(56 days)
The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.
The Allon 2001 vesion 5 system consists of the following elements:
- Temperature controlled disposable garment
- Body sensors
- Connecting flexible water pipes
- Heating/Cooling Unit
The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body.
The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise.
The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.
This submission describes the Allon 2001 version 5 Thermal Regulating System, a device intended to maintain pre-set body temperature as determined by a physician, including during surgical procedures, for adult and pediatric patients in various hospital settings.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a formal, quantifiable manner for clinical performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Allon 2001 - K003349 and Cincinnati Subzero - Blanketrol II) by comparing functional and safety specifications.
The table below summarizes the key performance specifications listed for the Allon 2001 version 5 and its predicate devices:
| Feature / Criterion | Allon 2001 / CSZ - Blanketrol (Predicate) | Allon 2001 version 5 (New Device) |
|---|---|---|
| Equipment Design | ||
| Dimensions | 26cm X 53cm X 52cm (Allon 2001) | 26cm W X 62.5cm D X 94cm H |
| Weight | 33 Kg (without water in reservoir) | The same |
| Mobility | Mobile with four wheels | The same |
| Power max. | 500 W max. | The same |
| Input power | 120/230 V ac with isolation transformer | The same |
| Water tank | 6 liter | The same |
| Control System | ||
| Water out temp' | 13-40.8 °C | The same |
| Set Point temp' | 30-40 °C | The same |
| Flow rate | 0.2-1.25Lpm | The same |
| Pressure rate | 0.1-1.3 bar | The same |
| Safety System | ||
| High primary temp' | 41°C (Allon 2001) / 45 °C (CSZ) | 42 °C |
| High secondary temp' | 42°C (Allon 2001) / 46 °C (CSZ) | 44 °C |
| High third temp' | 44°C (Allon 2001) / N/A (CSZ) | N/A |
| Low primary temp' | 10 °C | The same |
| Pressure valve | Yes | The same |
| Safety Alert / Alarms | ||
| Dislodged sensor | Yes | The same |
| Incorrect Patient temp' setting | Yes | The same |
| High/Low patient temp' limit | Yes | The same |
| Out of normothermia | Yes | The same |
| High/Low water temp' limit | Yes | The same |
| Low water | Yes | The same |
| Low water flow | Yes | The same |
| Water blocking | Yes | The same |
| Non - Operating Pump | Yes | The same |
| Monitoring/Indicators | ||
| Water out temp' | Yes | The same |
| Not enough water in tank | Yes | The same |
| Water in temp' | Yes | The same |
| Patient Surface Temp. | Yes | The same |
| Patient core Temp. | Yes | The same |
| Water pressure | Yes | The same |
| Graphic presentation | Yes | Modified, after changing machine interface lay-out display |
| Operating Buttons | ||
| Set Point temp' | Yes | The same |
| Silence Alarm | Yes | The same |
Note: The submission aims to demonstrate substantial equivalence, meaning the new device is as safe and effective as the predicate devices. The "acceptance criteria" here are implicitly met if the device's specifications are equivalent or improved without raising new safety or effectiveness concerns compared to the legally marketed predicates.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or performance on patient data. This is a temperature regulating medical device, and the submission focuses on engineering specifications and comparison to predicate devices, not on a clinical trial with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts on a test set is described for this type of device submission. The device's performance is assessed against technical specifications and comparison to existing devices, not a clinical gold standard review.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 device is a thermal regulating system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this device's safety and effectiveness is established through adherence to engineering design principles, international standards (implied via safety features), and comparison to the established performance and safety profiles of predicate devices that have been deemed safe and effective for their intended use.
8. The sample size for the training set
Not applicable. The submission does not describe a machine learning model or a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).