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.

Device Description

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.

AI/ML Overview

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.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR SOCLEAN 3+ BACTERIAL REDUCTION DEVICE

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Respiratory accessory microbial reduction device. A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories, such as hoses and masks, after cleaning. This device is not intended to replace the original accessory manufacturer's cleaning instructions.

NEW REGULATION NUMBER: 21 CFR 880.6993

CLASSIFICATION: Class II

PRODUCT CODE: QXQ

BACKGROUND

DEVICE NAME: SoClean 3+ Bacterial Reduction Device

SUBMISSION NUMBER: DEN210037

DATE DE NOVO RECEIVED: March 23, 2022

SPONSOR INFORMATION:

SoClean, Inc. 1 Vose Farm Road Peterborough, New Hampshire 03458

INDICATIONS FOR USE

The SoClean 3+ bacterial reduction device is indicated as follows:

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a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.

DEVICE DESCRIPTION

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 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+'s general processing architecture is diagramed in Figure 1 below. and Figure 2 provides a graphical illustration of the device's use configuration. Figure 3 shows how CPAP Masks rest within the SoClean 3+ Microbial Reduction Chamber during the processing cycles.

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Figure 1: SoClean 3+ System Function Diagram

Image /page/2/Picture/1 description: The image shows three different views of a medical device, possibly a CPAP machine, rendered in a technical drawing style. The top view shows the device with a connected hose, highlighting its interface and overall design. The bottom left view presents a compact, angled perspective of the device, focusing on its control panel and form factor. The bottom right view shows the device with the hose attached, emphasizing the connection point and the hose's flexibility.

(b)(4)

Figure 2: SoClean 3+ In Use Configuration

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Image /page/3/Figure/0 description: The image shows two SoClean 3+ units, one is a humidification unit. The image labels the ozone catalyst filter and PAP mask, which is inside a closed chamber. The image also labels the hose slot, pap hose, and hose port. The image is a diagram of the SoClean 3+ units and their components.

Figure 3: CPAP Mask Location During SoClean 3+ processing cycles

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 (Figure 4) 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. This damage can occur either via a direct reaction between ozone and/or through reactions with the radical by-products of ozone decomposition.

Image /page/3/Picture/3 description: The image shows a gray rectangle with a red border. At the top of the rectangle, the text "Humidification Unit" is visible. Below this text, the text "(b)(4)" is visible.

Figure 4: SoClean 3+ Humidification Unit

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The SoClean 3+ Microbial Reduction Cvcle takes approximately 90 minutes to complete and encompasses the following stepwise phases:

Step 1 Buildup Phase (builds up ozone levels in the system. 6-minute duration). .
Step 2 Pulsing Phase (pulses ozone into the system for 10-second periods interspersed . with 65-second dwell periods; 72-minute duration),
. Step 3 - Purge Phase (pumps fresh air without ozone through the system to remove residual ozone; 12-minute duration).

To initiate a Microbial Reduction Cycle, the following conditions must be met:

A CPAP Hose must be inserted and detected by the SoClean 3+ (2 places: connection to . the Hose Port and the Hose Slot).
A valid Ozone Catalyst Filter must be inserted and detected, .
The Filter Door must be closed, and .
The SoClean 3+ Microbial Reduction Chamber lid must be closed. .

Once these conditions are satisfied, a Microbial Reduction Cycle can be initiated via the User Interface (UI) by pressing the Microbial Reduction Cycle Button. Alternatively, the UI can allow for a Microbial Reduction Cycle to be started following a 2, 4, or 8-hour delay. When the Microbial Reduction Cycle is successfully completed, the Microbial Reduction level icon will light up green. The Microbial Reduction Level Icon remains illuminated until the lid is opened. If the Microbial Reduction Level Icon is orange, the system has detected either ozone concentrations outside of the specified limits or humidity levels in the bucket below a specified value. The ozone and relative humidity (RH) specifications for SoClean 3+ are 270 ± 15 ppm and > 70%, respectively.

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. This freshens the air within the CPAP airway before CPAP use. Ozone is not generated during the Fresh Air Cycle. No bactericidal efficacy claims, or other indications are made for the Fresh Air Cycle. Preprogrammed settings allow for the running of only 3 Fresh Air Cycles before a Microbial Reduction Cycle must be run, and LED indicators allow user to distinguish between whether a Microbial Reduction Cycle or a Fresh Air Cycle was last run.

