(125 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench testing of pump settings (pressure) | Met acceptance criteria |
| Bench testing of pump settings (flow rate) | Met acceptance criteria |
| Water bath heat time | Met acceptance criteria |
| Water bath temperatures | Met acceptance criteria |
| Operating conditions | Met acceptance criteria |
| Fluid ingress | Met acceptance criteria |
| Overfill tests | Met acceptance criteria |
| Spill tests | Met acceptance criteria |
| Software validation | Met acceptance criteria |
| Regression testing (software) | Met acceptance criteria |
| Usability validation testing | Met acceptance criteria |
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.
§ 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.