(26 days)
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.
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.
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.
The Belmont® Hyperthermia Pump, as described in the provided document, is a medical device for raising the temperature of the thoracic or peritoneal cavity by continuously lavaging with warmed sterile solution. The information relevant to acceptance criteria and the study is outlined below.
No AI/Algorithm-specific information is available in the provided document. The document describes a traditional medical device (Hyperthermia Pump) and its 510(k) submission, which focuses on hardware and software updates to an existing device, and non-clinical performance testing. Therefore, sections pertaining to AI/Algorithm performance (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable in this context and cannot be extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Belmont® Hyperthermia Pump are derived from its functional specifications and safety requirements. The document describes nonclinical tests performed to verify these aspects.
| Acceptance Criterion (Test Objective) | Reported Device Performance (Result) |
|---|---|
| Pumping Accuracy: Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, back pressure, ambient temperature). | Performed within specifications. |
| Warming Capability: Ability to warm cold fluids to the user-set temperature over the full range of flow rate and operating conditions. | Performed within specifications. |
| Safety Alarms & Detection: Ability to detect and alarm at unsafe or ineffective operating conditions (over-temperature, unsafe high line pressure, out of fluid, air in the line, internal fault conditions). | Performed within specifications. |
| Risk Mitigation: Verification and validation tests to ensure risks were mitigated and control methods implemented correctly. | Performed within specifications. (Implicitly, as the conclusion states performance within specifications). |
| Algorithm Validation (Software): Validation for each function element in the software specification, and extensive system testing with software. | Performed within specifications. (Implicitly, as the conclusion states performance within specifications). |
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. | Performed within specifications. |
| Medical Electrical Equipment - Electromagnetic Compatibility: Collateral Standard. | Performed within specifications. |
Study Demonstrating Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of nonclinical verification and validation tests. These tests were carried out to ensure that the updated hardware (chip replacement) and software, along with a brighter monochromatic display, maintained or improved performance and safety compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical laboratory testing of the device itself.
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of patient data. For medical devices undergoing nonclinical testing, the "test set" would refer to the number of devices or test conditions used. This information is not explicitly quantified (e.g., "tested 5 devices across X conditions").
- Data Provenance: The tests are nonclinical, conducted as part of the device manufacturer's verification and validation process. Therefore, data provenance is internal laboratory testing. It is not patient data from a specific country, nor is it retrospective or prospective in the clinical trial sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for device performance in nonclinical testing is established by engineering specifications, regulatory standards, and objective measurements using calibrated instruments. It does not involve expert human interpretation in the way that image analysis algorithms require ground truth from clinicians.
4. Adjudication Method for the Test Set
Not applicable. As this is nonclinical device performance testing, adjudication methods typically used for human interpretation or clinical trials (e.g., 2+1, 3+1) are not relevant. Performance is measured against predefined engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is a type of clinical study typically used for diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) to assess the impact of an AI algorithm on reader performance. This documentation pertains to a hyperthermia pump, a therapeutic device, and its nonclinical performance, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Belmont® Hyperthermia Pump is a physical medical device with integrated software and hardware for controlling fluid warming and flow. It is not an "algorithm" in the sense of a standalone diagnostic or predictive model. Its performance is measured as a completely integrated system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the nonclinical tests is based on:
- Engineering Specifications: Predefined performance parameters for flow rate, temperature accuracy, alarm thresholds, etc.
- Regulatory Standards: Compliance with industry standards like "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance" and "Medical Electrical Equipment - Electromagnetic Compatibility."
- Objective Measurement: Using calibrated instruments to measure flow rates, temperatures, pressures, and verify alarm functions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning algorithm that requires a "training set" of data. The device's operation is based on deterministic control logic and fixed algorithms programmed into its microprocessor, developed through engineering design rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Corporation780 Boston RoadBillerica, MA 01821 |
| Contact Person: | Uraiwan P. LabadiniQuality Assurance/Regulatory Affairs ManagerTelephone: (508) 663-0212 Ext. 128Fax: (508) 663-0214Email address: ulabadini@belmontinstrument.com |
| 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 UnderWhich Substantial Equivalence isClaimed: | The Belmont® Hyperthermia Pump cleared formarket entry originally under 510(k) K070654,1st modification cleared under 510(k) K090089. |
| Device Description: | The Belmont® Hyperthermia Pump combinesadvanced microprocessor technology with anefficient mechanical system to provide a highspeed, simple and safe system for rapid perfusionof warmed fluid. It can raise the temperature of thethoracic or peritoneal cavity to the desired targettemperature by continuously lavaging the cavitywith circulating warmed sterile solution, accordingto a protocol to be selected by the physician.The system monitors fluid temperature, patienttemperature, line pressure, and air in the fluid pathto ensure safe operation and alarms at all unsafeconditions. A hardware override circuit preventsunsafe operation in case of system computerfailure. A touch screen displays flow rate, total fluidpumped, output fluid temperature, targettemperature, patient temperature, line pressure,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:
§ 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).