(114 days)
No
The description focuses on automated cleaning and disinfection processes based on pre-defined parameters (time, temperature, concentration) and chemical indicators, with no mention of AI or ML technologies for decision-making, analysis, or adaptation.
No
The device is described as an automated cleaner and high-level disinfector for ultrasound probes, which are medical devices, but the Ethos system itself does not provide therapy to a patient.
No
The device is designed for cleaning and high-level disinfection of ultrasound probes, not for diagnosing a condition or disease. While it ensures the probes are disinfected for safe use, its function is maintenance/sterilization rather than diagnosis.
No
The device description clearly outlines a physical cleaner disinfector system that handles ultrasound probes, uses chemical solutions, and performs physical actions like rinsing and heating. This is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the cleaning and high-level disinfection of ultrasound probes. This is a process applied to a medical device (the ultrasound probe) to prepare it for reuse, not a test performed on a biological sample from a patient to diagnose a condition or provide information about a physiological state.
- Device Description: The description focuses on the mechanical and chemical processes involved in cleaning and disinfecting the probes. While it mentions a chemical indicator (QwikCheck) to verify the concentration of the disinfectant, this is a quality control measure for the disinfection process itself, not a diagnostic test on a patient sample.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) from a patient. IVDs are designed to perform tests on such samples.
The device is a medical device used for reprocessing other medical devices (ultrasound probes). The chemical indicator is a component of this reprocessing system to ensure the effectiveness of the disinfection.
N/A
Intended Use / 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PSW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified individuals trained in its use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Studies
Title: Biocompatibility Skin Irritation Test
Purpose: To ensure contact with a reprocessed device will not cause skin irritation to patients
Source & Acceptance Criteria: ISO 10993-10, under conditions of the study the device extract can be a slight irritant
Result: Slight irritant
Title: Biocompatibility Sensitization Test
Purpose: To ensure contact with a reprocessed device will not cause skin sensitization to patients
Source & Acceptance Criteria: ISO 10993-10, under conditions of the study the device extract can be a slight sensitizing
Result: Non-sensitizing
Title: Biocompatibility Cytotoxicity Test
Purpose: To ensure contact with a reprocessed device will not cause cellular damage to patients
Source & Acceptance Criteria: ISO 10993-5, under conditions of the study, device extract is not cytotoxic
Result: Not cytotoxic
Title: Toxicology Assessment
Purpose: To ensure there was no other toxicological risks
Source & Acceptance Criteria: FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants, evidence/ justifications provided device is non-toxic
Result: Low risk of Toxic
Title: Bacillus subtilis Bench Test
Purpose: To ensure AquaCide has sporicidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 966.04 for 5.0 hrs at 45 degrees C have no growth
Result: No growth
Title: Clostridium sporogenes Bench Test
Purpose: To ensure AquaCide has sporicidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 966.04 for 5.0 hrs at 45 degrees C have no growth
Result: No growth
Title: Mycobacterium terrae Bench Test
Purpose: To ensure AquaCide has tuberculocidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 965.12 for 3.0 mins at 45 degrees C have at least 6log reduction
Result: No growth
Title: Staphylococcus aureus Bench Test
Purpose: To ensure AquaCide has bactericidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 955.15 for 3.0 mins at 45 degrees C have at least 6log reduction
Result: No growth
Title: Salmonella enterica Bench Test
Purpose: To ensure AquaCide has bactericidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 955.14 for 3.0 mins at 45 degrees C have at least 6log reduction
Result: No growth
Title: Pseudomonas aeruginosa Bench Test
Purpose: To ensure AquaCide has bactericidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 964.02 for 3.0 mins at 45 degrees C have at least 6log reduction
Result: No growth
Title: Trichophyton interdigitale Bench Test
Purpose: To ensure AquaCide has fungicidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: (AOAC) Official Method 955.17 for 3.0 mins at 45 degrees C have at least 6log reduction
Result: No growth
Title: Herpes Simplex Virus Type 1 Bench Test
Purpose: To ensure AquaCide has virucidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: ASTM E1053-20 for 3.0 mins at 45 degrees C have greater than 6log reduction
Result: Greater than 6log reduction
Title: Human Influenza Virus A (H1N1) Bench Test
Purpose: To ensure AquaCide has virucidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: ASTM E1053-20 for 3.0 mins at 45 degrees C have greater than 6log reduction
Result: Greater than 6log reduction
Title: Adenovirus Type 1 Bench Test
Purpose: To ensure AquaCide has virucidal efficacy for a high-level disinfectant
Source & Acceptance Criteria: ASTM E1053-20 for 3.0 mins at 45 degrees C have greater than 6log reduction
Result: Greater than 6log reduction
Title: Mycobacterium Terrae Simulated Use Test
Purpose: To ensure when inoculated with the most robust organism, in the most challenging places on probes, in worst case conditions, the Ethos and AquaCide still perform high-level disinfection
Source & Acceptance Criteria: Performed in Ethos per FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants for 3.0 mins at 45 degrees C have greater than 6log reduction for all probes and all lots
Result: All lots and all probes had greater than a 6log reduction
Title: AquaCide Storage Stability Test
Purpose: To ensure that at the end of the 18 month shelf life time the AquaCide can still meet specifications for high-level disinfection
Source & Acceptance Criteria: FDA Submissions for Liquid Chemical Sterilants/High Level Disinfectants solubilized to meet MRC of 1750 ppm PAA at 18 months
Result: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
| 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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3
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
4
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
Disinfectant | Time | Temperature | Minimum Recommended
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.
