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510(k) Data Aggregation
(255 days)
Medivators (A Subsidiary of STERIS Corporation)
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.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Air/Water Valve | ||
| Gas (Air and CO2) flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Water flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Backflow prevention testing | Effective backflow prevention comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Button Cycling | Durable operation over repeated cycles comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Valve | ||
| Suction Bypass | Effective suction bypass comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Rate (water and soil) | Suction rates comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Valve Operation / Procedure Duration Test | Durable operation over typical procedure duration | Met acceptance criteria (implied by overall conclusion) |
| Biopsy Valve | ||
| Leak Testing | Minimal leakage comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Insufflation Testing | Effective maintenance of insufflation comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Auxiliary Waterjet Valve (Connector) | ||
| Flow Durability Testing | Durable flow over repeated use | Met acceptance criteria (implied by overall conclusion) |
| Torque Test | Adequate torque resistance for secure connection | Met acceptance criteria (implied by overall conclusion) |
| Packaging | ||
| ISO 11607/ASTM 4169 (sterile barrier) | Sterile barrier maintained after shipping/transit | Maintained sterile barrier (explicitly stated) |
| Biocompatibility | ||
| ISO 10993-1 (for patient-contacting portions) | Biocompatible as per ISO 10993-1 | Subject devices are biocompatible (explicitly stated) |
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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(244 days)
Medivators (A Subsidiary of STERIS Corporation)
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.
| Device Component | Test Performed | Implicit "Acceptance Criteria" (Substantial Equivalence) | Reported Performance (Implied "Met") |
|---|---|---|---|
| Air/Water Valve | Gas (Air and CO2) flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Water flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Backflow prevention | Effective prevention of backflow, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Suction Valve | Suction Bypass | Effective suction bypass, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Suction Rate (water and soil) | Effective suction of water and soil at rates comparable to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Biopsy Valve | Leak Testing | Minimal or no leakage, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Insufflation Testing | Effective maintenance of insufflation, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Auxiliary Waterjet (Connector) | Flow Durability Testing | Durable flow comparable to predicate, capable of extended use as intended. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Check Valve Functionality (Back Flow Prevention) | Effective backflow prevention, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical Strength Testing | Adequate mechanical strength for intended use, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| All Devices | Packaging Testing (ISO 11607/ASTM 4169) | Packaging maintains sterile barrier after shipping/transit, demonstrating sterility assurance. | Testing completed; packaging maintains sterile barrier. |
| All Devices | Biocompatibility (ISO 10993) | Patient-contacting portions of the device are biocompatible. | Test results show the subject devices are biocompatible. |
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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(140 days)
Medivators (A Subsidiary of STERIS Corporation)
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:
| Device Component | Type of Testing and Implied Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|
| Air/Water Valve | - Gas (Air and CO2) flow rate testing: Likely to ensure sufficient airflow for insufflation. |
- 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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(90 days)
Medivators
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.
The provided text describes the ENDOGATOR™ Hybrid Irrigation Tubing, a device for providing irrigation and supplying air/CO2 during GI endoscopic procedures. It compares this device to a predicate device (Universal Irrigation Solution Hybrid, K102855).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of acceptance criteria and the reported device performance
| Testing | Requirements | Reported Device Performance |
|---|---|---|
| Water Flow Rate | Lensing Flow Rate must be no lower than 10% of Predicate after calling for water for 20 seconds | Pass |
| Insufflation Air & CO2 Flow | Air & CO2 Flow Rate must be no lower than 10% of the predicate | Pass |
| Backflow Test | The backflow valve must withstand at least 10 PSI | Pass |
| Lens Rinsing Flow Rate | Lensing Flow Rate must be no lower than 10% of predicate after calling for water for 20 seconds | Pass |
| Durability of glue bonded connections | The bonded connections must meet or exceed 10 lbs of axial pull force and must maintain strength and durability requirements after being subjected to 2X EtO sterilization. | Pass |
Biocompatibility Testing:
- Requirements: Evaluated in accordance with ISO 10993-1:2018 for "Surface - Mucosal Membrane" with a contact duration of "Limited (
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(153 days)
Medivators Inc
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.
