(87 days)
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
| Acceptance Criteria Category | Specific Criteria (Inferred/General) | Reported Device Performance (Inferred/General) |
|---|---|---|
| Performance | Ability to heat and circulate physiologically compatible sterile solution 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." |
| Ability to raise core peritoneal temperature to a desired target. | "The intended use... is to raise the core temperature of the peritoneum to the desired targeted temperature..." (Implied successful function) | |
| Regulated temperature control of the heat exchanger. | "The Heat Exchanger is interfaced with heated water from a heater/cooler that provides regulated temperature control to the Heat Exchanger." | |
| Monitoring of circulating fluid temperature. | "The system monitors the temperature of the circulating Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution." | |
| Biocompatibility | Components in contact with fluids must be biocompatible. | Established for major components via predicate device 510(k)s. HemoCleanse, Inc. "also provided similar information." |
| Electrical Safety | Device must meet electrical safety standards. | Established for major components via predicate device 510(k)s. HemoCleanse, Inc. "also provided similar information." |
| Electromagnetic Compatibility (EMC) | Device must meet EMC standards. | Established for major components via predicate device 510(k)s. HemoCleanse, Inc. "also provided similar information." |
| Software Verification & Validation | Software functions must be verified and validated. | HemoCleanse, Inc. "provided software verification and validation information." |
| Safety (Clinical) | Recommended temperature for intended use is safe. | "Published clinical studies involving intra-peritoneal perfusion hyperthermia that demonstrated the safety of the recommended temperature for the intended use of the ThermoChem-HT™ System." |
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.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.