Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
Device Facts
| Record ID | K230381 |
|---|---|
| Device Name | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator |
| Applicant | Cs Medical, LLC |
| Product Code | PSW · Radiology |
| Decision Date | Jun 7, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
Indications for Use
The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. AquaCide cleaner/disinfectant is intended for use as a single use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes. AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector: High-level Disinfectant: AquaCide; Time: 3 minutes; Temperature: 47oC; Minimum Recommended Concentration: 1750 ppm peracetic acid. The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm. The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified individuals trained in its use.
Device Story
Automated system for cleaning/high-level disinfection of surface and endocavity ultrasound probes; utilizes single-use AquaCide (peracetic acid) and QwikCheck chemical indicator. User loads soiled probe (pre-cleaned/condom removed) into device; system heats AquaCide to 47°C, verifies concentration (1750 ppm MRC) via QwikCheck, performs 3-minute disinfection cycle, and rinses probe. Device prints verification report (time, temperature, cycle success) for clinical records. Used in clinical settings by trained personnel. Benefits include automated, standardized reprocessing, reduced user exposure to chemicals/vapors, and validated disinfection efficacy.
Clinical Evidence
Bench testing included sporicidal, tuberculocidal, bactericidal, fungicidal, and virucidal efficacy (AOAC/ASTM methods) showing >6-log reduction. Biocompatibility (ISO 10993) confirmed non-cytotoxic, non-sensitizing, and low skin irritation. Simulated-use testing confirmed >6-log reduction on probes. Clinical in-use testing on soiled probes confirmed complete microbial kill post-processing.
Technological Characteristics
Automated cleaner/disinfector; peracetic acid-based disinfection; 47°C operating temperature; 3-minute contact time; 1750 ppm MRC. Includes 5nm water filter for rinse. Software-controlled cycle with digital display and printout verification. Vapor management system via air circulation/filtration. Biocompatible materials.
Indications for Use
Indicated for cleaning and high-level disinfection of surface and endocavity ultrasound probes by qualified, trained individuals.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- TEEClean Automated TEE Probe Cleaner Disinfector with TEEZyme and TD-5 or TD-8 (K182891)
Reference Devices
- TD 200 Automated TEE Probe Disinfector with TD-12 and QwikCheck (K192228)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2023
CS Medical LLC Kendall Ashe Vice President, General Manager 2179 East Lyon Station Rd Creedmoor, North Carolina 27522
Re: K230381
Trade/Device Name: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW Dated: May 12, 2023 Received: May 12, 2023
Dear Kendall Ashe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K230381
#### Device Name
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide CleanerHigh-Level Disinfectant and QwikCheck Chemical Indicator
#### Indications for Use (Describe)
The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfectant bottles cannot be reused in the system.
AquaCide cleaner/disinfectant is intended for use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes.
AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector:
| High-level<br>Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|----------------------------|-----------|-------------|-----------------------------------|
| AquaCide | 3 minutes | 47oC | 1750 ppm peracetic acid |
The OwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified in its use.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(K) SUMMARY - K230381
510(k) Owner CS Medical L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Phone 919-255-9472 Fax 919-528-3400
#### Contact Name
Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Email: kendallashe@csmedicalllc.com
Submission Prepared 6-June-2023
CS Medical Trade Name Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
Common Name High level disinfection reprocessing instrument for ultrasonic transducers, liquid.