5
Comparison of Proposed Device to Reference Device and Primary Predicate Device
| | Proposed Device | Primary Predicate
Device | Reference Device | Comparison |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | CS Medical Ethos
Automated Ultrasound
Probe Cleaner
Disinfector with
AquaCide
Cleaner/High-Level
Disinfectant and
QwikCheck Chemical
Indicator (K230381) | TEEClean® Automated
TEE Probe Cleaner
Disinfector with
TEEZyme® Cleaner
and TD-5® or TD-8®
High-Level
Disinfectants
(K182891) | TD 200®
Transesophageal
Probe Disinfector and
TD-12 High-level
Disinfectant
(K192228) | |
| Classificatio
n Name
(CFR;
Product
code) | Diagnostic ultrasonic
transducer (21 C.F.R.
§ 892.1570, Product
Code PSW) | Diagnostic ultrasonic
transducer (21 C.F.R.
§ 892.1570, Product
Code PSW) | Diagnostic ultrasonic
transducer (21 C.F.R.
§ 892.1570, Product
Code PSW) | Proposed and
primary
predicate
same
classification |
| 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 | The TEEClean
automated cleaner
disinfector is intended
to replace manual
cleaning of
Transesophageal
(TEE) ultrasound
probes and automate
high-level disinfection
of TEE probes. The
system uses TEEZyme
enzymatic cleaner to
clean TEE probes as
well as TD-5 or TD-8
disinfectant to high
level disinfect TEE
probes. TEE probes
must undergo bedside
cleaning prior to
insertion into the
TEEClean.
The TD-5 or TD-8
disinfectant bottles
cannot be reused in
the system.
TD-5 disinfectant is
intended for use as a
single use high-level
disinfectant used | The TD 200
Automated TEE
Probe Disinfector with
TD-12 High Level
Disinfectant is
designed to provide
high-level disinfection
of Transesophageal
(TEE) ultrasound
probes. The system
can use TD-12
disinfectant, which is
designed to be used
only with the TD 200
disinfector. The
disinfectant bottles
cannot be reused in
the system.
TD-12 disinfectant is
intended for use as
single use high-level
disinfectant to be
used exclusively in
the TD 200 disinfector
for high-level
disinfection of TEE
ultrasound probes.
TD-12 high level
disinfectant and TD | Proposed
device and
primary
predicate
similar
indications for
use,
reference
device
provides
same
disinfectant |
6
| 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°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. | exclusively in the
TEEClean automated
cleaner disinfector for
high-level disinfection
of TEE ultrasound
probes. TD-5
disinfectant should be
used with the following
contact conditions in
the TEEClean
automated cleaner
disinfector:
High-level disinfectant
TD-5
Time - 5 minutes
Temperature - 38° -
40°C
Minimum
Recommended
Concentration
1.7% glutaraldehyde
TD-8 disinfectant is
intended for use as a
single use high-level
disinfectant used
exclusively in the
TEEClean automated
cleaner disinfector for
high-level disinfection
of TEE ultrasound
probes. TD-8
disinfectant should be
used with the following
contact conditions in
TEEClean automated
cleaner disinfector:
High-level disinfectant
TD-8
Time - 5 minutes
Temperature - 38° -
40°C Minimum
Recommended
Concentration
0.3% ortho-
phthalaldehyde
TEEZyme enzymatic
cleaner, TD-5 and TD-
8 high level
disinfectant and | 200 disinfector is
intended for use by
qualified individuals
trained in its use.
TD-12 disinfectant
should be used with
the following contact
conditions in TD 200
disinfector:
High-level Disinfectant
TD-12
Time 3 minutes
Temperature 38°C
Minimum
Recommended
Concentration
1750 ppm peracetic
acid |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
7
| | | TEEClean automated
cleaner disinfector
system are intended
for use by qualified
individuals trained in its
use. | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Instrument
ation For
Automation | Ethos® with
AquaCide® disinfector
is automated for single
use with only
AquaCide cleaner
disinfectant. The user
initiates the automated
cleaning and
disinfection cycles via
touchpad and receives
cleaning and
disinfection verification
ticket and data is
stored electronically. | TEEClean® with
TEEZyme® enzymatic
cleaner and TD-5® or
TD-8® disinfectors is
automated for single
use with only TD-5® or
TD-8® disinfectants.
The user initiates the
automated cleaning
and disinfection cycles
via touchpad and
receives cleaning and
disinfection verification
ticket and data is
stored electronically. | TD 200® with TD-12®
disinfector is
automated for single
use with only TD-12®
disinfectant. The user
initiates the
automated cycle via
touchpad and
receives disinfection
verification ticket. | Proposed
device and
primary
predicate
device
similar,
reference
device
provides
same
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
Ultrasound Probe
Cleaner Disinfector
with AquaCide and
QwikCheck system | TEEClean Automated
TEE Probe Cleaner
Disinfector with
TEEZyme Enzymatic
Cleaner and TD-5 or
TD-8 High-Level
Disinfectants system | TD 200/TD-12
disinfector/disinfecta
nt system | Compare |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------|
| 510(k) number | K230381 | K182891 | K192228 | |
| Intended Use | Automated cleaning and
high-level disinfection of
surface and endocavity
ultrasound probes | Automated cleaning and
high-level disinfection of
TEE ultrasound probes | Automated high-level
disinfection of TEE
ultrasound probes | Similar |
| Cleaner for use with the
device | AquaCide (Peracetic
Acid) 1750 ppm | TEEZyme