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The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

This document is a 510(k) premarket notification from the FDA for a medical device. It is not a study demonstrating the performance of an AI/ML powered device. Most of the requested information regarding AI/ML study design and results is therefore not applicable.

The device is the "Defendo Fujifilm 700 Single Use Cleaning Adapter," which is a non-sterile, single-use disposable valve intended to pre-clean endoscope air/water channels post-procedure. The submission is a "Special 510(k)" to obtain clearance for a non-sterile version of a previously cleared sterile device (K232329).

Here's the relevant information based on the provided text, with explanations why certain points are not applicable:

1. A table of acceptance criteria and the reported device performance

The document provides a summary table of non-clinical performance testing. The "Acceptance Criteria" column consistently states "Meet acceptance criteria" without detailing the specific numeric or qualitative thresholds for each test. However, the "Results" column consistently states "Pass," indicating that the device met these (undisclosed) criteria for all tests.

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: The document does not specify the sample size for any of the non-clinical tests conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that these are benchtop "non-clinical" performance tests for a physical device, the concepts of retrospective/prospective clinical data or patient data provenance do not apply.

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 is not applicable. The device is a mechanical cleaning adapter, not an AI/ML-powered diagnostic tool. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant to its performance testing. The "truth" here is objective physical measurements and functional performance as per engineering specifications.

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

Not applicable. As noted above, this is not a study requiring expert adjudication of clinical findings.

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/ML device, nor is it a clinical study involving human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance testing consists of engineering specifications, material properties, and functional requirements (e.g., specific flow rates, force thresholds, leak prevention). It is established through physical measurements and bench testing against predefined criteria, not against clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The provided text is a 510(k) summary for a medical device (VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM), which focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data. It is not an AI/ML device, and therefore, the information requested in the prompt regarding AI/ML specific criteria (such as training set, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and stated device performance for this non-AI/ML medical device from the provided text.

Here's the relevant information presented in the format requested, with explicit notes about the inapplicability of AI/ML specific criteria:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The "reported device performance" is given as "PASS" in the document, indicating that the device successfully met the stated acceptance criteria for each test.

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

The document does not explicitly state the numerical sample size used for the test set experiments (Simulated Use Testing, Parallel performance as biological indicator). It only indicates "100% pass" and "100% fail" which implies that, for the tests conducted, all units observed performed as expected.

Regarding data provenance:

• The tests are described as "Simulated Use Testing" and "Parallel performance as biological indicator." This suggests the data was generated in a controlled laboratory or testing environment simulating real-world conditions.
• The document does not specify the country of origin of the data providers or if it was retrospective or prospective data, as these concepts are generally not applicable to the non-clinical testing of a chemical indicator device.

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

This question is not applicable as the device is a chemical indicator for sterilization. Its "ground truth" is established by physical and chemical properties and calibrated against known sterilization parameters and biological indicators, not by human expert interpretation of images or data. No human experts are involved in establishing the "ground truth" for the performance of this type of device in the context of the described tests.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this type of device testing. The results (pass/fail for the indicator's chemical reaction) are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. This is not an AI-assisted diagnostic or interpretive device. There are no human readers whose performance is being compared with or without AI assistance.

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

This question is not applicable. This is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its design and chemical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by:

• Pre-defined sterilization cycle parameters (temperature, time, pressure – i.e., "pass conditions").
• Pre-defined under-sterilization conditions (e.g., "stated value -15% time and/or -1°C" – i.e., "fail conditions").
• The performance of a biological indicator (BI), which is the gold standard for demonstrating sterilization efficacy by showing inactivation of highly resistant bacterial spores. The integrator's performance is compared to the BI's performance, ensuring the integrator does not "pass" before the BI is inactivated.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical chemical indicator, not an AI/ML device that requires a "training set." Its design and functionality are based on chemical engineering principles, not machine learning from data.

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

This question is not applicable for the same reasons as #8.

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