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510(k) Data Aggregation
(109 days)
Aqua Medical, Inc.
The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF) energy to produce heated water vapor for the coagulating and ablating tissue. The RF energy heats liquid as it flows through the catheter, creating steam that is directed to the target tissue. The system includes the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. The catheter connects, fluidically and electrically, to the generator. A foot pedal is used to control the RF energy and vapor delivery.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F (2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm. This submission included only the modified circumferential catheter.
- Cassette (Syringe and Tubing): Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
This 510(k) clearance letter pertains to the Aqua Medical RF Vapor Ablation System. However, the provided document does not include acceptance criteria or the study details that prove the device meets such criteria.
The document states that "The proposed modifications do not introduce new safety and effectiveness concerns and support the company's substantial equivalency claim" and mentions "supporting non-clinical data" and "bench testing and scientific rationales." It lists various performance tests conducted for the Generator, Catheter, and Cassette components, but it does not provide any quantitative acceptance criteria or performance results from any clinical or even pre-clinical study testing the device's efficacy against specific metrics.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.
The information given is limited to:
- Device Name: Aqua Medical RF Vapor Ablation System
- Indications for Use: Coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract (e.g., Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), Radiation Proctitis (RP)) in adults.
- Modifications: To the generator, Cassette (syringe and tubing), and circumferential catheter.
- Tests Performed (Non-Clinical):
- Generator: EMC & Electrical Safety, Software validation, Generator Hardware Verification
- Catheter: Hardware Verification Testing, Simulated-use tissue validation (Lean Beef Testing)
- Cassette: Biocompatibility, Shelf-Life assessment, Sterilization Validation
- Conclusion: The device is substantially equivalent to the predicate device, and modifications do not raise new safety or effectiveness concerns.
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(220 days)
Aqua Medical, Inc.
The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor Ablation System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor Ablation System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation and ablation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF VaporAblation System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F -(2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. There are 3 types of RF Vapor catheters available. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The provided text is a 510(k) summary for the Aqua Medical RF Vapor Ablation System. It details the device's indications for use, its description, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports for AI/software devices, particularly those relating to clinical performance metrics based on a test set, human expert involvement, or comparative effectiveness studies.
The "Performance Data" section (Page 6-7) describes non-clinical testing for the device's hardware and a "Lean Beef Testing" experiment. This suggests that the device's performance relies primarily on its physical and functional attributes, rather than an AI component requiring a complex clinical validation study with extensively adjudicated ground truth, as would be typical for an AI-powered diagnostic or predictive device.
Therefore, many of the requested details about acceptance criteria and study proving performance (specifically for an AI/software component, human-in-the-loop, etc.) are not present in this document.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria or specific quantitative performance metrics in the way one would expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it mentions:
- Hardware Verification Testing:
- Acceptance Criteria (Implied): Catheter joint forces and sliding forces "passed the specification requirements." Fatigue cycle testing was completed to "validate the physical integrity and durability of the subject device."
- Reported Performance: "The catheter joint forces and sliding forces passed the specification requirements for the testing. The fatigue cycle testing was completed to validate the physical integrity and durability of the subject device under simulated-use conditions including extreme tortuosity, mechanical cycling, high-vapor output and temperature exposure." (No specific numbers provided).
- Lean Beef Testing:
- Acceptance Criteria (Implied): "Equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment." And "Equally desired ablation depths (penetration of heat) will be produced by both systems." (Based on the conclusion below).
- Reported Performance: "The Lean Beef testing demonstrated equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment. The test also demonstrated that the ablation depths for the modified Circumferential Delivery Catheters are substantially equivalent to those produced by the Predicate Circumferential Delivery Catheters through the dose ranges evaluated in the test. Equivalent ablation depths (penetration of heat) were produced by both systems supporting our substantial equivalency claim." (No specific quantitative values like mm or power settings are provided).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The "Lean Beef Testing" implies a laboratory, non-clinical setting (animal tissue model - "Lean Beef"). It is 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:
- Not applicable/Not mentioned. The testing described (hardware, lean beef) does not involve human expert interpretation of clinical data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used for clinical image or data interpretation studies, which are not described here.
