(125 days)
Not Found
No
The description focuses on hardware redesign, software user interface improvements, and basic control logic for temperature and flow, with no mention of AI/ML algorithms for decision-making, prediction, or adaptation.
Yes
The device is described as raising the core temperature of the peritoneum to a desired target temperature for therapeutic purposes.
No
The device is intended to raise the core temperature of the peritoneum, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines hardware components including a ThermoChem unit with an internal heating unit, a touchscreen monitor, and an Intraperitoneal Hyperthermia (IPH) Procedure Kit containing physical components like temperature probes, suction guards, a pressure sensor, a heat exchanger, a fluid reservoir, and tubing. While software is mentioned as being redesigned, it is part of a larger hardware system.
Based on the provided information, the ThermoChem™ HT-2000 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to raise the core temperature of the peritoneum by circulating warmed solution within the patient's body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device description details a system for warming and circulating fluid for direct infusion into the patient's peritoneal cavity. It involves a heat exchanger, fluid reservoir, and tubing set for patient connection.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The ThermoChem HT-2000 System does not perform any such analysis of patient specimens.
The ThermoChem HT-2000 System is a medical device used for a therapeutic procedure (hyperthermia) performed directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MLW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peritoneum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ThermoChem HT-2000 System underwent and met acceptance criteria of formal verification testing including bench testing of pump settings (pressure, flow rate); water bath heat time and temperatures; operating conditions; fluid ingress, overfill, and spill tests; software validation and regression testing; and usability validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ThermoChem HT-1000 System, K993330
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ThermoChem™ HT-2000 System
Traditional 510(k) Summary
| Submitted by: | ThermaSolutions, Inc. |
|---|---|
| 1889 Buerkle Road | |
| St. Paul, MN 55110 |
| Contact Person: | Steve Stonelake |
|---|---|
| Phone: | 651-209-3900 |
| Fax: | 651 209 3903 |
OCT 03 2013
- 29 September 2013 Date of Summary:
ThermoChem™ HT-2000 System and Device Trade Name: Intraperitoneal Hyperthermia (IPH) Procedure Kit Common or Usual Warmer, Peritoneal Dialysate Name:
Classification: 876.5630
Product Code: MLW
Predicate Device(s) ThermoChem HT-1000 System, K993330
1
pg 2 of 3
Device Description: 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 intended use of the ThermoChem™ HT-2000 System is to raise Intended Use: 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.
Technological The ThermoChem HT-2000 is a next-generation design of the Characteristics: currently-marketed ThermoChem HT-1000 system intended to integrate more-commercially-available components and incorporate changes to make the device easier to use, including a more userfriendly graphical user interface. In addition, the software was upgraded to incorporate currently-supported operating systems (QNX) and drivers. There was no change to the essential mode of operation of the device.
2
Performance Testing The ThermoChem HT-2000 System underwent and met acceptance criteria of formal verification testing including bench testing of pump settings (pressure, flow rate); water bath heat time and temperatures; operating conditions; fluid ingress, overfill, and spill tests; software validation and regression testing; and usability validation testing.
Substantial Based on device specifications and test results, the ThermoChem Equivalence: HT-2000 can be considered to be substantially equivalent to its predicate device, the ThermoChem HT-1000 system. Both devices share the same intended use and incorporate the same technological characteristics. Both devices are intended to be used with the ThermoChem IPH Procedure Kit. The ThermoChem HT-2000 is a next-generation design of the currently-cleared ThermoChem HT-1000 system intended to integrate morecommercially-available components and incorporate changes to make the device easier to use, including a more user-friendly graphical user interface.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
ThermaSolutions, Inc. % M.W. (Andy) Anderson, Ph.D., RAC Senior Principal Advisor Regulatory and Clinical Research Institute, Inc. (RCRI) 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416
Re: K131283
Trade/Device Name: ThermoChem™ HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit Regulation Number: 21 CFR$ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: MLW Dated: August 21. 2013 Received: August 22. 2013
Dear M.W. (Andy) Anderson,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - M.W. (Andy) Anderson, Ph.D., RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Beniamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ThermoChem™ HT-2000 System Traditional 510(k) Premarket Notification
Indications for Use Statement
| 510(k) Number: | K131583 |
|---|---|
| Device Name: | ThermoChem™ HT-2000 System and |
| Intraperitoneal Hyperthermia (IPH) Procedure Kit | |
| Intended Use: | 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. | |
| Prescription Use: | YES AND/OR Over-the-Counter Use: NO |
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner - S
2013.10.03 11:21:24 -04'00'