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510(k) Data Aggregation
(1062 days)
The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.
The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.
SoClean 3+ is an ozone-generating device used as an adjunct for bacterial reduction of certain compatible continuous positive airway pressure (CPAP) mask and hoses after performing the cleaning steps as recommended per the procedures of the original mask and hose manufacturer.
To use the device, the CPAP Hose is disconnected from the CPAP machine and inserted into the Hose Port on the SoClean 3+. The other end of the CPAP Hose (near where the CPAP Masks attaches) is routed through the SoClean 3+ Hose Slot and the CPAP Mask is placed inside the SoClean 3+ Microbial Reduction Chamber. The lid of the SoClean 3+ is then closed, and a "Microbial Reduction Cycle" is initiated which generates and conveys humidified ozone through the CPAP Hose and CPAP Mask and into the SoClean 3+ Microbial Reduction Chamber. Prior to its exhaust, ozone generated from SoClean 3+ is converted to molecular oxygen via an Ozone Catalyst Filter located on the SoClean 3+ device.
SoClean 3+ treatment is accomplished via a user-initiated and pre-programmed Microbial Reduction Cycle. During this cycle, SoClean 3+ produces ozone which is humidified in the SoClean 3+ Humidification Unit and conveyed through the CPAP Hose to the CPAP Mask and into the SoClean 3+ Microbial Reduction Chamber. A strong oxidant, ozone reduces bacteria on CPAP Mask and Hose surfaces by reacting with and damaging cell membranes and other biomolecules.
SoClean 3+ can also perform a Fresh Air Cycle, where only the Air Pump and the Exhaust Fan operate for 5 minutes to move fresh air through the CPAP airway. Ozone is not generated during the Fresh Air Cycle.
SoClean 3+ includes an Ultraviolet (UV) ozone sensor that monitors ozone concentrations, providing feedback to the Ozone Generator itself for ozone production adjustment and to the SoClean 3+ user via LED lights on the UI when measured ozone concentrations are above or below the prespecified 270 ± 15 ppm range.
The SoClean 3+ Bacterial Reduction Device is intended as an adjunct to reduce bacterial populations on certain compatible home use CPAP masks and ventilation hoses after cleaning. The primary acceptance criterion is a 3-log (99.9%) bacterial reduction of eight specified bacteria.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial Reduction: At least a 2-log or greater reduction of specified, clinically relevant microorganisms inoculated on intended respiratory device accessories after labeled processing time. The device must produce the minimum effective dose/concentration of the microbicidal agent to achieve this reduction. | A 3-log (99.9%) bacterial reduction was demonstrated for the following eight bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289). This reduction was achieved after a complete processing cycle, using SoClean 3+ units characterized to produce ozone at or below the minimum specification of 255 ppm over a shorter Microbial Reduction Cycle time (70 minutes). The firmware modifications and design verification demonstrated that the ozone sensor and feedback loop consistently generate ozone within the required concentration specification (270 ± 15 ppm) and accurately inform users when concentrations are outside this range. |
| Device Intercompatibility: Labeled respiratory device accessories and materials must function as intended after worst-case processing with the microbial reduction device. | Compatibility testing, including visual and mechanical evaluation, showed that using SoClean 3+ for processing ResMed CPAP Mask (Mirage FX) and ResMed CPAP Hoses (ClimateLine Air and SlimLine) for up to 6 months (183 days at 1 bacterial reduction cycle/day) does not adversely affect their safety or functionality. Some limited performance change (due to memory foam, natural rubber, nylon degradation) and discoloration (yellowing on silicone portions) may occur by the end of their use life. |
| Microbicidal Agent Release: Any release of the microbicidal agent into the use environment must be within safe limits for human exposure. | Testing demonstrated that the amount of ozone released into the environment during processing and remaining on the accessories after processing are below 0.05 ppm, as specified in 21 CFR 801.415. VOCs and PM tests on CPAP accessories after conditioning also met the requirements of ISO 18562-2 and ISO 18562-3, respectively. Toxicological risk assessment for chemical extractables and leachables showed low probable risk for patient exposure. |
| Biocompatibility: The respiratory device accessories intended to be processed with the microbial reduction device must be demonstrated to be biocompatible. | Cytotoxicity, irritation/intracutaneous reactivity, and sensitization tests on CPAP accessories (after conditioning with three back-to-back cycles and to EOUL) met requirements and showed no evidence of cytotoxicity, irritation, or sensitization. The device itself does not directly contact the patient. |
| Shelf Life: Performance data must support the shelf life of the device by demonstrating continued device functionality over the labeled shelf life. | A six-month shelf life of the unopened product from the date of manufacture was supported by storage stability studies. |
| In-Use Life: Performance data must support the in-use life of the device by demonstrating continued device functionality over the labeled in-use life. | An in-use period of two months of the opened container under specified storage/use conditions (10-32 °C and 15-65% RH) was supported by storage stability studies. |
| Usability/Human Factors Evaluation: Intended users can correctly use the device, based solely on reading the instructions for use. | A simulated-use human factors study with 16 patient users and 15 caregivers demonstrated that users understood the critical tasks for using the product. The study's conclusions established that SoClean 3+ is safe and effective for intended users, uses, and environments. |
| Software Verification, Validation, and Hazard Analysis: | The sponsor provided assessments (hazard analysis, SRS, SDS, traceability, V&V, cybersecurity) for firmware-controlled functions (ozone generator, optical sensors, logging, BLE, CLI). The probable risk was determined to be low, with a "Major" level of concern. |
| Electromagnetic Compatibility (EMC) and Electrical Safety: Performance data must demonstrate EMC and electrical safety. | Extensive EMC and electrical safety testing was performed according to relevant standards (CISPR11, FCC 47CFR Part 15 Subpart B, IEC 61000 series). All testing and results were adequate and met the standard requirements, mitigating the risk of electrical fault. |
| Thermal and Mechanical Safety: Performance data must demonstrate thermal and mechanical safety of the device. | Bench studies evaluated by the sponsor presumably included verification of the device's adherence to relevant mechanical and thermal safety standards, implicitly covered under the "Electrical/ Mechanical/Thermal Safety" testing mentioned (though specific data points for thermal and mechanical safety were not detailed beyond "All testing and results were adequate and met the above standards requirements"). |
The study that proves the device meets these acceptance criteria is primarily a non-clinical performance testing regime, specifically in vitro bacterial reduction studies and bench studies covering various aspects like compatibility, shelf life, in-use life, biocompatibility, VOC/PM emissions, ozone release, software, EMC, electrical safety, and human factors.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bacterial Reduction: Each test configuration contained three replicates. The test articles were CPAP accessories: ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing).
