HYPERTHERMIA PUMP

• K Number: K070654
• Device Name: HYPERTHERMIA PUMP
• Manufacturer: BELMONT INSTRUMENT CORP.
• Date Cleared: 2007-06-08 ( 91 days)
• Product Code: LGZ
• Regulation Number: 880.5725

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.

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.

Predicate Devices

K993330

Reference Devices

K993330

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "advanced microprocessor technology" and monitoring of various parameters, but there is no mention of AI, ML, or any learning or adaptive capabilities. The system operates based on pre-selected protocols and hardware overrides, not on data-driven algorithms.

Therapeutic

Yes

The device is intended to "raise the temperature of the thoracic or peritoneal cavity to the desired target temperature" to provide therapy.

Diagnostic

No

This device is designed to heat and circulate fluid within a body cavity to raise its temperature for therapeutic purposes (hyperthermia), which is a treatment, not a diagnostic function. While it monitors various parameters like fluid temperature and patient temperature, these are for monitoring the treatment's safety and effectiveness, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a system with mechanical components (pumping system), hardware for monitoring (sensors for fluid temperature, patient temperature, line pressure, air), a hardware override circuit, and a touch screen display. This is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this 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 sterile solution. This is a therapeutic procedure performed directly on the patient's body.
• Device Description: The description details a system for warming and circulating fluid within a body cavity. It monitors physical parameters like temperature, pressure, and flow rate.
• Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information for the diagnosis of a disease or condition. IVDs are specifically designed for in vitro examination of specimens derived from the human body.

The device is a therapeutic device used for hyperthermia treatment within body cavities.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LGZ

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.

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)

Nonclinical Tests were carried out to verify performance:

• The ability of the system to pump fluids accurately over the full range of flow rate and operating conditions including different input fluid temperatures, different back pressure, and change in ambient temperature.
• The ability of the system to warm fluid to the desired target temperature over the full range of flow rate and operating conditions.
• 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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K993330

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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)

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

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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

• 2. Contact Person: Uralwan P. Labadini, Quality Assurance/Regulatory Affairs Manager
     Telephone: [phone] Ext. 28 Fax: [phone]
• 3. Trade Name: The Belmont Hyperthermia Pump
• 4. Common name: Warmer, Thermal, Infusion Fluid
• 5. 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 [phone] fax [phone] www.belmontinstrument.com

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9. Brief 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 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

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.

• 11. 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.
• 12. 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.