Based on in vitro testing. SoClean 3+ demonstrated a 3-log bacterial reduction on the following bacteria: S. aureus ATCC 6538. K. aerogenes ATCC 13048. S. haemolyticus ATCC 29970. E. coli ATCC 11229, S. hominis ATCC 27844, K. pneumoniae ATCC 4352, P. aeruginosa ATCC 15442, and S. pyogenes ATCC 14289. Correlation between in vitro results and any clinical outcome has not been established.

The above in vitro 3-log bacterial reduction was established. according to the laboratory condition, on test article (Climateline Air Hose, SlimLine Hose, and Mirage FX Nasal Mask)

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that had either been conditioned (have undergone five (5) SoClean 3+ ozone pre-treatment cycles) or conditioned at the End of Useful Life (EOUL) (have undergone no less than 183 SoClean 3+ ozone pre-treatment cycles).

SoClean 3+ is intended for home use by CPAP user or lay person. The intended use environments include an electrical outlet in a well-ventilated room. Once the microbial reduction cycle has been initiated, the users should leave the room for the cycle, which takes 90 minutes to complete.

SUMMARY OF BENCH STUDIES

BACTERIAL REDUCTION AND SHELF LIFE

The SoClean 3+ bacterial reduction device is not intended for cleaning, disinfection, sanitization, or sterilization: it is intended to be used as an adjunct for bacterial reduction of certain compatible home use CPAP masks and ventilation hoses after the original CPAP accessory manufacturer's recommended cleaning procedures are performed. Performance related to bacterial reduction was reviewed as a part of the performance testing. The device includes instructions for bacterial reduction of CPAP accessories. Specifically, the sponsor has included bacterial reduction instructions that SoClean 3+ can be used with one specific ResMed CPAP Mask (Mirage FX) and two specific ResMed CPAP Hoses (ClimateLine Air, SlimLine).

The storage stability study is provided to support:

a six-month shelf life of the product from the date of manufacture of the (i) unopened product; and
(ii) an in-use period of two months of the opened container from the date of opening under the storage/use conditions at 10-32 °C and 15-65 % relative humidity (RH).

COMPATIBILITY

CPAP Mask and Hose compatibility testing was conducted in accordance with the following standard scientific practices with respect to design, documentation, etc.

· IEC 60601-1:2005+A1:2012+A2:2020. Medical electrical equipment Part 1: General requirements for basic safety and essential performance, Clause 11.1.1
ISO 17510:2015. Medical devices -- Sleep apnea breathing therapy -- Masks and o application accessories, Annex B, Annex C, Annex F, Annex G
o ISO 80601-2-70:2020
Medical Electrical Equipment Part 2-70: Particular requirements for basic safety o and essential performance of sleep apnea breathing therapy equipment. Clause 201.11.1.2.2
· ISO 5356-1, Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets

The results from compatibility testing, which also included visual and mechanical evaluation, show that using the SoClean 3+ as the bacterial reduction device for

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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. However, the compatible CPAP Mask and Hoses may still undergo limited performance change (due to memory foam, natural rubber and/or nylon degradation), and discoloration (yellowing on silicone portions of mask) by the end of their use life.

BIOCOMPATIBILITY

The SoClean 3+ does not directly contact the patient. However, SoClean 3+ processed PAP accessories contact patients via the skin (PAP Masks) and through gas pathway (PAP Masks and Ventilation Hoses). Therefore, SoClean 3+ is categorized as both a surface device and an externally communicating device with tissue contact and permanent contact duration (>30 days), in accordance with Guidance for Industry and Food and Drug Administration Staff -Use of International Standard ISO10993-1. 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'.

The sponsor provided the following studies to assess the potential toxicity of SoClean 3+ processed PAP accessories to a user.

