(57 days)
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 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.
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.
This document describes the premarket notification (510(k)) for the TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant and QwikCheck™ Chemical Indicators. This device is intended for the high-level disinfection of Transesophageal (TEE) ultrasound probes. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (TD 200/TD-12 disinfector/disinfectant system, K192228), with the main change being a new supplier for the QwikCheck Chemical Indicator.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "high-level disinfection" and the equivalence to the predicate device. The performance is assessed through various non-clinical tests.
| Acceptance Criteria (Implicit from Indication and Predicate) | Reported Device Performance (TD 200 with TD-12) |
| High-Level Disinfection of TEE Probes | Automated Simulated Use Studies: Measurably complete kill of microorganisms after TEE probe processing. |
| QwikCheck Chemical Indicator accuracy for MRC | The QwikCheck Chemical Indicator, with its starch and iodide agents, produces a color change within 30 seconds. A color similar to the FAIL block indicates ≤ 1750 ppm, while a color similar to the PASS block indicates > 1750 ppm peracetic acid. This indicates it properly discriminates between concentrations above and below the MRC. |
| Safety and Compatibility (Electrical, Biocompatibility, Material, TEE Probe) | Electrical Safety: Passed testing according to UL 61010-1, 3rd Edition. Biocompatibility: TD-12 is not a sensitizer, irritant, and non-cytotoxic. Residue levels on TEE probes are deemed not likely to have toxic effects. Material Compatibility: No observable effects from exposure of TD 200 materials to TD-12 disinfectant. TEE Probe Compatibility: No cosmetic or functional deterioration observed in GE, Philips, and Siemens TEE probes after processing. TD-12 probe compatibility testing was performed using a use-suspension of 3% w/v (3000ppm) PAA TD-12 at 38°C. |
| 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 documented evidence indicates that the TD 200 consistently performs as intended. All data collected met established acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
-
TD 200/TD-12 Disinfection Performance:
- Automated Simulated Use Studies: The exact sample size (number of runs or probes) is not specified, but the results state "In all cases there was a measurably complete kill of microorganisms." This implies a sufficient number of tests were conducted to support the claim.
- Clinical In-Use Testing: The exact sample size (number of soiled TEE probes) is not specified. The results state "In all cases, there was a complete kill of microorganisms after TEE probe processing." This implies a sufficient number of tests were conducted.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It appears to be prospective testing conducted by the manufacturer.
-
QwikCheck Chemical Indicator:
- Test Set Description: The summary describes its mechanism (starch and iodide agents, color change within 30 seconds) and how it visually indicates ppm levels (similar to FAIL block for ≤1750 ppm, similar to PASS block for >1750 ppm). No specific sample size for a test set proving its accuracy for this submission is provided, as the primary difference for this component is the change in supplier, implying the performance characteristics are already established and documented as part of that product's existing regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not suggest the use of human experts to establish ground truth for the disinfection or chemical indicator performance. The "ground truth" for disinfection is based on objective microbiological enumeration (complete kill of microorganisms), and for the chemical indicator, it's based on objective chemical concentration levels and colorimetric responses.
4. Adjudication Method for the Test Set
Not applicable, as there is no indication of human reader adjudication for these studies. The assessment of disinfection effectiveness and chemical indicator performance relies on objective laboratory methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is an automated disinfectant system and a chemical indicator, not an AI diagnostic tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of the automated disinfection system and the chemical indicator as standalone devices.
- TD 200/TD-12 Disinfector: Yes, the performance tests (automated simulated use studies, clinical in-use testing) assess the standalone performance of the TD 200 disinfector with TD-12 disinfectant in achieving high-level disinfection.
- QwikCheck Chemical Indicator: Yes, the description of its function and visual interpretation demonstrates its standalone capability to indicate disinfectant concentration.
7. The Type of Ground Truth Used
- For Disinfection Performance (TD 200/TD-12): The ground truth used is objective microbiological enumeration (i.e., "complete kill of microorganisms").
