BELMONT HYPERTHERMIA PUMP

K090089 · Belmont Instrument Corp. · LGZ · Feb 12, 2009 · General Hospital

Device Facts

• Record ID: K090089
• Device Name: BELMONT HYPERTHERMIA PUMP
• Applicant: Belmont Instrument Corp.
• Product Code: LGZ · General Hospital
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Special
• 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

Belmont Hyperthermia Pump functions as a fluid warming and circulation system. Device inputs include sterile solution; system heats fluid to physician-selected target temperature. Output is continuous lavage of thoracic or peritoneal cavity with warmed solution. Used in clinical settings (e.g., OR) by physicians to induce hyperthermia as part of a therapeutic protocol. Benefits include controlled, localized temperature elevation within body cavities to support clinical treatment goals.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Infusion pump (21 CFR 880.5725, Product Code LGZ). System designed for continuous circulation and heating of sterile solutions for cavity lavage. Technical details regarding specific materials, energy sources, or software architecture are not provided in the document.

Indications for Use

Indicated for patients requiring hyperthermia treatment of the thoracic or peritoneal cavity via continuous lavage with warmed sterile solution. Prescription use only.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Belmont Instrument Corporation Ms. Uraiwan Labadini Quality Assurance/Regulatory Affairs Manager 780 Boston Road Billerica, Massachusetts 01821

JAN 1 0 2017

Re: K090089

Trade/Device Name: Belmont Hyperthermia Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: January 13, 2009 Received: January 14, 2009

Dear Ms. Labadini:

This letter corrects our substantially equivalent letter of February 12, 2009.

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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Page 2 - Ms. Uraiwan Labadini

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 Parts 801 and 809), 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 yours,

## 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): Kog 0089

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 (Part 21 CFR 801 Subpart D)

:
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AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K090089