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The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.

These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided FDA 510(k) summary (K232067) describes the acceptance criteria and the study that proves the device meets those criteria for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, and Endogator Fujifilm 500/600 Single Use Connector.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit numerical acceptance criteria for each test. Instead, it states that "non-clinical performance testing was performed on the subject device to support the substantial equivalence determination" and concludes that the device "has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the performance of the new devices was within acceptable ranges compared to the predicate devices or met internal engineering specifications for each test.

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

The document does not specify the exact sample sizes used for each non-clinical performance test. It only mentions that "non-clinical performance testing was performed."

The data provenance is from non-clinical performance testing. There is no indication of human data, so country of origin and retrospective/prospective classification are not applicable in this context. These are laboratory/engineering tests performed by the manufacturer.

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

This information is not applicable. The performance tests are engineering and materials science tests, not clinical evaluations requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against established technical specifications or predicate device performance.

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

This information is not applicable as the studies were non-clinical performance tests, not clinical evaluations requiring adjudication of subjective assessments. The results would be objective measurements.

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, an MRMC comparative effectiveness study was not done. This device is a single-use valve/connector for endoscopes, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a mechanical accessory, not an algorithm.

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

The "ground truth" for these non-clinical performance tests would be objective measurements against established technical specifications or the performance of the legally marketed predicate devices. For example, a flow rate test would have a specified minimum/maximum flow, or a leak test would have a maximum allowable leak rate. Biocompatibility utilized ISO 10993 standards.

8. The sample size for the training set

This information is not applicable. This is a medical device accessory undergoing non-clinical performance testing, not a machine learning model requiring a training set.

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

This information is not applicable as there is no training set for this device.

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The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided text describes a 510(k) premarket notification for a set of single-use endoscopy valves. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with acceptance criteria for device performance. Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria, such as clinical effectiveness or diagnostic accuracy.

The document discusses non-clinical performance testing to support substantial equivalence, but these tests are not presented as meeting specific clinical acceptance criteria or performed as a comparative effectiveness study with human readers or standalone algorithm performance.

Here's an attempt to answer your questions based on the available information, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not use the term "acceptance criteria" for clinical performance. Instead, it describes non-clinical performance testing conducted to demonstrate the safety and effectiveness of the device as substantially equivalent to predicate devices. The "reported device performance" are the results of these non-clinical tests.

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

The document does not specify the sample size for individual non-clinical tests (e.g., how many valves were tested for flow rate or mechanical properties). It refers to "testing" as being performed on "the subject device."

The data provenance is from non-clinical performance testing conducted by the manufacturer, Medivators (A Subsidiary of STERIS Corporation), located in Conroe, TX 77303, USA. These are laboratory-based tests, not clinical data from patients.

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

This information is not applicable to this 510(k) submission. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human expert assessment is needed. This submission relies on engineering and laboratory testing for functional performance and safety.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to establish a definitive diagnosis or outcome, often from multiple expert opinions. The testing mentioned here is non-clinical and lab-based.

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 applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices, often involving AI. The devices described here are single-use endoscopic valves, which are mechanical accessories, not diagnostic imaging devices or AI tools.

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

This information is not applicable. Standalone algorithm performance is relevant for AI-based devices. The devices described here are mechanical endoscopic accessories.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document speaks of "non-clinical performance testing" and "biocompatibility assessment" to demonstrate substantial equivalence to predicate devices. The "ground truth," in this context, would be the established functional performance characteristics and safety profiles of the predicate devices, along with relevant engineering standards and regulatory requirements. It is based on engineering benchmarks, physical measurements, and internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11607/ASTM 4169 for packaging).

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train machine learning algorithms. The devices described are mechanical accessories and do not involve AI or machine learning.

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

This information is not applicable for the reasons stated in point 8.

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The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.

The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.

The provided text describes the acceptance criteria and the study conducted for Medivators' Defendo Fujifilm 700 Single-Use Valves Set, which includes several types of valves and a cleaning adapter. It's important to note that this submission is for accessories to endoscopes, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI/SaMD (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device clearance.

