CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

Q: Who is the manufacturer of CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

Cs Medical, LLC filed the 510(k) submission for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (K192228).

Q: What is the FDA product code for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

PSW. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K192228 · Cs Medical, LLC · PSW · Apr 1, 2020 · Radiology

Device Facts

Record ID	K192228
Device Name	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
Applicant	Cs Medical, LLC
Product Code	PSW · Radiology
Decision Date	Apr 1, 2020
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 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 1.75% peracetic acid

Device Story

System performs automated high-level disinfection of TEE ultrasound probes; utilizes dedicated TD-12 peracetic acid-based disinfectant. Process: user loads soiled, pre-cleaned probe into device; inserts fresh TD-12 bottle; system heats disinfectant to 38°C, soaks probe for 3 minutes, rinses, and prints verification report. Used in clinical settings by trained personnel. Output: disinfected probe and printed cycle verification report. Benefits: ensures standardized, automated disinfection; reduces user exposure to disinfectant vapors via integrated filtration; provides documented evidence of successful disinfection cycle.

Clinical Evidence

Clinical in-use testing performed on soiled TEE probes processed in the TD 200 system. Results showed complete kill of microorganisms after processing. Non-clinical testing included simulated-use studies, biocompatibility, material compatibility with GE/Philips/Siemens probes, and shelf-life stability. All tests met acceptance criteria.

Technological Characteristics

Automated disinfector; 110 VAC; potable water inlet. Materials: compatible with TEE probes. Disinfectant: 3.0% peracetic acid (TD-12). Sensing: temperature control (38°C), concentration monitoring via chemical indicator. Connectivity: built-in printer for cycle verification. Software: microcontroller-based, modified from TD 100 to enforce dedicated disinfectant use. Safety: UL 61010-1 compliant.

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

CS Medical TD 100® Transesophageal Probe Disinfector with TD-5® and TD-8® High Level Disinfectants (K160921)
Medivators Rapicide PA High Level Disinfectant (K082988)

Reference Devices

TD-8 High-Level Disinfectant (K160921)

Related Devices

K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator · Cs Medical, LLC · Nov 21, 2023
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
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
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

