The Belmont Hyperthermia Pump

K152208 · Belmont Instrument Corporation · LGZ · Sep 2, 2015 · General Hospital

Device Facts

• Record ID: K152208
• Device Name: The Belmont Hyperthermia Pump
• Applicant: Belmont Instrument Corporation
• Product Code: LGZ · General Hospital
• Decision Date: Sep 2, 2015
• 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

Device provides rapid perfusion of warmed fluid to thoracic or peritoneal cavities; used for hyperthermia therapy. System inputs: fluid temperature, patient temperature, line pressure, air-in-line detection. Operation: microprocessor-controlled mechanical pump circulates sterile solution; warms fluid to target temperature. Output: continuous lavage; touch screen displays flow rate, fluid volume, temperatures, pressure, and alarm status. Used in clinical settings; operated by physicians/clinical staff. Safety features: hardware override circuit for computer failure; battery backup for transport (warming disabled, monitoring active). Benefits: precise thermal control for cavity lavage; automated safety monitoring/alarms for over-temperature, high pressure, or air-in-line conditions.

Clinical Evidence

Bench testing only. Validation included: fluid pumping accuracy across flow rates/pressures/temperatures; warming performance; alarm verification for over-temperature, high pressure, out-of-fluid, and air-in-line conditions; risk assessment; software algorithm validation; and compliance with medical electrical equipment safety (IEC 60601-1) and electromagnetic compatibility standards.

Technological Characteristics

Microprocessor-controlled mechanical pump; high-speed fluid perfusion. Features touch screen interface, monochromatic high-contrast LCD. Monitors fluid/patient temperature, line pressure, air-in-line. Includes hardware override circuit for safety. Battery backup for mobile transport. Connectivity: standalone system. Sterilization: compatible with sterile solutions.

Indications for Use

Indicated for patients requiring thoracic or peritoneal cavity lavage with warmed sterile solution to reach a physician-selected target temperature.

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

• Belmont® Hyperthermia Pump (K070654)
• Belmont® Hyperthermia Pump (K090089)

Submission Summary (Full Text)

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

September 2, 2015

Belmont Instrument Corporation Uraiwan P. Labadini 780 Boston Road Billerica, Massachusetts 01821

Re: K152208

Trade/Device Name: Belmont® Hyperthermia Pump Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LGZ Dated: August 6, 2015 Received: August 7 2015

Dear Mr. Labadini:

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Part 801), 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/Resourcesfor You/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 |. Keith -S

Erin I. Keith, M.S. Division 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) K152208

Device Name The Belmont Hyperthermia Pump

Indications for Use (Describe)

The intended use of the Belmont Hyperthermia Pump is to raise 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Together. Saving lives.

Image /page/3/Picture/1 description: The image shows the logo for Belmont Instrument Corporation. The logo features the word "Belmont" in a stylized, blue font, with the "B" extending into a curved shape. Below "Belmont" is the text "INSTRUMENT CORPORATION" in a smaller, gray font.

# PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required By 21 CFR 807.92(c)]

| Special 510(k) No. | K152208 |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address: | Belmont Instrument Corporation<br>780 Boston Road<br>Billerica, MA 01821 |
| Contact Person: | Uraiwan P. Labadini<br>Quality Assurance/Regulatory Affairs Manager<br>Telephone: [phone] Ext. 128<br>Fax: [phone]<br>Email address: [e-mail] |
| Date Summary Prepared: | September 2, 2015 |
| Trade/Proprietary Name of Device: | The Belmont® Hyperthermia Pump |
| Regulatory Class: | Unclassified |
| Product Code: | LGZ (Warmer, Thermal, Infusion Fluid) |
| Legally Marketed Device Under<br>Which Substantial Equivalence is<br>Claimed: | The Belmont® Hyperthermia Pump cleared for<br>market entry originally under 510(k) K070654,<br>1st modification cleared under 510(k) K090089. |
| Device Description: | The Belmont® Hyperthermia Pump combines<br>advanced microprocessor technology with an<br>efficient mechanical system to provide a high<br>speed, simple and safe system for rapid perfusion<br>of warmed fluid. It can raise the temperature of the<br>thoracic or peritoneal cavity to the desired target<br>temperature by continuously lavaging the cavity<br>with circulating warmed sterile solution, according<br>to a protocol to be selected by the physician.<br><br>The system monitors fluid temperature, patient<br>temperature, line pressure, and air in the fluid path<br>to ensure safe operation and alarms at all unsafe<br>conditions. A hardware override circuit prevents<br>unsafe operation in case of system computer<br>failure. A touch screen displays flow rate, total fluid<br>pumped, output fluid temperature, target<br>temperature, patient temperature, line pressure,<br>alarm and status messages and proper procedures |

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to proceed safely after an alarm situation.

A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.

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.

Comparison of Technological Belmont Instrument Corporation is claiming Characteristics of the Device vs. substantial equivalence of of the Belmont® Hyperthermia Pump, to our Belmont® Hyperthermia the Legally Marketed Device: Pump which was originally cleared to market under 510(k) K070654 on June 8, 2007, and to the Belmont® Hyperthermia Pump 1000 ml/min flow rate was cleared to market under 510(k) K090089 on February 12, 2009.

> Belmont® The Hyperthermia Pump was a modification of the Rapid Infuser which has been in clinical use for more than 15 years; consequently a component used in the system had become obsolete and hard to obtain. Therefore, the system hardware (chip replacement), and software (to correspond with the chip changes) have been upgraded. At the same time, we are using a brighter monochromatic display with a higher contrast LCD to improve visibility. We have performed a rigorous validation to ensure that these updates are backward compatible with our existing system and no major functions have been altered.

Brief Discussion of Nonclinical Tests and their Results Submitted in the Application:

Specific Modifications being

reviewed in this submission:

In order to verify performance of the Belmont® Hyperthermia Pump in support of substantial equivalence, the following tests were carried out:

- a. 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 levels, and change in ambient temperature.

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Brief Discussion of Nonclinical Tests and their Results Submitted in the Application: Cont'd

- b. The ability of the system to warm cold fluids to the user set temperature over the full range of flow rate and operating conditions.
- c. The ability of the system to detect and alarm at unsafe or ineffective operating conditions including over temperature, the unsafe high line pressure condition, out of fluid, air in the line and at any of several internal fault conditions.
- d. We performed risk assessment and performed the verification and validation tests to ensure that these risks were mitigated and method of controls were implemented correctly.
- e. We validated each algorithm for each function element in the software specification using an approved procedure. We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met.
- f. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- g. Medical Electrical Equipment Collateral Standard: Electromagnetic Compatibility

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

The Belmont® Hyperthermia Pump is substantially equivalent to the Belmont® current product which received 510(k) approval at various times. Both systems are capable of high infusion flow rates, while maintaining infusate at user-set temperature, and both systems are suitable for use with sterile solutions. Both systems monitor flow rate. temperature, line pressure, and the presence of air at the input line or within the system, and alarm and stop the system at all unsafe conditions.

Belmont® The tests demonstrate that the Hyperthermia Pump is substantial equivalent and performs as well as the legally marketed device.

Conclusion: