(114 days)
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: 47 degrees C
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.
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 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 degrees. 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.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Ethos Automated Ultrasound Probe Cleaner Disinfector). It outlines the device's indications for use, comparison to predicate devices, and a summary of non-clinical studies performed to demonstrate its safety and effectiveness.
However, the document does not describe a study involving human readers or AI assistance, but rather studies demonstrating the efficacy of a cleaning and high-level disinfection device for ultrasound probes. Therefore, many of the requested criteria related to AI/human reader studies (e.g., MRMC studies, effect size, number of experts for ground truth, adjudication methods, training/test set sample sizes for AI models) are not applicable to this document.
The document primarily focuses on chemical and microbiological testing to validate the disinfection capabilities of the device and its associated chemicals.
Here's an attempt to extract the relevant information based on the provided text, while noting the inapplicable sections:
Device Under Review: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381)
Purpose of the Device: To provide cleaning and high-level disinfection of surface and endocavity ultrasound probes.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "performance" relates to its ability to clean and disinfect effectively, and the acceptance criteria are typically microbiological kill rates and chemical stability/concentration.
| Test Title | Acceptance Criteria (What success looks like) | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility Skin Irritation Test | ISO 10993-10: device extract can be a slight irritant (the acceptance criteria is the result here) | Slight irritant |
| Biocompatibility Sensitization Test | ISO 10993-10: device extract can be a slight sensitizing (the acceptance criteria is the result here) | Non-sensitizing |
| Biocompatibility Cytotoxicity Test | ISO 10993-5: device extract is not cytotoxic | Not cytotoxic |
| Toxicology Assessment | FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants: evidence/justifications provided device is non-toxic | Low risk of Toxic |
| Bacillus subtilis Bench Test (Sporicidal) | (AOAC) Official Method 966.04 for 5.0 hrs at 45°C: No growth | No growth |
| Clostridium sporogenes Bench Test (Sporicidal) | (AOAC) Official Method 966.04 for 5.0 hrs at 45°C: No growth | No growth |
| Mycobacterium terrae Bench Test (Tuberculocidal) | (AOAC) Official Method 965.12 for 3.0 mins at 45°C: At least 6log reduction | No growth (implies >6 log reduction, as typically "no growth" in such tests means the detection limit was not met after inoculation) |
| Staphylococcus aureus Bench Test (Bactericidal) | (AOAC) Official Method 955.15 for 3.0 mins at 45°C: At least 6log reduction | No growth (implies >6 log reduction) |
| Salmonella enterica Bench Test (Bactericidal) | (AOAC) Official Method 955.14 for 3.0 mins at 45°C: At least 6log reduction | No growth (implies >6 log reduction) |
| Pseudomonas aeruginosa Bench Test (Bactericidal) | (AOAC) Official Method 964.02 for 3.0 mins at 45°C: At least 6log reduction | No growth (implies >6 log reduction) |
| Trichophyton interdigitale Bench Test (Fungicidal) | (AOAC) Official Method 955.17 for 3.0 mins at 45°C: At least 6log reduction | No growth (implies >6 log reduction) |
| Herpes Simplex Virus Type 1 Bench Test (Virucidal) | ASTM E1053-20 for 3.0 mins at 45°C: Greater than 6log reduction | Greater than 6log reduction |
| Human Influenza Virus A (H1N1) Bench Test (Virucidal) | ASTM E1053-20 for 3.0 mins at 45°C: Greater than 6log reduction | Greater than 6log reduction |
| Adenovirus Type 1 Bench Test (Virucidal) | ASTM E1053-20 for 3.0 mins at 45°C: Greater than 6log reduction | Greater than 6log reduction |
| Mycobacterium Terrae Simulated Use Test | Performed in Ethos per FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants for 3.0 mins at 45°C: Greater than 6log reduction for all probes and all lots | All lots and all probes had greater than a 6log reduction |
| AquaCide Storage Stability Test | FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants: Solubilized to meet MRC of 1750 ppm PAA at 18 months | 18 month shelf life (meets specifications at 18 months) |
| Clinical In-Use Testing | Measurable complete kill of microorganisms after ultrasound probe processing | Measurable complete kill of microorganisms after ultrasound probe processing |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Bench Tests (Microbiological Efficacy): Not explicitly stated as numerical counts of "samples." Performance is typically demonstrated on multiple replicates of inoculated carriers/surfaces or cultures. The phrases "all lots" and "all probes" are used in some tests (e.g., Mycobacterium Terrae Simulated Use Test), suggesting multiple manufacturing lots of AquaCide and multiple types of probes were tested.
