(211 days)
Not Found
No
The description focuses on standard control systems, sensors, and a microprocessor for monitoring and reacting to conditions, which are typical for medical devices and do not indicate AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond predefined safety parameters.
Yes
The device is intended to raise the temperature of the thoracic or peritoneal cavity to a desired target temperature, which is a therapeutic intervention.
No
The device is described as a "Portable Hyperthermic Perfusion Device" used to raise and maintain the temperature of a body cavity, indicating a therapeutic function rather than a diagnostic one. It monitors parameters like temperature, flow, and pressure but does not identify or diagnose a condition or disease.
No
The device description clearly states it is comprised of two components, one durable (console with hardware like heater, pump, touchscreen) and one disposable (tubing set). While software is mentioned as a component, it is integral to the operation of the hardware and not a standalone software-only device.
Based on the provided information, the TTS100 Portable Hyperthermic Perfusion Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to raise the temperature of the thoracic or peritoneal cavity 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 is designed to heat and circulate fluid for direct application to internal body cavities. It does not involve the analysis of biological samples in vitro (outside of the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TTS100's function is to deliver a therapeutic treatment (hyperthermia) directly to the patient's internal cavities.
N/A
Intended Use / Indications for Use
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.
Product codes
LGZ
Device Description
The TTS100 Portable Hyperthermic Perfusion Device is a prescription device comprised of two components - one durable and one disposable. The TTS L00 Console is the durable component - a portable, unit containing heater, pump, user touchscreen, microprocessor, and interface electronics. The primary user interface of the TTS100 is a large, color touchscreen display that receives operational commands from the clinical user, and presents normal operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, line pressure, alarm and status messages, various timers and auxiliary temperatures. The TTS100 software monitors various sensors in the fluid path to ensure safe operation, automatically reacts to unsafe conditions, and alerts the clinical user to those conditions for resolution. Independent protection circuits prevent unsafe operation in the event of system software fault.
The disposable, single-use component is the Hyperthermic Lavage Tubing Set, which has two subcomponents - a Circulation Loop and an Accessory Kit. The Circulation Loop contains the filtered soft-shell fluid reservoir, inlet ports, vent lines, integrated distributed sensors, patient inlet circulation loop tubing, patient outlet circulation loop tubing, and drain line. The Accessory Kit - an integral component of the Hyperthermic Lavage Tubing Set - contains patient inlet and patient outlet tubing, tubing connectors, and auxiliary temperature sensors. Portions of the Accessory Kit can be implanted into the patient for use during the lavage procedure. The Circulation Loop does not have direct patient contact - only the circulating fluid within the loop contacts the patient. The Hyperthermic Lavage Tubing set is designed such that fluid travels through the Disposable Set without wetting the heater, pump or other TTS system components (e.g., only the internal surfaces of the Disposable Set are wetted), enabling rapid and straightforward post-processing of the TTS100 Console between patients. The Hyperthermic Lavage Tubing Set is supplied sterile, packaged in a proprietary-design container, and is only intended to be used in conjunction with the TTS100 Portable Hyperthermic Perfusion Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic or peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Non-Clinical Tests:
- FDA Recognized Consensus Standards: The TTS100 complies with and has been tested to AAMI/ANSI/ISO 10993-1, -5, -7, -10, -11 for Biocompatibility; IEC 60601-1 and IEC 60601-1-2 for Electrical Safety and EMC; AAMI/ANSI/ISO 11135-1 for Sterility; and ASTM D4169-05 for Packaging.
- Software Verification/Validation Testing: Tests were carried out to evaluate the TTS100's ability to:
- Heat fluids over the full range of fluid flowrates.
- Maintain fluid temperature over the full range of fluid flowrates.
- Detect and automatically respond to unsafe or ineffective operating conditions (e.g., sensor failure, excessive fluid temperature/pressure, component failures).
- Inform the clinical user of unsafe or ineffective operating conditions via notifications, alerts, alarms, and/or system faults.
- Mitigate against known or predictable operator errors.
- Store treatment parameters and data in non-volatile memory.
- Measure temperature accuracy over the full range of fluid flowrates within the operating pressure range.
- Measure pressure accuracy over the full range of fluid flowrates within the operating temperature range.
- Fluid flowrate accuracy over the full range of fluid flowrates within the operating temperature and pressure range.
- Key Results: The TTS100 performed within specification in all of the above tests.
- Human Factors: A human factors non-clinical study evaluated user- and patient-safety risks associated with the design of the TTS100 and demonstrated that task-risks have been identified, addressed and mitigated.
Clinical Tests: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
MAR - 4 2010
ThermalTherapeuticSystems, Inc.
