K131583 · Thermasolutions, Inc. · MLW · Oct 3, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K131583
Device Name
THERMOCHEM HT-2000
Applicant
Thermasolutions, Inc.
Product Code
MLW · Gastroenterology, Urology
Decision Date
Oct 3, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5630
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
ThermoChem HT-2000 system performs intraperitoneal hyperthermia (IPH) by circulating warmed sterile solutions (e.g., Lactated Ringer's) into the patient's peritoneal cavity. System comprises a main unit with internal heater, touchscreen monitor, and single-use IPH Procedure Kit (heat exchanger, fluid reservoir, tubing, temperature probes, suction guards, pressure sensor). Unit warms distilled/sterile water, which transfers heat to the perfusion solution via the heat exchanger. Warmed solution is pumped to the patient and returned to the reservoir. Used in clinical settings by healthcare providers to maintain target peritoneal temperature. Redesigned from HT-1000 for smaller footprint, improved component availability, and updated touchscreen interface. Output allows clinicians to monitor and control hyperthermia therapy, potentially benefiting patients by facilitating localized thermal treatment.
Clinical Evidence
Bench testing only. No clinical data. Verification testing included pump settings (pressure, flow rate), water bath heat time/temperature, operating conditions, fluid ingress/overfill/spill tests, software validation, and usability testing.
Technological Characteristics
System includes internal heating unit, touchscreen monitor, and disposable IPH kit. Uses QNX operating system. Connectivity via touchscreen interface. Essential mode of operation: closed-loop fluid heating and circulation. Components redesigned for commercial availability. Sterilization method not specified for unit; IPH kit components are previously cleared.
Indications for Use
Indicated for patients requiring intraperitoneal hyperthermia via continuous lavage of the peritoneum with warmed sterile solutions to achieve a target core temperature.
Regulatory Classification
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.
Special Controls
*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.
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### 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
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K131583
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.
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K131583
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.
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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.
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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
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ThermoChem™ HT-2000 System Traditional 510(k) Premarket Notification
### Indications for Use Statement
| 510(k) Number: | K131583 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ThermoChem™ HT-2000 System and<br>Intraperitoneal Hyperthermia (IPH) Procedure Kit |
| Intended Use: | The intended use of the ThermoChem™ HT-2000 System is to raise<br>the core temperature of the peritoneum to a desired target<br>temperature by continuously lavaging the peritoneum with circulating<br>and warmed Lactated Ringer's Solution, U.S.P., or another<br>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'
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
