(179 days)
No
The description focuses on automated cleaning and disinfection processes based on predefined parameters (time, temperature, concentration) and does not mention any learning or adaptive capabilities.
No
This device is an automated cleaner and disinfector for Transesophageal (TEE) ultrasound probes, not a device used for treating a disease or condition in a patient.
No
Explanation: The device is a cleaner and disinfector for TEE ultrasound probes, not a device used to diagnose medical conditions. Its purpose is to reprocess medical equipment.
No
The device description clearly indicates it is a physical automated cleaner disinfector system that uses specific chemical solutions (enzymatic cleaner and disinfectants) and involves physical processes like heating, soaking, and rinsing. The performance studies also include electrical safety testing and biocompatibility testing related to the physical device and chemicals, not just software validation.
Based on the provided text, the TEEClean® automated cleaner disinfector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to clean and high-level disinfect Transesophageal (TEE) ultrasound probes. This is a process applied to a medical device (the TEE probe) to prepare it for reuse, not a test performed on a biological sample to diagnose a condition or provide information about a patient's health.
- Device Description: The description details a system for cleaning and disinfecting a medical device. It involves enzymatic cleaning and high-level disinfection using specific chemicals and processes. This is consistent with reprocessing medical equipment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient
- Using reagents to detect or measure substances in a sample
- Performing tests for disease, conditions, or physiological states
The TEEClean® system is a medical device intended for the reprocessing of other medical devices (TEE probes). While it plays a crucial role in patient safety by ensuring the probes are properly disinfected, its function is not diagnostic in nature.
N/A
Intended Use / Indications for 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:
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.
Product codes (comma separated list FDA assigned to the subject device)
PSW
Device Description
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®. 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.
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)
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.
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 non-cytotoxic.
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. 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.
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 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
1
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
2
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
Disinfectant | Time | Temperature | Minimum Recommended
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
Disinfectant | Time | Temperature | Minimum Recommended
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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3
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
4
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
Disinfectant | Time | Temperature | Minimum Recommended
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
Disinfectant | Time | Temperature | Minimum Recommended
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.
5
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 ultrasonic | |||
| transducer (21 C.F.R. | ||||
| § 892.1570, Product | ||||
| Code PSW) | Liquid chemical | |||
| sterilants/high level | ||||
| disinfectant (21 CFR | ||||
| §876.1500, Product | ||||
| Code FEB) | Diagnostic ultrasonic | |||
| transducer (21 C.F.R. | ||||
| § 892.1570, Product | ||||
| Code PSW) | Proposed and | |||
| primary | ||||
| predicate | ||||
| same | ||||
| classification | ||||
| Indications | ||||
| for 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 | The EVOTECH® | |||
| System, a | ||||
| washer/disinfector, is | ||||
| indicated for | ||||
| use with the high level | ||||
| disinfectant CIDEX® | ||||
| OPA Concentrate | ||||
| Solution and an | ||||
| enzymatic detergent | ||||
| (CIDEZYME® GI) to | ||||
| achieve cleaning and | ||||
| high level disinfection | ||||
| of heat sensitive (> | ||||
| 60°C) semi-critical | ||||
| endoscopes. Manual | ||||
| cleaning of medical | ||||
| devices (endoscopes) | ||||
| is not required prior to | ||||
| placement in the | ||||
| EVOTECH® System | ||||
| when selecting those | ||||
| cycles that contain a | ||||
| wash stage. (Manual | ||||
| cleaning of medical | ||||
| devices [endoscopes] | ||||
| is required when | ||||
| selecting the Disinfect | ||||
| Only or | ||||
| Disinfect/Alcohol | The TD 100® | |||
| disinfector is | ||||
| designed to provide | ||||
| high-level disinfection | ||||
| of Transesophageal | ||||
| (TEE) probes. The | ||||
| system can use TD-5® | ||||
| or TD-8® disinfectants, | ||||
| which are designed to | ||||
| be used only with the | ||||
| TD 100® disinfector. | ||||
| The disinfectant bottles | ||||
| cannot be reused in | ||||
| the system. TD-5® and | ||||
| TD8® disinfectants are | ||||
| intended for use as | ||||
| single use high-level | ||||
| disinfectant to be | ||||
| used exclusively in the | ||||
| TD 100® disinfector | ||||
| for high-level | ||||
| disinfection of TEE | ||||
| ultrasound probes. | ||||
| TD-5® and TD-8® | ||||
| high level | ||||
| disinfectants and TD | ||||
| 100® disinfector | ||||
| system are intended | ||||
| for use by qualified | Proposed | |||
| device and | ||||
| primary | ||||
| predicate | ||||
| similar | ||||
| indications for | ||||
| use, | ||||
| reference | ||||
| device | ||||
| provides | ||||
| cleaning | ||||
| function |
6
| 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 | Flush cycles.) | individuals trained in
its use. TD-5®
disinfectant should be
used with the
following contact
conditions in TD 100®
disinfector:
High-level disinfectant
TD-5®
Time - 5 minutes
Temperature - 38° -
40°C
Minimum
Recommended
Concentration
1.7% glutaraldehyde
TD-8® disinfectant
should be used with
the following contact
conditions in TD 100®
disinfector:
High-level disinfectant
TD-8®
Time - 5 minutes
Temperature - 38° -
40°C Minimum
Recommended
Concentration
0.3% ortho-
phthalaldehyde |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| | 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. | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Instrument
ation For
Automation | 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. | The EVOTECH®
System, utilizes
CIDEZYME® GI
Enzymatic Detergent
and the high level
disinfectant CIDEX®
OPA Concentrate
Solution (ortho-
phthalaldehyde).