The provided text is a 510(k) Premarket Notification for the "Endo SmartCap™" device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria. The document describes a medical device accessory, not an AI/ML system.
Therefore, many of the requested details about acceptance criteria for AI/ML performance, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be found in this document because the device is a physical accessory (Endoscope and Accessories), not an AI/ML software.
However, I can extract the information related to the device's functional performance testing.
Here's what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance (for functional testing):
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Confirmation of flow rate | The average mean flow of the 100551-production sample must be no lower than 10% of the flow of the same tubeset without a filter | PASS |
| Prevention of backflow | The 100551 shall not allow water to backflow into the CO2EFFICIENT insufflator | PASS |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices/tests, but implies multiple production samples for the flow rate test ("average mean flow of the 100551-production sample").
- Data Provenance: The document does not specify the country of origin of the data. The tests conducted are functional performance tests of the device itself, not data-driven performance. The tests are retrospective in the sense that they were conducted for the 510(k) 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 the device is a physical accessory undergoing functional engineering tests (flow rate, backflow prevention), not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth. The "ground truth" here is the objective measurement of physical properties.
4. Adjudication method for the test set:
- Not applicable for functional engineering tests. The results are objective measurements against predefined engineering specifications.
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 physical medical accessory, not an AI/ML system for diagnostic assistance. No human reader studies with or without AI were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The reported tests are for the standalone physical device's functional performance.
7. The type of ground truth used:
- For flow rate and backflow prevention tests, the "ground truth" is established by engineering specifications and direct physical measurement. For example, for flow rate, it would involve direct measurement of water/gas volume over time. For backflow, it's the observation of whether water backflows into the insufflator.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for a training set.
In summary, this document is for a traditional medical device accessory (Endo SmartCap™) seeking 510(k) clearance based on substantial equivalence. The "study that proves the device meets the acceptance criteria" in this context refers to engineering performance testing rather than the clinical validation or AI algorithm performance studies typically associated with the detailed questions provided.
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(36 days)
Medivators Inc
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
The provided text describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Delivery Flow Rate Verification | Meet manufacturers minimum requirements for individual channel flushing volumes. | PASS |
| Tubing Durability Verification | The 24-hour tubing shall withstand at least 40 full automatic cycles without leaking. | PASS |
| Software Verification | Verification steps outlined in procedure must be met for acceptance of the protocol. | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.
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
An MRMC comparative effectiveness study was not done. The device is an electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.
- For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
- For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
- For Software Verification, the ground truth is the "verification steps outlined in procedure."
These are objective, measurable criteria rather than clinical ground truth established by experts.
8. The sample size for the training set
The document does not mention a "training set" as this device is not a machine learning or AI model.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set.
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(105 days)
Medivators Inc.
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.
The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.
Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm
The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).
The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.
Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.
The provided text describes the regulatory submission for the "Advantage Plus Pass-Thru Automated Endoscope Reprocessing System" (K172677). The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study involving human readers or expert consensus for AI performance.
Therefore, much of the requested information regarding AI-specific criteria, human expert involvement, ground truth establishment for training and test sets, and MRMC studies, is not applicable or not present in this document. This submission pertains to a medical device for high-level disinfection of endoscopes, not an AI/ML-driven diagnostic or image-analysis device.
However, I can extract the acceptance criteria and performance for the non-clinical performance tests that were conducted to demonstrate substantial equivalence of this device.