Classification Name Diagnostic Ultrasound Transducer (21 CFR 892.1570, Product Code PSW)
#### Legally Marketed Predicate Devices
TEEClean Automated TEE Probe Cleaner Disinfector with TEEZyme and TD-5 or TD-8 (K182891) - Primary Predicate Device
#### Reference Device
TD 200 Automated TEE Probe Disinfector with TD-12 and QwikCheck (K192228) - Reference Device
## Description of the CS Medical Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
The Ethos cleaner disinfector provides cleaning and high-level disinfection of surface and endocavity ultrasound probes when used according to the operating instructions and when used with AquaCide cleaner/disinfectant. The Ethos cleaner disinfector is for use only with AquaCide cleaner/disinfectant. The AquaCide cleaner/disinfectant is for use only in the Ethos cleaner disinfector. Thus, the Ethos cleaner disinfector, AquaCide cleaner/disinfectant represent a dedicated system. Each soiled ultrasound probe has the condom/cover removed and is bedside cleaned according to the ultrasound probe manufacturer's instructions before insertion into the Ethos cleaner disinfector. If a
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condom/cover is not used the user must manually clean the probe. A fresh, unopened bottle of granular PAA AquaCide cleaner/disinfectant is loaded into the Ethos brings in water, mixes and heats the AquaCide solution to a minimum of 47°. While that is occurring, the Ethos brings in water and the ultrasound probe is pre-rinsed. After temperature is achieved and MRC is confirmed, the Ethos bring the AquaCide solution to the probe and cleans and disinfects the ultrasound probe for at least three minutes. Then the Ethos thoroughly rinses the AquaCide off the ultrasound probe before the cycle is complete. The ultrasound probe is then removed from the Ethos and dried according to the ultrasound probe manufacturer's instructions. The Ethos is ready for a new cycle immediately after the preceding cycle is completed. The Ethos cleaner disinfector incorporates a method for validating the PAA solution through an automatic chemical indicator to ensure each dose of PAA is at or above the MRC. The Ethos cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the cleaning/disinfection. The ultrasound probe is then removed from the Ethos cleaner disinfector and dried according to the ultrasound probe manufacturer's instructions. The Ethos cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed.
## Indications for Use Statement:
The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The svstem uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system.
AquaCide cleaner/disinfectant is intended for use as a single use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes.
AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector:
| High-level<br>Disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| AquaCide | 3 minutes | 47°C | 1750 ppm peracetic acid |
The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified individuals trained in its use.
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Comparison of Proposed Device to Reference Device and Primary Predicate Device
| | Proposed Device | Primary Predicate<br>Device | Reference Device | Comparison |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | CS Medical Ethos<br>Automated Ultrasound<br>Probe Cleaner<br>Disinfector with<br>AquaCide<br>Cleaner/High-Level<br>Disinfectant and<br>QwikCheck Chemical<br>Indicator (K230381) | TEEClean® Automated<br>TEE Probe Cleaner<br>Disinfector with<br>TEEZyme® Cleaner<br>and TD-5® or TD-8®<br>High-Level<br>Disinfectants<br>(K182891) | TD 200®<br>Transesophageal<br>Probe Disinfector and<br>TD-12 High-level<br>Disinfectant<br>(K192228) | |
| Classificatio<br>n Name<br>(CFR;<br>Product<br>code) | Diagnostic ultrasonic<br>transducer (21 C.F.R.<br>§ 892.1570, Product<br>Code PSW) | Diagnostic ultrasonic<br>transducer (21 C.F.R.<br>§ 892.1570, Product<br>Code PSW) | Diagnostic ultrasonic<br>transducer (21 C.F.R.<br>§ 892.1570, Product<br>Code PSW) | Proposed and<br>primary<br>predicate<br>same<br>classification |
