TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator
Device Facts
| Record ID | K233049 |
|---|---|
| Device Name | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator |
| Applicant | Cs Medical, LLC |
| Product Code | PSW · Radiology |
| Decision Date | Nov 21, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
Intended Use
The TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use. TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector: High-Level Disinfectant: TD-12®; Time: 3 minutes; Temperature: 38°C; Minimum Recommended Concentration: 1750 ppm peracetic acid. QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
Device Story
Automated system for high-level disinfection of TEE ultrasound probes; utilizes TD-12 peracetic acid-based disinfectant. Process: bedside/manual pre-cleaning of probe; loading of fresh TD-12 bottle; automated cycle heating disinfectant to 38°C; 3-minute soak; rinse; printout of verification report (time, temperature, success/failure). QwikCheck chemical indicator used prior to cycle to verify peracetic acid concentration >1750 ppm. Used in clinical settings by trained personnel. Vapor management system uses air circulation and activated carbon filtration to control user exposure. Benefits: standardized, automated disinfection; reduced user exposure to disinfectant; verification of disinfection parameters.
Clinical Evidence
No clinical trials performed. Evidence consists of bench testing, including automated simulated-use studies demonstrating complete microbial kill, vapor management capacity testing, and material compatibility testing with GE, Philips, and Siemens TEE probes.
Technological Characteristics
Automated disinfector; 110 VAC; microcontroller-controlled. Uses peracetic acid (TD-12) at 38°C for 3 minutes. Vapor management via activated carbon filtration. QwikCheck indicator uses starch/iodide test paper. Electrical safety per UL 61010-1. Connectivity includes built-in printer for cycle verification.
Indications for Use
Indicated for high-level disinfection of Transesophageal (TEE) ultrasound probes by qualified, trained individuals.
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
Related Devices
- K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant · Cs Medical, LLC · Apr 1, 2020
- K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator · Cs Medical, LLC · Jun 7, 2023
- K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant · Cs Medical, LLC · Nov 3, 2016
- K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 · Cs Medical, LLC · Aug 18, 2005
- K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants · Cs Medical, LLC · Apr 12, 2019
Submission Summary (Full Text)
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November 21, 2023
CS Medical LLC Kendall Ashe Vice President, General Manager 2179 East Lyon Station Rd Creedmoor, North Carolina 27522
Re: K233049
Trade/Device Name: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW, MED, JOJ Dated: September 25, 2023 Received: September 25, 2023
Dear Kendall Ashe:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
# Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K233049
Device Name
TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with OwikCheck™ Chemical Indicators
Indications for Use (Describe)
The TD 2008 Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 2008 disinfector. The disinfectant be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-Level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|-------------------------|-----------|-------------|-----------------------------------|
| TD-12® | 3 minutes | 38°C | 1750 ppm peracetic acid |
OwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
Type of Use (*Select one or both, as applicable*)
| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) Summary
## K233049
510(k) Owner CS Medical L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Phone 919-255-9472 Fax 919-528-3400
Contact Name Kendall Ashe Vice President and General Manager, CS Medical, LLC 2179 E. Lyon Station Road Creedmoor. North Carolina 27522 Email: kendallashe@csmedicalllc.com
Submission Prepared 25-Sept-2023
CS Medical Trade Name TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators
Common Name TD 200 disinfector TD-12 disinfectant and QwikCheck chemical indicator
Classification Name Diagnostic ultrasonic transducer (21 CFR 892.1570, Primary Product Code. PSW Secondary Product Code, MED, JOJ
Legally Marketed Predicate Devices
1. TD 200/TD-12 disinfector/disinfectant system (K192228) - Primary Predicate
2. IBT Scientific Peracid Test (K964264)
## Description of the CS Medical TD 200® Disinfector with TD-12® High Level Disinfectant and QwikCheck™ Indicator
The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12 disinfectant. The TD 200 disinfector is for use only with TD-12 disinfectant. The TD-12 is for use only in the TD 200 disinfector. Thus, the TD 200 disinfector and TD-12 disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to at least 38°C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200 disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cvcle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
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## TD 200, TD-12, and QwikCheck Indications for Use Statement:
The TD 200® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|-------------------------|-----------|-------------|-----------------------------------|
| TD-12® | 3 minutes | 38°C | 1750 ppm peracetic acid |
QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750 ppm peracetic acid.
