TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

K182891 · Cs Medical, LLC · PSW · Apr 12, 2019 · Radiology

Device Facts

• Record ID: K182891
• Device Name: TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
• Applicant: Cs Medical, LLC
• Product Code: PSW · Radiology
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

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 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: TD-5® 5 minutes 38°-40°C 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: TD-8® 5 minutes 38°-40°C 0.3% ortho-phthalaldehyde. TEEZyme® enzymatic cleaner, TD-5® and TD-8® high level disinfectant, and TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.

Device Story

Automated reprocessing system for TEE ultrasound probes; replaces manual cleaning/disinfection. Inputs: soiled TEE probe, TEEZyme enzymatic cleaner, TD-5 (glutaraldehyde) or TD-8 (ortho-phthalaldehyde) disinfectant. Operation: device heats enzymatic cleaner, soaks probe, rinses; then heats disinfectant to 38-40°C, soaks for 5 minutes, rinses. Output: cleaned/disinfected probe, printed verification report (cycle success, time, temperature). Used in clinical settings by trained staff. Features: barcode/touchscreen input, USB data export, internal water filtration, vapor management system (activated carbon). Benefits: standardized cleaning/disinfection, reduced user exposure to chemical vapors, automated record-keeping for compliance.

Clinical Evidence

Bench testing only. Simulated-use studies demonstrated measurable reduction of soils using TEEZyme and complete microbial kill using TD-5/TD-8. Rinsing studies confirmed residual enzyme and disinfectant concentrations were within acceptable limits. Cytotoxicity testing confirmed reprocessed probes are non-cytotoxic. Vapor exposure studies validated the 12-month capacity of the vapor management filter.

Technological Characteristics

Automated cleaner/disinfector; 110 VAC power; microcontroller-based control. Materials: vapor management system with activated carbon filtration. Connectivity: USB port for data export, barcode/touchscreen interface. Sterilization/Disinfection: liquid chemical high-level disinfection (glutaraldehyde or OPA). Electrical safety: UL 61010-1 and UL 61010-2-040 compliant.

Indications for Use

Indicated for automated cleaning and high-level disinfection of transesophageal (TEE) ultrasound probes by qualified, trained personnel. Requires bedside pre-cleaning of probes prior to insertion.

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

• TD 100 Transesophageal Probe Disinfector with TD-5 and TD-8 High Level Disinfectants (K160921)

Reference Devices

• EVOTECH® Integrated Endoscope Disinfection System (K061899)

Submission Summary (Full Text)

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April 12, 2019

CS Medical L.L.C. Kendall Ashe Vice President 2179 East Lyon Station Road Creedmoor, North Carolina 27522

Re: K182891

Trade/Device Name: TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High Level Disinfectants Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW Dated: March 22, 2019 Received: March 22, 2019

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number (if known) K182891

#### Device Name

TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High-Level

Disinfectants

#### Indications for Use (Describe)

The TEEClean automated cleaner disinfector is intended to replace manual cleaning of Transesonaged (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 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 used 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<br>Disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|------|-------------|--------------------------------------|
| | TD-5 | 5 minutes | 38°-40°C |

TD-8 disinfectant is intended for use as a single 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<br>Disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-8 | 5 minutes | 38°-40°C | 0.3% ortho-phthalaldehyde |

TEEZyme enzymatic cleaner, TD-5 and TD-8 high level disinfectant, and TEEClean automated cleaner disinfector system are intended for use by qualified individuals trained 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 - K182891

510(k) Owner CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, North Carolina 27522 Phone [phone] Fax [phone]

#### Contact Name

Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, North Carolina 27522 Email: [e-mail]

Submission Prepared 9-April-2019

CS Medical Trade Name

TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High-Level Disinfectants

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 Device

CS Medical TD 100 Transesophageal Probe Disinfector with TD-5 and TD-8 High Level Disinfectants (K160921) - Primary Predicate Device

#### Reference Device

EVOTECH® Integrated Endoscope Disinfection System (K061899) -Reference Device

# Description of the CS Medical TEEClean® Automated TEE Probe Cleaner
Disinfector with TEEZyme® Cleaner and TD-5® or TD-8ª High-Level Disinfectants

The TEEClean® cleaner disinfector provides cleaning and high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TEEZyme® enzymatic cleaner and TD-5® or TD-8 disinfectant. The TEEClean® cleaner disinfector iss for use only with TEEZyme®
enzymatic cleaner and TD-5® or TD-8® disinfectant. Thus, the TEEClean® cleaner disinfector, TEEZyme® enzymatic cleaner, and TD-5º or TD-8º disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned to the TEE probe manufacturer's instructions 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®, soaks the

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TEE probe, and thoroughly rinses the enzymatic cleaner off the TEE probe before the cleaning cycle is complete. The TEEClean® cleaner disinfector then heats TD-5® or TD-® disinfectant to 38°-40°C, soaks the TEE probe at least five (5) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the disinfection cycle is complete. The TEEClean® cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the disinfection. The TEE probe is then removed from the TEEClean® cleaner disinfector and dried according to the TEE probe manufacturer's instructions. The TEEClean® cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5% or TD-80 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.

