(229 days)
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
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 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 cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
The provided document describes the FDA 510(k) clearance for the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant. This device is a high-level disinfection system for transesophageal (TEE) ultrasound probes. The acceptance criteria and the study that proves the device meets them are detailed primarily through non-clinical performance testing rather than human-in-the-loop studies involving expert readers.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through its ability to achieve high-level disinfection, stability of the disinfectant, and safety aspects. The performance is reported as a "complete kill of microorganisms" or "measurable complete kill."
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (TD 200® with TD-12®) |
|---|---|---|
| High-Level Disinfection Efficacy | Bactericidal Activity: | |
| Staphylococcus aureus | 3.0 min at 37°C (Complete Kill/Total Kill) | |
| Salmonella enterica | 3.0 min at 37°C (Complete Kill/Total Kill) | |
| Pseudomonas aeruginosa | 3.0 min at 37°C (Complete Kill/Total Kill) | |
| Tuberculocidal Activity: | ||
| Mycobacterium terrae | 3.0 min at 37°C (Complete Kill/Total Kill) | |
| Fungicidal Activity: | ||
| Trichophyton mentagrophytes | 3.0 min at 37°C (Complete Kill/Total Kill) | |
| Sporicidal Activity: | ||
| Bacillus subtilis | 5.0 hrs at 37°C (Complete Kill/Total Kill) | |
| Clostridium sporogenes | 5.0 hrs at 37°C (Complete Kill/Total Kill) | |
| Virucidal Activity: | ||
| Poliovirus Type 1 | 3.0 min at 37°C (Complete Inactivation) | |
| Herpes Simplex Virus Type 1 | 3.0 min at 37°C (Complete Inactivation) | |
| Human Influenza Virus A | 3.0 min at 37°C (Reported) | |
| Adenovirus Type 1 | 3.0 min at 37°C (Reported) | |
| Simulated Use Performance | Efficacy in automated system under simulated conditions | In all cases, a measurably complete kill of microorganisms after TEE probe processing. |
| Clinical In-Use Testing | Efficacy with soiled TEE probes after routine clinical use | In all cases, there was a complete kill of microorganisms after TEE probe processing. |
| Biocompatibility | Non-sensitizer, non-irritant, non-cytotoxic, and safe residue levels | TD-12® is not a sensitizer, nor an irritant and is non-cytotoxic. Residue levels on TEE probes are not likely to have toxic effects on humans. |
| Material Compatibility | No observable effects on materials from disinfectant exposure | No observable effects from exposure to TD-12® disinfectant on materials. Material compatibility performed with GE, Philips, and Siemens TEE probes showed no cosmetic or functional deterioration. |
| Disinfectant Stability | Shelf life of disinfectant | Stable for a shelf life of at least twelve (12) months. |
| Electrical Safety | Compliance with electrical safety standards | Passed all testing in accordance with UL 61010-1. 3rd Edition. |
| Software Validation | Consistent performance as intended | All qualification activities successfully completed, consistently performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise numerical sample size for "Clinical In-Use Testing" or "Automated Simulated use studies." It states "In all cases" there was a complete kill, implying all tested units/probes/cycles met the criteria. For the specific test organisms, the results are presented for each organism type (e.g., Bacillus subtilis, Mycobacterium terrae).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the implication is that the studies were conducted under controlled conditions to support regulatory clearance, likely prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This device focuses on disinfection efficacy rather than diagnostic accuracy involving human image interpretation. Therefore, the "ground truth" is established through microbiological and chemical analysis, not expert human readers.
- Experts: Not applicable in the context of human interpretation. The "experts" would be qualified microbiologists, chemists, and engineers conducting the tests according to established standards.
- Qualifications: Not specified for individuals, but implied by the nature of regulatory testing (e.g., adherence to Good Laboratory Practices or similar standards).
