(179 days)
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:
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 TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.
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 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.
The provided document is a 510(k) summary for a medical device (TEEClean® Automated TEE Probe Cleaner Disinfector). It describes the device, its intended use, and comparisons to predicate devices, along with summaries of non-clinical testing.
However, the document does not contain the kind of detailed information about acceptance criteria and study results typically found for AI/ML-based medical devices, specifically:
- A table of acceptance criteria and reported device performance for an AI/ML model: The acceptance criteria here are related to physical device performance (e.g., disinfectant contact time, temperature, rinsing effectiveness, microbial kill) and safety (electrical safety, biocompatibility, vapor exposure), not AI/ML performance metrics like sensitivity, specificity, or AUC.
- Sample sizes used for a "test set" and "training set": While "simulated use studies" and "routine clinical use" studies are mentioned for performance testing, the sample sizes (number of probes or cycles) are not specified in the summary. There's no separate mention of training and test sets in the context of an AI/ML model for diagnostic or other AI-driven tasks.
- Number/qualifications of experts, adjudication methods for ground truth, MRMC studies, standalone AI performance, or ground truth types (pathology, outcomes data) for an AI/ML system. These are all concepts relevant to the validation of AI/ML algorithms in diagnostic or clinical decision support, which is not the primary function of this device as described.
Therefore, based on the provided text, it is not possible to describe the acceptance criteria and study that proves an AI/ML device meets the acceptance criteria. The document pertains to a physical automated cleaning and disinfection device, not an AI/ML system.
The "Performance Testing" section describes the studies done:
- Disinfectant vapor exposure studies: Performed in a room with zero air exchanges to demonstrate filter capacity.
- Automated Simulated use studies with TEEZyme® Cleaner: Showed measurable reduction of soils.
- Automated Simulated use studies with TD-5 and TD-8: Showed measurably complete kill of microorganisms.
- Routine Clinical Use studies: Soiled TEE probes subjected to cleaning and disinfection, showing measurable complete kill of microorganisms.
The acceptance criteria for these would be qualitative (e.g., "acceptable" soil reduction, "complete kill of microorganisms," "filter has capacity for 12 months"). Specific quantitative thresholds are not provided in this summary.
In summary, the provided document does not describe an AI/ML-based device or its validation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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-levelDisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| 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-levelDisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| 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 919-255-9472 Fax 919-528-3400
Contact Name
Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, North Carolina 27522 Email: kendallashe@csmedicalllc.com
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-levelDisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| 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-levelDisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| 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(CFR; Product code) | Diagnostic ultrasonictransducer (21 C.F.R.§ 892.1570, ProductCode PSW) | Liquid chemicalsterilants/high leveldisinfectant (21 CFR§876.1500, ProductCode FEB) | Diagnostic ultrasonictransducer (21 C.F.R.§ 892.1570, ProductCode PSW) | Proposed andprimarypredicatesameclassification |