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, not performed. This device is an ablation system, not a diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device generates vapor for ablation; its performance is not measured as an "algorithm only" in the context of diagnostic or predictive AI. The software controls the generator, but its performance is tied to the physical delivery system.
7. The type of ground truth used:
- For hardware testing: Mechanical and physical specifications.
- For Lean Beef Testing: Ablation depth and characteristics measured directly in the beef tissue. This is a physical/material measurement rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI model that undergoes a "training" phase with a dataset. The software mentioned is for control of the generator, not for learning from vast datasets.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of an AI model for this device.
In summary, the provided FDA 510(k) summary focuses on the substantial equivalence of modifications to an existing physical medical device (RF vapor ablation system) through engineering and bench testing, rather than a clinical study evaluating an AI component's performance. The "performance data" section primarily refers to non-clinical tests demonstrating the device's physical and functional equivalency.
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(30 days)
Aqua Medical, Inc.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components: Aqua RF Vapor Generator: A software-controlled RF generator is operated i through a graphical user interface (GUI) and incorporates a svringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter. Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7 F (2.3 mm) and a lengths between145 cm and 210 cm. There are 4 types of RF Vapor catheters available. Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract in adults. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum percentage of coagulation, specific temperature achieved). However, it does describe the types of tests performed to demonstrate substantial equivalence to the predicate device. The performance data is presented as verification that the new catheter design performs as intended and is as safe and effective as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Aqua Medical RF Vapor System has identical indications for use as the previously cleared Aqua RF Vapor System (predicate device). |
| Technological Equivalence | The new Aqua Medical Circumferential RF Vapor Ablation Catheter design was tested to ensure it performs as intended via hardware verification testing. Comparative simulated use bench model testing was conducted to support substantial equivalency and demonstrate that the new design functions in an equivalent manner as the previously cleared Aqua Medical Focal RF Vapor Catheters. |
| Safety and Effectiveness | Comparative validation testing and verification testing demonstrated that the additional catheter design is substantially equivalent to the previously cleared Aqua RF Focal Vapor Catheter. The device is considered as safe and effective as its predicate without raising any new safety and/or effectiveness concerns. This was supported by: Hardware Verification TestingSimulated tissue model testingBiocompatibility Testing (cytotoxicity, sensitization, and irritation)Packaging and shelf-life testingSterilization Validation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the simulated use bench model testing or other performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, beyond stating "simulated tissue model" which implies a prospective, controlled lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided text. The evaluation focuses on the device's technical performance and equivalence to a predicate, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The Aqua Medical RF Vapor System is a physical medical device (catheter-based system using RF energy for tissue coagulation), not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not applicable and was not mentioned.
7. Type of Ground Truth Used
Based on the description of "simulated tissue model" and various verification and validation tests, the ground truth for the performance evaluations likely involved established scientific and engineering standards for tissue coagulation, material properties, biocompatibility, and sterilization effectiveness. The "ground truth" would be objective measurements and observations against these standards, rather than expert consensus on medical images or patient outcomes.
8. Sample Size for the Training Set
Since this is a physical medical device and not an AI or machine learning algorithm, the concept of a "training set" in the context of data for model development is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted above, a training set is not applicable for this type of device.
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(30 days)
Aqua Medical, Inc.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using RF (radiofrequency) energy. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7 F (2.3 mm) and a length of 145 cm. There are 3 types of RF Vapor catheters available.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The provided text is a 510(k) summary for the Aqua Medical RF Vapor System, which describes modifications to an already cleared device. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, ground truth establishment, or expert qualifications. The document primarily focuses on demonstrating substantial equivalence to a predicate device, based on identical intended use and technological modifications (new catheter designs) that do not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or training set, or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, expert consensus, etc.).
- How ground truth for a training set was established.
