(51 days)
The Microheater 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 system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.
The Belmont Microheater 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 heating technology used is resistive heating of two plates within the heater unit. The Microheater 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 cartridge, 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 Microheater is not meant to be used with pressurized infusers. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.
This document is a 510(k) premarket notification for the Belmont Microheater, a blood and fluid warmer. The provided text describes the device, its intended use, and a summary of nonclinical tests performed to support its substantial equivalence to a predicate device. However, it does not provide the detailed acceptance criteria and study results in the format requested.
Specifically, the document states:
- "11. Summary of Nonclinical Tests and Results" lists two verification tests:
- "Verify the ability of the system to warm cold fluids to physiological temperature."
- "Verify the ability of the system to detect and alarm at unsafe or ineffective operating conditions."
- It also states: "In order to verify performance of the Belmont Microheater in support of substantial equivalence, the following tests were carried out."
- Under "12. Conclusion," it mentions: "Both systems have the same intended use, and are capable of heating blood products or intravenous fluids prior to administration to physiological temperature. Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats."
This summary indicates that tests were performed to verify performance against certain implicit criteria (e.g., reaching physiological temperature, detecting and alarming unsafe conditions, implementing a fail-safe circuit). However, the document does not explicitly define specific numerical acceptance criteria (e.g., a target temperature range, alarm thresholds), nor does it present the reported device performance data against such criteria in a table format.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred or stated as "not provided" based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated/Inferred) | Reported Device Performance (Summary in document) |
|---|---|
| Warm cold fluids to physiological temperature | "Capable of heating blood products or intravenous fluids prior to administration to physiological temperature." |
| Detect and alarm at unsafe or ineffective operating conditions | "System provides the user with alarm, alarm message... The device stops heating and alarms if an alarm or fault condition occurs." |
| Independent fail-safe circuit stops heating and alarms if system overheats | "Both systems have an independent fail-safe circuit which stops heating and alarms if the system overheats." |
| Compliance with listed standards (e.g., ANSI/AAMI/ISO 11135-1994, UL 2601-1, EN 60601-1) | "Verify that the device is in compliance with the following standards." (No specific results stated, only that verification was done). |
Note: The document provides a summary of tests and a conclusion of capability, but not the specific numerical acceptance criteria (e.g., "target temperature of 37 ± 1°C") or the detailed performance results that demonstrate meeting these criteria (e.g., "average temperature achieved was 37.2°C with a standard deviation of 0.5°C").
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the following tests were carried out" but does not give the number of trials, units tested, or data points collected for these nonclinical tests.
- Data Provenance: The tests were "carried out" by Belmont Instrument Corporation. It's an internal company study for regulatory submission. It's prospective in the sense that the testing was performed specifically for this submission. Country of origin not explicitly stated for the testing, but the company is based in Billerica, MA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a fluid warmer, and the described tests are nonclinical performance validations (e.g., heating to a certain temperature, alarm function). The "ground truth" for these tests would be objective measurements (e.g., temperature probes, electrical sensors), not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, the tests are objective performance validations, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hardware device (fluid warmer), not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device. The "standalone" performance would be its ability to warm fluids and alarm, which is implicitly what the nonclinical tests addressed, but the term "standalone" typically refers to AI algorithm performance without human intervention. The device operates autonomously to achieve its intended function (warming fluids) and has an "independent fail-safe circuit."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests (warming, alarming): The "ground truth" would be objective physical measurements (e.g., temperature readings from calibrated sensors, verification of alarm activation under specific faulty conditions).
- For compliance with standards: The ground truth is successful adherence to the requirements outlined in the referenced standards (e.g., ethylene oxide sterilization efficacy, biological compatibility, electrical safety requirements).
8. The sample size for the training set:
- Not Applicable. This is a hardware device, not a machine learning or AI model that requires a training set. The device's operational parameters and safety features are designed and engineered, not "trained" on data.
9. How the ground truth for the training set was established:
- Not Applicable. (See #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.