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.

Device Description

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.

AI/ML Overview

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.

Summary

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DEC 3 0 1999

993330

Section 2: 510(k) Summary

General Information

Submitter Name and Address:

HemoCleanse, Inc. 2700 Kent Avenue West Lafayette, IN 47906

Contact: Stephen R. Ash. MD. FACP Chairman, Director of R&D (765) 463-9540

510(k) Summary Preparation Date: September 30, 1999

Device Trade Name: ThermoChem-HT System

Device Common Name: Thermal Infusion Fluid Warmer (80LGZ)

Device Classification Name: Unclassified

Predicate Devices

The ThermoChem-HT System incorporates the following components used in legally marketed cardiopulmonary bypass systems and peritoneal dialysis systems to circulate warmed fluids: internal water heater/cooler, a roller-type fluid pump, inputs for monitoring temperature, and a disposable circuit with an integral heat exchanger, fluid reservoir, and tubing connectors. The system also includes computer record storage and a touch screen that directs the user through setup and use.

Device Description

(continued)

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Page 2: 510(k) Summary for ThermoChem-HTTM System

Intended Use

Laboratory/Clinical Tests

The major components of the ThermoChem-HT™ System are legally marketed devices used in either cardiopulmonary bypass systems or peritoneal dialysis systems to circulate warmed fluids. The manufacturers' 510(k) submissions have established the perform-ance, biocompatability, electrical safety, and electromagnetic compatability, as appro-priate, for these components, HemoCleanse, Inc. also provided similar information for the ThemoChem-HT™ System . In addition, HemoCleanse, Inc. provided software verification and validation information and published clinical studies involving intra-peritoneal perfusion hyperthermia that demonstrated the safety of the recommended temperature for the intended use of the ThermoChem-HTTM System.

Conclusions

The ThermoChem-HT™ System is substantially equivalent to legally marketed devices intended to circulate warmed fluids through the peritoneal cavity.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1999

Stephen R. Ash, M.D., FACP Chairman, Director of R&D HemoCleanse, Inc. 2700 Kent Avenue West Lafayette, IN 47906

RE:

K993330 ThermoChem-HT System Thermal Infusion Fluid Warmer Dated: November 2, 1999 Received: November 3, 1999 Regulatory Class: II 21 CFR 876.5630/Procode: 78 MLW

Dear Dr. Ash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ﺴﺮ

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_________ ThermoChem-HT

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 49 3330 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.