| Indications<br>for Use | The Ethos automated<br>ultrasound probe<br>cleaner disinfector is<br>designed to provide<br>cleaning and high-<br>level disinfection of<br>surface and<br>endocavity ultrasound<br>probes. The system<br>uses AquaCide<br>cleaner/disinfectant,<br>which is designed to<br>be used only with the<br>Ethos automated<br>cleaner disinfector.<br>The disinfectant<br>bottles cannot be<br>reused in the system.<br>AquaCide<br>cleaner/disinfectant is<br>intended for use as a<br>single use cleaner and<br>high-level disinfectant,<br>used exclusively in the<br>Ethos automated<br>cleaner disinfector for<br>cleaning and high-<br>level disinfection of<br>surface and<br>endocavity ultrasound | The TEEClean<br>automated cleaner<br>disinfector is intended<br>to replace manual<br>cleaning of<br>Transesophageal<br>(TEE) ultrasound<br>probes and automate<br>high-level disinfection<br>of TEE probes. The<br>system uses TEEZyme<br>enzymatic cleaner to<br>clean TEE probes as<br>well as TD-5 or TD-8<br>disinfectant to high<br>level disinfect TEE<br>probes. TEE probes<br>must undergo bedside<br>cleaning prior to<br>insertion into the<br>TEEClean.<br>The TD-5 or TD-8<br>disinfectant bottles<br>cannot be reused in<br>the system.<br>TD-5 disinfectant is<br>intended for use as a<br>single use high-level<br>disinfectant used | The TD 200<br>Automated TEE<br>Probe Disinfector with<br>TD-12 High Level<br>Disinfectant is<br>designed to provide<br>high-level disinfection<br>of Transesophageal<br>(TEE) ultrasound<br>probes. The system<br>can use TD-12<br>disinfectant, which is<br>designed to be used<br>only with the TD 200<br>disinfector. The<br>disinfectant bottles<br>cannot be reused in<br>the system.<br>TD-12 disinfectant is<br>intended for use as<br>single use high-level<br>disinfectant to be<br>used exclusively in<br>the TD 200 disinfector<br>for high-level<br>disinfection of TEE<br>ultrasound probes.<br>TD-12 high level<br>disinfectant and TD | Proposed<br>device and<br>primary<br>predicate<br>similar<br>indications for<br>use,<br>reference<br>device<br>provides<br>same<br>disinfectant |
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| probes.<br>AquaCide<br>cleaner/disinfectant<br>should be used with<br>the following contact<br>conditions in the Ethos<br>automated cleaner<br>disinfector:<br><br>High-level Disinfectant<br>AquaCide<br><br>Time 3 minutes<br><br>Temperature 47°C<br><br>Minimum<br>Recommended<br>Concentration<br><br>1750 ppm peracetic<br>acid<br><br>The QwikCheck<br>Chemical Indicator is<br>for use in Ethos to<br>determine whether the<br>concentration of<br>peracetic acid, the<br>active ingredient in<br>AquaCide, is above or<br>below the Minimum<br>Recommended<br>Concentration (MRC)<br>of 1750 ppm.<br><br>The Ethos cleaner<br>disinfector with<br>AquaCide and<br>QwikCheck are<br>intended for use by<br>qualified individuals<br>trained in its use. | exclusively in the<br>TEEClean automated<br>cleaner disinfector for<br>high-level disinfection<br>of TEE ultrasound<br>probes. TD-5<br>disinfectant should be<br>used with the following<br>contact conditions in<br>the TEEClean<br>automated cleaner<br>disinfector:<br><br>High-level disinfectant<br>TD-5<br><br>Time - 5 minutes<br><br>Temperature - 38° -<br>40°C<br><br>Minimum<br>Recommended<br>Concentration<br>1.7% glutaraldehyde<br><br>TD-8 disinfectant is<br>intended for use as a<br>single use high-level<br>disinfectant used<br>exclusively in the<br>TEEClean automated<br>cleaner disinfector for<br>high-level disinfection<br>of TEE ultrasound<br>probes. TD-8<br>disinfectant should be<br>used with the following<br>contact conditions in<br>TEEClean automated<br>cleaner disinfector:<br><br>High-level disinfectant<br>TD-8<br><br>Time - 5 minutes<br><br>Temperature - 38° -<br>40°C Minimum<br>Recommended<br>Concentration<br>0.3% ortho-<br>phthalaldehyde<br>TEEZyme enzymatic<br>cleaner, TD-5 and TD-<br>8 high level<br>disinfectant and | 200 disinfector is<br>intended for use by<br>qualified individuals<br>trained in its use.<br><br>TD-12 disinfectant<br>should be used with<br>the following contact<br>conditions in TD 200<br>disinfector:<br><br>High-level Disinfectant<br>TD-12<br><br>Time 3 minutes<br><br>Temperature 38°C<br><br>Minimum<br>Recommended<br>Concentration<br><br>1750 ppm peracetic<br>acid |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| | | TEEClean automated<br>cleaner disinfector<br>system are intended<br>for use by qualified<br>individuals trained in its<br>use. | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Instrument<br>ation For<br>Automation | Ethos® with<br>AquaCide® disinfector<br>is automated for single<br>use with only<br>AquaCide cleaner<br>disinfectant. The user<br>initiates the automated<br>cleaning and<br>disinfection cycles via<br>touchpad and receives<br>cleaning and<br>disinfection verification<br>ticket and data is<br>stored electronically. | TEEClean® with<br>TEEZyme® enzymatic<br>cleaner and TD-5® or<br>TD-8® disinfectors is<br>automated for single<br>use with only TD-5® or<br>TD-8® disinfectants.