(31 days)
buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.
The Belmont buddy plus™ Fluid Warmer is a nonelectromagnetic blood or fluid warming device intended for warming blood, blood products, and intravenous solutions to physiological temperature prior to administration. It is designed for use by healthcare professionals in clinical environments to prevent hypothermia, specifically for applications where the flow rate is 6 liters/hour (100 ml/min) or less.
Here's a breakdown of the acceptance criteria and the study information presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements/Features) | Reported Device Performance |
|---|---|
| Ability to warm cold fluids to physiological temperature. | Stated as performing "as intended according to the specifications of the device" for heating blood products or intravenous fluids to physiological temperature. |
| Ability to protect the patient and detect/alarm at unsafe or ineffective operating conditions. | The device "monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs." The study verified the "ability of the system to protect the patient and to detect and alarm at unsafe or ineffective operating conditions." |
| Intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less. | This is an intended use specification, not a direct performance result from the verification testing described. The device is designed for this flow rate. |
| Sterile, non-pyrogenic fluid path for the disposable set. | The disposable set "has a sterile, non-pyrogenic fluid path, and is for single-patient use only." This is a design characteristic, not a direct performance result from the functional tests mentioned. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a numerical sample size for the "nonclinical tests." It only states that "the following tests were carried out."
- Data Provenance: Not specified, but the testing was conducted by Belmont Instrument Corporation, presumably in-house or through a contracted laboratory to demonstrate performance. The testing is implied to be prospective, as it was done to "verify performance" for K062774.
3. Number of Experts and their Qualifications for Ground Truth of Test Set
This type of information is not applicable to this device. The Belmont buddy plus™ Fluid Warmer is a medical device for warming fluids, and its performance and safety are typically evaluated through engineering and functional tests against established physical and safety criteria, rather than through expert consensus on qualitative assessments or diagnostic interpretation. Therefore, there are no "experts" establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image analysis) where ambiguous cases require expert resolution. The nonclinical tests described for the fluid warmer are objective, measurable performance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess the impact of AI assistance on human performance. The Belmont buddy plus™ Fluid Warmer is a therapeutic/supportive care device, not a diagnostic one involving human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed in the sense that the device's technical specifications and functional capabilities were tested independently to verify its performance against design requirements. The "nonclinical tests" fall under this category, evaluating the device's ability to warm fluids and its safety features directly.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective engineering specifications and safety standards. For example:
- Physiological temperature: This is a defined temperature range (e.g., 37°C ± a certain tolerance). The device's ability to achieve and maintain this temperature is measured directly.
- Alarm conditions: These are defined fault conditions, and the "ground truth" is whether the device accurately detects them and triggers the appropriate alarm.
8. Sample Size for the Training Set
This information is not applicable. The Belmont buddy plus™ Fluid Warmer is not an AI/ML-driven device that requires a training set. Its design and operation are based on conventional engineering principles of resistive heating and electronic control, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 864.9205 Blood and plasma warming device.
(a)
Nonelectromagnetic blood or plasma warming device —(1)Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.