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The ScopeFlow Pure™ is intended to be used in in conjunction with a flexible endoscope to insufflate air/CO2 and supply sterile water during endoscopic procedures. The ScopeFlow Pure™ is compatible with the different sterile water bottles available. It is intended to be used for 24 hours and then disposed of.

The ScopeFlow Pure™ is used to convey sterile water from an external water source to a flexible endoscope to aid its function. The ScopeFlow Pure™ consists of: 1) PVC tubing is used provide the method of transferring the sterile water from the external source to the flexible endoscope. This sterile water is used to clean the lens of the flexible endoscope during operation or to assist in improving the flexible endoscopes visual field. 2) An endoscope connector at the distal end of the device. For the ScopeFlow Pure™ the three different connectors are designed to fit Olympus, Pentax and Fujinon endoscopes. The connectors are manufactured from medical grade plastic, which is used as an outer housing and medical grade TPE or silicone which are used as seals to prevent water and air from escaping during use. The ScopeFlow Pure™ functions by using a two parallel tubes configuration to supply air to the water bottle and provide water to the flexible endoscope. The HYBRID configuration consists of the ScopeFlow Pure™ and an EndoStream™ units being used together. The HYBRID models function in the same way but instead of using a separate sterile bottle for irrigation of the lens and irrigation of the GI Tract, one bottle of sterile water is used as the feed for both, the Hybrid has only one screwcap.

The provided text is a 510(k) premarket notification summary for the ScopeFlow Pure™ device. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance, rather than presenting a performance study evaluating acceptance criteria in the way one would for a novel AI/ML device.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not present in this type of FDA submission.

Here's an breakdown of what can be extracted and what is missing based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a diagnostic test's sensitivity, specificity, accuracy, or similar metrics for a new AI/ML algorithm. Instead, it describes performance testing related to the device's physical properties and functionality.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document refers to "Performance testing" without detailing sample sizes for each test.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The tests are laboratory-based for physical and biological properties.

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)

Not applicable. The ground truth for these types of engineering and biocompatibility tests is based on established technical standards (e.g., ISO standards, physical measurements). No human experts are described as establishing "ground truth" in the diagnostic sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of diagnostic interpretations.

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 an irrigation/suction system for endoscopes, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the performance tests mentioned (sterilization, biocompatibility, functionality) would be determined by the pass/fail criteria of the respective ISO standards and engineering specifications. For biocompatibility, it's about meeting toxicological thresholds; for sterilization, it's demonstrating sterility assurance levels; for functionality, it's about meeting predefined operational parameters.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.

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

Not applicable. No training set is involved.

Summary of Device and Study:

The ScopeFlow Pure™ is an irrigation/suction system intended for use with flexible endoscopes to insufflate air/CO2 and supply sterile water during endoscopic procedures. It comes in various configurations compatible with Olympus, Pentax, and Fujinon endoscopes.

The study described (or rather, the testing performed as part of the 510(k) submission) is a series of engineering and biological tests designed to demonstrate the device's safety and effectiveness. These include:

• Sterilization Validation: Demonstrated compliance with ISO 11135.
• Package and Shelf-life Testing: Completed, ensuring the device remains effective and sterile over time.
• Biocompatibility Testing: Evaluated for cytotoxicity, intracutaneous irritation, and sensitization according to ISO 10993, confirming the materials are safe for patient contact.
• Functionality and Performance Integrity Testing: Demonstrated that the device functions as intended (insufflates air/CO2 and supplies sterile water).

The conclusion of the 510(k) submission is that the ScopeFlow Pure™ is substantially equivalent to legally marketed predicate devices (Medivators "EndoSmart Bottle, Rinse and Insufflation System" and The Endo SmartCap Company "The Endo SmartCap") based on similarities in indications for use, materials, performance testing, technological characteristics, principle of operation, and design features. The tests conducted support this claim of substantial equivalence by ensuring the new device meets relevant safety and performance standards equivalent to the predicate devices.

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The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump.

The EndoStream™ is available in two (2) configurations: PFE130 and PFE230. The EndoStream™ is used to convey sterile water from an external water source to a flexible endoscope to aid its function. This sterile water is used to clean the lens of the flexible endoscope during operation or to assist in improving the flexible endoscopes visual field. The device consists of PVC tubing and an endoscope connector with a medical grade plastic check valve. It functions by using a single lumen in conjunction with a peristaltic pump to provide water to the flexible endoscope. EndoStream™ connects a sterile water supply into the proximal end of an endoscope. Once connected, EndoStream™ allows sterile water to flow into the endoscope which carries it into the Gastrointestinal (GI) tract to flush out the GI tract during endoscopic procedures. It is a tubing with a cap which directly screws onto a sterile water bottle. The tubing extremity connects to the endoscope via the pump head on a peristaltic irrigation pump. A back flow valve is integrated in the extremity of each EndoStream™ tubing ensuring the unidirectional flow from the sterile water bottle to the endoscope, thus guaranteeing the prevention of risks of cross contamination.

The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump. The performance data section indicates that the device underwent several tests to demonstrate functionality and performance integrity.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Dye Penetration
• Seal Strength Testing
• Visual Seal
  The implication is that the device maintained its integrity and functionality over its claimed shelf-life. |
  | Biocompatibility (ISO 10993) | Tested for:
• Cytotoxicity
• Intracutaneous Irritation Test
• Sensitization
  The implication is that the materials used are biocompatible and met the requirements of ISO 10993. |
  | Functionality & Performance Integrity | The EndoStream™ product was also tested to demonstrate functionality and performance integrity. Specific quantitative metrics are not provided, but the conclusion states "Any differences do not raise any new issues of safety or effectiveness," suggesting successful performance. |

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

The document does not specify the exact sample sizes used for the sterilization validation, shelf-life/aging, biocompatibility, or functionality tests. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable. This device is a medical accessory (tubing for irrigation), and the described tests are primarily engineering and material science evaluations, not clinical performance studies requiring expert interpretation of results for ground truth establishment.

4. Adjudication method for the test set

Not applicable. The tests mentioned (sterilization, shelf-life, biocompatibility, functionality) are objective measurements conducted according to established standards. They do not involve subjective interpretation or a need for adjudication methods like 2+1 or 3+1.

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. The EndoStream™ is an irrigation tubing, not an AI-powered diagnostic or assistive device. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant.

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

Not applicable. The EndoStream™ is a physical medical device (tubing), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the tests performed would be defined by the specifications and acceptance criteria of the respective standards (ISO 11135, ASTM 1980, ISO 10993) and the device's own functional requirements. For example:

• Sterilization: Ground truth is the absence of viable microorganisms after the sterilization process, confirmed by biological indicator tests or sterility assurance levels defined by ISO 11135.
• Shelf-Life/Aging: Ground truth is the device maintaining its physical and functional properties (e.g., no dye penetration, specified seal strength, no visual degradation) over the tested period, according to ASTM 1980.
• Biocompatibility: Ground truth is the absence of cytotoxic effects, irritation, or sensitization as per the criteria of ISO 10993.
• Functionality: Ground truth would be the device's ability to consistently and reliably convey sterile water from the source to the endoscope without leaks, blockages, or failure of the check valve, as designed.

8. The sample size for the training set

Not applicable. This document describes performance testing for a physical medical accessory, not the development or training of an AI algorithm.

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

Not applicable. No training set was used as this is not an AI/algorithm-based device.

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