<br>The user initiates the<br>automated cleaning<br>and disinfection cycles<br>via touchpad and<br>receives cleaning and<br>disinfection verification<br>ticket and data is<br>stored electronically. | TD 200® with TD-12®<br>disinfector is<br>automated for single<br>use with only TD-12®<br>disinfectant. The user<br>initiates the<br>automated cycle via<br>touchpad and<br>receives disinfection<br>verification ticket. | Proposed<br>device and<br>primary<br>predicate<br>device<br>similar,<br>reference<br>device<br>provides<br>same<br>disinfectant |
# Comparison of Operational Principles
| Ethos (K230381) | TEEClean (K182891) | TD 200 (K192228) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Ethos cleaner disinfector provides high-level disinfection of surface and endocavity ultrasound probes when used according to the operating instructions, and when used with AquaCide cleaner disinfectant. Each soiled ultrasound probe has the condom/cover removed and pre-cleaned before insertion into the Ethos. A fresh, unopened bottle of AquaCide cleaner disinfectant is loaded into the Ethos. The Ethos heats the AquaCide cleaner disinfectant to the correct temperature and MRC while spraying the ultrasound probe with water. After MRC is confirmed the AquaCide solution is sprayed in the ultrasound probe at the correct temperature and time for disinfection. Then the Ethos thoroughly rinses the AquaCide off the | The TEEClean cleaner disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TEEZyme enzymatic cleaner and either TD-5 or TD-8 disinfectant. Each soiled ultrasound probe is pre-cleaned manually before insertion into the TEEClean cleaner disinfector. A fresh, unopened bottle of TD-5 or TD-8 disinfectant is loaded into the TEEClean cleaner disinfector. The TEEClean cleaner disinfector heats the TEEZyme enzymatic cleaner to the correct temperature, soaks the ultrasound probe, and then thoroughly rinses the enzymatic cleaner off the ultrasound probe before the cycle is complete. The TEEClean cleaner disinfector then heats the TD5 or TD-8 disinfectant to the | The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-12 disinfectant. Each soiled ultrasound probe is pre- cleaned and manually cleaned before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to the correct temperature, soaks the ultrasound probe, and then thoroughly rinses the disinfectant off the ultrasound probe before the |
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| ultrasound probe before the cycle | correct temperature, soaks the | cycle is complete. The |
|------------------------------------|--------------------------------------|--------------------------------|
| is complete. The ultrasound | ultrasound probe, and then | ultrasound probe is then |
| probe is then removed from the | thoroughly rinses the disinfectant | removed from the TD 200 |
| Ethos and dried according to the | off the ultrasound probe before the | disinfector and dried |
| ultrasound probe manufacturer's | cycle is complete. The ultrasound | according to the TEE probe |
| instructions. The | probe is then removed from the | manufacturer's instructions. |
| Ethos cleaner disinfector is ready | TEEClean cleaner disinfector and | The TD 200 disinfector is |
| for a new cycle immediately after | dried according to the ultrasound | ready for a new cycle |
| the preceding cycle is completed. | probe manufacturer's instructions. | immediately after the |
| A fresh bottle of AquaCide | The TEEClean cleaner disinfector | preceding cycle is |
| cleaner disinfectant is used with | is ready for a new cycle | completed. A fresh bottle of |
| each cycle and mixed inside the | immediately after the preceding | TD-12 disinfectant is used |
| Ethos, monitoring of the | cycle is completed. Because a | with each cycle and mixed |
| disinfectant's potency required at | fresh bottle of TD-5 or TD-8 | inside the TD 200 monitoring |
| the MRC of 1750 ppm and | disinfectant is used with each | of the disinfectant's potency |
| QwikCheck is used. Due to the | disinfection cycle, no monitoring of | required at the MRC of 1750 |
| disinfectant cycling through the | the disinfectant's potency is | ppm and QwikCheck is |
| entire AquaCide system, the | required, nor is there any | used. Due to the disinfectant |
| Ethos disinfects itself by the | requirement for daily testing of the | cycling through the entire TD |