Cytotoxicity, irritation/intracutaneous reactivity, and sensitization on CPAP . accessories after conditioning with three back-to-back cycles and conditioning to EOUL. The test article extracts met the requirements of the tests and showed no evidence of cytotoxicity, irritation, or sensitization under the testing condition.
. Volatile Organic Compounds (VOCs) and Particulate Matter (PM) tests on CPAP accessories after conditioning with three (3) back-to-back cycles and conditioning to EOUL. The test article extracts met the requirements of the tests and the acceptance criteria of ISO 18562-2 Test for emission of particulate matter and ISO 18562-3 Test for emission of volatile organic compounds were met.

The sponsor provided exhaustive chemical extractable and leachable testing for Trace Metals, Volatile Organic Compounds (VOC). Semi-Volatile Organic Compounds (SVOC), and Non-Volatile Organic Compounds (NVOC). Toxicological risk assessment for systemic toxicity, genotoxicity, and carcinogenicity of the chemical extractables and leachables showed that the probable risk for patient exposure to SoClean 3+ processed CPAP accessories is low.

The sponsor also provided testing to demonstrate 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.

SOFTWARE AND CYBERSECURITY

The SoClean 3+ device contains an air pump, fan, humidifier, ozone generator, catalyst filter, microbial reduction chamber, humidification unit, and a User Interface (UI) made up primarily of physical push buttons and Light-Emitting Diode (LED) indicators lights.

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The device has physical buttons and LEDs to implement the user interface, as well as a progress bar, consisting of a sequence of LEDs.

Certain SoClean 3+ functionality is controlled by firmware.

The internal ozone generator. .
. Signals from optical sensors on the device.
. Logging to a memory chip to store device logs for major system events.
Capable of communicating with Bluetooth Low Energy (hereafter BLE). Note . that BLE functionality is specifically designed to be utilized by the manufacturer and is disabled for end-users.
. Capable of communicating via a Command-Line Interface (CLI) over a serial (UART) interface during manufacturing and testing.

The sponsor provided the following assessments, demonstrating that the probable risk is low:

. Level of concern as "Major"
. Device hazard analysis
Software requirements specification (SRS) .
. Architecture design chart
Software design document (SDS) .
. Traceability analysis
. Software Development Environment Description
. Verification and Validation documentation (V&V)
0 Revision level history
. Unresolved anomalies
. Cybersecurity

ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY

The EMC and Electrical Safety was evaluated to mitigate the risk of electrical fault resulting in injury to patient or user. The following Electrical/ Mechanical/Thermal Safety, and electromagnetic compatibility (EMC) testing has been performed:

Radiated Emissions: CISPR11 ed6.2 (2015 +A1:2016 +A2:2019), FCC 47CFR . Part 15 Subpart B (2023-08)
AC Mains Conducted Emissions: CISPR11 ed6.2 (2015 +A1:2016 +A2:2019) .
Harmonics: IEC 61000-3-2 ed3.2 (2005 +A1:2008 +A2:2009) .
Flicker: IEC 61000-3-3 ed3.0 (2013-05) .
. Electro-Static Discharge Immunity Test: IEC 61000-4-2 ed2.0 (2008-12), CENELEC EN 61000-4-2 (2009)
Radiated. Radio-Frequency, Electromagnetic Immunity: IEC 61000-4-3 ed3.0 . (with A1:2007+A2:2010), CENELEC EN 61000-4-3 (2006), A1 (2008) and A2 (2010)
Immunity to Proximity Fields from FR Wireless Communications Equipment .
Electrical Fast Transient/Burst Immunity Test: IEC 61000-4-4 ed3.0 (2012-04), . CENELEC EN 61000-4-4 (2012)

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Immunity to Surges: IEC 61000-4-5 ed3.1 (2014 +A1:2017), CENELEC EN . 61000-4-5 (2014)
. Radio-Frequency, Electromagnetic Immunity Test: IEC 61000-4-6 ed4.0 (2013). CENELEC EN 61000-4-6 (2014)
Power Frequency Magnetic Field Immunity Test: IEC 61000-4-8 ed2.0 (2009-09) .
Voltage Dips/Interruptions Immunity Test: IEC 61000-4-11:2014 +A1:2017. . CENELEC EN 61000-4-11 (2004)
. Immunity to Proximity Magnetic Fields in the Frequency Range of 9 kHz to 13.56 MHz IEC 61000-4-39 ed1.0 (2017-03)

All testing and results were adequate and met the above standards requirements.