The study focuses on demonstrating the substantial equivalence of these new single-use accessories to existing predicate devices, primarily through engineering and performance testing, and biocompatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerically reported device performance against those criteria in a summary format. Instead, it describes various "Non-Clinical Performance Testing" conducted for each component (Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Waterjet Valve (Connector), Cleaning Adapter). The conclusion states that the "subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use," implying that all tests performed achieved their respective pass/fail criteria.

However, we can infer the types of acceptance criteria from the performed tests:

• Water flow rate testing: Likely to ensure sufficient water flow for lens washing.
• Backflow prevention testing: To prevent backflow of contents.
• Mechanical testing:
  • Depression Force
  • Valve Application Force
  • Valve Removal Force
  • Force to Disassemble via Axial Pull
    (Ensures proper function, insertion, removal, and integrity).
• Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
  | Suction Valve | - Suction Bypass: To ensure proper suction path.
• Suction Rate (water and soil): To demonstrate adequate aspiration capability.
• Mechanical testing:
  • Depression Force
  • Valve Application Force
  • Valve Removal Force
  • Force to Disassemble via Axial Pull
    (Ensures proper function, insertion, removal, and integrity).
• Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
  | Biopsy Valve | - Workability / Instrument Access Testing: To ensure smooth passage and exchange of endoscopic instruments.
• Slit Length / Dimensional Stability: To maintain proper sealing and instrument passage.
• Confirmatory testing: To ensure continued performance as intended, especially given the change in sterility status compared to a prior predicate. | Met criteria (Substantially Equivalent) |
  | Auxiliary Waterjet Valve (Connector) | - Flow Rate / Durability Testing: To ensure adequate irrigation flow and sustained performance.
• Backflow Prevention Test: To prevent backflow. | Met criteria (Substantially Equivalent) |
  | Cleaning Adapter | - Gas Flow Rate: To ensure proper air channel cleaning.
• Water Flow Rate: To ensure proper water channel cleaning.
• Mechanical Testing:
  • Depression Force
  • Adapter Application Force
  • Adapter Removal Force
    (Ensures proper function, insertion, and removal).
• Button Cycling / Durability Testing: To ensure repeated functional use for pre-cleaning. | Met criteria (Substantially Equivalent) |
  | Packaging | - ISO 11607/ASTM 4169 testing: To ensure sterile barrier maintenance after shipping/transit. | Met criteria (Sterile Barrier Maintained) |
  | Biocompatibility | - ISO 10993-1 assessment: "Biocompatibility testing conducted on the patient-contacting portions... in accordance with the ISO 10993 standard." "The test result shows that the subject devices are biocompatible." | Met criteria (Biocompatible) |

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

The document does not specify the exact sample sizes (N) for each of the performance tests. It states that "Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination."

Data provenance: The testing was performed by Medivators (A Subsidiary of STERIS Corporation) in Conroe, Texas, USA. It's engineering performance test data, not patient data, so "country of origin of the data" in the sense of patient demographics is not applicable. The data is retrospective based on the tests performed for this submission.

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

This is not applicable as this is a 510(k) submission for physical medical device accessories (valves, connectors, adapters), not an AI/software device that requires human expert review for "ground truth" establishment from medical images or clinical data. The "ground truth" for these performance tests is based on engineering specifications, physical measurements, and functional requirements.

4. Adjudication method for the test set

Not applicable, as this is related to expert consensus for AI/SaMD ground truth, which is not relevant for this device.

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 not an AI/SaMD.

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

Not applicable. This is not an AI/SaMD.

7. The type of ground truth used

The "ground truth" for the performance of these physical accessories is defined by established engineering and functional specifications, industry standards (e.g., ISO 11607 for packaging, ISO 10993 for biocompatibility), and the performance of the legally marketed predicate devices. The tests verify that the subject devices meet these specifications for safe and effective use.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD, so there is no "training set."

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

Not applicable.

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