| conclusion of the cycle. | disinfectant solution. Due to the | 200 system, the TD 200 |
| | disinfectant cycling through entire | disinfects itself by the |
| | TEEClean system, the TEEClean | conclusion of the disinfection |
| | disinfects itself at the conclusion | cycle. |
| | of the disinfection cycle. | |
Comparison of Critical Design Features, Process Monitors, and Process Parameters
| Characteristic | Ethos Automated<br>Ultrasound Probe<br>Cleaner Disinfector<br>with AquaCide and<br>QwikCheck system | TEEClean Automated<br>TEE Probe Cleaner<br>Disinfector with<br>TEEZyme Enzymatic<br>Cleaner and TD-5 or<br>TD-8 High-Level<br>Disinfectants system | TD 200/TD-12<br>disinfector/disinfecta<br>nt system | Compare |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------|
| 510(k) number | K230381 | K182891 | K192228 | |
| Intended Use | Automated cleaning and<br>high-level disinfection of<br>surface and endocavity<br>ultrasound probes | Automated cleaning and<br>high-level disinfection of<br>TEE ultrasound probes | Automated high-level<br>disinfection of TEE<br>ultrasound probes | Similar |
| Cleaner for use with the<br>device | AquaCide (Peracetic<br>Acid) 1750 ppm | TEEZyme<br>< 1% Subtilisins | N/A | Similar |
| Dedicated Disinfectants<br>for use with the device | AquaCide (Peracetic<br>Acid) | TD-5 (Glutaraldehyde);<br>TD-8 (Ortho-<br>phthalaldehyde) | TD-12 (Peracetic Acid) | Similar |
| Disinfectant Minimum<br>Recommended<br>Concentration | AquaCide (Peracetic<br>Acid) 1750 ppm | TD-5 (1.7%<br>Glutaraldehyde); TD-8<br>(0.3% Ortho-<br>phthalaldehyde) | TD-12 (Peracetic Acid)<br>1750 ppm | Similar |
| Disinfectant Buffer<br>System | Sodium<br>Carbonate and<br>Sulfamic Acid | Phosphates | Sodium<br>Carbonate and<br>Sulfamic Acid | Similar |
| Disinfectant pH | 8.5 - 9.0 | 7.45 - 7.55 | 8.5 - 9.0 | Similar |
| Operating principles | Peracetic acid<br>sterilization | Aldehyde sterilization | Peracetic acid<br>sterilization | Similar |
| Process monitors | Digital display screen, printout | Digital display screen, printout | Digital display screen, printout | Same |
| Process parameters | Cleaning: 7 min contact 38 - 54°C.<br>Disinfection: 3 min contact at least 47°C. | Cleaning: 3 min contact at least 45°C.<br>Disinfection: 5 min contact at 38 - 40°C. | Cleaning: N/A<br>Disinfection: 3 min contact at least 38°C. | Similar |
| Software/firmware<br>control | Yes | Yes | Yes | Same |
| Performance claims | Cleaning and High-level disinfection | Cleaning and High-level disinfection | High-level disinfection | Same |
| Provides high-level<br>disinfection for heat-<br>sensitive ultrasound<br>probes | Yes | Yes | Yes | Same |
| Uses cleaner | Yes | Yes | No | Same |
| Uses peracetic acid<br>based disinfectant | Yes | No | Yes | Similar |
| Uses aldehyde based<br>disinfectants | No | Yes | No | Similar |
| Single-use disinfectants<br>only i.e. no open bottle<br>shelf life of disinfectant | Yes | Yes | Yes | Same |
| Single-use disinfectants<br>unopened shelf life | 18 months | 12 months | 18 months | Similar |
| Biocompatibility - skin<br>irritation passing results | Yes | Yes | Yes | Same |
| Biocompatibility -<br>sensitization passing<br>results | Yes | Yes | Yes | Same |
| Biocompatibility -<br>cytotoxicity passing<br>results | Yes | Yes | Yes | Same |
| Toxicology assessment<br>passing results | Yes | Yes | Yes | Same |
| Automated disinfection<br>cycle | Yes | Yes | Yes | Same |
| Uses 5nm water filter<br>for rinse water | Yes | Yes | No | Same |
| Disinfection process<br>user control via<br>software functions with<br>success/failure print out | Yes | Yes | Yes | Same |
| User hazard to<br>disinfectant<br>contact reduced by | Yes | Yes | Yes | Same |
| bottle loading system | | | | |
| User hazard to vapor exposure controlled by vapor management system utilizing air circulation and filtration with no room air circulation required | Yes | Yes | Yes | Same |
{9}------------------------------------------------
{10}------------------------------------------------
# Summary of Non-Clinical Studies
| Title | Purpose | Source & Acceptance Criteria | Result |
|---------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Biocompatibility Skin Irritation Test | To ensure contact with a reprocessed device will not cause skin irritation to patients | ISO 10993-10, under conditions of the study the device extract can be a slight irritant | Slight irritant |