## Comparative Table for Indications for Use
| | Proposed Device | Predicate Device | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Element | TD 200 Disinfector with TD-<br>12 High-Level disinfectant<br>with QwikCheck Chemical<br>Indicator | TD 200 Disinfector with TD-<br>12 High-Level Disinfectant | |
| Classification<br>Name (CFR;<br>Product code) | Diagnostic ultrasonic<br>transducer (21 C.F.R. §<br>892.1570, product code<br>PSW) | Diagnostic ultrasonic<br>transducer (21 C.F.R. §<br>892.1570, product code<br>PSW) | Same |
| Indications for<br>Use | The TD 200 disinfector is<br>designed to provide high-<br>level disinfection of<br>Transesophageal (TEE)<br>ultrasound probes. The<br>system can use TD-12<br>disinfectant, which is<br>designed to be used only<br>with the TD 200 disinfector.<br>The disinfectant bottles<br>cannot be reused in the<br>system.<br>TD-12 disinfectant is<br>intended for use as single<br>use high-level disinfectant<br>to be used exclusively in the | The TD 200 disinfector is<br>designed to provide high-<br>level disinfection of<br>Transesophageal (TEE)<br>ultrasound probes. The<br>system can use TD-12<br>disinfectant, which is<br>designed to be used only<br>with the TD 200 disinfector.<br>The disinfectant bottles<br>cannot be reused in the<br>system.<br>TD-12 disinfectant is<br>intended for use as single<br>use high-level disinfectant<br>to be used exclusively in the | Same |
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| TD 200 disinfector for high-<br>level disinfection of TEE<br>ultrasound probes.<br>TD-12 high level<br>disinfectant and TD 200<br>disinfector is intended for<br>use by qualified individuals<br>trained in its use.<br>TD-12 disinfectant should<br>be used with the following<br>contact conditions in TD<br>200 disinfector: | TD 200 disinfector for high-<br>level disinfection of TEE<br>ultrasound probes.<br>TD-12 high level<br>disinfectant and TD 200<br>disinfector is intended for<br>use by qualified individuals<br>trained in its use.<br>TD-12 disinfectant should<br>be used with the following<br>contact conditions in TD<br>200 disinfector: |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| High-level Disinfectant TD-<br>12<br>Time - 3 Minutes<br>Temperature - 38°C<br>Minimum Recommended<br>Concentration (MRC) 1750<br>ppm Peracetic Acid | High-level Disinfectant TD-<br>12<br>Time - 3 Minutes<br>Temperature - 38°C<br>Minimum Recommended<br>Concentration (MRC) 1.75%<br>Peracetic Acid |
| QwikCheck Chemical<br>Indicators are used prior to<br>the disinfection cycle to<br>ensure that the disinfectant<br>used is above the minimum<br>recommended<br>concentration (MRC) of<br>1750ppm peracetic acid. | |
## Comparison of Proposed TD 200 Device to Primary Predicate TD 200 Device
| Features | Proposed Device<br>TD 200® Automated<br>TEE Probe<br>Disinfector with TD-<br>12® High Level<br>Disinfectant with<br>QwikCheck Chemical<br>Indicator | Predicate Device<br>TD 200® Automated<br>TEE Probe<br>Disinfector with TD-<br>12® High Level<br>Disinfectant<br>(K192228) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------|
| 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<br>disinfectant contact time, at<br>least 180 seconds and<br>disinfects at 38°C | Yes | Yes | Same |
| 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 serial number, lot<br>number of disinfectant, probe<br>number, and operator number<br>on output ticket | Yes | Yes | Same |
| Minimal footprint, secured to<br>wall for stability | Yes | Yes | Same |
| Design | | | |
| Intended Use | Automated high-level<br>disinfection of TEE<br>probes | Automated high-level<br>disinfection of TEE<br>probes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Peracetic Acid high-<br>level disinfection | Peracetic Acid high-<br>level disinfection | Same |
| Process monitors | Digital display<br>screen, printout | Digital display<br>screen, printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | High-level<br>disinfection | High-level<br>disinfection | Same |
| Provides high-level<br>disinfection for heat-sensitive<br>TEE probes | Yes | Yes | Same |
| Uses PAA-based<br>disinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| 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<br>controlled by a<br>microcontroller processor. | Yes | Yes | Same |
| The system shall provide a<br>built-in printer. | Yes | Yes | Same |
| Specifications | | | |
| Dedicated Disinfectants for<br>use with the device | Peracetic acid<br>(TD-12) | Peracetic acid<br>(TD-12) | Same |
| Disinfectant Minimum<br>Recommended Concentration | 1750 ppm Peracetic<br>Acid | 1.75% Peracetic Acid | Same |
| 110 VAC | Yes | Yes | Same |
| Potable Water Inlet | Yes | Yes | Same |
| User hazard to vapor<br>exposure controlled by<br>vapor management<br>system utilizing air<br>circulation and filtration<br>with no room air<br>circulation required | Yes | Yes | Same |
| Use a chemical indicator | Yes | Yes | Same |
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## Comparison of Proposed TD 12 Device to Primary Predicate TD 12 Device
| Physical<br>Properties | Proposed Device<br>TD-12 | Predicate Device<br>TD-12 (K192228) | Comparison |
|--------------------------------------------------|---------------------------------------|---------------------------------------|------------|
| Active<br>Ingredients | 0.30%<br>peracetic acid | 0.30%<br>peracetic acid | Same |
| Inert<br>Ingredients | 99.7% | 99.7% | Same |
| Water-Based<br>Liquid | No | No | Same |
| pH Value | 8.5 – 9.0 | 8.5 – 9.0 | Same |
| Buffer System | Sodium Carbonate and<br>Sulfamic Acid | Sodium Carbonate and<br>Sulfamic Acid | Same |
