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510(k) Data Aggregation
(255 days)
Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator
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)
Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator
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)
Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR
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)
ENDOGATOR Hybrid Irrigation Tubing
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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(28 days)
EndoGator Endoscopy Irrigation Tubing
The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).
The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.
The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic device.
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(189 days)
ENDOGATOR ADVANTAGE IRRIGATION PUMP
The EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
The EndoGator Advantage Irrigation Pump EGA-500 is the second generation development of the current Byrne Medical EGP-100 Irrigation Pump. The EndoGator Advantage provides for a slightly higher flow rate of endoscope irrigation water and contains an attached water bottle heater to afford the clinician the option of performing water irrigation with warmed water as compared to room temperature.
The EndoGator Advantage Irrigation Pump works by turning a peristaltic roller pump head to move liquid through a tube set and into an endoscope system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated. The unit incorporates a "Prime" feature which allows the unit to operate for a predetermined period of time.
The device includes a water bottle warming cradle that is intended to maintain a bottle of sterile water for irrigation at a target temperature of 37°C with a tolerance of ±3°C. The water bottle heating element is attached to the underside of the aluminum cradle which then conducts heat through the bottle to warm the water. The heating element is controlled by dual temperature sensors for redundancy and safety.
This document describes the EndoGator Advantage Irrigation Pump EGA-500, a medical device. The information provided is primarily for a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a study proving the device meets explicit acceptance criteria in the context of AI/algorithm performance.
Therefore, many of the requested items related to AI/algorithm performance, such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from the provided text.
However, based on the non-clinical performance data and device description, we can infer some aspects related to acceptance criteria and how they were addressed.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/algorithm-based device and the document describes a 510(k) submission for an irrigation pump, the "acceptance criteria" are derived from the performance claims and testing conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" reflects the successful outcomes of these tests.
| Acceptance Criteria Category | Specific Criteria (Inferred from testing) | Reported Device Performance/Conclusion |
|---|---|---|
| Flow and Pressure | Equivalent or acceptable flow and pressure characteristics compared to predicate devices. | "Flow and pressure comparison" was performed, implying that the EGA-500 demonstrated comparable or acceptable performance to the predicate EndoGator EGP-100 and Olympus AFU-100. |
| Water Temperature | Maintain target temperature of 37°C ±3°C for sterile water for irrigation. | "Water temperature consistency and distribution" and "Heater performance" testing were conducted. The device aims to maintain water at a target temperature of 37°C ±3°C, and the testing supports this capability. The added water warming feature is deemed acceptable as it introduces water heated to approximately the same temperature as surrounding GI tissues. |
| Pump Performance | Reliable and consistent operation of the peristaltic roller pump head. | "Pump performance" testing was conducted to ensure the pump operates consistently and reliably. The description notes safety features like the pump head not operating when open and ceasing operation if opened during activation, and a "Prime" feature. |
| Safety - Electrical | Compliance with IEC 60601-1 (Electrical safety). | The device meets "Electrical safety IEC 60601-1" standards, indicating it passed relevant electrical safety tests. |
| Safety - EMC | Compliance with IEC 60601-1-2 (Electromagnetic compatibility). | The device meets "Electromagnetic compatibility IEC 60601-1-2" standards, indicating it passed relevant EMC tests. |
| Simulated Use | Safe and effective operation in simulated clinical settings. | "Simulated-use" testing was performed, suggesting the device functioned as intended under conditions mimicking its intended use. |
| Risk Analysis | Identification and mitigation of potential risks. | "Risk analysis" was conducted. The document states that "Any additional risks presented by the added water warming feature on the subject device are acceptable because it is simply being used to introduce water that is heated to approximately the same temperature as the surrounding tissues in gastrointestinal (GI) tract," implying that identified risks were assessed and deemed acceptable or mitigated. |
| Indications for Use | Equivalent indications for use as predicate devices. | The device has "equivalent indications for use as the predicate devices." All devices share the same intended performance and method of sterile water irrigation during GI endoscopy. |
Study Information (Based on the provided text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. Bench testing was performed on the device itself.
- Data Provenance: Not specified. Testing was conducted by Medivators, a US-based company, likely implying testing occurred in the USA. The data would be prospective as it was generated specifically for this 510(k) submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-AI medical device; "ground truth" in the context of expert consensus on images or outcomes is not relevant here. Device performance criteria were likely established by engineering and regulatory standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for bench testing of device performance against engineering specifications.
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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-assisted device, nor does the document describe a human reader study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (irrigation pump), not an algorithm. The "standalone" performance here refers to the device operating on its own as designed, which is inherent in the "bench testing" mentioned.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. For this device, the "ground truth" or reference for assessment would be:
- Engineering specifications and design requirements: For pump performance, flow rates, and pressure.
- Regulatory standards: Such as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
- Predicate device performance: For comparative equivalence of function.