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for disinfection efficacy is determined by objective laboratory measurements (e.g., microbial counts, chemical residue analysis), not subjective human judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a high-level disinfector, not an AI-powered diagnostic imaging tool for human readers. There are no "human readers" involved in the direct purpose of the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire performance evaluation of the TD 200® Disinfector is "standalone" in the sense that its primary function (disinfection) is automated and assessed directly for its output (microbial kill, residue levels). There is no "human-in-the-loop" performance component for the disinfection process itself. The "Software Validation" section details the functioning of the algorithm/software controlling the device.
7. The Type of Ground Truth Used
The ground truth used is primarily microbiological efficacy (complete kill of specified microorganisms for bactericidal, tuberculocidal, fungicidal, sporicidal, and virucidal activity), supported by chemical analysis (disinfectant residue levels, stability) and mechanical/electrical performance (software validation, electrical safety, material compatibility). No pathology reports or outcomes data on patients were used; the focus is on the device's ability to disinfect a medical instrument.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/Machine Learning device that undergoes a "training phase" with a dataset in the typical sense. Its design and performance are based on chemical, microbiological, and engineering principles rather than learning from data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI model. The "ground truth" for the device's development would be established through scientific literature, industry standards (e.g., for disinfection efficacy), and internal research and development.
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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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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
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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)
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510(K) Summary
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
-
- 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
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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 TEEProbe Disinfector with TD-12® High Level Disinfectant(K192228) | TD 100®Transesophageal ProbeDisinfector and TD-5and TD-8 High- levelDisinfectant (K160921) | |
| ClassificationName(CFR;Productcode) | Diagnostic ultrasonictransducer (21 C.F.R. §892.1570, product codePSW) | Diagnostic ultrasonictransducer (21 C.F.R. §892.1570, product codePSW) | Liquid chemicalsterilants/high leveldisinfectant (21 CFR§880.6885, ProductCode MED) |
| Indications foruse | The TD 200® AutomatedTEE Probe Disinfector withTD-12® High LevelDisinfectant is designed toprovide high-leveldisinfection ofTransesophageal (TEE)ultrasound probes. Thesystem can use TD-12®disinfectant, which is | The TD 100 disinfector isdesigned to providehigh-level disinfection ofTransesophageal (TEE)probes. The system canuse TD-5 or TD-8disinfectants, which aredesigned to be used onlywith the TD 100disinfector. The | Rapicide PA High LevelDisinfectant is aperacetic acid based,two part disinfectant.Part A contains theactive ingredients andPart B containsanticorrosive agentsand surfactants. Part Aand Part B are mixed in |
| designed to be used onlywith the TD 200®disinfector. The disinfectantbottles cannot be reused inthe system. | disinfectant bottles cannotbe reused in the system.TD-5 and TD8disinfectants are intendedfor use as single usehigh-level disinfectant tobe used exclusively inthe TD 100 disinfectorfor high-level disinfectionof TEE ultrasoundprobes. TD-5 and TD-8high level disinfectantsand TD 100 disinfectorsystem are intended foruse by qualifiedindividuals trained in itsuse. TD-5 disinfectantshould be used with thefollowing contactconditions in TD 100disinfector: | the machine and dilutedwith water.The MinimumRecommendedConcentration (MRC) ofRapicide PA is 850 ppmof peracetic acid. A teststrip is used to ensurethat the use solution isabove the MRC.Rapicide PA High LevelDisinfectant is intendedfor use with theAdvantage PlusEndoscopeReprocessing System toprovide high leveldisinfection ofendoscopes when usedaccording to thedirections for use.Rapicide PA should beused under the followingcontact conditions: | |