| Minimum<br>Recommended<br>Concentration<br>(MRC) | 1750 ppm | 1.75% | Same |
| Dilution<br>Required | Yes | Yes | Same |
| Activation<br>Required | Yes | Yes | Same |
| High-Level<br>Disinfection<br>Claim | Yes | Yes | Same |
| Sterilization<br>Claim | No | No | Same |
| Maximum Re-<br>Use Period | Single Use | Single Use | Same |
| PAA Test | Yes | Yes | Same |
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| Strip Available | | | |
|----------------------------------------|-----------|-----------|------|
| Use in<br>Automated<br>Disinfector | Required | Required | Same |
| Manual Use | No | No | Same |
| Disinfectant<br>Temperature<br>Minimum | 38°C | 38°C | Same |
| Disinfection<br>Time | 3 Minutes | 3 Minutes | Same |
## Comparative Table between QwikCheck Chemical Indicators
| Element | QwikCheck Chemical<br>Indicator (proposed<br>device) | QwikCheck Chemical<br>Indicator (device used<br>in conjunction with<br>K192228) | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification Name<br>(CFR; Product code) | Sterilization Process<br>Indicator (21 C.F.R. §<br>880.2800, product code<br>JOJ) | Sterilization Process<br>Indicator (21 C.F.R. §<br>880.2800, product code<br>JOJ) | Same |
| Indications for Use<br>for Chemical<br>Indicator | QwikCheck Chemical<br>Indicators are used prior<br>to the disinfection cycle<br>to ensure that the<br>disinfectant used is<br>above the minimum<br>recommended<br>concentration (MRC) of<br>1750ppm peracetic acid. | The QwikCheck™<br>Chemical Indicator is a<br>qualitative chemical<br>indicator dedicated for<br>use in determining<br>whether the<br>concentration of<br>peracetic acid, the active<br>ingredient in CS<br>Medical's TD-12 Solution,<br>is above or below the<br>established Minimum<br>Recommended<br>Concentration (MRC)<br>according to the solution<br>manufacturer. | Similar |
| Analyte | Peracetic acid in TD-12<br>Solution | Peracetic acid in TD-12<br>Solution | Same |
| Indicator Strip | 0.2" x 0.2" test paper<br>attached to a plastic<br>handle | 0.2" x 0.2" test paper<br>attached to a plastic<br>handle | Same |
| Indicator Agents | Starch and iodide | Starch and iodide | Same |
| Minimum Time of<br>Color Change | 30 seconds | 30 seconds | Same |
| Results | A test pad which is<br>similar in color to the<br>FAIL color block<br>indicates the solution is ≤<br>1750 ppm. If the color of<br>the test pad is similar to<br>the PASS block, the<br>solution is > 1750 ppm | A test pad which is<br>similar in color to the<br>FAIL color block<br>indicates the solution is ≤<br>1750 ppm. If the color of<br>the test pad is similar to<br>the PASS block, the<br>solution is > 1750 ppm | Same |
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The only one difference between the subject and predicate devices is a change of supplier of the QwikCheck Chemical Indicator.
## Summary of Non-Clinical Testing
## Software Validation
All qualification activities defined in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant Verification and Validation Plan were successfully completed and provided documented evidence that the TD 200 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 TD 200 Verification and Validation Summary Report and the associated qualification documents for the TD 200 detail the successful completion of all requirements of the TD 200 Master Verification and Validation Plan.
## Electrical Safety Testing
The TD 200 Automated TEE Probe Disinfector withTD-12 High LevelDisinfectant 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.
## Biocompatibility
Under conditions of the study, TD-12 is not a sensitizer, nor an irritant and is non-cytotoxic. Transesophageal probes processed in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were evaluated for disinfectant residue. The analysis indicates that the level of residue on the TEE probes are not likely to have toxic effects on humans.
#### Material Compatibility
The materials used to construct the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were exposed to TD-12 disinfectant for a pre-determined period of time. There were no observable effects from exposure to TD-12 disinfectant on materials.
## Compatibility Testing with TEE Probes
The TD 200 Automated TEE Probe Disinfector withTD-12 High Level Disinfectant should be used only with TEE probes which have been tested and approved by TEE probe manufacturers. Material Compatibility has been performed with GE, Philips and Siemens TEE probes. These probes did not have cosmetic nor functional deterioration. TD-12 probe compatibility testing was
completed using a use-suspension of 3% w/v (approximately 3000ppm) PAA TD-12 at 38°C.
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## Performance Testing
TD-12 High Level Disinfectant 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 TD-12 were conducted in the TD 200 disinfector. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.
#### Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant using standard operating parameters. In all cases, there was a complete kill of microorganisms after TEE probe processing.
No clinical in-use testing was performed with the QwikCheck chemical indicators as no clinical in-use testing was performed with the predicate chemical indicators so this testing is not applicable.
## Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant with QwikCheck Chemical Indicators is as safe, as effective, and performs as well as or better than the legally marketed predicate device CS Medical TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant (K192228).
