Search Results

The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.

The provided document is a 510(k) summary for the LAGIS Suction Irrigation System, which is a medical device, not an AI/ML algorithm. Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device is not applicable to this document.

This document details:

• Device Name: LAGIS Suction Irrigation System
• Intended Use: To provide suction and irrigation functions in laparoscopic procedures to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
• Regulatory Class: Class II (Product Code GCJ - Laparoscope, General & Plastic Surgery)
• Predicate Device: Taiwan Surgical Disposable Suction Irrigation (K150253)
• Performance Tests: The summary lists performance bench tests conducted to verify design characteristics and ensure the device can be used as intended. These include:
  • Biocompatibility testing (following ISO 10993-1)
  • Sterilization validation (according to ISO 11135)
  • Functional and performance characteristics (airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force performances).
• Conclusion: The tests met the predefined acceptance criteria, and no new questions of safety and effectiveness were identified. The device was deemed substantially equivalent to the predicate device.

Since the device is a physical medical instrument (suction irrigation system) and not a software/AI product, the detailed questions about AI model training, test sets, expert ground truth, adjudication methods, and MRMC studies are irrelevant to this submission.

Ask a specific question about this device

The Diversatek Healthcare PureFlo™ System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction pump or electrosurgical unit.

The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

This submission includes the Diversatek Healthcare PureFlo™ Irrigation System and Water Bottle Tubing. All devices within this submission are provided sterile.

The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

The irrigation system consists of irrigation tubing and a single-use auxiliary water jet connector. The tubing is inserted into a water bottle and the cap is screwed on the water bottle. The roller pump tubing of the irrigation tubing is then positioned within one of the specified pumps. The tubing is then connected to the auxiliary water jet connector. The auxiliary water jet connector is then connected to the auxiliary water port of the endoscope. To activate the flow of water, the foot pedal of the pump is pressed. The tubing should be primed prior to insertion of the endoscope in the patient.

The auxiliary water jet connector is replaced after each patient. The irrigation tubing can be used for up to 24 hours on multiple patients.

The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

With the pinch clip open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the Gl endoscope. The tubing is then primed prior to insertion of the endoscope in the patient.

The water bottle tubing can be used for up to 24 hours on multiple patients.

The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

The PureFlo™ Water Bottle Tubing CO2 is used with either air or CO2.

If using with air: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The white pinch clamp is then closed. The tubing is then primed prior to insertion of the endoscope in the patient.

If using with CO2: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The CO2 Connector / Luer Lock is then connected to the luer lock connection on the CO2 insufflator. The CO2 source and insufflator is then turned on. Then turn on the light source of the processor. The tubing is then primed prior to insertion of the endoscope in the patient.

The water bottle tubing CO2 can be used for up to 24 hours on multiple patients.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for the Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing units. While explicit "acceptance criteria" are not listed with numerical thresholds, the document states: "All test results passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device." This implies that the acceptance criteria were defined by achieving outcomes comparable to or superior to the predicate devices and demonstrating safety and effectiveness.

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

• Sample Size: The document does not specify the exact number of units used for each non-clinical test. It states "Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on Diversatek Healthcare samples from final, finished devices that were subjected to all manufacturing processes for the 'to be marketed' device (including sterilization, environmental conditioning, and transportation)."
• Data Provenance: The data is from non-clinical bench testing performed by Diversatek Healthcare. It is prospective in the sense that fresh, "to be marketed" devices were used for testing. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to meet U.S. regulatory standards.

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

This section is not applicable as the described study is a non-clinical bench testing study, not a clinical study involving human experts or ground truth in that sense. The "ground truth" for these tests would be the established engineering and biological specifications and performance standards.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reason as point 3. No human experts were involved in adjudicating outcomes for these bench tests. The results were likely assessed against predetermined engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical bench testing, not a clinical study comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is not applicable. The device described (irrigation system/water bottle tubing) is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was based on established engineering specifications, performance standards, and biological safety criteria (e.g., ISO 10993-1 for biocompatibility). The claim is for "substantial equivalence" to predicate devices, inferring that the performance benchmarks of the predicate devices also serve as a form of reference.

8. The Sample Size for the Training Set:

This section is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set."

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

The subject BD Surgiphor™ Antimicrobial Irrigation System is a terminally sterilized 450 mL aqueous solution for irrigation and debridement of wounds. The device includes one bottle of Surgiphor™ solution (0.5% Povidone Iodine) which is used to loosen and remove wound debris. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the loosening and removal of debris, and foreign materials, including microorganisms, from wounds. The povidone iodine in the Surgiphor™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text describes a 510(k) premarket notification for a medical device called the "BD Surgiphor™ Antimicrobial Irrigation System." This submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K213616).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance:

The core of this 510(k) submission is to demonstrate that a modified device is substantially equivalent to a predicate device, not to establish new performance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily tied to demonstrating that the changes made do not negatively impact the safety or effectiveness of the device compared to the predicate.