Here's the information based on the provided text:
Acceptance Criteria and Reported Device Performance
The device is an Automated Endoscope Reprocessor (AER) intended for high-level disinfection. The performance testing conducted was to demonstrate its physical and microbiological effectiveness in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated-Use Testing (Demonstrates high-level disinfection with Rapicide PA HLD and Intercept Plus detergent) | Achieve 6-log reduction of the test organism in each endoscope channel and endoscope exterior. | Pass |
| Clinical In-Use Testing (Demonstrates high-level disinfection after patient/clinical use) | Demonstrate no viable organisms remain after reprocessing. | Pass |
| Water-Line/Self-Disinfection Cycle Testing (Evaluation of bactericidal effectiveness of the self-disinfection cycle and biofilm analysis) | Survivors after the SDC must be ≤ 10 CFU of test organism per 100 mL. | |
| Absence of biofilm formation following self-disinfection cycle. | Pass | |
| Rinse Residual Testing (Evaluation of residual levels of Rapicide PA and Intercept Plus) | Any chemistry residuals must be equal to or lower than the lowest reported LD50 exposure with a 10-fold safety margin. | Pass |
| Material Compatibility (Demonstrates system compatibility with Rapicide PA HLD and Intercept Plus Detergent) | Acceptance criteria included dimensional and weight changes |
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(142 days)
MEDIVATORS INC.
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
The provided text is a 510(k) Summary for the "Scope Buddy Plus Endoscope Flushing Aid" and details its equivalence to a predicate device, not its acceptance criteria or a study proving it meets such criteria in the traditional sense of a clinical trial for diagnostic performance.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Fluid Pump CP-3, K914524) rather than establishing novel safety and effectiveness through a clinical performance study with acceptance criteria like sensitivity, specificity, or accuracy. Therefore, many of the requested points below are not directly applicable or available in this type of submission.
However, I can extract information related to the device's functional performance testing which serves as a form of "acceptance criteria" for its intended mechanical function.
Here's an attempt to answer your questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical flushing aid, the "acceptance criteria" from the document revolve around its ability to deliver fluids according to manufacturer specifications and meet safety standards.
| Acceptance Criteria (Functional Performance) | Reported Device Performance |
|---|---|
| Detergent Dosing Capability: Ability to dose a set volume of detergent. | Demonstrated the ability of the subject device to dose a set volume of detergent. (Specific volumes/tolerances are not detailed in this summary, but the general capability was affirmed.) |
| Fluid Delivery Flow Rate Performance: Meet or exceed the endoscope manufacturer's requirements for fluid delivery through endoscope channels during manual cleaning. | Determined the flushing times required by the subject device to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning. (Specific flow rates/tolerances are not detailed, but compliance with requirements was affirmed.) |
| Electrical Safety: Compliance with IEC 61010-1. | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 61326-1. | Compliance demonstrated. |
| Software Validation: Compliance with FDA's guidance for software in medical devices. | Software Validation conducted as recommended per FDA's guidance. (Specific validation results are not detailed.) |
| Human Factors/Usability: Safe and effective use by users per IEC 62366-1 and FDA guidance. | Human Factors/Usability Evaluation conducted to validate that users can safely and effectively use the subject device. (Specific evaluation results are not detailed.) |
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 for Test Set: The document does not specify sample sizes for any of the functional or safety tests. These types of tests typically involve a set number of devices or iterations to demonstrate performance and compliance, but the exact numbers are not provided in this summary.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given that Medivators Inc. is a US-based company and the submission is to the US FDA, the testing was likely conducted in the US and prospectively as part of the device development and validation.
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 question is not applicable to this type of device. The "ground truth" for a mechanical flushing aid is its ability to perform its specified function (e.g., deliver a certain volume of fluid, meet safety standards). This is assessed through engineering and performance testing, not via expert interpretation of diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images). For engineering and functional tests, results are typically objective measurements against a predefined specification, not subjective interpretations requiring adjudication.
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 question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a mechanical device, not an AI-powered diagnostic tool involving human readers or interpretation of cases. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is not an algorithm, but a mechanical flushing aid. While it has software, its "standalone" performance refers to its ability to pump fluids, which is what the functional performance testing assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is objective measurement against engineering specifications and regulatory standards. For example:
- Detergent Dosing/Fluid Delivery: Measured volumes and flow rates compared to pre-defined manufacturer requirements.
- Electrical Safety/EMC: Compliance with specified international standards (IEC 61010-1, IEC 61326-1) based on test measurements.