POB 82670 Pittsburgh, PA 15218 Phone: 412.571.2622 www.thermaltherapeutics.com
510(k) Summary
Model TTS100 Portable Hyperthermic Perfusion Device
510(k) Number: K092366
Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
1.0 21CFR 807.92(A)(1)
1.1 Applicant's Information
J. Michael Fausset BS CP Chief Technical Officer ThermalTherapeutic Systems, Inc. Mobile: 765 427.3308 Fax: 412 291.1951 E: imf@thermaltheraneutics.com I: http://www.thermaltherapeutics.com Medical Establishment Registration No .: pending
1.2 Submitter's Information
James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 961 Moon Township, PA 15108 Mobile: 724 713.2298 Fax: 412 291.1951 E: ir@coastalco.com I: http://www.coastakcg.com
- 1.3 Date
March 1, 2010
2.0 21CFR 807.92(A)(2)
2.1 Device Information
Trade/Proprietary Name: TTS100 Portable Hyperthermic Perfusion Device Common Name: TTS100 Portable Hyperthermic Perfusion Device Model Number: TTS100 ·Regulation Number: None Regulation Name: None Regulatory Class: Unclassified, pre-amendment device; non-exempt from 510(k) Device Classification Name: Warmer, thermal, Infusion fluid Classification Panel: General Hospital Classification Product Code(s): LGZ
2.2 Device Classification
Infusion fluid thermal warmers and their accessories are unclassified, Pre-Amendment devices. 510(k) premarket notification submissions for these devices are reviewed by the General Hospital Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices,
1
ThermalTherapeuticSystems, Inc.
3.0 21CFR 807.92(A)(3)
3.1 Predicate Device Information
| PREDICATE DEVICES | |||
|---|---|---|---|
| 510(k) # | DEVICE | 510(k) SPONSOR | 510(k) |
| CLEARANCE DATE | |||
| K993330 | ThermoChem-HT System | Hemocleanse, Inc. | 12/30/1999 |
| K070654 | Belmont Hyperthermia Pump | Belmont Instrument, Inc. | 6/8/2007 |
4.0 21CFR 807.92(A)(4)
4.1 Device Description
The TTS100 Portable Hyperthermic Perfusion Device is a prescription device comprised of two components - one durable and one disposable. The TTS L00 Console is the durable component - a portable, unit containing heater, pump, user touchscreen, microprocessor, and interface electronics. The primary user interface of the TTS100 is a large, color touchscreen display that receives operational commands from the clinical user, and presents normal operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, line pressure, alarm and status messages, various timers and auxiliary temperatures. The TTS100 software monitors various sensors in the fluid path to ensure safe operation, automatically reacts to unsafe conditions, and alerts the clinical user to those conditions for resolution. Independent protection circuits prevent unsafe operation in the event of system software fault.
The disposable, single-use component is the Hyperthermic Lavage Tubing Set, which has two subcomponents - a Circulation Loop and an Accessory Kit. The Circulation Loop contains the filtered soft-shell fluid reservoir, inlet ports, vent lines, integrated distributed sensors, patient inlet circulation loop tubing, patient outlet circulation loop tubing, and drain line. The Accessory Kit - an integral component of the Hyperthermic Lavage Tubing Set - contains patient inlet and patient outlet tubing, tubing connectors, and auxiliary temperature sensors. Portions of the Accessory Kit can be implanted into the patient for use during the lavage procedure. The Circulation Loop does not have direct patient contact - only the circulating fluid within the loop contacts the patient. The Hyperthermic Lavage Tubing set is designed such that fluid travels through the Disposable Set without wetting the heater, pump or other TTS system components (e.g., only the internal surfaces of the Disposable Set are wetted), enabling rapid and straightforward post-processing of the TTS100 Console between patients. The Hyperthermic Lavage Tubing Set is supplied sterile, packaged in a proprietary-design container, and is only intended to be used in conjunction with the TTS100 Portable Hyperthermic Perfusion Device.
5.0 21CFR 807.92(A)(5)
- 5.1 Indications for Use
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.
6.0 21CFR 807.92(A)(6)
6.1 Technological Characteristics Comparison to Predicate Device(s)
As compared to the predicate devices, the TTS100 Portable Hyperthermic Perfusion Device has the same operating principle, energy type, environmental specifications, and performance specifications. All devices use a roller-type fluid pump, touchscreen-based clinical user Interface for machine set-up and control, sensor monitoring of various fluid temperatures, and a proprietary-design disposable set including large fluid reservoir to circulate sterile fluid into and out of the body cavity. For the TTS100, fluid in the reservoir is heated via direct heat to the desired temperature, and the heater drain tubing passes through a roller pump and out to the patient inlet. Fluid returns from the patient outlet wia gravity drain back to the fluid reservoir. The TTS100 monitors circulating fluid temperature and pressure, and automatically responds to ineffective or unsafe operating conditions.
2
ThermalTherapeuticSystems, Inc.
