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.

Device Description

The Belmont Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can 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. The system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid pumped, output fluid temperature, target temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

AI/ML Overview

The provided text describes the Belmont Hyperthermia Pump, but does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars for a medical device. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with performance metrics and ground truth establishment against specific acceptance criteria.

However, based on the nonclinical tests described, I can infer some aspects and present the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "Summary of Nonclinical Tests")	Reported Device Performance
Pumping Accuracy: Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, different back pressure, ambient temperature changes).	Performed within specification.
Warming Capability: Ability to warm fluid to the desired target temperature over the full range of flow rate and operating conditions.	Performed within specification.
Safety and Alarm Functionality: Ability to detect and alarm at unsafe or ineffective operating conditions (operator errors, sensor failures, internal system malfunctions).	Performed within specification, including sounding an audible alarm, stopping heating, and pumping at all unsafe conditions.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "nonclinical tests" but does not detail the number of units tested, the number of test scenarios, or the quantity of data generated.
Data Provenance: Not specified. These are nonclinical (bench) tests, so there's no patient data or country of origin mentioned. The tests were conducted internally by Belmont Instrument Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for diagnostic or prognostic purposes. The performance was measured against engineering specifications and safety parameters.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations. Device performance was evaluated against defined engineering specifications.

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

Not applicable. This is a medical device (hyperthermia pump), not an AI-powered diagnostic or assistive technology for human readers.

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

Applicable in principle, as the device operates largely autonomously to maintain temperature and flow. The "nonclinical tests" described represent standalone performance evaluations of the device's functions (pumping, warming, alarming) against its internal specifications. The document states it "performed within specification in all of the above tests."

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

For the nonclinical tests, the "ground truth" or reference standard would be the engineering specifications and design requirements of the device for pumping accuracy, temperature control, and safety alarm thresholds.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with three stylized human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

JAN 1 0 2017

Mr. Uraiwan P. Labadini Ouality Assurance/Regulatory Affairs Manager Belmont Instrument Corporation 780 Boston Road Billerica, Massachusetts 01821

Re: K070654

Trade/Device Name: Belmont Hyperthermia Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: March 9, 2007 Received: March 9, 2007

Dear Mr. Labadini:

This letter corrects our substantially equivalent letter of June 8, 2007.

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 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of

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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 Parts 801 and 8091 ), 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 vours.

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

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Indications for Use

510(k) Number (if known):

Device Name: Belmont Hyperthermia Pump

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Oblision Sign-Off) Civision of Anesthestology, General Hoapttal, infection Control, Dental Devices

Page 1 of _1

510(k) Number:_

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K070654

Image /page/3/Picture/1 description: The image shows the logo for Belmont Instrument Corporation. The logo features the word "Belmont" in a stylized font, with the words "Instrument Corporation" in a smaller font underneath. Below the company name is the tagline "Creating a New Standard of Care".

JUN - 8 2007

Registered in Accordance with ISO 13485

Premarket Notification 510(k) Summary [As Required by 21 CFR 807.92(a)]

Date prepared: March 9, 2007

Submitter & 1. Belmont Instrument Corporation · Manufacturing Site: 780 Boston Road Billerica, MA 01821
Establishment Registration Number: 1219702
1. Contact Person: Uralwan P. Labadini, Quality Assurance/Regulatory Affairs Manager
  Telephone: (978) 663-0212 Ext. 28 Fax: (978) 663-0214
1. Trade Name: The Belmont Hyperthermia Pump
1. Common name: Warmer, Thermal, Infusion Fluid
1. Classification name: Warmer, Thermal, Infusion Fluid
હે. Product Code: 80 LGZ Device Class: Class II

Performance Standards: No performance standards have been officially adopted by the F.D.A.
The Belmont Hyperthermia Pump is substantially equivalent to the 8. ThermoChem-HT System, which was the subject of Premarket Notification #K993330 and received F.D.A 510(k) concurrence to market on December 30, 1999.

780 Boston Road, Billerica, MA 01821 tel 978.663.0212 fax 978.663.0214 www.belmontinstrument.com

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9. Brief Description:

The system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer A touch screen displays flow rate, total fluid pumped, output fluid failure. femperature, targef temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

10. Intended Use

1. Summary of the technological characteristics of the Belmont Hyperthermia Pump compared to the predicate device. ThermoChem-HT System.
  These two devices have the same operating principle, energy type, environmental specifications, or performance specifications. These two devices use roller-type fluid pump, touch screen to direct the user through set-up and use, a disposable set including large fluid reservoir to circulate sterile fluid into and out of the body cavity. Flow from the patient outlet is drained into the large reservoir, then through a roller pump and then to a heat exchanger. The heat exchanger warms fluid to the desired target temperature and then passes to the body cavity through the patient line/return line. These systems also monitor the circulating sterile fluid temperature. The Hyperthermia Pump sounds an audible alarm, stops heating, and pumping at all unsafe conditions.
1. Summary of Nonclinical Tests and Results
  In order to verify performance of the Belmont Hyperthermia Pump in support of substantial equivalence, the following tests were carried out:
The ability of the system to pump fluids accurately over the full range of flow a. rate and operating conditions including different input fluid temperatures, different back pressure, and change in ambient temperature.

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The ability of the system to warm fluid to the desired target temperature over b. the full range of flow rate and operating conditions.
The ability of the system to detect and alarm at unsafe or ineffective C. operating conditions including operator errors, the failure of the system sensors, and other internal system malfunctions.

The Belmont Hyperthermia Pump performed within specification in all of the above tests.

Conclusion: The Belmont Hyperthermia Pump is substantially equivalent to the 13. ThermoChem-HT System, a legally marketed devices intended to circulate warmed sterile fluid through the body cavity.

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).