HUMAN FACTORS

A simulated-use human factors (HF) study was provided in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." It included participants representative of the positive airway pressure (PAP) patient users, and caregivers who may facilitate set-up and daily use of the device on behalf of the PAP patient user. During the session, participants (16 patient users and 15 caregivers) were provided with SoClean 3+ that were targeted in this validation study. Specifically, participants first engaged in simulated first-time use of the SoClean 3+. divided between a setup scenario (first 13 study tasks) and a use scenario (next 7 study tasks), and then by knowledge tasks (last 14 tasks). Following the session, participants answered questions and provided feedback regarding use-related issues and the product itself. The study included 34 assessments which evaluated the critical tasks for using the product and found that users understood.

The provided human factors validation testing results, analyses, and conclusions established that SoClean 3+ is safe and effective for the intended users, its intended uses, and use environments.

PERFORMANCE TESTING - BENCH

The sponsor conducted the following performance conditions and tests to support that the device can achieve its intended use:

A six-month shelf life (unopened) and two-month in-use life have been . demonstrated.
. The test article from compatible ResMed Mirage FX mask and ResMed ClimateLine and SlimLine (ventilation hoses) had either been conditioned (have undergone five (5) SoClean 3+ ozone pre-treatment cycles) or conditioned until End of Useful Life (EOUL, have undergone >= 183 SoClean 3 + ozone pretreatment cycles). Each test configuration contained three replicates.
. The tested microorganisms included the following eight bacteria: Staphylococcus aureus ATCC 6538, Staphylococcus haemolyticus ATCC 29970, Pseudomonas aeruginosa ATCC 15442, Staphylococcus hominis ATCC 27844, Streptococcus pyogenes ATCC 14289, Klebsiella pneumoniae ATCC 4352, Klebsiella

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aerogenes ATCC 13048, and Escherichia coli ATCC 11229. The target inoculum amount was equal to or above 1 x 106 CFU per device. Appropriate extraction control, recovery factor, positive control, negative control, and neutralization control have been included for each test configuration.

As a worse-case condition, all SoClean 3+ units utilized for testing were . characterized to produce ozone at or below the minimum specification of 255 ppm over a shorter Microbial Reduction Cycle time (70 minutes). A 3-log (99.9%) bacterial reduction for all tested bacteria has been demonstrated on the above conditions.
. The firmware has been modified, the Design Verification Evaluation and Testing Support reports are able to demonstrate that the ozone sensor and feedback loop. (a) consistently generates ozone within the required concentration specification (270 ± 15 ppm), and (b) accurately informs users when ozone concentrations are outside of this range.

LABELING

The labeling consists of a user guide and package labels. The user guide contains a description of the device (including the mechanism of action of bacterial reduction; in vitro bacterial logreduction test results), contraindications, warnings, precautions for processing three compatible CPAP accessories |SoClean 3+ has been tested for use with ResMed Mirage FX (mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10], and information on shelf-life, use-life, maintenance, storage, transport conditions, and disposal. The user guide includes a statement that SoClean 3+ should not be used as a replacement for routine cleaning as recommended by the CPAP accessory manufacturer.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of a respiratory accessory microbial reduction device:

Risks to Health	Mitigation Measures
Respiratory tract infection due todevice failure leading to inadequatemicrobial reduction	Non-clinical performance testingSoftware verification, validation, and hazard analysisShelf life validationIn-use life validationLabeling
Damage to respiratory accessoriesresulting in reduced performance ofrespiratory accessories	Non-clinical performance testingLabeling
Adverse events, e.g., respiratorymucous membrane, pulmonary, or skinirritation, due to chemical exposure	Non-clinical performance testingBiocompatibility evaluationHuman factors/usability evaluationLabeling

Identified Risks to Health and Mitigation Measures

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Respiratory tract infection due to usererror leading to inadequate cleaning ofaccessory device	Human factors/usability evaluationLabeling
Injury from electrical, mechanical, orthermal hazards	Electrical safety testingElectromagnetic compatibility testingMechanical and thermal safety testingSoftware verification, validation, and hazard analysisLabeling