| Biocompatibility Sensitization Test | To ensure contact with a reprocessed device will not cause skin sensitization to patients | ISO 10993-10, under conditions of the study the device extract can be a slight sensitizing | Non-sensitizing |
| Biocompatibility Cytotoxicity Test | To ensure contact with a reprocessed device will not cause cellular damage to patients | ISO 10993-5, under conditions of the study, device extract is not cytotoxic | Not cytotoxic |
| Toxicology Assessment | To ensure there was no other toxicological risks | FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants, evidence/ justifications provided device is non-toxic | Low risk of Toxic |
| Bacillus subtilis Bench Test | To ensure AquaCide has sporicidal efficacy for a high-level disinfectant | (AOAC) Official Method 966.04 for 5.0 hrs at 45°C have no growth | No growth |
| Clostridium sporogenes Bench Test | To ensure AquaCide has sporicidal efficacy for a high-level disinfectant | (AOAC) Official Method 966.04 for 5.0 hrs at 45°C have no growth | No growth |
| Mycobacterium terrae Bench Test | To ensure AquaCide has tuberculocidal efficacy for a high-level disinfectant | (AOAC) Official Method 965.12 for 3.0 mins at 45°C have at least 6log reduction | No growth |
| Staphylococcus aureus Bench Test | To ensure AquaCide has bactericidal efficacy for a high-level disinfectant | (AOAC) Official Method 955.15 for 3.0 mins at 45°C have at least 6log reduction | No growth |
| Salmonella enterica Bench Test | To ensure AquaCide has bactericidal efficacy for a high-level disinfectant | (AOAC) Official Method 955.14 for 3.0 mins at 45°C have at least 6log reduction | No growth |
| Pseudomonas aeruginosa Bench Test | To ensure AquaCide has bactericidal efficacy for a high-level disinfectant | (AOAC) Official Method 964.02 for 3.0 mins at 45°C have at least 6log reduction | No growth |
{11}------------------------------------------------
| Trichophyton<br>interdigitale Bench Test | To ensure AquaCide has<br>fungicidal efficacy for a<br>high-level disinfectant | (AOAC) Official Method 955.17 for<br>3.0 mins at 45°C have at least 6log<br>reduction | No growth |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Herpes Simplex Virus<br>Type 1 Bench Test | To ensure AquaCide has<br>virucidal efficacy for a high-<br>level disinfectant | ASTM E1053-20 for 3.0 mins at<br>45°C have greater than 6log<br>reduction | Greater than 6log<br>reduction |
| Human Influenza Virus<br>A (H1N1) Bench Test | To ensure AquaCide has<br>virucidal efficacy for a high-<br>level disinfectant | ASTM E1053-20 for 3.0 mins at<br>45°C have greater than 6log<br>reduction | Greater than 6log<br>reduction |
| Adenovirus Type 1<br>Bench Test | To ensure AquaCide has<br>virucidal efficacy for a high-<br>level disinfectant | ASTM E1053-20 for 3.0 mins at<br>45°C have greater than 6log<br>reduction | Greater than 6log<br>reduction |
| Mycobacterium Terrae<br>Simulated Use Test | To ensure when inoculated<br>with the most robust<br>organism, in the most<br>challenging places on<br>probes, in worst case<br>conditions, the Ethos and<br>AquaCide still perform<br>high-level disinfection | Performed in Ethos per FDA<br>Submissions for Liquid Chemical<br>Sterilants/High Level Disinfectants<br>for 3.0 mins at 45°C have greater<br>than 6log reduction for all probes<br>and all lots | All lots and all<br>probes had greater<br>than a 6log<br>reduction |
| AquaCide Storage<br>Stability Test | To ensure that at the end<br>of the 18 month shelf life<br>time the AquaCide can still<br>meet specifications for<br>high-level disinfection | FDA Submissions for Liquid<br>Chemical<br>Sterilants/High Level Disinfectants<br>solubilized to meet MRC of 1750<br>ppm PAA at 18 months | 18 month shelf life |
#### Clinical In-Use Testing
After routine use, soiled surface and endocavity probes were subjected to cleaning and disinfection in the Ethos® cleaner disinfector with AquaCide® and QwikCheck® under standard operating parameters. In all cases there was a measurable complete kill of microorganisms affer ultrasound probe processing.
## Conclusion
Based on the intended use, technological characteristics, non-clinical performance data, and clinical in-use testing, Ethos® Automated Ultrasound Probe Cleaner Disinfector with AquaCide® Cleaner/High-Level Disinfectant and QwikCheck® Chemical Indicator (K230381) is as safe, as effective, and performs as well as or better than the legally marketed predicate device TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High-Level Disinfectants (K182891).