## Indications for Use Statement

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-80 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 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<br>Disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-5® | 5 minutes | 38°-40°C | 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-80 disinfectant should be used with the following contact conditions in TEEClean® automated cleaner disinfector:

| High-level<br>Disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-8® | 5 minutes | 38°-40°C | 0.3% ortho-phthalaldehyde |

TEEZyme® enzymatic cleaner, TD-5® and TD-8® high level disinfectant, and TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.

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## Technological Characteristics:

# Comparison of Proposed Device to Reference Device and Primary Predicate Device

| Element | Proposed Device | Reference Device | Primary Predicate Device | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name<br>(CFR; Product code) | Diagnostic ultrasonic<br>transducer (21 C.F.R.<br>§ 892.1570, Product<br>Code PSW) | Liquid chemical<br>sterilants/high level<br>disinfectant (21 CFR<br>§876.1500, Product<br>Code FEB) | 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 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<br>TEEZyme® enzymatic<br>cleaner to clean TEE<br>probes as well as TD-<br>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 | The EVOTECH®<br>System, a<br>washer/disinfector, is<br>indicated for<br>use with the high level<br>disinfectant CIDEX®<br>OPA Concentrate<br>Solution and an<br>enzymatic detergent<br>(CIDEZYME® GI) to<br>achieve cleaning and<br>high level disinfection<br>of heat sensitive (><br>60°C) semi-critical<br>endoscopes. Manual<br>cleaning of medical<br>devices (endoscopes)<br>is not required prior to<br>placement in the<br>EVOTECH® System<br>when selecting those<br>cycles that contain a<br>wash stage. (Manual<br>cleaning of medical<br>devices [endoscopes]<br>is required when<br>selecting the Disinfect<br>Only or<br>Disinfect/Alcohol | The TD 100®<br>disinfector is<br>designed to provide<br>high-level disinfection<br>of Transesophageal<br>(TEE) probes. The<br>system can use TD-5®<br>or TD-8® disinfectants,<br>which are designed to<br>be used only with the<br>TD 100® disinfector.<br>The disinfectant bottles<br>cannot be reused in<br>the system. TD-5® and<br>TD8® disinfectants are<br>intended for use as<br>single use high-level<br>disinfectant to be<br>used exclusively in the<br>TD 100® disinfector<br>for high-level<br>disinfection of TEE<br>ultrasound probes.<br>TD-5® and TD-8®<br>high level<br>disinfectants and TD<br>100® disinfector<br>system are intended<br>for use by qualified | Proposed<br>device and<br>primary<br>predicate<br>similar<br>indications for<br>use,<br>reference<br>device<br>provides<br>cleaning<br>function |

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| 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-5®<br>disinfectant should be<br>used with the following<br>contact conditions in<br>the TEEClean®<br>automated cleaner<br>disinfector:<br>High-level disinfectant<br>TD-5®<br>Time - 5 minutes<br>Temperature - 38° -<br>40°C<br>Minimum<br>Recommended<br>Concentration<br>1.7% glutaraldehyde<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>High-level disinfectant<br>TD-8®<br>Time - 5 minutes<br>Temperature - 38° -<br>40°C Minimum<br>Recommended<br>Concentration<br>0.3% ortho-<br>phthalaldehyde<br>TEEZyme® enzymatic | Flush cycles.) | individuals trained in<br>its use. TD-5®<br>disinfectant should be<br>used with the<br>following contact<br>conditions in TD 100®<br>disinfector:<br>High-level disinfectant<br>TD-5®<br>Time - 5 minutes<br>Temperature - 38° -<br>40°C<br>Minimum<br>Recommended<br>Concentration<br>1.7% glutaraldehyde<br>TD-8® disinfectant<br>should be used with<br>the following contact<br>conditions in TD 100®<br>disinfector:<br>High-level disinfectant<br>TD-8®<br>Time - 5 minutes<br>Temperature - 38° -<br>40°C Minimum<br>Recommended<br>Concentration<br>0.3% ortho-<br>phthalaldehyde |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| | cleaner, TD-5® and<br>TD-8® high level<br>disinfectant, and<br>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 | 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. | The EVOTECH®<br>System, utilizes<br>CIDEZYME® GI<br>Enzymatic Detergent<br>and the high level<br>disinfectant CIDEX®<br>OPA Concentrate<br>Solution (ortho-<br>phthalaldehyde).<br>The user initiates the<br>automated process.<br>Data for each step of<br>the process are<br>printed immediately or<br>stored electronically. | TD 100® with 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 cycle via<br>touchpad and<br>receives disinfection<br>verification ticket. | Proposed<br>device and<br>primary<br>predicate<br>device same,<br>reference<br>device<br>provides<br>cleaning<br>function |

