(87 days)
Not Found
Not Found
No
The description focuses on standard medical device components and functions like heating, pumping, temperature monitoring, and fluid circulation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies summary.
Yes
The device is intended to raise the core temperature of the peritoneum to a desired temperature by continuously lavaging it with warmed solution, which is a direct therapeutic action.
No
The device is designed to heat and circulate fluid within the peritoneum to raise its temperature, which is a therapeutic function, not a diagnostic one. While it monitors temperature, this monitoring is for controlling the treatment, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a water heater/cooler, fluid pump, touch screen, and a disposable circuit with a heat exchanger and fluid reservoir. While software is mentioned for verification and validation, it is part of a larger hardware system.
Based on the provided information, the ThermoChem-HT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to raise the core temperature of the peritoneum by circulating warmed fluid within the patient's body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device describes a system for heating and circulating fluid into and out of the peritoneal cavity. This is a physical intervention on the patient.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The ThermoChem-HT System is a medical device used for a therapeutic purpose (hyperthermia treatment of the peritoneum), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
80LGZ, 78 MLW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum, peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
(continued)
1
Page 2: 510(k) Summary for ThermoChem-HTTM System
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.
Intended Use
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.
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.
2
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
3
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)