| Indicationsfor use | The TEEClean®automated cleanerdisinfector is intendedto replace manualcleaning ofTransesophageal(TEE) ultrasoundprobes and automatehigh-level disinfectionof TEE probes. Thesystem usesTEEZyme® enzymaticcleaner to clean TEEprobes as well as TD-5® or TD-8®disinfectant to highlevel disinfect TEEprobes. TEE probesmust undergo bedsidecleaning prior toinsertion into theTEEClean®.The TD-5® or TD-8®disinfectant bottlescannot be reused inthe system.TD-5® disinfectant is | The EVOTECH®System, awasher/disinfector, isindicated foruse with the high leveldisinfectant CIDEX®OPA ConcentrateSolution and anenzymatic detergent(CIDEZYME® GI) toachieve cleaning andhigh level disinfectionof heat sensitive (>60°C) semi-criticalendoscopes. Manualcleaning of medicaldevices (endoscopes)is not required prior toplacement in theEVOTECH® Systemwhen selecting thosecycles that contain awash stage. (Manualcleaning of medicaldevices [endoscopes]is required whenselecting the DisinfectOnly orDisinfect/Alcohol | The TD 100®disinfector isdesigned to providehigh-level disinfectionof Transesophageal(TEE) probes. Thesystem can use TD-5®or TD-8® disinfectants,which are designed tobe used only with theTD 100® disinfector.The disinfectant bottlescannot be reused inthe system. TD-5® andTD8® disinfectants areintended for use assingle use high-leveldisinfectant to beused exclusively in theTD 100® disinfectorfor high-leveldisinfection of TEEultrasound probes.TD-5® and TD-8®high leveldisinfectants and TD100® disinfectorsystem are intendedfor use by qualified | Proposeddevice andprimarypredicatesimilarindications foruse,referencedeviceprovidescleaningfunction |
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| intended for use as asingle use high-leveldisinfectant usedexclusively in theTEEClean® automatedcleaner disinfector forhigh-level disinfectionof TEE ultrasoundprobes. TD-5®disinfectant should beused with the followingcontact conditions inthe TEEClean®automated cleanerdisinfector:High-level disinfectantTD-5®Time - 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-8®disinfectant should beused with the followingcontact conditions inTEEClean® automatedcleaner disinfector:High-level disinfectantTD-8®Time - 5 minutesTemperature - 38° -40°C MinimumRecommendedConcentration0.3% ortho-phthalaldehydeTEEZyme® enzymatic | Flush cycles.) | individuals trained inits use. TD-5®disinfectant should beused with thefollowing contactconditions in TD 100®disinfector:High-level disinfectantTD-5®Time - 5 minutesTemperature - 38° -40°CMinimumRecommendedConcentration1.7% glutaraldehydeTD-8® disinfectantshould be used withthe following contactconditions in TD 100®disinfector:High-level disinfectantTD-8®Time - 5 minutesTemperature - 38° -40°C MinimumRecommendedConcentration0.3% ortho-phthalaldehyde |
|---|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| cleaner, TD-5® andTD-8® high leveldisinfectant, andTEEClean® automatedcleaner disinfectorsystem are intendedfor use by qualifiedindividuals trained in itsuse. | ||||
|---|---|---|---|---|
| Instrumentation ForAutomation | 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. | The EVOTECH®System, utilizesCIDEZYME® GIEnzymatic Detergentand the high leveldisinfectant CIDEX®OPA ConcentrateSolution (ortho-phthalaldehyde).The user initiates theautomated process.Data for each step ofthe process areprinted immediately orstored electronically. | TD 100® with TD-5® orTD-8® disinfectors isautomated for singleuse with only TD-5® orTD-8® disinfectants.The user initiates theautomated cycle viatouchpad andreceives disinfectionverification ticket. | Proposeddevice andprimarypredicatedevice same,referencedeviceprovidescleaningfunction |
Comparison of Proposed Device to Primary Predicate Device
| Proposed DeviceTEEClean® Automated TEEProbe Cleaner Disinfectorwith TEEZyme® Cleaner andTD-5® or TD-8® High-LevelDisinfectants | Primary PredicateDeviceTD 100®Transesophageal ProbeDisinfector and TD-5®and TD-8® High- levelDisinfectant (K160921) | Comparison | |
|---|---|---|---|
| Features | |||
| The system shall utilize adisinfectant that has at least aone year shelf life from thedate of manufacture. | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Same |
| User hazard to disinfectantcontact reduced by bottleloading system | Yes | Yes | Same |
| The system shall provide adisinfection cycle that has a | Yes | Yes | Same |
| disinfectant contact time, atleast 300 seconds andtemperature 38-40°C | |||
| Disinfectant residues shall berinsed until the disinfectantresidue is below atoxicologically significantlevel. | Yes | Yes | Same |