- Biocompatibility/Toxicology: Not explicitly stated as numerical counts. These are typically performed on extracts from the device materials or reprocessed items.
- Clinical In-Use Testing: "Soiled surface and endocavity probes" were used, but the specific number (sample size) is not provided.
- Data Provenance: The document does not specify the country of origin for the data; it focuses on adherence to FDA guidelines and recognized standards (e.g., ISO, AOAC, ASTM). The studies are generally retrospective in the sense that they are conducted in a lab setting to support a premarket submission, not in real-world clinical trials. All studies are "non-clinical" as described in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This document describes device efficacy testing (microbiological kill, chemical properties, biocompatibility) rather than creating ground truth for an AI diagnostic model by human experts. The "ground truth" for the disinfection efficacy is established through standardized microbiological methods and chemical analysis, performed by trained laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 are typically for reconciling discrepancies in expert opinion when establishing ground truth for diagnostic image sets. This is not relevant to the type of device testing described.
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
- Not Applicable: No MRMC study was performed as this is not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an automated cleaning and disinfection device, not an algorithm. Its "standalone performance" is its ability to disinfect as measured by the non-clinical studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for disinfection efficacy is established through:
- Microbiological Standards: Demonstrated reduction/kill of specific microorganisms (bacteria, fungi, viruses, spores) on inoculated samples, measured by established laboratory methods (e.g., AOAC, ASTM).
- Chemical Analysis: Verification of disinfectant concentration (e.g., 1750 ppm peracetic acid) and stability over time.
- Biocompatibility Standards: Assessment against ISO 10993 for irritation, sensitization, and cytotoxicity.
8. The sample size for the training set
- Not Applicable: This is not an AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI device that requires "ground truth for a training set."
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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-levelDisinfectant | 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-levelDisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| 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 PredicateDevice | Reference Device | Comparison | |
|---|---|---|---|---|
| Element | CS Medical EthosAutomated UltrasoundProbe CleanerDisinfector withAquaCideCleaner/High-LevelDisinfectant andQwikCheck ChemicalIndicator (K230381) | TEEClean® AutomatedTEE Probe CleanerDisinfector withTEEZyme® Cleanerand TD-5® or TD-8®High-LevelDisinfectants(K182891) | TD 200®TransesophagealProbe Disinfector andTD-12 High-levelDisinfectant(K192228) | |
| Classification Name(CFR;Productcode) | Diagnostic ultrasonictransducer (21 C.F.R.§ 892.1570, ProductCode PSW) | Diagnostic ultrasonictransducer (21 C.F.R.§ 892.1570, ProductCode PSW) | Diagnostic ultrasonictransducer (21 C.F.R.§ 892.1570, ProductCode PSW) | Proposed andprimarypredicatesameclassification |
| Indicationsfor Use | The Ethos automatedultrasound probecleaner disinfector isdesigned to providecleaning and high-level disinfection ofsurface andendocavity ultrasoundprobes. The systemuses AquaCidecleaner/disinfectant,which is designed tobe used only with theEthos automatedcleaner disinfector.The disinfectantbottles cannot bereused in the system.AquaCidecleaner/disinfectant isintended for use as asingle use cleaner andhigh-level disinfectant,used exclusively in theEthos automatedcleaner disinfector forcleaning and high-level disinfection ofsurface andendocavity ultrasound | The TEECleanautomated cleanerdisinfector is intendedto replace manualcleaning ofTransesophageal(TEE) ultrasoundprobes and automatehigh-level disinfectionof TEE probes. Thesystem uses TEEZymeenzymatic cleaner toclean TEE probes aswell as TD-5 or TD-8disinfectant to