The main change in the subject device (K221504) from its predicate (K213616) is the removal of the SurgiRinse™ solution bottle. The device still includes one bottle of Surgiphor™ solution. The manufacturer asserts that the fundamental "mechanism of action" (mechanical loosening and removal of debris and foreign materials, including microorganisms, from wounds through fluid pressure) remains unchanged. The povidone iodine in the Surgiphor™ solution continues to act as a preservative.

Given this context, the acceptance criteria are implicitly met by demonstrating that the modified device performs comparably to the predicate device, specifically by showing that removing the rinse bottle does not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a modified device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or accuracy (as one might see for an AI/ML device). Instead, the acceptance criteria are met by demonstrating that the changes do not degrade performance or safety.

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

The document does not describe a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects. This 510(k) relies on design verification and validation testing and standards compliance to demonstrate substantial equivalence to a predicate device, given a minor change (removal of one component from a kit).

Therefore, there is no mention of data provenance (country of origin, retrospective/prospective) because the studies are primarily engineering and quality control tests (sterilization, packaging, shelf-life) rather than clinical performance studies on patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically relevant for diagnostic AI/ML devices where a clinical reference standard is needed. This device is a physical irrigation system, and its "ground truth" for substantial equivalence is derived from a combination of:

• The established performance and safety of its predicate device.
• Laboratory testing (sterilization, packaging) against recognized standards.
• Engineering assessment that a structural change (removing a bottle) does not alter intended use or introduce new risks.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Clinical adjudication methods are not relevant for the type of testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic aids, particularly AI/ML algorithms, in how they affect human reader performance. This device is an irrigation system, not a diagnostic tool, and the submission is focused on physical and chemical equivalence and safety, not on human interpretation of outputs.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

• Engineering specifications and design verification: Ensuring the physical and chemical properties of the device (solution composition, packaging, sterility) remain consistent with safe and effective operation as defined by standards.
• Predicate device's established safety and effectiveness: The fundamental "truth" is that the predicate device was already deemed safe and effective for its intended use, and the current submission argues that the modified device maintains this "truth" despite the change.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device does not involve an AI/ML component.

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

This information is not applicable. Since there is no training set, there is no ground truth established for it.

In summary:

The provided FDA letter and 510(k) summary pertain to a physical medical device (an irrigation system) undergoing a minor modification. The "acceptance criteria" and "study" described are primarily related to engineering validation, quality control testing (e.g., sterility, shelf-life), and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. It does not involve the types of studies (e.g., clinical trials, AI/ML performance evaluations) that would typically require the detailed information on test sets, expert readers, or ground truth methodologies for diagnostic or AI-powered devices. The crucial point of this submission is the statement: "The changes do not impact the safety or effectiveness of the subject device [compared to the predicate device]."

Ask a specific question about this device

BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text describes a 510(k) premarket notification for the "BD Surgiphor Antimicrobial Irrigation System." It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of "microorganisms" to the device's indications for use.

Based on the provided text, the device is a medical irrigation system, not an AI/ML device. Therefore, the questions about acceptance criteria, study design, and performance related to AI/ML (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.

The document primarily addresses the substantial equivalence of a physical medical device. The "performance testing" section refers to standard medical device testing (e.g., sterility, biocompatibility, packaging, stability, fluid pressure testing for mechanical action), not AI/ML model performance.

Here's a summary of what is provided regarding acceptance criteria and performance, as applicable to this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one would for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that "Substantial equivalence has been confirmed through performance testing." The performance testing described is primarily focused on demonstrating the physical and chemical properties and safety of the device, rather than a diagnostic or predictive performance metric.

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

• Not applicable for an AI/ML context. The tests are for the physical device, not an algorithm processing data.

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. Ground truth in the context of an AI/ML study does not apply to this physical device.

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

• Not applicable. This relates to expert review of data for AI/ML model 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:

• Not applicable. This study type is for evaluating AI assistance in diagnostic tasks.

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

• Not applicable. There is no algorithm being evaluated in this submission.

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

• Not applicable in the AI/ML sense. The "ground truth" for this device's effectiveness relies on the mechanical action of fluid physically removing debris, which is demonstrated through fluid pressure testing and comparison to predicate devices, rather than a diagnostic 'truth'. The claim for "microorganism removal" is based on its mechanical action, not a specific antimicrobial kill claim.

8. The sample size for the training set:

• Not applicable. There is no training set for an AI/ML model.