- Software Validation: Adherence to software development lifecycle processes and functional requirements.
- Human Factors/Usability: Observation and assessment of user interaction against usability goals and safety criteria.
8. The sample size for the training set
- This question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven model training.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no "training set" for this type of device.
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(108 days)
MEDIVATORS, INC.
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.
The Medivators AmplifEYE device, an endoscope accessory, does not present Acceptance Criteria in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Arc EndoCuff and Arc Endocuff Vision) rather than defining specific performance thresholds as acceptance criteria for a new clinical indication or outcome.
The study presented is a non-clinical performance evaluation comparing the AmplifEYE with its predicate devices.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance:
As no explicit acceptance criteria are provided in the document for the AmplifEYE's primary function of "keeping the suitable depth of endoscope's view field" or "helping the endoscope with being inserted into the gastrointestinal tract," a table of acceptance criteria and reported device performance cannot be created as requested. The document primarily focuses on demonstrating equivalence through design and non-clinical testing.
The document highlights:
| Parameter | Acceptance Criteria (Not explicitly stated, but implied by equivalence) | Reported Device Performance (AmplifEYE) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (facilitate endoscopic therapy, maintain suitable depth of view, aid insertion). | Claimed equivalent by Medivators. |
| Principle of Operation | Equivalent to predicate devices. | Claimed equivalent by Medivators. |
| Scientific Technology | Equivalent to predicate devices. | Claimed equivalent by Medivators. |
| Sterilization Method | Demonstrate equivalent sterility assurance to predicate devices' irradiation method, even if different. | Ethylene Oxide sterilization validated to provide equivalent sterility assurance. |
| Open Wings Diameter | Equivalent performance, no questions of safety or efficacy despite slight size difference. | Slight greater open wings diameter than predicates, but bench testing and animal testing demonstrated equivalent performance and no safety/efficacy concerns. |
| Force to Remove | (Implied to be within acceptable limits for safe use and equivalent to predicates) | Tested as part of Design Verification. Specific values not reported. |
| Force to Deflect | (Implied to be within acceptable limits for safe use and equivalent to predicates) | Tested as part of Design Verification. Specific values not reported. |
| Shelf-life | (Implied to meet required duration and maintain functionality/sterility) | Validated (Functional Testing, Sterile Barrier Integrity Testing). Specific duration not reported. |
| Biocompatibility | Conformance to ISO 10993-1. | Polymer conforming to ISO 10993-1. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for specific tests.
- Bench Testing: Indicated for "open wing diameter difference" and "Design Verification (Force to Remove Testing, Force to Deflect Testing)". The exact number of units or repetitions used for these tests is not provided.
- Animal Testing: Performed. The number and type of animals used are not specified.
- Data Provenance: Not specified, but likely internal company testing (Medivators Inc.). The document does not indicate external or multi-center trial data. The data is non-clinical, related to device characteristics and animal studies, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This study is a non-clinical evaluation for substantial equivalence, primarily focusing on engineering and material performance, and animal testing. It does not involve human subjects or the establishment of a medical 'ground truth' by experts in a diagnostic or clinical efficacy context.
4. Adjudication Method for the Test Set:
- Not Applicable. As no 'ground truth' from human data or expert consensus is established for a diagnostic or efficacy claim, no adjudication method would be relevant or discussed in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or other tools on human reader performance with medical images, which is not the scope of this device or its evaluation. The AmplifEYE is a physical accessory to an endoscope, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, in spirit, as a non-clinical standalone device evaluation. The testing performed (Design Verification, Shelf-life, Sterilization Validation, Animal Testing) evaluates the device's inherent characteristics and performance without human interaction in a diagnostic or interpretive loop. However, it's important to note this is not an "algorithm-only" performance as the device is mechanical/physical, not software. The performance demonstrated in these tests is for the device itself.
7. The Type of Ground Truth Used:
- Engineering specifications, industry standards, and biological response.
- For Design Verification (Force to Remove, Force to Deflect): Ground truth would be defined by engineering design requirements and acceptable ranges for mechanical properties.