The user initiates the
automated process.
Data for each step of
the process are
printed immediately or
stored electronically. | TD 100® with TD-5® or
TD-8® disinfectors is
automated for single
use with only TD-5® or
TD-8® disinfectants.
The user initiates the
automated cycle via
touchpad and
receives disinfection
verification ticket. | Proposed
device and
primary
predicate
device same,
reference
device
provides
cleaning
function |
Comparison of Proposed Device to Primary Predicate Device
| | Proposed Device
TEEClean® Automated TEE
Probe Cleaner Disinfector
with TEEZyme® Cleaner and
TD-5® or TD-8® High-Level
Disinfectants | Primary Predicate
Device
TD 100®
Transesophageal Probe
Disinfector and TD-5®
and TD-8® High- level
Disinfectant (K160921) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Features | | | |
| The system shall utilize a
disinfectant that has at least a
one year shelf life from the
date of manufacture. | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Same |
| User hazard to disinfectant
contact reduced by bottle
loading system | Yes | Yes | Same |
| The system shall provide a
disinfection cycle that has a | Yes | Yes | Same |
| disinfectant contact time, at
least 300 seconds and
temperature 38-40°C | | | |
| Disinfectant residues shall be
rinsed until the disinfectant
residue is below a
toxicologically significant
level. | Yes | Yes | Same |
| Reduced height of machine
for easy load of TEE probe | Yes | Yes | Same |
| Machine number, lot number
of disinfectant, probe number,
operator number on output
ticket | Yes | Yes | Same |
| Minimal footprint, secured to
wall for stability | Yes | Yes | Same |
| Bar code data entry or
touchscreen input | Yes | No | See reference
device |
| Separate drain for
disinfectant | Yes | No | See reference
device |
| USB port for downloading
session reports | Yes | No | See reference
device |
| Internal water filter with
service reminder | Yes | No | See reference
device |
| The system shall create a
record of every clean and
disinfect attempt (e.g.,
successful, failed, and user
aborted cleaning and
disinfection cycles, error
conditions, etc.) in memory
and apply a unique,
sequential accession number
to each record. | Yes | No | See reference
device |
| The system shall create a
record in memory for every
error event that occurs and
apply a unique, sequential
number to each record. | Yes | No | See reference
device |
| The system shall notify users
when preventative | Yes | No | See reference
device |
| maintenance is required. | | | |
| Design | | | |
| Intended Use | Automated cleaning and
high-level disinfection of
TEE probes | Automated high-level
disinfection of TEE
probes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Enzymatic cleaning and
aldehyde high-level
disinfection | Aldehyde high-level
disinfection | See reference
device |
| Process monitors | Digital display screen,
printout | Digital display screen,
printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | Cleaning and High-level
disinfection | High-level disinfection | See reference
device |
| Provides high-level
disinfection for heat-sensitive
TEE probes | Yes | Yes | Same |
| Uses enzymatic cleaner | Yes | No | See reference
device |
| Uses glutaraldehyde- based
disinfectant | Yes | Yes | Same |
| Uses OPA-based
disinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| Filter rinse water | Yes | No | See reference
device |
| Disinfection process with
success/failure print out. | Yes | Yes | Same |
| User hazard to vapor
exposure controlled by vapor
management system utilizing
air circulation and activated
carbon filtration | Yes | Yes | Same |
| The system shall be designed
to utilize a modular
electronics controller box. | Yes | Yes | Same |
| The system shall be
controlled by a
microcontroller processor. | Yes | Yes | Same |
| The system shall provide a
built-in printer. | Yes | Yes | Same |
| Specifications | | | |
| Dedicated enzymatic cleaner
for use with the device | TEEZyme® Cleaner | No | See reference
device |
| Dedicated Disinfectants for
use with the device | Glutaraldehyde (TD-5);
Ortho-phthalaldehyde (TD-8) | Glutaraldehyde (TD-5);
Ortho-phthalaldehyde
(TD-8) | Same |
| Disinfectant Minimum
Recommended
Concentration | 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 Device
TEEClean® Automated TEE
Probe Cleaner Disinfector
with TEEZyme® Cleaner
and TD-5® or TD-8® High-
Level Disinfectants | Reference Device
EVOTECH® Integrated
Endoscope Disinfection
System (K061899) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------|
| Bar code data entry or | Yes | Yes | Same |
| touchscreen input | | | |
| Separate drain for
disinfectant | Yes | Same | |
| USB port for downloading
session reports | Yes | Same | |
| Internal water filter with
service reminder | Yes | Same | |
| The system shall create a
record of every clean and
disinfect attempt (e.g.,
successful, failed, and user
aborted cleaning and
disinfection cycles, error
conditions, etc.) in memory
and apply a unique,
sequential accession number
to each record. | Yes | Same | |
| The system shall create a
record in memory for every
error event that occurs and
apply a unique, sequential
number to each record. | Yes | Same | |
| The system shall notify users
when preventative
maintenance is required. | Yes | Same | |
| Operating principles | Enzymatic cleaning and
aldehyde high-level
disinfection | Same | |
| Performance claims | Cleaning and High-level
disinfection | Same | |
| Uses enzymatic cleaner | Yes | Same | |
| Dedicated enzymatic cleaner
for use with the device | TEEZyme® Cleaner | Same | |
11
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).