| TD-12® disinfectant isintended for use as singleuse high-level disinfectantto be used exclusively inthe TD 200® disinfector forhigh-level disinfection ofTEE ultrasound probes. | High-level disinfectantTD-5Time - 5 minutesTemperature - 38° to40°CMinimum RecommendedConcentration1.7% glutaraldehyde | Time - 5 minutesTemperature – 30°MinimumRecommendedConcentration (MRC)850ppm | |
| TD-12® high leveldisinfectant and TD 200®disinfector is intended foruse by qualified individualstrained in its use. | TD-8 disinfectant shouldbe used with thefollowing contactconditions in TD 100disinfector:High-level disinfectantTD-8Time - 5 minutesTemperature - 38° to40°CMinimum RecommendedConcentration | ||
| TD-12® disinfectant shouldbe used with the followingcontact conditions in TD200® disinfector: | |||
| High-level disinfectant TD-12®Time - 3 MinutesTemperature - 38°CMinimum RecommendedConcentration (MRC)1.75% Peracetic Acid | |||
| 0.3% ortho-phthalaldehyde | |||
| Instrumentation ForAutomation | TD 200® Automated TEEProbe Disinfector with TD-12® High Level Disinfectantis automated for single usewith only TD-12®disinfectant. The userinitiates the automatedcycle via touchpad andreceives disinfectionverification ticket. Softwarehas been modified ascompared to the predicateTD 100 (K160921) tofacilitate the only choice ofTD-12® disinfectant. Otheraspects of theinstrumentation areidentical to current TD 100with TD-5 and TD-8 devices. | TD 100 with TD-5 or TD-8disinfectors is automatedfor single use with onlyTD-5 or TD-8disinfectants. The userinitiates the automatedcycle via touchpad andreceives disinfectionverification ticket. | Rapicide PA isindicated for manualuse and use withundesignated (legallymarketed) automaticreprocessors thatprovide designatedcontact conditions. |
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Comparison of Proposed Device to Primary Predicate Device
| ProposedDevice | PredicateDevice | PredicateDevice | Comparison | |
|---|---|---|---|---|
| TD 200®Automated TEEProbeDisinfector withTD-12® HighLevelDisinfectant(K192228) | TD 100®Transesophageal ProbeDisinfector andTD-5 and TD-8High- levelDisinfectant(K160921) | RapicidePA(K082988) | ||
| Features | ||||
| The system shall utilize adisinfectant that has at least aone year shelf life from thedate of manufacture. | Yes | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Yes | Same |
| User hazard to disinfectantcontact reduced by bottleloading system | Yes | Yes | N/A | Same |
| The system shall provide adisinfection cycle that has adisinfectant contact time, atleast 180 seconds anddisinfects at 38°C | Yes | No | N/A | TD-12 has ashorterdisinfectiontime vs TD 100 |
| Disinfectant residues shall berinsed until the disinfectantresidue is below atoxicologically significantlevel. | Yes | Yes | N/A | Same |
| Machine number, lot numberof disinfectant, probe number,operator number on outputticket | Yes | Yes | N/A | Same |
| Design | ||||
| Intended Use | Automated high-level disinfectionof TEE probes | Automatedhigh-leveldisinfection ofTEE probes | High-leveldisinfectionofendoscopes | Same |
| Manual Pre-cleaning | Yes | Yes | Yes | Same |
| Operating principles | Peracetic Acidhigh-leveldisinfection | Aldehyde high-leveldisinfection | PeraceticAcid high-leveldisinfection | Same (TD-12and RapicidePA) |
| Process monitors | Digital displayscreen, printout | Digital displayscreen, printout | N/A | Same |
| Software/firmware control | Yes | Yes | N/A | Same |
| Performance claims | High-leveldisinfection | High-leveldisinfection | High-leveldisinfection | Same |
| Provides high-leveldisinfection for heat-sensitiveTEE probes | Yes | Yes | Yes | Same |
| Uses PAA-baseddisinfectants | Yes | No | Yes | Same (TD-12and RapicidePA) |
| Automated disinfection cycle | Yes | Yes | N/A | Same |
| Disinfection process withsuccess/failure print out. | Yes | Yes | N/A | Same |
| User hazard to vaporexposure controlled by vapormanagement system utilizingair circulation and activatedcarbon filtration | Yes | Yes | N/A | Same |
| The system shall be designedto utilize a modularelectronics controller box. | Yes | Yes | N/A | Same |
| The system shall becontrolled by amicrocontroller processor. | Yes | Yes | N/A | Same |
| The system shall provide abuilt-in printer. | Yes | Yes | N/A | Same |
| Specifications | ||||
| Dedicated Disinfectants foruse with the device | Peracetic acid(TD-12) | Glutaraldehyde(TD-5); Ortho-phthalaldehyde(TD-8) | Rapicide PAperaceticacid | Same (TD-12and RapicidePA) |
| Disinfectant MinimumRecommended Concentration | 1.75% PeraceticAcid (TD-12) | 1.7%glutaraldehyde(TD-5)0.3% ortho-phthalaldehyde(TD-8) | 850 ppmperaceticacid | Similar (TD-12and RapicidePA) |
| 110 VAC | Yes | Yes | N/A | Same |
| Potable Water Inlet | Yes | Yes | N/A | Same |
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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).
