The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Device Description

The PERFORMER HT is a prescription electromechanical device intended to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extracorporeal circulation of warmed. physiologically compatible sterile solution.

The PERFORMER HT equipment is designed to:

operate the treatment execution by means of a color touch-screen display .
. control the temperature of solution perfused to the Patient through the extracorporeal circuit
control the flow rates of roller pumps .
control the volume in the extracorporeal circuit and Patient's body cavity .
monitor Patient's body cavity temperatures .
monitor the extracorporeal circuit pressures .
. detect air in the circuit
change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves .

The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to:

inout Patient information .
operate the various treatment phases
display treatment parameters (e.g, flows, pressures, temperatures) .
set treatment parameters .
. set alarm limits
display graphical trending of temperature probes connected to the HTS module
· read alarm and alert messages

The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity.

The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution:

· circulation line
·. heater bag
· reservoir
· table pack (Patient inlet and outlet lines) with thermal protections

The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.

AI/ML Overview

The Performer HT is a prescription electromechanical device for isolated hyperthermic perfusion. It circulates warmed, physiologically compatible sterile solution in the thoracic or peritoneal cavity. It controls solution temperature and flow rates, monitors volumes/pressures/temperatures, and detects air. The device is intended for use by qualified medical professionals.

Here's an analysis of its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device should do)	Reported Device Performance (What the device does)
Ability to heat and pump fluids accurately over the full range of flow rate and operating conditions.	Performed within specifications.
Ability to maintain fluid temperature over the full range of fluid flow rates.	Performed within specifications.
Ability to control pressures, volumes, and flow rate accuracy over the full range of fluid flow rate within operating temperature and pressure range.	Performed within specifications.
Ability to detect and alarm at unsafe or ineffective operating conditions (e.g., operator errors, sensor failures, system malfunctions).	Performed within specifications.
Ability to mitigate against known or predictable operator errors.	Performed within specifications.
Ability to store parameters and data in non-volatile memory.	Performed within specifications.
Compliance with various recognized standards for: - Quality management (ISO 14971, EN ISO 13485, EN ISO 14971) - Packaging and labeling (EN 980, EN 1041, ASTM D4169-04a) - Biocompatibility (AAMI ANSI ISO 10993 series) - Electrical safety (IEC 60601 series) - Sterility (AAMI ANSI ISO 11135, ISO 11607 series, ASTM F1980-07, AAMI ANSI ISO 11737) - Human Factors (IEC 62366, EN 62366) - Software (IEC 62304, EN 62304)	The PERFORMER HT is designed to, complies with, and has been tested to, the FDA Recognized Consensus Standards listed in the table.
Software ability to meet performance specifications.	Verified through described tests at unit, integration, and system level for all functions, actuators, and parameters.
User interface optimization and mitigation of user- and patient-safety risks concerning human factors.	Demonstrated that task-risks and errors have been identified, addressed, and either eliminated or reduced in a simulated use environment.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a specific test set in the context of clinical trials or retrospective studies on actual patient data. The testing primarily involved non-clinical tests conducted on the PERFORMER HT system (equipment and disposable).

Data Provenance: The tests were performed by the manufacturer, RanD S.r.l. in Italy, as part of their 510(k) submission. Therefore, the data provenance is from the manufacturer's testing environment and simulated use, and it is prospective in the sense that the tests were designed and executed to evaluate the device's performance against pre-defined specifications. It is not patient or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this medical device primarily relates to its engineering specifications, safety standards, and functional performance as verified through non-clinical testing. There is no mention of a ground truth established by human experts in a diagnostic or clinical context. The "ground truth" is defined by the technical specifications and recognized consensus standards that the device is tested against.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations are compared against a consensus ground truth.

In this case, the device's performance was evaluated against predefined engineering specifications and recognized standards. The "adjudication" would involve technical experts (engineers, quality assurance personnel) verifying that the test results met these objective criteria.