# Comparison of Proposed Device to Primary Predicate Device

| | Proposed Device<br>TEEClean® Automated TEE<br>Probe Cleaner Disinfector<br>with TEEZyme® Cleaner and<br>TD-5® or TD-8® High-Level<br>Disinfectants | Primary Predicate<br>Device<br>TD 100®<br>Transesophageal Probe<br>Disinfector and TD-5®<br>and TD-8® High- level<br>Disinfectant (K160921) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Features | | | |
| The system shall utilize a<br>disinfectant that has at least a<br>one year shelf life from the<br>date of manufacture. | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Same |
| User hazard to disinfectant<br>contact reduced by bottle<br>loading system | Yes | Yes | Same |
| The system shall provide a<br>disinfection cycle that has a | Yes | Yes | Same |
| disinfectant contact time, at<br>least 300 seconds and<br>temperature 38-40°C | | | |
| Disinfectant residues shall be<br>rinsed until the disinfectant<br>residue is below a<br>toxicologically significant<br>level. | Yes | Yes | Same |
| Reduced height of machine<br>for easy load of TEE probe | Yes | Yes | Same |
| Machine number, lot number<br>of disinfectant, probe number,<br>operator number on output<br>ticket | Yes | Yes | Same |
| Minimal footprint, secured to<br>wall for stability | Yes | Yes | Same |
| Bar code data entry or<br>touchscreen input | Yes | No | See reference<br>device |
| Separate drain for<br>disinfectant | Yes | No | See reference<br>device |
| USB port for downloading<br>session reports | Yes | No | See reference<br>device |
| Internal water filter with<br>service reminder | Yes | No | See reference<br>device |
| The system shall create a<br>record of every clean and<br>disinfect attempt (e.g.,<br>successful, failed, and user<br>aborted cleaning and<br>disinfection cycles, error<br>conditions, etc.) in memory<br>and apply a unique,<br>sequential accession number<br>to each record. | Yes | No | See reference<br>device |
| The system shall create a<br>record in memory for every<br>error event that occurs and<br>apply a unique, sequential<br>number to each record. | Yes | No | See reference<br>device |
| The system shall notify users<br>when preventative | Yes | No | See reference<br>device |
| maintenance is required. | | | |
| Design | | | |
| Intended Use | Automated cleaning and<br>high-level disinfection of<br>TEE probes | Automated high-level<br>disinfection of TEE<br>probes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Enzymatic cleaning and<br>aldehyde high-level<br>disinfection | Aldehyde high-level<br>disinfection | See reference<br>device |
| Process monitors | Digital display screen,<br>printout | Digital display screen,<br>printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | Cleaning and High-level<br>disinfection | High-level disinfection | See reference<br>device |
| Provides high-level<br>disinfection for heat-sensitive<br>TEE probes | Yes | Yes | Same |
| Uses enzymatic cleaner | Yes | No | See reference<br>device |
| Uses glutaraldehyde- based<br>disinfectant | Yes | Yes | Same |
| Uses OPA-based<br>disinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| Filter rinse water | Yes | No | See reference<br>device |
| Disinfection process with<br>success/failure print out. | Yes | Yes | Same |
| User hazard to vapor<br>exposure controlled by vapor<br>management system utilizing<br>air circulation and activated<br>carbon filtration | Yes | Yes | Same |
| The system shall be designed<br>to utilize a modular<br>electronics controller box. | Yes | Yes | Same |
| The system shall be<br>controlled by a<br>microcontroller processor. | Yes | Yes | Same |
| The system shall provide a<br>built-in printer. | Yes | Yes | Same |
| Specifications | | | |
| Dedicated enzymatic cleaner<br>for use with the device | TEEZyme® Cleaner | No | See reference<br>device |
| Dedicated Disinfectants for<br>use with the device | Glutaraldehyde (TD-5);<br>Ortho-phthalaldehyde (TD-8) | Glutaraldehyde (TD-5);<br>Ortho-phthalaldehyde<br>(TD-8) | Same |
| Disinfectant Minimum<br>Recommended<br>Concentration | 1.7% glutaraldehyde (TD-5)<br>0.3% ortho-phthalaldehyde<br>(TD-8) | 1.7% glutaraldehyde (TD-<br>5)<br>0.3% ortho-<br>phthalaldehyde (TD-8) | Same |
| 110 VAC | Yes | Yes | Same |
| Potable Water Inlet | Yes | Yes | Same |
| Filter rinse water | Yes | Yes | Same |
| Direct Drainage to Waste | Yes | Yes | Same |

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The technological differences between the cleaning phase of the, Proposed Device, TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5® or TD-8® High-Level Disinfectants and the, Reference Device, EVOTECH® Integrated Endoscope Disinfection System (K061899) are small and are addressed by the use of similar testing methodology for evaluating the performance of the cleaning phase. Both devices used a proprietary, enzymatic detergent to soak the respective probes and achieve cleaning. Both devices used a spectroscopic method to assay protein residues in the test soil before and after cleaning. Both devices used a spectroscopic method to assay carbohydrate/carbon residues in the test soil before and after cleaning.

