(270 days)
Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.
Surfacide Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices.
Helios+ delivers a defined dose to a defined distance and area sufficient for 2-log microbial reduction of vegetative bacteria and Clostridioides difficile spores.
Helios+ is used in operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present.
Helios+ includes 1-3 UV-C emitters, 1-3 safety sensors, a control tablet, and 2 joiners that link the emitters for transport and serve as warning stands when the device is in use. Simultaneous use of multiple UV-C emitters can reduce shadowed areas by providing multiple direct lines of sight to non-critical medical device surfaces.
The provided FDA 510(k) clearance letter for the Helios+ UV-C System (K242604) pertains to a whole-room microbial reduction device. This document focuses on the device's technical specifications, non-clinical performance (microbial reduction, safety, materials compatibility, etc.), and a comparison to a predicate device.
Crucially, the document explicitly states under "Non-Clinical Tests Summary" that "CLINICAL TESTING – Non – Applicable."
This means that this device's acceptance criteria and proven performance are based solely on non-clinical (laboratory and simulated use) studies, not on clinical studies involving human patients, human readers, or human interpretation of outputs. Therefore, several of the requested categories related to clinical study design, human expert adjudication, and multi-reader multi-case studies are not applicable to the information provided in this 510(k) summary.
Here's a breakdown of the applicable information based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Criteria for Helios+ UV-C System
The Helios+ UV-C System is a Whole Room Microbial Reduction Device, and its clearance is based on non-clinical performance data demonstrating its ability to reduce microbial load.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microbial Reduction | 2-log (99%) reduction of select bacterial organisms and Clostridioides difficile spores. | Achieved a 99% (2-log) microbial reduction of select bacterial organisms and Clostridioides difficile (spore). |
| Bacteriostasis (Surfaces) | Verification of potential inherent bacteriostatic properties of intended in-use surfaces. | Bacteriostasis of intended in-use surfaces verified. |
| Recovery Validation | Verification of expected effectiveness of microbial recovery methods. | Recovery validation testing provided and verified. |
| Dose Hierarchy | Identification of the most UV-C resistant microorganisms. | Dose hierarchy of UV-C resistance identified. |
| Simulated Use Performance | Microbial log reduction of the most resistant microorganism on medical device surfaces commensurate with intended 2-log reduction. | Demonstrated 2-log microbial reduction of the most resistant microorganism on medical device surfaces. |
| In-Use Testing (Real-World Conditions) | Statistically significant reduction in bacterial load in sampled patient rooms, bathrooms, and operating rooms. | In all tests, Helios+ delivered a statistically significant reduction in bacterial load. |
| Photobiological Safety | Compliance with IEC 62471 "Photobiological Safety of Lamps and Lamp Systems." | Met IEC 62471 criteria. |
| Exposure Prevention | System operation only in an unoccupied environment. | Performance testing demonstrated the system prevents exposure and ensures operation only in an unoccupied environment. |
| Accelerated Materials Damage | Compliance with ISO 4582, ASTM D256-10, and ASTM A370-22. | Materials damage testing results met specified standards. |
| Ozone Production | No measurable ozone production; levels of toxic chemicals below 29 CFR 1910.1000 acceptance levels. | Helios+ does not produce measurable ozone. Levels of toxic chemicals were below specified acceptance levels. |
| Electrical Safety | Conformance with IEC 61010-1. | In conformance with IEC 61010-1. |
| Electromagnetic Compatibility (EMC) | Conformance with IEC 61326-1. | In accordance with IEC 61326-1. |
| Cybersecurity & Software | Adequate cybersecurity and software functionality per FDA guidance. | Demonstrated according to FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of surfaces tested, number of rooms in in-use testing). It indicates "select bacterial organisms and C. difficile spores" were tested for microbial reduction and "Patient rooms, bathrooms, and operating rooms were sampled" for in-use testing.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's an FDA 510(k) submission, the testing would typically be conducted by or for the submitting company, PreventaMed Technologies, Inc., dba Surfacide Manufacturing, Inc., which is based in Waukesha, Wisconsin, United States. The studies are described as non-clinical tests, encompassing lab-based and simulated use environments, rather than prospective or retrospective clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The acceptance criteria and testing for this device are based on objective, quantifiable physical and microbial measurements (e.g., log reduction, ozone levels, material degradation standards, electrical safety standards). There is no "ground truth" established by human experts in a subjective interpretation sense (like radiologists interpreting images).
4. Adjudication Method for the Test Set
- Not Applicable. As the testing is non-clinical and relies on objective measurements, no adjudication by human experts is described or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. No MRMC study was done because the device is a whole-room microbial reduction system, not an AI or imaging device that assists human readers. The document explicitly states "CLINICAL TESTING – Non – Applicable."
6. Standalone Performance
- Yes, in the context of device function. The "Non-Clinical Tests Summary" describes tests of the device's standalone performance in achieving microbial reduction and meeting various safety and performance standards without human intervention beyond operation. For example, "Simulated use performance testing demonstrated microbial log reduction..." and "Performance testing was completed to demonstrate the system will prevent exposure and ensure that device operation can only occur in an unoccupied environment."
7. Type of Ground Truth Used
- The ground truth for the non-clinical tests was established through:
- Microbiological assays: Measuring log reduction of specific bacterial and spore organisms (e.g., on test coupons/surfaces).
- Physical and Chemical Measurements: Quantifying UV-C dosage, ozone levels, material strength/degradation, electrical parameters.
- Compliance with Industry Standards: Adherence to established standards like IEC 62471, ISO 4582, ASTM D256-10, ASTM A370-22, IEC 61010-1, IEC 61326-1, and 29 CFR 1910.1000.
8. Sample Size for the Training Set
- Not applicable in the typical AI/ML sense. The Helios+ UV-C System is a physical device that performs a function (UV-C disinfection), not a software or AI algorithm that "learns" from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here. The device's parameters (e.g., UV-C output, cycle times) would be determined through engineering design and optimization based on scientific principles of UV-C disinfection, informed by tests like the optimized kill curve.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The underlying scientific principles for UV-C effectiveness (e.g., wavelength, intensity, exposure time, distance) are well-established. The device's design and operating parameters are based on these principles and validated through the non-clinical tests described.
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