7.0 21CFR 807.92(B)(1)
7.1 Performance Data - Discussion of Non-Clinical Tests
- 7.1.1 FDA Recognized Consensus Standards
The TTS100 is designed to, complies with, and has been tested as part of verification and validation activities to, the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:
| REQUIREMENT | REFERENCE # | TITLE |
|---|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2003(E) | Biological evaluation of medical devices - Part |
| 1: Evaluation and testing | ||
| AAMI/ANSI/ISO 10993-5:1999 | Biological evaluation of medical devices - Part | |
| 5: Tests for in vitro cytotoxicity | ||
| AAMI / ANSI / ISO 10993- | ||
| 7:1995(R)2001 | Biological Evaluation of Medical Devices - Part | |
| 7: Ethylene Oxide Sterilization Residuals. | ||
| AAMI/ANSI/ISO 10993-10:2002 | Biological evaluation of medical devices - | |
| Part 10: tests for irritation and delayed-type | ||
| hypersensitization | ||
| AAMI/ANSI/ISO 10993-11:2006 | Biological evaluation of medical devices - Part | |
| 11: Tests for systematic toxicity | ||
| Electrical | ||
| Safety, EMC | IEC | |
| 60601-1:1988+A1:1991+A2:1995 | ||
| (IEC 60601-1+A1+A2) | Medical electrical equipment - Part 1: General | |
| Requirements for Safety, 1988; Amendment 1, | ||
| 1991-11, Amendment 2, 1995 | ||
| IEC 60601-1-2:2001+A1:2004 | ||
| (IEC 60601-1-2+A1) | Medical Electrical Equipment - Part 1-2: General | |
| Requirements for Safety - Collateral standard: | ||
| Electromagnetic Compatibility - Requirements | ||
| and Tests (Ed. 2.1) | ||
| Sterility | AAMI / ANSI / ISO 11135-1:2007 | Sterilization of health care products - |
| Ethylene oxide - Part 1: Requirements for the | ||
| development, validation, and routine control of | ||
| a sterilization process for medical devices. | ||
| Packaging | ASTM D4169-05:2005 | Standard Practice for Performance Testing of |
| Shipping Containers and Systems |
7.1.2 Software Verification/Validation Testing
As part of software verification/validation activities, and in support of substantial equivalence, the following tests were carried out the TTS100 to evaluate its ability to meet product performance specifications. Specifically, the TTS100 was tested to assess ...
- I The ability of the TTS100 to heat fluids over the full range of fluid flowrates.
- The ability of the TTS100 to maintain fluid temperature over the full range of fluid flowrates. E
- E The ability of the TTS100 to detect and automatically respond to unsafe or ineffective operating conditions, as caused by the failure of the system sensors, excessive fluid temperature, excessive fluid pressure, or system-internal component failures.
- The ability of the TTS100 to inform the clinical user of those unsafe or ineffective operating conditions via notifications, alerts, alarms, and/or system faults.
- D The ability of the TTS100 to mitigate against known or predictable operator errors.
- The ability of the TTS100 to store treatment parameters and data in non-volatile memory. D
- ם Measured temperature accuracy over the full range of fluid flowrates within the operating pressure range.
- D Measured pressure accuracy over the full range of fluid flowrates within the operating temperature range.
- Fluid flowrate accuracy over the full range of fluid flowrates within the operating temperature and pressure range.
The TTS100 performed within specification in all of the above tests.
3
K092366
ThermalTherapeuticSystems, Inc.
7.1.3 Human Factors
A human factors non-cilnical study evaluated user- and patient-safety risks associated with the design of the TTS100, and demonstrated that the task-risks have been identified, addressed and mitigated.
8.0 21CFR 807.92(s)(2)
-
8.1 Performance Data Discussion of Clinical Tests
N/A -
9.0 21CFR 807.92(B)(3)
9.1 Conclusions
Based upon safety and performance testing and compliance with voluntary standards, ThermalTherapeutic Systems, Inc. believes that the TTS100 Portable Hyperthermic Perfusion Device is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Thermal Therapeutic Systems, Incorporated C/O Mr. James Jochen Rogers General Manager Coastal Consulting Group, Limited P.O. Box 961 Moon Township, Pennsylvania 15108
JAN 1 0 2017
Re: K092366
Trade/Device Name: TTS100 Portable Hyperthermic Perfusion Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: March 3, 2010 Received: March 4, 2010
Dear Mr. Rogers:
This letter corrects our substantially equivalent letter of March 4, 2010.
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 either 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.
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
5
Page 2 - Mr. James Jochen Rogers
CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device 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 Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K092366
Device Name: TTS100 Portable Hyperthermic Perfusion Device
Indications For Use:
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according lo a protocol to be selected by the physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Charles Schwab
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092366
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