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

• Not applicable. There is no training set for an AI/ML model.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, questions 1 (in the AI/ML context), 2, 3, 4, 5, 6, 7 (in the AI/ML context), 8, and 9 are not addressed in the text as they pertain to AI/ML model development and validation. The acceptance criteria and performance discussions are framed within the context of a medical device's physical, chemical, and sterility properties, and its intended mechanical action, demonstrating substantial equivalence to legally marketed predicates.

Ask a specific question about this device

The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.

SURGIPHOR™ Wound Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of SURGIPHOR™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. The povidone iodine in the SURGIPHOR™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

The provided text is a 510(k) Summary for the SURGIPHOR™ Wound Irrigation System. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It describes non-clinical testing (bench studies, animal studies, biocompatibility) and some clinical testing (Human Repeat Insult Patch Test) to support its claims.

However, the document does not describe an acceptance criteria table related to an AI/ML-based device, nor does it detail a study proving such a device meets specific performance criteria in terms of metrics like sensitivity, specificity, or AUC, established through ground truths and expert consensus for a clinical decision support AI/ML system.

The "device" in this document is a physical wound irrigation system, not a software or AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML device performance (sample size for test/training set, expert involvement, ground truth establishment, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.

In summary, the provided document does not contain the information requested regarding acceptance criteria and performance study details for an AI/ML device. It describes the regulatory submission for a physical medical device (wound irrigation system) based on substantial equivalence to existing products.

Ask a specific question about this device

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.

The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

The provided document is a 510(k) summary for the DANNIK Laparoscopic Suction Irrigation System. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or study details in the format requested for AI/algorithm performance evaluation.

This document describes a medical device (a physical instrument), not an AI/software device. Therefore, many of the requested fields, such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable in this context.

Based on the document, here's what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not a software or AI product that uses test sets of data. The "test set" here refers to the device itself being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a physical device is its manufacturing specifications and performance standards, established through engineering design and testing, not expert consensus on medical images or patient data. The document mentions evaluation by a "Design Engineer."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in medical imaging or clinical data for AI models.

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 a physical surgical tool and does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is defined by established engineering and manufacturing standards, and the performance of the predicate device. This is confirmed through bench testing rather than clinical outcomes or pathological analysis.

8. The sample size for the training set: Not applicable. There is no "training set" for a physical device in this context.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The water bottle cap irrigation 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.

The EndoChoice Water Bottle Cap Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures.

The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade stainless steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down while in the water bottle.

The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap.

Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow.

As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow.

Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter.

The water bottle cap system is supplied sterile and can be used up to 24 hours.

The provided document is a 510(k) summary for the EndoChoice Water Bottle Cap Irrigation System. It discusses the device's equivalence to a predicate device based on non-clinical testing. However, the document does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets (as this is not an AI/algorithm-based device and thus doesn't have a "test set" in that context), ground truth, or MRMC studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the other points, as the necessary information is not present in the provided text.

The document only states that:

• Non-clinical testing (benchtop funcional performance testing, post-aging; and biocompatibility testing per ISO 10993-1) was performed.
• "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device."

This indicates that internal acceptance criteria for these tests were met, but the specific criteria and detailed results are not provided.

Ask a specific question about this device

The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

The provided document is a 510(k) premarket notification for the Peristeen™ Anal Irrigation System. It states that no changes have been made to the device design, materials, components, technological characteristics or manufacturing processes of the subject device compared to the predicate. The only change being effected is the release of an updated Instructions For Use (IFU).

Therefore, the document explicitly states: "As such, testing for Performance, Shelf Life and Biocompatibility was not deemed necessary to support substantial equivalence. No clinical testing was performed, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Because no new performance testing was conducted for this submission, the document does not contain the information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Ask a specific question about this device

To be used as a general purpose suction and/or irrigation device during open or laparoscopic surgical procedures; including general, gynecologic, thoracic, otolaryngologic, plastic and urologic.

Not Found

This FDA document is a 510(k) clearance letter for the VTI Suction Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document provided does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter is an administrative notification of clearance and refers to a premarket notification, but the content of that notification (which would contain the study details) is not included here.

Therefore, I cannot fulfill your request for the tables and study descriptions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) premarket notification (K141323) submitted by Vascular Technology, Inc. to the FDA. This notification would typically include:

• A summary of the non-clinical and/or clinical performance data.
• A comparison to a predicate device, including performance data.
• The deemed acceptance criteria for performance.
• The details of any validation studies performed.

Ask a specific question about this device

The Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

Not Found

This document is an FDA 510(k) clearance letter for the Torrent Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter primarily addresses regulatory compliance and market authorization.

Therefore, I cannot provide the requested table and study details based on the provided text. The information typically found in a 510(k) Summary or a more detailed biocompatibility/performance report would be necessary to answer your questions.

Ask a specific question about this device