(89 days)
The Fisher & Paykel Healthcare PW810 Patient Warmer is an Infrared Lamp (as per 89 ILY, 21 CFR §890.5500) containing an infrared heating element to be positioned above an operating table or similar patient bed, in order to maintain a patient's body temperature by means of controlled radiant heat.
The PW810 is intended to provide topical heating to patients in clinical situations where external thermal support is required or desirable. This may include during or following surgical procedures, hypothermia recovery, and severe burns patients.
Situations which necessitate unobstructed access to a patient may indicate the need for a radiant heat source, in preference to thermal regulation systems which rely on extensive surface contact with a patient. Minimal direct contact by a warming system may also be required for particular injuries to patients.
The PW810 Patient Warmer consists of a heater assembly and controller unit, with mounting pole and base sections.
The heater assembly includes a single rod infrared heating element housed inside a parabolic reflector. An observation lamp is mounted at the back of the heater unit. The heater can be rotated to either side of the warmer, away from the patient. A metal grill on the underside of the heater prevents contact with the element.
The controller unit supports the heater assembly, and contains the device electronics, control panel and labels. The front panel contains the control buttons, temperature displays, main power switch and temperature sensor socket. Controls include operating mode and temperature selection, and lamp operation. LED displays include indicators for operating mode, alarms, lamp, and heater power, with 3-digit temperature displays. The main label is located on the controller rear panel. and the power socket is mounted in the underside.
A single pole mounting system supports the controller unit, with two sections of stainless steel tubing providing a height adjustment option. A height indication scale is etched into the pole sections to enable optimum heater-to-patient distance to be set. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with casters which include foot-operated brake levers.
Accessories for the patient warmer include the skin temperature sensor probe and an accessory hook for IV bags or other small items.
In Patient mode, the PW810 provides stable control of skin temperature by automatically adjusting the heater power to compensate for varving metabolic and environmental conditions. In Standby mode, power is maintained at a constant level of 25% ready for use.
A double-thermistor sensor probe measures the patient's skin temperature, and audible and visual alarms alert the user to high or low temperature situations, equipment fault, power failure and periodic reminders to reassess the patient's clinical condition. Independent safety features are included to control maximum output and avoid thermal injury to the patient.
The provided text describes a 510(k) summary for the Fisher & Paykel PW810 Patient Warmer, focusing on its safety and effectiveness. However, it does not contain the specific type of detailed acceptance criteria, device performance metrics, or study design information typically found in a clinical trial report for AI/ML devices. The document explicitly states that it primarily discusses "non-clinical tests" and "clinical verification studies" without providing quantitative results or detailed methodologies.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication methods, MRMC study details, standalone performance, training set details) cannot be extracted from this document, as the focus is on demonstrating equivalence to predicate devices and adherence to medical device standards for a traditional medical device, not an AI/ML system.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Mechanical Safety | Device meets requirements of IEC 60601-1 and UL 2601-1. |
| Electrical Safety | Device meets requirements of IEC 60601-1 and UL 2601-1. |
| Thermal Safety | Device meets requirements of IEC 60601-1 and UL 2601-1. Independent safety features control maximum output and avoid thermal injury. Meets IEC 60601-2-21, including temperature distribution & variance, accuracy of temperature control, and maximum irradiance levels (overall IR and near IR). |
| Environmental Conditions | Testing carried out. |
| Electromagnetic Compatibility | Device meets requirements of IEC 60601-1-2. |
| Functional Verification | Testing carried out. Meets design and performance functional requirements. |
| Temperature Control | "Provides stable control of skin temperature by automatically adjusting the heater power." "Ability to control the set temperature accurately for a stable situation." |
| Irradiance Distribution Patterns | Testing carried out. Meets IEC 60601-2-21. |
| Alarms | Audible and visual alarms for high/low temperature, equipment fault, power failure, and periodic reminders. |
| Patient Warming Ability | Clinical verification studies demonstrated the ability "to progressively warm up patients with reduced body temperature" and "successful use of the warmer and its ability to provide effective patient warming." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The term "patients" is used generically for clinical verification studies, but no numbers are given.
- Data Provenance: Not specified. The company is based in New Zealand, but the location or nature (retrospective/prospective) of the clinical verification studies is not mentioned.
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)
- Not applicable/Not specified. The clinical verification studies mentioned appear to be direct physiological measurements or observations of patient warming, rather than expert interpretation of data needing ground truth adjudication in the context of an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 document describes a traditional medical device (infrared patient warmer), not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an AI algorithm in the traditional sense, but rather a control system for temperature regulation. Its "standalone" performance refers to its ability to warm patients and control temperature as designed, which is discussed under "Clinical verification studies" and "Technological Characteristics."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance appears to be direct physiological measurements (e.g., skin temperature, body temperature) and adherence to established medical device standards (IEC 60601-1, UL 2601-1, IEC 60601-2-21) for safety and performance (e.g., temperature distribution, accuracy of control, irradiance levels). The clinical verification studies observed the device's ability to "progressively warm up patients" and "control the set temperature accurately," implying direct measurement of these parameters.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML device requiring a training set. The device's operation is based on fixed algorithms for temperature control, not machine learning from a dataset.
9. How the ground truth for the training set was established
- Not applicable.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.