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510(k) Data Aggregation
(110 days)
Patient Warming System is a modular, electrically conductive Temperature Management System with adjustable temperature in a pre-defined range. The Patient Warming System is intended to prevent or treat hypothermia and maintain normothermia.
The Patient Warming System is intended primarily for use in hospital and surgical centers.
The Patient Warming System patient population includes adult and pediatric patients but excludes infant and neonatal patients.
Patient Warming System is a modular conductive patient warming system to be used during the pre-, intra-, and post-operative stages of surgical procedures to provide heating to patients for treatment of hypothermia, maintenance of normothermia and provide thermal comfort when conditions exist.
The STERIS Patient Warming System is a new product addition to STERIS. The STERIS Patient Warming System consists of a controller and one to three heating accessories as desired by the user such as the Heated Torso Pad and Overbody Warming Blanket. The controller uses software to control the heating elements for warming the contact surface of the accessory to the user selected temperature.
The Patient Warming System will be available in the following configurations.
- Controller, Power Supply, and Torso Pad Set (Foot Pad, Heated Torso Pad, ● and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
- Controller and Power Supply
- . Torso Pad Set (Foot Pad, Heated Torso Pad, and Head Pad)
- o Foot Pad and Head Pad are not heated and not subject to this 510(k)
- Heated Torso Pad
- Overbody Warming Blanket ●
The provided document is a 510(k) Summary for the STERIS Patient Warming System, which is a medical device. It does not describe a study involving an AI/Machine Learning device or a diagnostic device. The acceptance criteria and the study described are for a patient warming system, focusing on its safety, performance, and functionality in maintaining patient normothermia, rather than a diagnostic or imaging-based AI system.
Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI, etc.) are not applicable to this type of device and the information provided in the document.
However, I can extract the acceptance criteria and reported device performance for the STERIS Patient Warming System as detailed in the document.
Acceptance Criteria and Reported Device Performance for STERIS Patient Warming System
The STERIS Patient Warming System is a patient warming device, not an AI or diagnostic device. The "acceptance criteria" and "study" refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device for FDA clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | The STERIS Patient Warming System and warming accessories were tested for conformance to IEC 80601-2-35: Particular requirements of the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use. | PASS |
| Pressure Management | The Underbody Warming Pad must not exhibit a peak pressure higher than 20% more than the existing torso pad. | |
| For 5th Percentile female peak pressure shall be below 70 mmHg. | ||
| For 95th Percentile male peak pressure shall be below 100 mmHg. | PASS | |
| Human Factors | Typical users are capable of following the written instructions for use to correctly use the STERIS Patient Warming System with simulated patients. | PASS |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | PASS |
| Electrical Safety Conformance | IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
Points 2-9 in the Request are Not Applicable to this Device/Submission:
As this is a 510(k) summary for a physical patient warming system and not an AI or diagnostic imaging device, the following points are not addressed by the provided document:
- 2. Sample sized used for the test set and the data provenance: Not applicable. Tests are functional/safety tests, not data set evaluations.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an AI/diagnostic device.
- 4. Adjudication method for the test set: Not applicable. Ground truth for an AI/diagnostic device.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for diagnostic interpretation, not a warming device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm for standalone diagnostic performance.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be physical measurements of temperature, pressure, electrical safety parameters, and successful operation based on standards.
- 8. The sample size for the training set: Not applicable. No training set for an AI model.
- 9. How the ground truth for the training set was established: Not applicable. No training set for an AI model.
The document demonstrates that the STERIS Patient Warming System met the established non-clinical performance criteria, confirming its safety and effectiveness relative to a legally marketed predicate device.
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