(538 days)
Not Found
No
The description focuses on standard control system components (microprocessor, sensors, alarms) and software verification/validation for safety and performance within specifications. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is intended to raise the temperature of a body cavity, which is a therapeutic action, and its name includes "Hyperthermic Perfusion System," indicating a therapeutic function. The predicate devices are also therapeutic devices.
No
The device is described as a hyperthermic perfusion system intended to raise the temperature of the thoracic or peritoneal cavity. It performs a therapeutic function by continuous lavage with a warmed solution, rather than diagnosing a condition.
No
The device description clearly outlines both hardware components (control console with heater, pump, touch screen, microprocessor, etc.) and a disposable hardware kit (tubing set, cannulae, temperature probes, fluid reservoir). While software is mentioned as part of the control console and subject to verification/validation, the device is fundamentally a hardware system with integrated software control.
Based on the provided information, the HEITER 3000 Hyperthermic Perfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to raise the temperature of the thoracic or peritoneal cavity by circulating a warmed solution. This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system for heating and pumping fluid for lavage within a body cavity. It does not describe any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample for diagnostic purposes.
- Detecting or measuring substances in a sample.
- Providing information for the diagnosis, monitoring, or treatment of a disease based on sample analysis.
The HEITER 3000 is a therapeutic device used for hyperthermic perfusion, a treatment method.
N/A
Intended Use / Indications for Use
The HEITER 3000 Hyperthermic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as sterile saline or Lactated Ringers.
Product codes (comma separated list FDA assigned to the subject device)
LGZ
Device Description
The HEITER 3000 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics.
The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The HEITER 3000 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault.
The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
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
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)
Software Verification / Validation Testing: The HEITER 3000 was tested to assess its ability to:
- heat fluids over the full range of fluid flow rates.
- maintain fluid temperature over the full range of fluid flow rates.
- 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.
- inform the clinical user of those unsafe or ineffective operator conditions via notifications, alerts, alarms, and/or system faults.
- mitigate against unknown or predictable operator errors.
- store non-patient, procedure specific treatment parameters and machine data in non-volatile memory.
- measure temperature accuracy over the full range of fluid flow rates within the operating pressure range.
- measure pressure accuracy over the full range of fluid flow rates within the operating temperature range.
- measure fluid flow rate accuracy over the full range of fluid flow rates within the operating temperature pressure range.
Key results: The HEITER 3000 performed within specifications in all of the above tests.
Human Factors / Non-Clinical Study Testing: A human factors non-clinical study was performed, providing diverse groups of pump users with a product inservice on the HEITER 3000, and testing those groups on the setup and performance of a simulated hyperthermic lavage procedure on the HEITER 3000.
Key results: The testing identified potential user and patient safety risks associated with the design of the HEITER 3000, and the results demonstrated that the task-risks have successfully been addressed and mitigated.
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.
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
§ 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
510(k) Summary
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
K102900
General Information
| Classification | Unclassified |
|---|---|
| Product Code: | LGZ |
| Classification Name: | Warmer, Thermal, Infusion Fluid |
| Trade Name | HEITER 3000 Hyperthermic Perfusion System |
| Submitter | HEI, Inc. |
| 4801 N. 63rd Street | |
| Boulder, CO 80301 | |
| Tel: 720.622.4216 | |
| Contact |
Indications for Use
The HEITER 3000 Hyperthermic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as sterile saline or Lactated Ringers.
Predicate Devices
| K092366 | TTS100 Portable Hyperthermic Perfusion Device
Thermal Therapeutic Systems, Inc |
|---------|-----------------------------------------------------------------------------------|
| K070654 | Belmont Hyperthermia Pump
Belmont Instruments |
Device Description
The HEITER 3000 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics.
The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area.
1
The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The HEITER 3000 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault.
The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
Technological Characteristics Comparison to Predicate Devices
As compared to the predicate devices, the HEITER 3000 Hyperthermic Perfusion Device has the same operating principle, energy type, environmental specifications, and performance specifications. All of the 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. In the HEITER 3000, fluid in the reservoir is directly heated to the desired temperature, the heater drain tubing passes through a roller pump and out to the patient inlet. Fluid returns from the patient outlet via gravity drain back to the fluid reservoir. The HEITER 3000 monitors circulating fluid temperature and pressure, and automatically responds to ineffective or unsafe operating conditions.