- Provenance: In vitro testing, which typically refers to laboratory studies. The country of origin is not specified but is implied to be part of the sponsor's (SoClean, Inc. Peterborough, New Hampshire, USA) development and regulatory submission process. These are prospective experimental studies.
- Human Factors: The study included 16 patient users and 15 caregivers as participants.
- Provenance: This was a simulated-use human factors study, indicating a prospective study conducted with representative users. Location not specified.
- Other Bench Studies (Compatibility, Biocompatibility, VOC/PM, Ozone Release, Shelf Life, In-use Life, Software, EMC/Electrical Safety): Specific sample sizes for these tests are generally stated as "test articles" or "assessments" without explicit numbers for every condition. For example, for compatibility, it refers to processing "ResMed CPAP Mask (Mirage FX) and ResMed CPAP Hoses (ClimateLine Air and SlimLine) for up to 6 months". Biocompatibility involved "test article extracts".
- Provenance: These are experimental bench studies, likely prospective, conducted in a laboratory setting. Country of origin not specified.
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 type of device approval (for a bacterial reduction device) does not involve expert review for "ground truth" establishment in the way medical imaging AI devices do (e.g., radiologists reviewing images). Instead, objective, quantifiable laboratory measurements and established scientific standards serve as the "ground truth."
- For bacterial reduction, the ground truth is established by standard microbiological plating and counting methods performed by trained microbiologists.
- For chemical emissions, biocompatibility, electrical safety, and EMC, the ground truth is determined by adherence to internationally recognized standards (e.g., ISO, IEC, CFR) using calibrated lab equipment operated by qualified technicians and scientists.
- For human factors, usability experts design and analyze the study, and the "ground truth" is based on user performance against critical tasks and user feedback.
The document does not specify the number or qualifications of individual experts who performed these tests, but it implies adherence to standard scientific practices and regulatory guidelines which require qualified personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
"Adjudication method" like 2+1 or 3+1 typically refers to how discrepancies are resolved among multiple human reviewers establishing ground truth in subjective assessments (e.g., image interpretation). This concept is not applicable to the testing performed for the SoClean 3+ device, which relies on objective, quantitative measurements and adherence to predefined standards. There was no multi-reader, subjective interpretation requiring 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
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study assesses how AI assistive technology impacts human performance (e.g., radiologists' diagnostic accuracy). The SoClean 3+ device is a physical bacterial reduction device, not an AI diagnostic tool, and therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The concept of "standalone performance" for an algorithm without human-in-the-loop is also not directly applicable in the context of this device. The SoClean 3+ is a device that performs a physical action (ozone generation for bacterial reduction). Its performance is inherently "standalone" in that the ozone generation process and its resulting bacterial reduction efficacy are measured scientifically without human intervention being part of the mechanism of action for bacterial killing. However, appropriate human use (following instructions for cleaning, loading, initiating cycles) is required for the device to perform its intended function.
The "standalone performance" of the device's function (i.e., its ability to produce ozone, deliver it, and reduce bacteria) was evaluated through the in vitro bacterial reduction tests and characterization of ozone output (270 ± 15 ppm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth used for the SoClean 3+ device's performance evaluation largely consists of:
- Microbiological Culture Results: For bacterial reduction, the "ground truth" is the quantifiable reduction in colony-forming units (CFU) observed after device processing, determined by standard microbiological laboratory techniques.
- Adherence to International Standards and Regulatory Limits: For compatibility, biocompatibility, chemical emissions (VOCs, PM, ozone release), electrical safety, and EMC, the ground truth is defined by meeting predefined thresholds and requirements set by established international standards (e.g., ISO, IEC, CISPR, FDA regulations like 21 CFR 801.415).
- Empirical Observation/Measurement: For shelf life and in-use life, the ground truth is empirically demonstrated continued functionality over time.
- User Performance and Feedback: For human factors, the ground truth is derived from observed user success or failure in critical tasks and qualitative/quantitative feedback from representative users.
8. The sample size for the training set
The concept of a "training set" is relevant to machine learning or AI models. Since the SoClean 3+ is a physical device and not an AI/ML product, there is no "training set" in the conventional sense. The device's design and operating parameters are developed through engineering and scientific principles, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
As there is no "training set" nor an AI model in the traditional sense, this question is not applicable. The device's operating specifications (e.g., ozone concentration, cycle times) are established through research, engineering design, and iterative testing, not through establishing ground truth for a training dataset.
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