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/CAD (Computer-Aided Detection/Diagnosis) device, nor is it a device that is typically evaluated through MRMC studies. The PERFORMER HT is an electromechanical device for hyperthermic perfusion.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The performance tests described comprehensively evaluate the PERFORMER HT system (equipment and disposable) in its standalone capacity, to ensure it meets its functional and safety specifications. Even though it's an electromechanical device and not an algorithm, the tests assess its "standalone" operational capabilities without human intervention beyond initiating and monitoring the tests. The human factors study separately assessed user interaction, but the core performance tests were for the device itself.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on pre-defined engineering specifications, recognized consensus standards, and established operational parameters. For example:

Temperature control: The ability to heat and maintain fluid temperature within a specified range defines the ground truth for this function.
Flow rate accuracy: The specified acceptable deviation from target flow rates serves as the ground truth.
Alarm functionality: The system's response to simulated unsafe conditions (e.g., sensor failure) according to its design is the ground truth.
Compliance with standards: The requirements outlined in international and European standards (e.g., ISO 14971, IEC 60601-1) form the ground truth for safety, quality, and electrical compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is an electromechanical system, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's design and functionality are based on engineering principles and validated through testing, not learned from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this type of device.

Summary

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K120-026

5. 510(k) Summarv

MAY - 8 2012

21 CFR 807.92(a)(1): Submitter and Manufacturing site information RanD S.r.l. via Statale 12. 62 41036 Medolla (MO) - ITAL Y Telephone: +39 0535 49283 Fax: +39 0535 660636 Contact person: Simone Ceretti

Establishment registration number: 3003793891

Date of the present summary preparation: 28th December, 2011

21 CFR 807.92(a)(2): Device information
Trade name	PERFORMER HT / HANG&GO HT BASIC
Device Classification Name	Warmer, thermal, infusion fluid
Classification Review Panel	General Hospital
Classification Product Code	LGZ
Regulatory Class	Unclassified, pre-amendment device

21 CFR 807.92(a)(3): Predicate devices

The PERFORMER HT is substantially equivalent to the Belmont Hyperthermia Pump (K070654, dtd June 8th, 2007).

21 CFR 807.92(a)(4): Description of the device

The PERFORMER HT equipment is designed to:

operate the treatment execution by means of a color touch-screen display .
. control the temperature of solution perfused to the Patient through the extracorporeal circuit
control the flow rates of roller pumps .
control the volume in the extracorporeal circuit and Patient's body cavity .
monitor Patient's body cavity temperatures .
monitor the extracorporeal circuit pressures .
. detect air in the circuit
change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves .

The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to:

inout Patient information .
operate the various treatment phases
display treatment parameters (e.g, flows, pressures, temperatures) .
set treatment parameters .
. set alarm limits
display graphical trending of temperature probes connected to the HTS module

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· read alarm and alert messages
The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity.

The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution:

· circulation line
·. heater bag
· reservoir
· table pack (Patient inlet and outlet lines) with thermal protections

The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.

21 CFR 807.92(a)(5): Intended use

The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed. physiologically compatible sterile solution, according to a protocol to be selected by the physician.

The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Predicate device intended use

The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

21 CFR 807.92(a)(6): Comparison of technological characteristics

The PERFORMER HT has the same operating principle, energy type, environmental specifications, and performance specifications of the Belmont device. It uses roller-type fluid pumps, touch screen to direct the User through set-up preparation and use, control and monitoring of fluid temperatures, and a proprietary-design disposable set including large fluid reservoir to circulate sterile fluid into and out of the body cavity. Flow from the reservoir is delivered by action of the roller pump to the heater exchanger to be heated to the desired target temperature, and then to the Patient, From the Patient, the fluid is pumped from the return line back into the reservoir. The PERFORMER HT monitors circulating flow, temperatures, pressures and volumes, detects air in the circuit and automatically responds to ineffective or unsafe operating conditions by sounding audible alarms, stopping heating and pumping in case of hazardous conditions for User/Patient.

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21 CFR 807.92(b)(1): Discussion of the non-clinical tests

The PERFORMER HT is designed to, complies with, and has been tested to, the FDA Recognized Consensus Standards listed in the table below, as applicable to the equipment, the disposable lines set and the components:

Area	US Recognized standard #	EU Recognized standard #	Title
General	ISO 14971:2007	EN ISO 13485:2003 / AC:2007	Medical devices -- Quality management systems -- Requirements for regulatory purposes
		EN ISO 14971:2007	Medical devices - Application of risk management to medical devices

Packaging andlabeling		EN 980:2008	Symbols for use in the labelling of medical devices
		EN 1041:2008	Information supplied by the manufacturer with medical devices
		ASTM D4169-04a	Standard Practice for Performance Testing of Shipping Containers and Systems

