(29 days)
The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.
The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Unit and the IOB Warming Blankets. The IOB Warming Unit, model IOB-507, draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32℃, 38℃, and 43℃. These temperature settings are servo-controlled by a thermistor placed at the end of the hose where the hose connects to the blanket. The unit can also deliver ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the average contact surface temperature of the blanket. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the unit to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow options. A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and produces an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. IOB warming blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.
The document describes the IOB Temperature Management System Model IOB-507, which includes the IOB Warming Unit and IOB Warming Blankets. The system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. The device is a Class II device with product code DWJ (Thermal regulating system).
No clinical studies were performed. The device's substantial equivalence determination is based on non-clinical tests. Therefore, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of human performance or clinical outcomes.
However, based on the non-clinical tests mentioned, we can infer some performance characteristics and the tests conducted to demonstrate them.
1. A table of acceptance criteria and the reported device performance
Since no specific acceptance criteria for clinical performance are provided, this table focuses on the performance characteristics assessed through non-clinical testing.
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| IOB Warming Unit Model IOB-507 | |
| Temperature Settings Accuracy (from Table 1) | 43°C +/- 2°C, 38°C +/- 2°C, 32°C +/- 2°C, Ambient |
| Forced Air Over Temperature Shut-off (from Table 1) | Auto-shuts heater off at 47°C +/- 2°C |
| Electrical Safety and EMC (from Section VII.1.a) | Meets relevant applicable IEC standards (IEC 60601-1, IEC 60601-1-2) |
| Usability and Alarm System (from Section VII.1.a) | Meets relevant applicable IEC standards, meets design specifications, performs as intended. |
| Software Validation (from Section VII.1.a) | Software validation report shows device performs as intended. |
| Air Velocity (from Table 1 and Section VII.1.a) | 30-45cfm (device performance reported from Table 1, air velocity testing performed per Section VII.1.a) |
| IOB Warming Blankets | |
| Temperature Uniformity (from Section VII.1.b) | All test results show temperature uniformity equivalence between the IOB Warming Blankets and the predicate. (Tested by measuring five testing points on blanket surface at different IOB Warmer settings) |
| Shelf-life (from Section VII.1.c) | 3 years (stability tests performed) |
| Transport Simulation (Container / Package Integrity) (from Section VII.1.d) | No package damage was observed. All product hold integrity after the transport testing. (Tested according to ASTM D4169) |
| Leakage (Blanket Integrity) (from Section VII.1.e) | No leakage was found. (Bubble testing carried out according to ASTM F2096) |
| Biocompatibility (Cytotoxicity, Irritation, Sensitivity) (from Section VII.1.f) | Demonstrated to be suitable for the intended use of the product. (Tested according to ISO 10993 for a limited contact device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for non-clinical tests (e.g., how many units of the warming unit or blankets were tested for each criterion). The data provenance is not mentioned, but as these are non-clinical (laboratory) tests, the concept of "country of origin of the data," "retrospective," or "prospective" as typically applied to clinical studies is not directly relevant. These tests would have been performed in a controlled laboratory environment by the manufacturer or a third-party testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The non-clinical tests described (electrical safety, temperature accuracy, material stability, etc.) do not involve human interpretation or the establishment of ground truth by clinical experts. These are objective engineering and material science tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical studies or image interpretation tasks performed by multiple human readers, which is not the case here.
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
No MRMC study was done, as this device does not involve AI or human readers for diagnostic interpretation. It is a temperature management system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical temperature management system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable. The non-clinical tests described use objective physical measurements and established engineering and material science standards (e.g., IEC, ASTM, ISO) as their "ground truth" or reference for evaluating performance.
8. The sample size for the training set
This information is not applicable, as this is a non-AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable, as this is a non-AI/ML device.
§ 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).