- For Sterilization Validation: Ground truth involves demonstrating a Sterility Assurance Level (SAL), often 10^-6, through established microbiological testing methods.
- For Biocompatibility: Ground truth is adherence to standards like ISO 10993-1.
- For Animal Testing: Ground truth would be observed physiological responses, safety, and functionality in a living system.
8. The Sample Size for the Training Set:
- Not Applicable. As described, this is not an AI/machine learning device; therefore, there is no "training set." The device is a physical medical accessory.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
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(200 days)
MEDIVATORS INC.
The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.
Rapicide PA High-Level Disinfectant Test Strips have the ability to measure the disinfectant use solution concentration above 850ppm PAA. This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black color.
The Medivators Rapicide PA High-Level Disinfectant Test Strips are designed to ensure that the Rapicide PA High-Level Disinfectant Solution is above its minimum recommended concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning a solid black color when the solution is above 850ppm PAA, while a "fail" is indicated by the pad turning dark grey, violet grey, light grey, or white (no color change) if the solution is at or below the MRC.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC, positive response at higher concentrations. | Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive response at higher concentrations. |
| Comparative Sensitivity and Specificity | Comparative sensitivity and specificity of 1 (implicitly, indicating perfect agreement with a reference method or ideal performance). | Met Acceptance Criteria: Comparative sensitivity and specificity of 1. |
| Analytic Specificity – Contaminants | Negative response at MRC (for contaminants), positive response at higher concentration (for the active ingredient). (This implies the device should not give a false positive due to contaminants at MRC, and correctly identify the active ingredient above MRC). | Met Acceptance Criteria: Negative response at MRC, positive response at higher concentration. |
| Analytic Specificity - Other Germicides | Negative response to other germicides. (Ensuring the device is specific to peracetic acid and does not react with other common germicides). | Met Acceptance Criteria: Negative response to other germicides. |
| Shelf Life | Met specifications after storage for a labeled shelf life of 12 months (unopened). | Met Acceptance Criteria: Met specifications after storage for labeled shelf life of 12 months (unopened). |
| In-Use (Open Bottle) Stability | Met specifications after storage for a labeled open bottle shelf life of one month. | Met Acceptance Criteria: Met specifications after storage for labeled open bottle shelf life of one month. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each of the tests (Dynamic Range, Comparative Sensitivity and Specificity, Analytic Specificity – Contaminants, Analytic Specificity - Other Germicides, Shelf Life, In-Use Stability). It only indicates that "non-clinical tests" were performed.
The data provenance is from Medivators Inc., a company based in Minneapolis, MN, USA. The data is retrospective as it was generated prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a chemical indicator, the ground truth would likely be established by a laboratory assay (e.g., titration or spectrophotometry) to precisely determine the peracetic acid concentration, rather than by human experts interpreting the results.
4. Adjudication method for the test set:
This information is not applicable as the test strips are chemical indicators with a direct visual output (color change). The outcome is determined by the specific chemical reaction embedded in the strip, not by expert adjudication.
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 is not applicable. The device is a chemical test strip, not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a chemical test strip, not an algorithm. The "standalone" performance is the inherent chemical reaction on the strip.
7. The type of ground truth used:
The ground truth used for these chemical test strips would be the actual concentration of peracetic acid in the disinfectant solution, determined by a precise analytical method (e.g., chemical titration, spectrophotometry, or a validated reference standard). The document implies this by referring to "concentrations at or below MRC" and "higher concentrations."
8. The sample size for the training set:
This information is not provided as chemical test strips do not typically involve a "training set" in the context of machine learning or AI. The performance of the test strip is a result of its chemical formulation and manufacturing process, optimized through R&D and verified through testing.
9. How the ground truth for the training set was established:
This is not applicable as there isn't a "training set" in the traditional sense for these chemical test strips. The chemical composition is designed to react at specific concentrations, and the ground truth for validating this design (during R&D and manufacturing quality control) would be established using precise analytical methods to determine peracetic acid concentrations in control solutions.
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