The document mentions "Hardware Verification Testing," "Simulated tissue model," "Biocompatibility Testing," and "Sterilization Validation" as performance data conducted to support the modifications, but it does not detail their methods, results, or acceptance criteria in the context of device performance metrics.
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(182 days)
Aqua Medical, Inc.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor System uses a catheter to deliver heat to the tissue surface undergoing treatment. The heat, which is created by the application of RF energy to a bipolar electrode pair located inside the catheter tip, is delivered to the tissue through heated water vapor generated inside the catheter. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue.
The Aqua Medical RF Vapor System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheter: a disposable, sterile, single-use catheter with a diameter of 7 F (2.3 mm) and a length of 145 cm. It includes an integrated cable for attachment to the generator and a Luer-connector that facilitates connection to the saline delivery tubing.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) that provide a means of delivering saline to the catheter during treatment.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including the esophagus. This covers conditions such as Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), and Radiation Proctitis (RP) in adults. The device was deemed substantially equivalent to its predicate, the Halo 90 System by Barrx Medical, Inc.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or precise reported device performance metrics in a readily tables format as might be expected for a diagnostic AI device. Instead, the "acceptance criteria" appear to be demonstrating substantial equivalence to the predicate device, the HALO® System, through comparative testing. The performance is assessed in terms of its ability to achieve similar tissue coagulation effects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | All tests successfully conducted: Cytotoxicity, Hemolysis, Systemic Toxicity, Intracutaneous, Sensitization, Pyrogenicity. |
| Electrical Safety and EMC | Complied with IEC 60601-1:2005/EN 60601-1:2006 and IEC 60601-1-2:2007 standards. |
| Software V&V | Verification and validation testing conducted, documentation provided, considered "major" level of concern. |
| Bench Testing | HW Verification Testing, System Validation Testing, Distal Assembly Pull Test, Lesion Comparative testing successfully completed. |
| Animal Study (Tissue Coagulation Ability) | Demonstrated ability to create thermal coagulative tissue injury that penetrates in depth to the external muscularis of the esophagus in healthy swine. No pathological complications, esophageal perforation, significant hemorrhage, or clinical complications. Results showed substantial equivalence to HALO® system. |
| Substantial Equivalence to Predicate | The Aqua Medical RF Vapor System has the same indications for use and is substantially equivalent in technological and performance characteristics to the HALO® predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the animal study conducted to demonstrate the therapeutic effect.
- Sample Size: A total of 6 animals (swine) were utilized in the animal study.
- 3 animals were treated and evaluated acutely (Day = 0).
- 3 animals were treated and evaluated subacutely (48 hours).
- Data Provenance: The study was conducted on healthy swine, suggesting a controlled, prospective animal study environment. The country of origin is not specified, but it's an industry-conducted study for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states, "The histopathological evaluation assessed acute thermal coagulation through the cross-sectional layers of the esophagus."
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The text mentions "histopathological evaluation," which implies assessment by qualified pathologists. However, specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the histopathological evaluation. It states that the evaluation was conducted, but details on how agreement was reached among multiple potential evaluators (if more than one was involved) are absent. It's common for a single expert or a small group to provide the assessment in such studies without a formal adjudication process beyond standard peer review.
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.
- The device is a direct therapeutic device (RF vapor system for tissue coagulation), not a diagnostic AI device intended to assist human readers in image interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this type of medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable in the context of the Aqua Medical RF Vapor System. This is a therapeutic device that physically treats tissue, not an AI algorithm. Its operation involves user interaction (choice of power settings, advancing the catheter), making "standalone algorithm performance" an irrelevant concept here.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for evaluating the device's performance in the animal study was based on histopathological evaluation. This involved assessing "acute thermal coagulation through the cross-sectional layers of the esophagus."
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware and software system for therapy delivery, not an AI/machine learning model that undergoes a "training phase" on a dataset in the conventional sense. The software primarily controls the RF generator and syringe pump based on user input and predefined parameters.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The software verification and validation would have been performed against functional requirements and design specifications rather than against a ground truth dataset from a training set.
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