG-530N is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The provided text is a 510(k) summary for the Fujinon EG-530N Gastroscope. It describes the device, its intended use, comparison to a predicate device, and a conclusion on substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would.

The "Performance Data" section states: "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device." This indicates engineering and materials testing, but not clinical performance metrics like diagnostic accuracy, sensitivity, or specificity.

Therefore, many of your requested items cannot be extracted from this document, as it is a regulatory submission focused on substantial equivalence rather than a clinical performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study for evaluating diagnostic performance. The "testing" mentioned refers to engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts for clinical performance is described.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a gastroscope, 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 an endoscope, not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" here is the device's adherence to engineering standards and technical specifications, not clinical outcomes or pathology.

8. The sample size for the training set: Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "meeting acceptance criteria":

The document effectively states that the Fujinon EG-530N Gastroscope meets its "acceptance criteria" by demonstrating substantial equivalence to existing legally marketed devices (predicates). This is the primary regulatory pathway used here. The criteria for acceptance by the FDA were that the device is as safe and effective as its predicates, which was argued based on:

• Similar indications for use.
• Identical material composition.
• Similar viewing direction, image size, bending, reprocessing/sterilization methods.
• Use of the same processor and peripherals.
• Minor differences (e.g., smaller diameter, field of view) were deemed not to raise new safety or effectiveness concerns.
• The addition of transnasal indication was supported by existing FDA clearance for similar devices.
• Passing of standard engineering safety tests (electrical, thermal, EMC).

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The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho. The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series. The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Instruments.

The provided text describes a 510(k) submission for Fujinon G5 Bronchoscopes (Models EB-470S, EB-250S, and EB-270P). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Fujinon EB-310S, K954707) by outlining changes and similarities in technical characteristics, indications for use, and material composition.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
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): This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
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: This information is not present in the provided text. The device is an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the provided text.
8. The sample size for the training set: This information is not present in the provided text.
9. How the ground truth for the training set was established: This information is not present in the provided text.

The document states under "Performance Data [21 CFR 807.92(b)(1)]":
"The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device."

This indicates that some performance testing was conducted, but it's limited to electrical safety, thermal, and EMC, and the specific acceptance criteria and detailed results of these tests are not provided in the summary. The core of the submission is demonstrating equivalence, not necessarily a new performance study against specific criteria beyond safety and basic physical characteristics.

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