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. April 1, 2020 CS Medical L.L.C. Kendall Ashe Vice President and General Manager 2179 East Lyon Station Road Creedmoor, North Carolina 27522 Re: K192228 Trade/Device Name: TD 200® Disinfector with TD-12® High Level Disinfectant Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW, MED Dated: February 27, 2020 Received: February 27, 2020 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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). Sincerely, For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192228 Device Name TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant #### Indications for Use (Describe) The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 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 | 1.75% peracetic acid | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(K) Summary K192228 510(k) Owner CS Medical L.L.C. 2179 E. Lvon Station Road Creedmoor, North Carolina 27522 Phone 919-255-9472 Fax 919-528-3400 Contact Name Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Email: kendallashe@csmedicalllc.com Submission Prepared 26-Feb-2020 CS Medical Trade Name TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant Common Name TD 200® Classification Name Diagnostic ultrasonic transducer (21 CFR 892.1570, Primary Product Code, PSW Secondary Product Code, MED Legally Marketed Predicate Devices - CS Medical TD 100® Transesophageal Probe Disinfector with TD-5® and TD-8® High 1. Level Disinfectants (K160921) - Primary Predicate - 2. Medivators Rapicide PA High Level Disinfectant (K082988) #### Reference Device - TD-8 High-Level Disinfectant (K160921) 1. #### Description of the CS Medical TD 200® Automated Tee Probe Disinfector with TD-12® High Level Disinfectant The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant 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 2008 K192228 Page 1 of 10 {4}------------------------------------------------ disinfector and dried according to the TEE probe manufacturer's instructions. The TD 2008 disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC. # Indications for Use Statement The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200% disinfector. The disinfectant bottles cannot be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 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 | 1.75% peracetic acid | #### Technological Characteristics: ### Table C1.a: Comparative Table for TD 200® | | Proposed Device | Predicate Device | Predicate Device | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Element | | TD 200® Automated TEE Probe Disinfector with TD- 12® High Level Disinfectant (K192228) | TD 100® Transesophageal Probe Disinfector and TD-5 and TD-8 High- level Disinfectant (K160921) | | Classification Name (CFR; Product code) | Diagnostic ultrasonic transducer (21 C.F.R. § 892.1570, product code PSW) | Diagnostic ultrasonic transducer (21 C.F.R. § 892.1570, product code PSW) | Liquid chemical sterilants/high level disinfectant (21 CFR §880.6885, Product Code MED) | | Indications for use | The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is | 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 | Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in | | designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system. | 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 individuals trained in its use. TD-5 disinfectant should be used with the following contact conditions in TD 100 disinfector: | the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC. Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA should be used under the following contact conditions: | | | 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. | High-level disinfectant TD-5 Time - 5 minutes Temperature - 38° to 40°C Minimum Recommended Concentration 1.7% glutaraldehyde | Time - 5 minutes Temperature – 30° Minimum Recommended Concentration (MRC) 850ppm | | | TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use. | 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° to 40°C Minimum Recommended Concentration | | | | 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 (MRC) 1.75% Peracetic Acid | | | | | | 0.3% ortho- phthalaldehyde | | | | Instrumentati on For Automation | TD 200® Automated TEE Probe Disinfector with TD- 12® High Level Disinfectant is automated for single use with only TD-12® disinfectant. The user initiates the automated cycle via touchpad and receives disinfection verification ticket. Software has been modified as compared to the predicate TD 100 (K160921) to facilitate the only choice of TD-12® disinfectant. Other aspects of the instrumentation are identical to current TD 100 with TD-5 and TD-8 devices. | 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. | Rapicide PA is indicated for manual use and use with undesignated (legally marketed) automatic reprocessors that provide designated contact conditions. | {5}------------------------------------------------ {6}------------------------------------------------ Comparison of Proposed Device to Primary Predicate Device | | Proposed Device | Predicate Device | Predicate Device | Comparison | |---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------| | | TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant (K192228) | TD 100® Transesophage al Probe Disinfector and TD-5 and TD-8 High- level Disinfectant (K160921) | Rapicide PA (K082988) | | | Features | | | | | | The system shall utilize a disinfectant that has at least a one year shelf life from the date of manufacture. | Yes | Yes | Yes | Same | | Single-use disinfectants only | Yes | Yes | Yes | Same | | User hazard to disinfectant contact reduced by bottle loading system | Yes | Yes | N/A | Same | | The system shall provide a disinfection cycle that has a disinfectant contact time, at least 180 seconds and disinfects at 38°C | Yes | No | N/A | TD-12 has a shorter disinfection time vs TD 100 | | Disinfectant residues shall be rinsed until the disinfectant residue is below a toxicologically significant level. | Yes | Yes | N/A | Same | | Machine number, lot number of disinfectant, probe number, operator number on output ticket | Yes | Yes | N/A | Same | | Design | | | | | | Intended Use | Automated high- level disinfection of TEE probes | Automated high-level disinfection of TEE probes | High-level disinfection of endoscope s | Same | | Manual Pre-cleaning | Yes | Yes | Yes | Same | | Operating principles | Peracetic Acid high-level disinfection | Aldehyde high- level disinfection | Peracetic Acid high- level disinfection | Same (TD-12 and Rapicide PA) | | Process monitors | Digital display screen, printout | Digital display screen, printout | N/A | Same | | Software/firmware control | Yes | Yes | N/A | Same | | Performance claims | High-level disinfection | High-level disinfection | High-level disinfection | Same | | Provides high-level disinfection for heat-sensitive TEE probes | Yes | Yes | Yes | Same | | Uses PAA-based disinfectants | Yes | No | Yes | Same (TD-12 and Rapicide PA) | | Automated disinfection cycle | Yes | Yes | N/A | Same | | Disinfection process with success/failure print out. | Yes | Yes | N/A | Same | | User hazard to vapor exposure controlled by vapor management system utilizing air circulation and activated carbon filtration | Yes | Yes | N/A | Same | | The system shall be designed to utilize a modular