HYPERTHERMIA PUMP

K070654 · Belmont Instrument Corp. · LGZ · Jun 8, 2007 · General Hospital

Device Facts

• Record ID: K070654
• Device Name: HYPERTHERMIA PUMP
• Applicant: Belmont Instrument Corp.
• Product Code: LGZ · General Hospital
• Decision Date: Jun 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Belmont Hyperthermia Pump is a system for rapid perfusion of warmed sterile solution into thoracic or peritoneal cavities. It utilizes a roller-type fluid pump and a heat exchanger to circulate and warm fluid. The system includes a disposable set with a large fluid reservoir; fluid is drained from the patient, pumped through the heat exchanger, and returned to the body cavity. A microprocessor-based system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path. A touch screen displays flow rate, fluid volume, temperatures, and pressure, while providing procedural guidance. The device features a hardware override circuit to prevent unsafe operation in the event of computer failure. It is intended for clinical use under physician supervision. By maintaining precise cavity temperatures, the device supports hyperthermia treatment protocols, potentially benefiting patients by facilitating controlled thermal therapy.

Clinical Evidence

Bench testing only. Testing verified system performance regarding fluid pumping accuracy across various flow rates, back pressures, and ambient temperatures; the ability to warm fluid to target temperatures; and the efficacy of safety sensors and alarm systems for detecting operator errors, sensor failures, and internal malfunctions.

Technological Characteristics

Microprocessor-controlled roller-type fluid pump; heat exchanger for fluid warming; touch screen interface; disposable fluid circuit with reservoir. Monitors fluid/patient temperature, line pressure, and air in path. Includes hardware override circuit for safety. Connectivity/software details not specified beyond microprocessor control.

Indications for Use

Indicated for patients requiring thoracic or peritoneal cavity lavage with warmed sterile solution to achieve a target temperature, as determined by a physician-selected protocol.

Regulatory Classification

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.

Predicate Devices

• ThermoChem-HT System (K993330)

Submission Summary (Full Text)

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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)

A

(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

7.

- 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.