| PhysicalProperties | ProposedDevice | ReferenceDevice | 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 peroxideand 5%peroxyacetic acidPart B - 4% | Similar (TD-12and RapicidePA) |
| Inert Ingredients | 97.0% | 99.41% | Part A - 73%Part B – 95.7% | TD-12, TD-8,and RapicidePA havedifferent inertingredients |
| Water-BasedLiquid | No | Yes | Yes | Same afterhydration ofTD-12 |
| pH Value | 8.5 – 9.0 | 7.45 – 7.55 | 0.4±.3 Part A11.4 - 12.4 Part BCombined Part Aand B is 4.2 | TD-12, TD-8,and RapicidePA havedifferent pHvalues |
Table C1.b: Comparative Table (Physical Properties) for TD-12®, TD-8®, Rapicide PA
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| Buffer System | SodiumCarbonate andSulfamic Acid | Phosphates | TrisodiumPhosphate | TD-12, TD-8,and RapicidePA havedifferentbuffer system |
|---|---|---|---|---|
| MinimumRecommendedConcentration(MRC) | 1.75% | 0.3% | 850 ppm | TD-12 andRapicide PAhave differentMRC |
| Dilution Required | Yes | No | Yes | Same (TD-12and RapicidePA) |
| ActivationRequired | Yes | No | Yes | Same (TD-12and RapicidePA) |
| High-LevelDisinfection Claim | Yes | Yes | Yes | Same |
| SterilizationClaim | No | No | No | Same |
| Maximum Re-UsePeriod | Single Use | Single Use | 28 Days | Same (TD-12and TD-8).Rapicide PAnot single use. |
| PAA Test StripAvailable | Yes | No | Yes | Same (TD-12and RapicidePA) |
| Use in AutomatedDisinfector | Required | Required | Optional | Same (TD-12and TD-8).OptionalRapicide PA |
| Manual Use | No | No | Optional | Same (TD-12and TD-8).OptionalRapicide PA |
| DisinfectantTemperatureMinimum | 38°C | 38°C | 30°C | Same (TD-12and TD-8).Rapicide PAhas lower MinTemp |
| 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 |
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| TuberculocidalMycobacteriumterrae | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
|---|---|---|---|---|
| BactericidalStaphylococcusaureus | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| BactericidalSalmonellaenterica | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| BactericidalPseudomonasaeruginosa | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| FungicidalTrichophytonmentagrophytes | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| VirucidalPoliovirus Type1 | 3.0 min at 37°C | 5.0 min at 37°C | CompleteInactivation forPolio Virus Type 2 | Same (TD-12and TD-8).Type 2 forRapicide PA |
| VirucidalHerpes SimplexVirus Type 1 | 3.0 min at 37°C | 5.0 min at 25°C | CompleteInactivation | Same |
| VirucidalHumanInfluenza VirusA | 3.0 min at 37°C | 5.0 min at 25°C | Not performed | Same (TD-12and TD-8) |
| VirucidalAdenovirusType 1 | 3.0 min at37°C | 5.0min at 25°C | Not performed | Same (TD-12and TD-8) |
| Simulated UseMycobacteriumterrae | 3.0 min at 37°C | 5.0 min at 37°C | >6 log Reduction | Same |
| Clinical In-UseWild-type frompatients | 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
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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.
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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).
§ 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.