electronics controller box. | Yes | Yes | N/A | Same | | The system shall be controlled by a microcontroller processor. | Yes | Yes | N/A | Same | | The system shall provide a built-in printer. | Yes | Yes | N/A | Same | | Specifications | | | | | | Dedicated Disinfectants for use with the device | Peracetic acid (TD-12) | Glutaraldehyde (TD-5); Ortho- phthalaldehyde (TD-8) | Rapicide PA peracetic acid | Same (TD-12 and Rapicide PA) | | Disinfectant Minimum Recommended Concentration | 1.75% Peracetic Acid (TD-12) | 1.7% glutaraldehyde (TD-5) 0.3% ortho- phthalaldehyde (TD-8) | 850 ppm peracetic acid | Similar (TD-12 and Rapicide PA) | | 110 VAC | Yes | Yes | N/A | Same | | Potable Water Inlet | Yes | Yes | N/A | Same | {7}------------------------------------------------ {8}------------------------------------------------ The technological differences between the high-level disinfection phase of the Proposed Device (TD 200) K192228 and Predicate Device (TD 100) K160921 are small except for the type of high-level disinfectants. The differences between TD-12 and Rapicide PA are small except for the Minimum Recommended Concentration (MRC), which are similar. Both devices, TD 200 and TD 100, achieve the same high-level disinfection of TEE probes using the same technological methods. Both TD-12 and Rapicide PA are peracetic acid high-level disinfectants which achieve high-level disinfection useful for the disinfection of TEE and Endoscopy probes. Both Proposed (TD-12) and Predicate (Rapicide PA) devices have similar physical properties (Table C1.b) and disinfection properties (Table C1.c). | Physical Properties | Proposed Device | Reference Device | Predicate Device | Comparison | |------------------------|------------------------|-------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------| | | TD-12® | TD-8 | Rapicide PA | | | 510(k) Number | K192228 | K160921 | K082988 | | | Active Ingredients | 3.0% peracetic acid | 0.59% Ortho- phthaladehyde | Part A - 22% hydrogen peroxide and 5% peroxyacetic acid Part B - 4% | Similar (TD-12 and Rapicide PA) | | Inert Ingredients | 97.0% | 99.41% | Part A - 73% Part B – 95.7% | TD-12, TD-8, and Rapicide PA have different inert ingredients | | Water-Based Liquid | No | Yes | Yes | Same after hydration of TD-12 | | pH Value | 8.5 – 9.0 | 7.45 – 7.55 | 0.4±.3 Part A 11.4 - 12.4 Part B Combined Part A and B is 4.2 | TD-12, TD-8, and Rapicide PA have different pH values | # Table C1.b: Comparative Table (Physical Properties) for TD-12®, TD-8®, Rapicide PA {9}------------------------------------------------ | Buffer System | Sodium Carbonate and Sulfamic Acid | Phosphates | Trisodium Phosphate | TD-12, TD-8, and Rapicide PA have different buffer system | |--------------------------------------------------|------------------------------------------|------------|------------------------|-----------------------------------------------------------------------| | Minimum Recommended Concentration (MRC) | 1.75% | 0.3% | 850 ppm | TD-12 and Rapicide PA have different MRC | | Dilution Required | Yes | No | Yes | Same (TD-12 and Rapicide PA) | | Activation Required | Yes | No | Yes | Same (TD-12 and Rapicide PA) | | High-Level Disinfection Claim | Yes | Yes | Yes | Same | | Sterilization Claim | No | No | No | Same | | Maximum Re-Use Period | Single Use | Single Use | 28 Days | Same (TD-12 and TD-8). Rapicide PA not single use. | | PAA Test Strip Available | Yes | No | Yes | Same (TD-12 and Rapicide PA) | | Use in Automated Disinfector | Required | Required | Optional | Same (TD-12 and TD-8). Optional Rapicide PA | | Manual Use | No | No | Optional | Same (TD-12 and TD-8). Optional Rapicide PA | | Disinfectant Temperature Minimum | 38°C | 38°C | 30°C | Same (TD-12 and TD-8). Rapicide PA has lower Min Temp | | Disinfection Time | 3 Minutes | 5 Minutes | 5 Minutes | Similar | # Table C1.c: Comparative Table (Test Organism) for TD-12®, TD-8, Rapicide PA | Test | Proposed Device | Reference Device | Predicate Device | Comparison | |-------------------|-----------------|------------------|------------------|------------| | Organism | | | | | | | TD-12® | TD-8 | Rapicide PA | | | Sporicidal | 5.0 hrs at | 32.0 hrs at | Total Kill | Same | | Bacillus subtilis | 37°C | 37°C | | | | Sporicidal | 5.0 hrs at | 32.0 hrs at | Total Kill | Same | | Clostridium | 37°C | 37°C | | | | sporogenes | | | | | {10}------------------------------------------------ | Tuberculocidal Mycobacterium terrae | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | |-----------------------------------------------|-----------------|-----------------|----------------------------------------------------|--------------------------------------------------------| | Bactericidal Staphylococcus aureus | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | | Bactericidal Salmonella enterica | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | | Bactericidal Pseudomonas aeruginosa | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | | Fungicidal Trichophyton mentagrophytes | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | | Virucidal Poliovirus Type 1 | 3.0 min at 37°C | 5.0 min at 37°C | Complete Inactivation for Polio Virus Type 2 | Same (TD-12 and TD-8). Type 2 for Rapicide PA | | Virucidal Herpes Simplex Virus Type 1 | 3.0 min at 37°C | 5.0 min at 25°C | Complete Inactivation | Same | | Virucidal Human Influenza Virus A | 3.0 min at 37°C | 5.0 min at 25°C | Not performed | Same (TD-12 and TD-8) | | Virucidal Adenovirus Type 1 | 3.0 min at37°C | 5.0min at 25°C | Not performed | Same (TD-12 and TD-8) | | Simulated Use Mycobacterium terrae | 3.0 min at 37°C | 5.0 min at 37°C | >6 log Reduction | Same | | Clinical In-Use Wild-type from patients | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same | ### 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. ### 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 {11}------------------------------------------------ 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 with TD-12® High Level Disinfectant 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. ### 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. # 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 onmaterials. # Compatibility Testing with TEE Probes The TD 200® Automated TEE Probe Disinfector with TD-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. ### Performance Testing Disinfectant (TD-12®) 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. After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200® disinfector with TD-12® disinfectant with standard operating parameters. In all cases there was a measurably complete kill of microorganisms after TEE probe processing. ### Stability TD-12® high level disinfectant has been tested and shown to be stable for a shelf life of at least twelve (12) months. {12}------------------------------------------------ # Conclusion The conclusions drawn from the nonclinical and clinical tests demonstrates that the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is as safe, as effective, and performs as well as or better than the legally marketed predicate device Medivators Rapicide PA High Level Disinfectant (K082988).

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

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CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

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