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the respiratory accessory microbial reduction device is subject to the following special controls:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- Microbial reduction testing must demonstrate at least 2 log or greater reduction (i) of the indicated, clinically relevant microorganisms inoculated on the intended respiratory device accessories after the labeled processing (exposure) time;
- (ii) Performance testing must demonstrate that the device can produce the minimum effective dose or concentration of the microbicidal agent that is necessary to achieve the intended 2 log or greater microbial reduction;
- Device intercompatibility testing must demonstrate that the labeled respiratory (iii) device accessories (e.g., masks and hoses) and materials function as intended after worst-case processing with the microbial reduction device: and
- (iv) Performance testing must demonstrate that any release of the microbicidal agent into the use environment is within safe limits for human exposure.
(2) The respiratory device accessories intended to be processed with the microbial reduction device must be demonstrated to be biocompatible.
(3) Performance data must support the shelf life of the device by demonstrating continued device functionality over the labeled shelf life.
(4) Performance data must support the in-use life of the device by demonstrating continued device functionality over the labeled in-use life.
Usability/human factors evaluation must demonstrate that intended users can correctly (5) use the device, based solely on reading the instructions for use.
(6) Software verification, validation, and hazard analysis must be performed.
Performance data must demonstrate the electromagnetic compatibility (EMC) and (7) electrical safety of the device.
(8) Performance data must demonstrate thermal and mechanical safety of the device.
(9) Labeling must include:
- Directions for use including: (i)
  - (A) A statement that the device is not intended to replace the respiratory accessory device manufacturer's recommended cleaning procedures;
  - (B) Instructions for how to determine the minimum effective dose or concentration is achieved to ensure the device is functioning as intended:

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(C) Instructions for how to detect and respond to electrical, mechanical, thermal, or chemical hazardous operating conditions;
(D) Instructions for periodic maintenance and cleaning/reprocessing of the microbial reduction device;
(ii) An expiration date or shelf life:
Use life information; (iii)
Information on respiratory device accessories or materials that can and cannot be (iv) used with the microbial reduction device. This information must also be disclosed in the package label; and
(v) Safety information regarding exposure to hazardous chemicals or compounds, process residues, or degraded materials from the use of the microbial reduction. device and related adverse reactions.

BENEFIT-RISK DETERMINATION

Benefit

The bench studies performed support bacterial reduction using the SoClean 3+ device for processing respiratory accessory devices by demonstrating that bacteria on the washed respiratory accessory devices were reduced by at least 3-log on eight (8) different pure-cultured vegetative microorganisms. The subject bacterial reduction device, an ozone-generating device with 72-minute processing time, is intended to be used by patient user and/or caregiver in a home environment. The probable benefit of SoClean 3+ is to serve as an adjunct for bacterial reduction of certain compatible CPAP respiratory accessories, on the condition that the manufacturer's recommended cleaning procedures were performed before the use of SoClean 3+ device. Limitations of the testing include that the bacterial reduction of SoClean 3+ device must be in addition to CPAP accessory manufacturer's cleaning procedures. The clinical benefit of added bacterial reduction from the device use after CPAP accessory manufacturer's cleaning procedures is unknown. No clinical testing was performed and as such, the in vitro results should not be correlated with any clinical outcome.

Risk

The identified risks include but are not limited to inadequate microbial reduction causing patient respiratory tract infection. CPAP accessory incompatible with microbial reduction device reducing CPAP therapy benefits, adverse events caused by exposure to microbicidal agent, residues, condensate, and/or degraded materials, and inappropriate labeling causing use/user errors. These risks can be mitigated with appropriate performance testing, material compatibility testing, biocompatibility testing and toxicological risk assessment, as well as human factors studies and by the special controls and labeling.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

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Benefit/Risk Conclusion

In conclusion, given the available information above, the following indications for use statement is supported:

The probable benefits outweigh the probable risks for the SoClean 3+ bacterial reduction device. The device provides benefits, and the risks can be mitigated using general controls and the identified special controls.

CONCLUSION

The De Novo request for the SoClean 3+ Bacterial Reduction Device is granted and the device is classified as follows:

Product Code: OXQ Device Type: Respiratory accessory microbial reduction device Regulation Number: 21 CFR 880.6993 Class: II

Regulation Number and Section

N/A