Biocompatibility	AAMI ANSI ISO 10993-1:2009	EN ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluation and testing
		EN ISO 10993-4:2002	Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood
	AAMI ANSI ISO 10993-5:2009	EN ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
	AAMI ANSI ISO 10993-7:2008	EN ISO 10993-7:2009	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
	ISO 10993-10:2002/Amd1:2006	EN ISO 10993-10:2002/Amd 1:2006	Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
	AAMI ANSI ISO 10993-11:2006	EN ISO 10993-11:2006	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
	IEC 60601-1:1988/Amd1:1991 & Amd 2:1995	EN 60601-1:1990/Amd1:1993 & Amd 2:1995	Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995


Electrical safety	IEC 60601-1-1:2000	EN 60601-1-1:2001	Medical electrical equipment - Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems
	AAMI ANSI IEC 60601-1-2:2001	EN 60601-1-2:2001	Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

	IEC 60601-1-4:2000	EN 60601-1-4:1996/Amd 1:1999	Medical electrical equipment - Part 1-4:General requirements for safety -Collateral standard: Programmable electrical medical systems


		EN 60601-1-6:2004	Medical electrical equipment -- Part 1-6:General requirements for basic safety and essential performance - Collateral Standard: Usability




Sterility	AAMI ANSI ISO 11135-1:2007	EN 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.



	AAMI ANSI ISO 11607-1:2006	EN ISO 11607-1:2009	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems




	AAMI ANSI ISO 11607-2:2006	EN ISO 11607-2:2006	Packaging for terminally sterilizedmedical devices - Part 2: Validationrequirements for forming, sealing andassembly processes
	ASTM F1980-07		Standard Guide for Accelerated Aging ofSterile Barrier Systems for MedicalDevices.
	AAMI ANSI ISO 11737-1:2006	EN ISO 11737-1:2006	Sterilization of medical devices-Microbiological methods-Part 1:Determination of the population ofmicroorganisms on product
Human factors	IEC 62366:2007	EN 62366:2008	Medical devices - Application of usabilityengineering to medical devices
Software	IEC 62304:2006	EN 62304:2006	Medical device software - Software lifecycle processes

Table 1: Applicable Reference Standards list

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Tests were carried out on the PERFORMER HT system (equipment and disposable) to assess:

. The ability of the system to heat and pump fluids accurately over the full range of flow rate and operating conditions;
The ability of the system to maintain fluid temperature over the full range of fluid . flow rates:
. The ability of the system to control the pressures, volumes and flow rate accuracy over the full range of fluid flow rate within the operating temperature and pressure range;
. The ability of the system to detect and alarm at unsafe or ineffective operating conditions including operator errors, the failure of the system sensors, and other internal system malfunctions;
The ability of the system to mitigate against known or predictable operator errors; .
The ability of the system to store parameters and data in non-volatile memory. .

The PERFORMER HT performed within the specifications in all of the above tests.

Software verification and validation

PERFORMER HT software ability to meet performance specifications has been verified through the tests described above. Software control of all functions, actuators and parameters has been verified at unit, integration and system level.

Human Factors

A human factors non-clinical study was conducted in a simulated use environment with the purpose to optimize the system's user interface through human factors analysis, testing and validation. The study evaluated user- and patient-safety risks associated with the design of the PERFORMER HT system and demonstrated that the task-risks and errors that occur during use of the device have been identified, addressed and either eliminated or reduced.

21 CFR 807.92(b) (3): Conclusions

Based upon safety and performance testing and compliance with voluntary standards, RanD believes that the PERFORMER HT is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Simone Ceretti Regulatory Affairs RanD S.r.l. Via Statle 12, 62 MEDOLLA ITALY 41036

MAY - 8 2012

Re: K120026

Trade/Device Name: PERFORMER HT System Regulation Number: Unclassified Regulation Name: Thermal Fluid Warmer Regulatory Class: II Product Code: LGZ Dated: April 24, 2012 Received: April 26, 2012

Dear Ms. Ceretti:

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 approvisions 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 (1 vir 1), it may be our 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 - Ms. Ceretti

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 (OS) 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 O.m

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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4. Indications for Use Statement

510(k) Number (if known): none

Device Name: PERFORMER HT system

Indications for Use:

The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kld C. Ch 5/8/12
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120026

4 - 1

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).