(212 days)
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery, ICU).
The PW820 is operated at a fixed skin surface temperature setting of either 41°C or 37°C. The setting of 41°C is intended for adult patients under general anesthetic. The setting of 37℃ is intended for pediatric and infant patients and for non-anesthetised adults.
The PW820 is for use with infants only during surgery.
The PW820 Surgical 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. Two spotlights (designed to set the distance of the heater from the patient) are mounted at the back of the heater assembly. The heater assembly can be swung either side of the warmer, away from the patient, or rotated through ± 90° along the patient axis. A metal grill on the underside of the heater prevents contact with the heating 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 display, main power switch and temperature sensor socket. Controls include temperature selection and positioning spotlight operation. LED displays include indicators for set temperature, alarms, positioning spotlights, heater power, and a 3digit skin temperature display. The main label is located on the controller rear panel. and the power socket is mounted in the underside of the controller.
A single pole mounting system supports the controller unit, with two sections of stainless steel tubing providing height adjustment. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with castors which include foot-operated brake levers.
Accessories for the PW820 include 'Reusable' and 'Single Use' skin temperature sensor probes, cord tidy, I.V. pole and bag hook.
When switched on, with the desired temperature selected and sensor positioned correctly on the patient, the PW820 provides stable control of skin temperature by automatically adjusting the heater power to compensate for varying metabolic and environmental conditions. Audible and visual alarms alert the user to high/low temperature situations, faults and power failure. Independent safety features are included to control maximum output and avoid thermal injury to the patient.
Here's an analysis of the provided 510(k) summary, aiming to extract information about acceptance criteria and the supporting study, formatted as requested.
It's important to note that the provided document is a 510(k) summary for a medical device (a patient warmer), not a submission for an AI/ML powered device. Therefore, many of the requested fields related to AI-specific testing (e.g., test set, ground truth experts, MRMC studies, training set) are not applicable and thus cannot be populated from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with general medical device standards.
Acceptance Criteria and Device Performance for Fisher & Paykel Healthcare PW820 Surgical Patient Warmer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Safety & EMC | IEC 60601-1 (Medical Electrical Equipment) | Device meets the requirements of the standards. |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Device meets the requirements of the standards. | |
| UL 2601-1 (US deviations for IEC 60601-1) | Device meets relevant deviations. | |
| Functional Safety | Independent safety features to control maximum output and avoid thermal injury. | Included and function as designed. |
| Efficacy in Warming | At least as effective as a forced air warming blanket in maintaining patient temperature intra-operatively and during recovery. | Clinical trial results showed the PW820 was "at least as effective as the warming blanket in maintaining patient temperature during both surgery and the recovery period." |
| Design & Performance Functional Requirements | (General, implied by engineering and non-clinical tests) | Testing indicates it meets design and performance functional requirements. |
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 for Test Set: The document mentions "a randomized, controlled trial" but does not specify the number of patients included in this clinical test.
- Data Provenance: Not explicitly stated, but clinical tests were conducted for market approval in the US, so it’s likely data was collected in a country with recognized clinical research standards (e.g., US, New Zealand, etc.). The study was a prospective randomized, controlled trial.
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. This is a medical device (patient warmer) validation, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" in this context is patient temperature, measured objectively.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, the "test set" (clinical trial) involved objective measurement of patient temperature, not subjective assessments requiring expert 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 not an AI-powered device. The clinical study compared the device (PW820) to a competitor (forced air warming blanket), not human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm, but a standalone physical medical device. The clinical study evaluated its performance as a standalone warmer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The primary "ground truth" for the clinical study was objective patient temperature measurements, specifically core body temperature, and potentially skin surface temperature (given the device's function). This is a direct physiological outcome, not based on expert consensus, pathology, or subjective interpretation.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
§ 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.