Software Verification / Validation Testing
As part of the software verification/validation activities, and in support of substantial equivalence, the following tests were carried out on the HEITER 3000 to evaluate its ability to meet product performance specifications. Specifically, the HEITER 3000 was tested to assess its ability to:
- heat fluids over the full range of fluid flow rates. -
- maintain fluid temperature over the full range of fluid flow rates.
- 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.
- inform the clinical user of those unsafe or ineffective operator conditions via notifications, alerts, alarms, and/or system faults.
- mitigate against unknown or predictable operator errors.
- store non-patient, procedure specific treatment parameters and machine data in non-volatile memory.
- ・ measure temperature accuracy over the full range of fluid flow rates within the operating pressure range.
- measure pressure accuracy over the full range of fluid flow rates within the operating temperature range.
- measure fluid flow rate accuracy over the full range of fluid flow rates within the operating temperature pressure range.
The HEITER 3000 performed within specifications in all of the above tests.
2
Human Factors / Non-Clinical Study Testing
A human factors non-clinical study was performed, providing diverse groups of pump users with a product inservice on the HEITER 3000, and testing those groups on the setup and performance of a simulated hyperthermic lavage procedure on the HEITER 3000. The testing identified potential user and patient safety risks associated with the design of the HEITER 3000, and the results demonstrated that the task-risks have successfully been addressed and mitigated.
Verification of Safety Requirements
The HEITER 3000 is designed to, does comply with, and has been tested as part of verification and validation testing to the FDA Recognized Consensus listed below, as is applicable to the features and components of the HEITER 3000.
| Electrical
Safety, EMC | IEC 60601-1:1998+A1:1991+A2:1995
(IEC 60601-1+A1+A2) | Medical Electrical Equipment –
Part 1: General Requirements for
Safety, 1998; Amendment 1, 1991-
11, Amendment 2, 1995 |
|---------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-1-2:2001+A1:2004
(IEC 60601-1+A1+A2) | Medical Electrical Equipment –
Part 1-2: General Requirements
for Safety - Collateral standard:
Electromagnetic Compatibility –
Requirements and Test (Ed. 2.1) |
| | AAMSI/ANSI/ISO 11135-1:2003(E) | Biological evaluation of medical
devices - Part 1: Evaluation and
Testing |
|------------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AAMSI/ANSI/ISO 10993-1:2007 | Biological evaluation of medical
devices - Part 5: Tests for in vitro
cytotoxicity |
| Biocompatibility | AAMSI/AMSI/ISO 10993-
7:1995(R)2001 | Biological evaluation of medical
devices - Part 7: Ethylene Oxide
Sterilization Residuals |
| | AAMSI/ANSI/ISO 10993-10:2002 | Biological evaluation of medical
devices - Part 10: Tests for
Irritation and Delayed-type
Hypersensitization |
| | AAMSI/ANSI/ISO 10993-11:2006 | Biological evaluation of medical
devices - Part 11: Tests for
Systemic Toxicity |
| Sterility | AAMSI/ANSI/ISO 10993-1:2003(E) | Sterilization of Health Care Products - Ethylene oxide - Part 1:
Requirement for the the
development, validation, and
routine control of a sterilization
process for medical devices |
3
| Packaging | ASTM D4169-05:2005 | Sterilization of Health Care
Products - Ethylene oxide - Part 1:
Requirement for the the
development, validation, and
routine control of a sterilization
process for medical devices |
| ----------- | -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Summary of Substantial Equivalence
Based upon safety and performance testing and compliance with voluntary standards, HEI, Incorporated believes that the HEITER 3000 Hyperthermic Perfusion Device is substantially equivalent to the features of the predicate products, and does not raise any new questions of safety or effectiveness. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 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" around the perimeter. Inside the circle is a stylized design resembling an abstract human figure or a caduceus, with three curved lines representing the body and a wavy line at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory Mathison Regulatory Affairs HEI, Inc. 4801 N. 63td Street Boulder, Colorado 80301
MAR 2 1 2012
Re: K102900
Trade/Device Name: HEITER 3000 Hyperthermic Perfusion System Regulation Number: None Regulation Name: None Regulatory Class: II Product Code: LGZ Dated: January 27, 2012 Received: January 30, 2012
Dear Mr. Mathison:
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.
5
Page 2 - Mr. Mathison
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/CentersOffices/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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K 102900
Device Name:
HEITER 3000 Hyperthermic Perfusion System
510(k) Number (if known):
Indications for Use:
The HEITER 3000 Hyperthermic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as saline or Lactated Ringer's.
X
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chapman
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K102900 510(k) Number:
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