Comparison of Proposed Device to Reference Device

| | Proposed Device<br>TEEClean® Automated TEE<br>Probe Cleaner Disinfector<br>with TEEZyme® Cleaner<br>and TD-5® or TD-8® High-<br>Level Disinfectants | Reference Device<br>EVOTECH® Integrated<br>Endoscope Disinfection<br>System (K061899) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------|
| Bar code data entry or | Yes | Yes | Same |
| touchscreen input | | | |
| Separate drain for<br>disinfectant | Yes | Same | |
| USB port for downloading<br>session reports | Yes | Same | |
| Internal water filter with<br>service reminder | Yes | Same | |
| The system shall create a<br>record of every clean and<br>disinfect attempt (e.g.,<br>successful, failed, and user<br>aborted cleaning and<br>disinfection cycles, error<br>conditions, etc.) in memory<br>and apply a unique,<br>sequential accession number<br>to each record. | Yes | Same | |
| The system shall create a<br>record in memory for every<br>error event that occurs and<br>apply a unique, sequential<br>number to each record. | Yes | Same | |
| The system shall notify users<br>when preventative<br>maintenance is required. | Yes | Same | |
| Operating principles | Enzymatic cleaning and<br>aldehyde high-level<br>disinfection | Same | |
| Performance claims | Cleaning and High-level<br>disinfection | Same | |
| Uses enzymatic cleaner | Yes | Same | |
| Dedicated enzymatic cleaner<br>for use with the device | TEEZyme® Cleaner | Same | |

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## Non-Clinical Testing:

#### Software Validation

All qualification activities defined in the TEEClean® Master Verification and Validation Plan were successfully completed and provided documented evidence that the TEEClean® consistently performs as intended. All data collected during test execution met the established acceptance criteria, was recorded on the data forms, and satisfactorily completed. The TEEClean® Verification and Validation Summary Report

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and the associated qualification documents for the TEEClean® detail the successful completion of all requirements of the TEEClean® Master Verification and Validation Plan.

#### Electrical Safety Testing

The TEEClean® cleaner disinfector has been investigated and passed all testing in accordance with UL 61010-1, 3rd Edition; Standard for Safety, Electrical Equipment For Measurement, Control, and Laboratory Use; Part 1: General Requirements; Rev. April 29, 2016 and UL 61010-2-040, 2nd Edition; Standard for Safety, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials: Rev. January 15. 2016

#### Biocompatibility

Rinsing studies were performed on the rinsing the TEE probe shaft receives from the TEEClean cleaner disinfector after cleaning. Measured concentrations of the enzymes (TEEZyme® Cleaner) were taken from the rinse water and were judged acceptable.

Rinsing studies were performed on the rinsing the TEE probe shaft receives from the TEEClean cleaner disinfector after high-level disinfection. Measured concentrations of the disinfectant aldehydes (glutaraldehyde for TD-5® disinfectant, ortho-phthalaldehyde for TD-8® disinfectant) were taken from the rinse water and were judged acceptable.

Cytotoxicity testing was performed on TEE probes reprocessed in the TEEClean® cleaner disinfector with TD-5 and TD-8°. All probes passed and were considered noncytotoxic.

#### Performance Testing

Disinfectant (TD-5 and TD-80) vapor exposure studies were performed in a room with zero air exchanges and showed the main vapor management filter has capacity for 12 months of use.

Automated Simulated use studies with TEEZyme® Cleaner were conducted in the TEEClean® cleaner disinfector. In all cases there was a measurable reduction of soils to levels to allow for subsequent, successful high-level disinfection.

Automated Simulated use studies with TD-5 and TD-8 were conducted in the TEEClean® cleaner disinfector. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.

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After routine clinical use, soiled TEE probes were subjected to cleaning and disinfection in the TEEClean® cleaner disinfector with TEEZyme® Cleaner and TD-5° or TD-8° disinfectant with standard operating parameters. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.

### Conclusion:

Based on the intended use, technological characteristics and non-clinical performance data, the TEEClean® Automated TEE Probe Cleaner Disinfector with TEEZyme® Cleaner and TD-5 or TD-8 High-Level Disinfectants is as safe, as effective, and performs as well or better than the legally marketed predicate device TD 100% Disinfector with TD-5 and TD-8 High Level Disinfectants (K160921).