- Thermodynamic principles/specifications: For temperature control (37°C ±3°C).
- Not applicable in the conventional sense. For this device, the "ground truth" or reference for assessment would be:
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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(104 days)
ENDOGATOR
The EndoGator™ system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).
The Byrne Medical EndoGator™ System is composed of the following:
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- EndoGator™ Irrigation Tubing, and
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- EndoGator™ Irrigation Accessories
The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.
The provided text describes a 510(k) premarket notification for the “EndoGator™ System,” a device intended to provide irrigation during GI endoscopic procedures. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the requested elements for a detailed study description are not available in the provided document.
Here's a breakdown of the information that can be extracted or inferred, and what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Functionally equivalent in safety and efficacy to predicate devices. | "Flow and pressure testing was completed with representative scopes and evaluated based on various pump settings; real-time flow rate data was collected." |
| Appropriate materials for the application. | "made from materials that are appropriate for the application." |
| Provides water to irrigator pumps or cauterizing units. | "The EndoGator™ System and all predicate devices provide water to irrigator pumps or cauterizing units." |
Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum flow rate, maximum pressure deviation). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing legally marketed devices (predicates). The reported performance is a qualitative statement that the device was tested for flow and pressure and found to be functionally equivalent.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "representative scopes" were used for flow and pressure testing.
- Data Provenance: Not specified, but likely internal testing by Byrne Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device (a water bottle adapter for irrigation) is physical performance (flow, pressure, material compatibility) rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described or implied for the performance testing of this mechanical 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 device is not an AI-powered diagnostic or assistive tool, so an MRMC comparative effectiveness study involving human readers and AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing would be established engineering standards and validated measurement techniques for flow rate and pressure, combined with material science evaluations. The document refers to "extensive safety, performance, and validations" and "real-time flow rate data was collected," indicating a focus on physical performance rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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(12 days)
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.
The provided document states that the Byrne Medical, Inc. EndoGator Endoscopy Irrigation Pump is substantially equivalent to its predicate device, the Meditron Endolav Model EL-100 (K882048), based on a comparison of specifications and the successful completion of EMI and Safety Testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's performance in the traditional sense of a clinical study. Instead, it compares the specifications of the EndoGator EGP-100 to its predicate device, the Meditron Endovav EL-100, as part of demonstrating substantial equivalence. The "acceptance criteria" here are implied to be achieving comparable or superior performance to the predicate device for relevant parameters, and meeting safety/EMC standards.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (EndoGator EGP-100) | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Endoscopic irrigation for use with washing catheters, integral endoscope water jet channels, and endoscope working channels. | Endoscopic irrigation for use with washing catheters, integral endoscope water jet channels, and endoscope working channels. | Yes |
| Regulation # | 21 CFR 876.1500 | 21 CFR 876.1500 | Yes |
| Target Population | Male/Female pediatric to adult | Male/Female pediatric to adult | Yes |
| Prescription Device | Yes | Yes | Yes |
| Dimensions (H x W xD) | 4.5" x 5" x 8" | 3.5" x 6" x 8" | Not directly "same," but considered acceptable for substantial equivalence (smaller size) |
| Classification | Class I, Type BF, Ordinary Equipment for Continuous operation | Class I, Type BF, Ordinary Equipment for Continuous operation | Yes |
| Min flow rate | 15 ml/min | 0 ml/min | Not directly "same," but an improvement (lower minimum) and considered acceptable. |
| Max flow rate | 650 ml/min | 550 ml/min | Not directly "same," but within a comparable range and considered acceptable. |
| Min Pressure | 2 PSI | 0 PSI | Not directly "same," but an improvement (lower minimum) and considered acceptable. |
| Max Pressure | 40 PSI | 48 PSI | Not directly "same," but an improvement (higher maximum) and considered acceptable. |
| Pump type | Peristaltic | Peristaltic | Yes |
| EMI and Safety Testing | Meet specified acceptance criteria | Successfully conducted and expected to meet specified acceptance criteria (as stated in Conclusions) | Yes, planned and accepted as part of the overall submission. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical data or patient samples. The evaluation is based on a comparison of device specifications and the results of engineering tests (EMI and Safety). Therefore, there is no sample size for a test set, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there is no clinical "test set" with ground truth established by experts, this information is not provided. The substantial equivalence relies on comparing technical specifications and engineering test results.
4. Adjudication method for the test set
Not applicable. There is no clinical "test set" requiring an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an irrigation pump, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance, in the context of this 510(k) submission, is established through:
- Comparison to a legally marketed predicate device's established performance and specifications.
- Engineering standards and testing: Specifically, EMI (Electromagnetic Interference) and Safety Testing (referred to as "Test Review" and affirmed in the "Conclusions"). These tests verify the device's electrical and mechanical integrity against recognized standards.
8. The sample size for the training set
Not applicable. This device is a mechanical pump, not a learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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