highlevel disinfect TEEprobes. TEE probesmust undergo bedsidecleaning prior toinsertion into theTEEClean.The TD-5 or TD-8disinfectant bottlescannot be reused inthe system.TD-5 disinfectant isintended for use as asingle use high-leveldisinfectant used | The TD 200Automated TEEProbe Disinfector withTD-12 High LevelDisinfectant isdesigned to providehigh-level disinfectionof Transesophageal(TEE) ultrasoundprobes. The systemcan use TD-12disinfectant, which isdesigned to be usedonly with the TD 200disinfector. Thedisinfectant bottlescannot be reused inthe system.TD-12 disinfectant isintended for use assingle use high-leveldisinfectant to beused exclusively inthe TD 200 disinfectorfor high-leveldisinfection of TEEultrasound probes.TD-12 high leveldisinfectant and TD | Proposeddevice andprimarypredicatesimilarindications foruse,referencedeviceprovidessamedisinfectant |
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| probes.AquaCidecleaner/disinfectantshould be used withthe following contactconditions in the Ethosautomated cleanerdisinfector:High-level DisinfectantAquaCideTime 3 minutesTemperature 47°CMinimumRecommendedConcentration1750 ppm peraceticacidThe QwikCheckChemical Indicator isfor use in Ethos todetermine whether theconcentration ofperacetic acid, theactive ingredient inAquaCide, is above orbelow the MinimumRecommendedConcentration (MRC)of 1750 ppm.The Ethos cleanerdisinfector withAquaCide andQwikCheck areintended for use byqualified individualstrained in its use. | exclusively in theTEEClean automatedcleaner disinfector forhigh-level disinfectionof TEE ultrasoundprobes. TD-5disinfectant should beused with the followingcontact conditions inthe TEECleanautomated cleanerdisinfector:High-level disinfectantTD-5Time - 5 minutesTemperature - 38° -40°CMinimumRecommendedConcentration1.7% glutaraldehydeTD-8 disinfectant isintended for use as asingle use high-leveldisinfectant usedexclusively in theTEEClean automatedcleaner disinfector forhigh-level disinfectionof TEE ultrasoundprobes. TD-8disinfectant should beused with the followingcontact conditions inTEEClean automatedcleaner disinfector:High-level disinfectantTD-8Time - 5 minutesTemperature - 38° -40°C MinimumRecommendedConcentration0.3% ortho-phthalaldehydeTEEZyme enzymaticcleaner, TD-5 and TD-8 high leveldisinfectant and | 200 disinfector isintended for use byqualified individualstrained in its use.TD-12 disinfectantshould be used withthe following contactconditions in TD 200disinfector:High-level DisinfectantTD-12Time 3 minutesTemperature 38°CMinimumRecommendedConcentration1750 ppm peraceticacid |
|---|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| TEEClean automatedcleaner disinfectorsystem are intendedfor use by qualifiedindividuals trained in itsuse. | ||||
|---|---|---|---|---|
| Instrumentation ForAutomation | Ethos® withAquaCide® disinfectoris automated for singleuse with onlyAquaCide cleanerdisinfectant. The userinitiates the automatedcleaning anddisinfection cycles viatouchpad and receivescleaning anddisinfection verificationticket and data isstored electronically. | TEEClean® withTEEZyme® enzymaticcleaner and TD-5® orTD-8® disinfectors isautomated for singleuse with only TD-5® orTD-8® disinfectants.The user initiates theautomated cleaningand disinfection cyclesvia touchpad andreceives cleaning anddisinfection verificationticket and data isstored electronically. | TD 200® with TD-12®disinfector isautomated for singleuse with only TD-12®disinfectant. The userinitiates theautomated cycle viatouchpad andreceives disinfectionverification ticket. | Proposeddevice andprimarypredicatedevicesimilar,referencedeviceprovidessamedisinfectant |
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 AutomatedUltrasound ProbeCleaner Disinfectorwith AquaCide andQwikCheck system | TEEClean AutomatedTEE Probe CleanerDisinfector withTEEZyme EnzymaticCleaner and TD-5 orTD-8 High-LevelDisinfectants system | TD 200/TD-12disinfector/disinfectant system | Compare |
|---|---|---|---|---|
| 510(k) number | K230381 | K182891 | K192228 | |
| Intended Use | Automated cleaning andhigh-level disinfection ofsurface and endocavityultrasound probes | Automated cleaning andhigh-level disinfection ofTEE ultrasound probes | Automated high-leveldisinfection of TEEultrasound probes | Similar |
