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The intended use of the ThermoChem™ HT-2000 System is to raise the core temperature of the peritoneum to a desired target temperature by continuously lavaging the peritoneum with circulating and warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The ThermoChem HT-2000 System is a next-generation design of the currently marketed ThermoChem HT-1000 System and consists of the ThermoChem unit, a touchscreen monitor and an Intraperitoneal Hyperthermia (IPH) Procedure Kit, or "Disposable." The ThermoChem unit houses an internal heating unit that warms distilled or sterile water to a desired temperature. This water is circulated around a single-use heat exchanger (included in the IPH Procedure Kit) where it warms Lactated Ringer's (or another physiologically compatible sterile solution) for infusion into the patient's peritoneal cavity. The IPH Procedure Kit contains two temperature probes, two suction guards, and a pressure sensor as well as a Perfusion Kit consisting of a heat exchanger, a fluid reservoir, and tubing set. The warmed Lactated Ringer's (or other physiologically compatible sterile solution) is pumped through the tubing to the patient and then returns to the fluid reservoir. The IPH Procedure Kit is a convenience kit of previously 510(k)-cleared devices that are repackaged / relabeled by ThermaSolutions, Inc. The ThermoChem HT-2000 unit has been redesigned to physically reduce the size of the unit and to allow use of components that are more commercially available. The software and touchscreen monitor user interface have been redesigned to make the device easier to use. The redesigned ThermoChem unit will continue to use the currently-marketed IPH Procedure Kit for use with the ThermoChem HT-1000 System.

The ThermoChem™ HT-2000 System underwent formal verification testing to demonstrate its performance and substantial equivalence to its predicate device, the ThermoChem HT-1000 System.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes categories of performance testing that were conducted and that the device "met acceptance criteria." However, it does not explicitly state the specific numerical acceptance criteria for each test, nor does it provide the detailed quantitative results ("reported device performance") beyond the general statement that criteria were met.

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

The document does not specify the sample size used for any of the performance tests. The data provenance is described as "bench testing," meaning the tests were conducted in a laboratory setting, not with human patient data.

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

This information is not applicable. The performance testing described (bench testing, software validation, usability validation) does not involve establishing ground truth from expert consensus on clinical data. The tests focus on the device's functional and operational performance.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are technical performance evaluations rather than clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. The submission is for a Traditional 510(k) for a medical device (a heat exchanger system), not an AI/imaging diagnostic device that typically undergoes MRMC studies. The focus is on demonstrating that the new device (HT-2000) is substantially equivalent to a previously cleared device (HT-1000) based on functional and design changes.

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

The device is a medical system with hardware and software, not a standalone algorithm in the typical sense of AI/diagnostic software. The performance testing focuses on the integrated system's functionality. Therefore, a "standalone (algorithm only)" performance study as defined for AI models is not applicable in this context.

7. The Type of Ground Truth Used

For the functional and performance tests, the "ground truth" would be the engineering specifications and design requirements of the device. For example, for pump settings, the ground truth would be the target pressure and flow rate values as designed. For water bath temperatures, the ground truth would be the specified temperature range. No expert consensus, pathology, or outcomes data were used as ground truth for these tests.

8. The Sample Size for the Training Set

Not applicable. The ThermoChem™ HT-2000 System is a physical medical device with integrated software, not an AI model that undergoes machine learning training with a "training set" of data in the common understanding of that term. While software development involves testing and iteration, the concept of a "training set" for an AI algorithm does not apply here.

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 model for this device.

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The Daytripper CAPD travel warmer carrying case's intended use is to warm a single bag of peritoneal dialysate (if below 37°C) up to body temperature and maintain it until required for an exchange procedure. The Daytripper also serves as a carrying case and insulator for the dialysate.

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The provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Daytripper CAPD Warmer." It states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance or the other requested study details based on the provided text. The document is strictly an FDA clearance letter and does not include the technical study report.

