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.

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.

AI/ML Overview

The provided text describes the HEITER 3000 Hyperthermic Perfusion System and its substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria in the format requested for AI/diagnostic devices.

Instead, the document details:

Software Verification/Validation Testing: A series of internal tests were performed to assess the device's ability to heat/maintain fluid temperature, detect and respond to unsafe conditions, inform users of these conditions, mitigate operator errors, store data, and measure accuracy of temperature, pressure, and flow rates.
Human Factors / Non-Clinical Study Testing: A study involving diverse pump users to identify and mitigate safety risks during simulated hyperthermic lavage procedures.
Verification of Safety Requirements: Compliance with FDA Recognized Consensus Standards for electrical safety, EMC, biocompatibility, sterility, and packaging.

The statement "The HEITER 3000 performed within specifications in all of the above tests" indicates that the device met its internal specifications for these technical and safety aspects, but these are not presented as explicit "acceptance criteria" with corresponding "reported device performance" in a comparative table format that would typically be seen for a diagnostic AI algorithm. There are no detailed performance metrics like sensitivity, specificity, or AUC that would be expected for such a request.

Therefore, many of the requested fields cannot be filled from the provided text because the submission is for a medical device (a physical system) and not an AI or diagnostic algorithm, and the type of evaluation described is typical for hardware and software functionality testing, not clinical comparative effectiveness or standalone algorithm performance.

Here's an attempt to extract relevant information given the constraints and the nature of the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit from "Tests Carried Out")	Reported Device Performance (Summary Statement)
Ability to heat fluids over the full range of fluid flow rates.	Performed within specifications in all tests.
Ability to maintain fluid temperature over the full range of fluid flow rates.	Performed within specifications in all tests.
Ability to detect and automatically respond to unsafe/ineffective operating conditions (sensor failure, excessive fluid temp/pressure, internal component failures).	Performed within specifications in all tests.
Ability to inform clinical user of unsafe/ineffective conditions via notifications, alerts, alarms, and/or system faults.	Performed within specifications in all tests.
Ability to mitigate against unknown or predictable operator errors.	Performed within specifications in all tests.
Ability to store non-patient, procedure-specific treatment parameters and machine data in non-volatile memory.	Performed within specifications in all tests.
Measurement of temperature accuracy over the full range of fluid flow rates within the operating pressure range.	Performed within specifications in all tests.
Measurement of pressure accuracy over the full range of fluid flow rates within the operating temperature range.	Performed within specifications in all tests.
Measurement of fluid flow rate accuracy over the full range of fluid flow rates within the operating temperature-pressure range.	Performed within specifications in all tests.
Compliance with IEC 60601-1:1998+A1:1991+A2:1995 (Electrical Safety).	Complies with and tested to this standard.
Compliance with IEC 60601-1-2:2001+A1:2004 (EMC).	Complies with and tested to this standard.
Compliance with AAMSI/ANSI/ISO 11135-1:2003(E) (Biological evaluation of medical devices).	Complies with and tested to this standard.
Compliance with AAMSI/ANSI/ISO 10993-1:2007 (Biocompatibility - In vitro cytotoxicity).	Complies with and tested to this standard.
Compliance with AAMSI/AMSI/ISO 10993-7:1995(R)2001 (Biocompatibility - Ethylene Oxide Sterilization Residuals).	Complies with and tested to this standard.
Compliance with AAMSI/ANSI/ISO 10993-10:2002 (Biocompatibility - Irritation and Delayed-type Hypersensitization).	Complies with and tested to this standard.
Compliance with AAMSI/ANSI/ISO 10993-11:2006 (Biocompatibility - Systemic Toxicity).	Complies with and tested to this standard.
Compliance with AAMSI/ANSI/ISO 10993-1:2003(E) (Sterility - Ethylene oxide sterilization).	Complies with and tested to this standard.
Compliance with ASTM D4169-05:2005 (Packaging).	Complies with and tested to this standard.
Mitigation of potential user and patient safety risks identified in human factors study.	Results demonstrated task-risks successfully addressed and mitigated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Software Verification/Validation & Safety Requirements: No explicit "sample size" is mentioned in terms of patient data or clinical cases. These tests were performed on the device itself ("the HEITER 3000 was tested"). The data provenance is internal testing by the manufacturer.
Human Factors Study: The text mentions "diverse groups of pump users" for the non-clinical study. No specific number for the sample size of users is given. This was a prospective simulation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this device submission. The "ground truth" for a physical medical device's performance is typically its design specifications and recognized standards, which are verified through various engineering and functional tests, not expert consensus on medical images or patient outcomes. The human factors study involved "pump users" but their role was not to establish ground truth in the diagnostic sense, rather to evaluate usability and safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving interpretation, not for validating the functional performance of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/diagnostic device. The evaluation focuses on the device's functional performance, safety, and substantial equivalence to predicate devices, not on improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical system; it's not an algorithm evaluated for standalone performance. The device's "standalone" performance is assessed through its functional tests as described in the software verification/validation section.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is its design specifications, established engineering principles, and compliance with recognized national and international consensus standards (e.g., IEC 60601 series, ISO 10993 series, ASTM D4169). For the human factors study, the ground truth relates to identified user errors and safety risks being successfully mitigated.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning model.

Summary

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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 StreetBoulder, CO 80301Tel: 720.622.4216
	Contact

Indications for Use

Predicate Devices

K092366	TTS100 Portable Hyperthermic Perfusion DeviceThermal Therapeutic Systems, Inc
K070654	Belmont Hyperthermia PumpBelmont Instruments

Device Description

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.

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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.

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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.

ElectricalSafety, EMC	IEC 60601-1:1998+A1:1991+A2:1995(IEC 60601-1+A1+A2)	Medical Electrical Equipment –Part 1: General Requirements forSafety, 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 Requirementsfor Safety - Collateral standard:Electromagnetic Compatibility –Requirements and Test (Ed. 2.1)

	AAMSI/ANSI/ISO 11135-1:2003(E)	Biological evaluation of medicaldevices - Part 1: Evaluation andTesting
	AAMSI/ANSI/ISO 10993-1:2007	Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity
Biocompatibility	AAMSI/AMSI/ISO 10993-7:1995(R)2001	Biological evaluation of medicaldevices - Part 7: Ethylene OxideSterilization Residuals
	AAMSI/ANSI/ISO 10993-10:2002	Biological evaluation of medicaldevices - Part 10: Tests forIrritation and Delayed-typeHypersensitization
	AAMSI/ANSI/ISO 10993-11:2006	Biological evaluation of medicaldevices - Part 11: Tests forSystemic Toxicity
Sterility	AAMSI/ANSI/ISO 10993-1:2003(E)	Sterilization of Health Care Products - Ethylene oxide - Part 1:Requirement for the thedevelopment, validation, androutine control of a sterilizationprocess for medical devices

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Packaging	ASTM D4169-05:2005	Sterilization of Health CareProducts - Ethylene oxide - Part 1:Requirement for the thedevelopment, validation, androutine control of a sterilizationprocess for medical devices
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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.

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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.

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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

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Indications for Use

K 102900

Device Name:

HEITER 3000 Hyperthermic Perfusion System

510(k) Number (if known):

Indications for Use:

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:

Page 1 of 1

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Regulation Number and Section

§ 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).