| Reduced height of machinefor easy load of TEE probe | Yes | Yes | Same |
| Machine number, lot numberof disinfectant, probe number,operator number on outputticket | Yes | Yes | Same |
| Minimal footprint, secured towall for stability | Yes | Yes | Same |
| Bar code data entry ortouchscreen input | Yes | No | See referencedevice |
| Separate drain fordisinfectant | Yes | No | See referencedevice |
| USB port for downloadingsession reports | Yes | No | See referencedevice |
| Internal water filter withservice reminder | Yes | No | See referencedevice |
| The system shall create arecord of every clean anddisinfect attempt (e.g.,successful, failed, and useraborted cleaning anddisinfection cycles, errorconditions, etc.) in memoryand apply a unique,sequential accession numberto each record. | Yes | No | See referencedevice |
| The system shall create arecord in memory for everyerror event that occurs andapply a unique, sequentialnumber to each record. | Yes | No | See referencedevice |
| The system shall notify userswhen preventative | Yes | No | See referencedevice |
| maintenance is required. | |||
| Design | |||
| Intended Use | Automated cleaning andhigh-level disinfection ofTEE probes | Automated high-leveldisinfection of TEEprobes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Enzymatic cleaning andaldehyde high-leveldisinfection | Aldehyde high-leveldisinfection | See referencedevice |
| Process monitors | Digital display screen,printout | Digital display screen,printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | Cleaning and High-leveldisinfection | High-level disinfection | See referencedevice |
| Provides high-leveldisinfection for heat-sensitiveTEE probes | Yes | Yes | Same |
| Uses enzymatic cleaner | Yes | No | See referencedevice |
| Uses glutaraldehyde- baseddisinfectant | Yes | Yes | Same |
| Uses OPA-baseddisinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| Filter rinse water | Yes | No | See referencedevice |
| Disinfection process withsuccess/failure print out. | Yes | Yes | Same |
| User hazard to vaporexposure controlled by vapormanagement system utilizingair circulation and activatedcarbon filtration | Yes | Yes | Same |
| The system shall be designedto utilize a modularelectronics controller box. | Yes | Yes | Same |
| The system shall becontrolled by amicrocontroller processor. | Yes | Yes | Same |
| The system shall provide abuilt-in printer. | Yes | Yes | Same |
| Specifications | |||
| Dedicated enzymatic cleanerfor use with the device | TEEZyme® Cleaner | No | See referencedevice |
| Dedicated Disinfectants foruse with the device | Glutaraldehyde (TD-5);Ortho-phthalaldehyde (TD-8) | Glutaraldehyde (TD-5);Ortho-phthalaldehyde(TD-8) | Same |
| Disinfectant MinimumRecommendedConcentration | 1.7% glutaraldehyde (TD-5)0.3% ortho-phthalaldehyde(TD-8) | 1.7% glutaraldehyde (TD-5)0.3% ortho-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 DeviceTEEClean® Automated TEEProbe Cleaner Disinfectorwith TEEZyme® Cleanerand TD-5® or TD-8® High-Level Disinfectants | Reference DeviceEVOTECH® IntegratedEndoscope DisinfectionSystem (K061899) | Comparison | |
|---|---|---|---|
| Bar code data entry or | Yes | Yes | Same |
| touchscreen input | |||
| Separate drain fordisinfectant | Yes | Same | |
| USB port for downloadingsession reports | Yes | Same | |
| Internal water filter withservice reminder | Yes | Same | |
| The system shall create arecord of every clean anddisinfect attempt (e.g.,successful, failed, and useraborted cleaning anddisinfection cycles, errorconditions, etc.) in memoryand apply a unique,sequential accession numberto each record. | Yes | Same | |
| The system shall create arecord in memory for everyerror event that occurs andapply a unique, sequentialnumber to each record. | Yes | Same | |
| The system shall notify userswhen preventativemaintenance is required. | Yes | Same | |
| Operating principles | Enzymatic cleaning andaldehyde high-leveldisinfection | Same | |
| Performance claims | Cleaning and High-leveldisinfection | Same | |
| Uses enzymatic cleaner | Yes | Same | |
| Dedicated enzymatic cleanerfor 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).
§ 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.