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The intended use of the ThermoChem-HT System is to raise the core temperature of the peritoneum to the desired targeted temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The principal components, features and functions of the ThermoChem-HT System include an internal water heater/cooler, roller-type fluid pump, inputs for monitoring temperature, touch screen to direct the user through set-up and use, computer record storage, and disposable circuit that includes an integrated heat exchanger, fluid reservoir, and tubing connectors. The user provides and places commercially available introduction and drainage catheters into the patient's peritoneal cavity. One catheter acts as an Inlet and the other as an Outlet. The user also provides the Lactated Ringer's Solution. U.S.P., or another physiologically compatible sterile solution that is circulated into and out of the peritoneal cavity.

The system heats Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution, and circulates it into and out of the peritoneal cavity. Flow from the patient Outlet Catheter gravity drains into a fluid reservoir, then through to a roller Pump and then to an inline, disposable Heat Exchanger. The Heat Exchanger is interfaced with heated water from a heater/cooler that provides regulated temperature control to the Heat Exchanger. The heated solution then passes to the peritoneal cavity through the Inlet Catheter. The inline reservoir also aids in priming the disposable circuit and maintaining adequate fluid volumes. The system monitors the temperature of the circulating Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The provided text describes a 510(k) summary for the "ThermoChem-HT System", a Thermal Infusion Fluid Warmer. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets them in the way modern regulatory submissions might.

Based on the provided text, the acceptance criteria and study information are largely conceptual and focus on the safety and performance already established for components used in predicate devices. There is no explicit table of acceptance criteria with corresponding performance metrics from a dedicated study of the ThermoChem-HT System itself. Instead, the document relies on the prior approvals of its constituent parts and general principles.

Here's an attempt to extract and synthesize the requested information, noting where specific details are not provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific "test set" for the ThermoChem-HT System in the context of performance metrics from a new study. Instead, it relies on:

• The established performance and safety of its components through prior 510(k) submissions.
• "Published clinical studies involving intra-peritoneal perfusion hyperthermia" which are mentioned as demonstrating safety, but no details on their sample size or provenance are given for these external studies.
• Internal "laboratory/clinical tests" by HemoCleanse, Inc. for biocompatibility, electrical safety, EMC, and software, but the sample sizes for these are not specified.

Therefore, specific sample sizes for a dedicated "test set" for the ThermoChem-HT system are not provided. The data provenance relies on prior regulatory approvals and external publications.

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

This information is not provided. The submission relies on pre-existing data and regulatory approvals, not on a new test set requiring expert ground truth establishment for novel device performance.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set in the context of expert 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

This is not applicable. The ThermoChem-HT System is a medical device for warming fluids, not an AI-powered diagnostic or decision-support tool that would involve human "readers" or AI assistance in this context.

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

This is not applicable. The ThermoChem-HT System describes a physical device with an electromechanical function, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the ThermoChem-HT System largely comes from:

• Established engineering and safety standards: For electrical safety, EMC, and software verification/validation.
• Prior regulatory approvals: For the performance and biocompatibility of the system's major components, which are used in other legally marketed devices (cardiopulmonary bypass, peritoneal dialysis).
• Published clinical literature: For the safety of intra-peritoneal perfusion hyperthermia, which supports the intended use's safety claims.

There is no mention of pathology or outcomes data specifically generated for the ThermoChem-HT System itself in this summary to establish ground truth in a clinical trial sense.

8. The Sample Size for the Training Set

This is not applicable. The device does not employ machine learning or AI that would require a "training set" in this context.

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

This is not applicable as there is no training set for an AI/ML algorithm.

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For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the cialysate to within one degree of 98.6.(body temperature) As a preferred alternative to heating the dialysate using a commercial heating pad on microwave oven. The solution is heated in it's original packaging, The solution (dialysate) can be heated when travelling the car cigarette lighter adapter.

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I'm sorry, but the provided text does not contain enough information to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Freedom Traveller," which is used to heat dialysate for kidney patients.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size for test or training sets.
• Information on expert ground truth establishment or adjudication methods.
• Any multi-reader multi-case (MRMC) study results or effect sizes.
• Standalone algorithm performance.
• Specific types of ground truth used.

The only technical detail provided regarding performance is in the "Indications For Use" section, stating: "To heat the dialysate to within one degree of 98.6 (body temperature)." This is an indication for use, not an acceptance criterion with associated study data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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