| Cleaner for use with thedevice | AquaCide (PeraceticAcid) 1750 ppm | TEEZyme< 1% Subtilisins | N/A | Similar |
| Dedicated Disinfectantsfor use with the device | AquaCide (PeraceticAcid) | TD-5 (Glutaraldehyde);TD-8 (Ortho-phthalaldehyde) | TD-12 (Peracetic Acid) | Similar |
| Disinfectant MinimumRecommendedConcentration | AquaCide (PeraceticAcid) 1750 ppm | TD-5 (1.7%Glutaraldehyde); TD-8(0.3% Ortho-phthalaldehyde) | TD-12 (Peracetic Acid)1750 ppm | Similar |
| Disinfectant BufferSystem | SodiumCarbonate andSulfamic Acid | Phosphates | SodiumCarbonate andSulfamic Acid | Similar |
| Disinfectant pH | 8.5 - 9.0 | 7.45 - 7.55 | 8.5 - 9.0 | Similar |
| Operating principles | Peracetic acidsterilization | Aldehyde sterilization | Peracetic acidsterilization | 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.Disinfection: 3 min contact at least 47°C. | Cleaning: 3 min contact at least 45°C.Disinfection: 5 min contact at 38 - 40°C. | Cleaning: N/ADisinfection: 3 min contact at least 38°C. | Similar |
| Software/firmwarecontrol | Yes | Yes | Yes | Same |
| Performance claims | Cleaning and High-level disinfection | Cleaning and High-level disinfection | High-level disinfection | Same |
| Provides high-leveldisinfection for heat-sensitive ultrasoundprobes | Yes | Yes | Yes | Same |
| Uses cleaner | Yes | Yes | No | Same |
| Uses peracetic acidbased disinfectant | Yes | No | Yes | Similar |
| Uses aldehyde baseddisinfectants | No | Yes | No | Similar |
| Single-use disinfectantsonly i.e. no open bottleshelf life of disinfectant | Yes | Yes | Yes | Same |
| Single-use disinfectantsunopened shelf life | 18 months | 12 months | 18 months | Similar |
| Biocompatibility - skinirritation passing results | Yes | Yes | Yes | Same |
| Biocompatibility -sensitization passingresults | Yes | Yes | Yes | Same |
| Biocompatibility -cytotoxicity passingresults | Yes | Yes | Yes | Same |
| Toxicology assessmentpassing results | Yes | Yes | Yes | Same |
| Automated disinfectioncycle | Yes | Yes | Yes | Same |
| Uses 5nm water filterfor rinse water | Yes | Yes | No | Same |
| Disinfection processuser control viasoftware functions withsuccess/failure print out | Yes | Yes | Yes | Same |
| User hazard todisinfectantcontact 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 |
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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 |
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| Trichophytoninterdigitale Bench Test | To ensure AquaCide hasfungicidal efficacy for ahigh-level disinfectant | (AOAC) Official Method 955.17 for3.0 mins at 45°C have at least 6logreduction | No growth |
|---|---|---|---|
| Herpes Simplex VirusType 1 Bench Test | To ensure AquaCide hasvirucidal efficacy for a high-level disinfectant | ASTM E1053-20 for 3.0 mins at45°C have greater than 6logreduction | Greater than 6logreduction |
| Human Influenza VirusA (H1N1) Bench Test | To ensure AquaCide hasvirucidal efficacy for a high-level disinfectant | ASTM E1053-20 for 3.0 mins at45°C have greater than 6logreduction | Greater than 6logreduction |
| Adenovirus Type 1Bench Test | To ensure AquaCide hasvirucidal efficacy for a high-level disinfectant | ASTM E1053-20 for 3.0 mins at45°C have greater than 6logreduction | Greater than 6logreduction |
| Mycobacterium TerraeSimulated Use Test | To ensure when inoculatedwith the most robustorganism, in the mostchallenging places onprobes, in worst caseconditions, the Ethos andAquaCide still performhigh-level disinfection | Performed in Ethos per FDASubmissions for Liquid ChemicalSterilants/High Level Disinfectantsfor 3.0 mins at 45°C have greaterthan 6log reduction for all probesand all lots | All lots and allprobes had greaterthan a 6logreduction |
| AquaCide StorageStability Test | To ensure that at the endof the 18 month shelf lifetime the AquaCide can stillmeet specifications forhigh-level disinfection | FDA Submissions for LiquidChemicalSterilants/High Level Disinfectantssolubilized to meet MRC of 1750ppm 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).
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
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.(b)
Classification. Class II.