- For QwikCheck Chemical Indicator: The ground truth is objective chemical concentration levels (1750 ppm peracetic acid) and its associated colorimetric response.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The studies described are for verification and validation of the device's physical and chemical performance.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
-
TD 200/TD-12 disinfector/disinfectant system (K192228) - Primary Predicate
-
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-12 High-Level disinfectantwith QwikCheck ChemicalIndicator | TD 200 Disinfector with TD-12 High-Level Disinfectant | |
| ClassificationName (CFR;Product code) | Diagnostic ultrasonictransducer (21 C.F.R. §892.1570, product codePSW) | Diagnostic ultrasonictransducer (21 C.F.R. §892.1570, product codePSW) | Same |
| Indications forUse | The TD 200 disinfector isdesigned to provide high-level disinfection ofTransesophageal (TEE)ultrasound probes. Thesystem can use TD-12disinfectant, which isdesigned to be used onlywith the TD 200 disinfector.The disinfectant bottlescannot be reused in thesystem.TD-12 disinfectant isintended for use as singleuse high-level disinfectantto be used exclusively in the | The TD 200 disinfector isdesigned to provide high-level disinfection ofTransesophageal (TEE)ultrasound probes. Thesystem can use TD-12disinfectant, which isdesigned to be used onlywith the TD 200 disinfector.The disinfectant bottlescannot be reused in thesystem.TD-12 disinfectant isintended for use as singleuse high-level disinfectantto be used exclusively in the | Same |
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| TD 200 disinfector for high-level disinfection of TEEultrasound probes.TD-12 high leveldisinfectant and TD 200disinfector is intended foruse by qualified individualstrained in its use.TD-12 disinfectant shouldbe used with the followingcontact conditions in TD200 disinfector: | TD 200 disinfector for high-level disinfection of TEEultrasound probes.TD-12 high leveldisinfectant and TD 200disinfector is intended foruse by qualified individualstrained in its use.TD-12 disinfectant shouldbe used with the followingcontact conditions in TD200 disinfector: |
|---|---|
| High-level Disinfectant TD-12Time - 3 MinutesTemperature - 38°CMinimum RecommendedConcentration (MRC) 1750ppm Peracetic Acid | High-level Disinfectant TD-12Time - 3 MinutesTemperature - 38°CMinimum RecommendedConcentration (MRC) 1.75%Peracetic Acid |
| QwikCheck ChemicalIndicators are used prior tothe disinfection cycle toensure that the disinfectantused is above the minimumrecommendedconcentration (MRC) of1750ppm peracetic acid. |
Comparison of Proposed TD 200 Device to Primary Predicate TD 200 Device
| Features | Proposed DeviceTD 200® AutomatedTEE ProbeDisinfector with TD-12® High LevelDisinfectant withQwikCheck ChemicalIndicator | Predicate DeviceTD 200® AutomatedTEE ProbeDisinfector with TD-12® High LevelDisinfectant(K192228) | Comparison |
|---|---|---|---|
| The system shall utilize adisinfectant that has at least aone-year shelf life from thedate of manufacture. | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Same |
| User hazard to disinfectantcontact reduced by bottleloading system | Yes | Yes | Same |
| The system shall provide adisinfection cycle that has adisinfectant contact time, atleast 180 seconds anddisinfects at 38°C | Yes | Yes | Same |
| Disinfectant residues shall berinsed until the disinfectantresidue is below atoxicologically significantlevel. | Yes | Yes | Same |
| Reduced height of machinefor easy load of TEE probe | Yes | Yes | Same |
| Machine serial number, lotnumber of disinfectant, probenumber, and operator numberon output ticket | Yes | Yes | Same |
| Minimal footprint, secured towall for stability | Yes | Yes | Same |
| Design | |||
| Intended Use | Automated high-leveldisinfection of TEEprobes | Automated high-leveldisinfection of TEEprobes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Peracetic Acid high-level disinfection | Peracetic Acid high-level disinfection | Same |
| Process monitors | Digital displayscreen, printout | Digital displayscreen, printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | High-leveldisinfection | High-leveldisinfection | Same |
| Provides high-leveldisinfection for heat-sensitiveTEE probes | Yes | Yes | Same |
| Uses PAA-baseddisinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| Disinfection process withsuccess/failure print out. | Yes | Yes | Same |
| User hazard to vaporexposure controlled by vapormanagement system utilizingair circulation and activatedcarbon filtration | Yes | Yes | Same |
| The system shall becontrolled by amicrocontroller processor. | Yes | Yes | Same |
| The system shall provide abuilt-in printer. | Yes | Yes | Same |
| Specifications | |||
| Dedicated Disinfectants foruse with the device | Peracetic acid(TD-12) | Peracetic acid(TD-12) | Same |
| Disinfectant MinimumRecommended Concentration | 1750 ppm PeraceticAcid | 1.75% Peracetic Acid | Same |
| 110 VAC | Yes | Yes | Same |
| Potable Water Inlet | Yes | Yes | Same |
| User hazard to vaporexposure controlled byvapor managementsystem utilizing aircirculation and filtrationwith no room aircirculation 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
| PhysicalProperties | Proposed DeviceTD-12 | Predicate DeviceTD-12 (K192228) | Comparison |
|---|---|---|---|
| ActiveIngredients | 0.30%peracetic acid | 0.30%peracetic acid | Same |
| InertIngredients | 99.7% | 99.7% | Same |
| Water-BasedLiquid | No | No | Same |
| pH Value | 8.5 – 9.0 | 8.5 – 9.0 | Same |
| Buffer System | Sodium Carbonate andSulfamic Acid | Sodium Carbonate andSulfamic Acid | Same |
| MinimumRecommendedConcentration(MRC) | 1750 ppm | 1.75% | Same |
| DilutionRequired | Yes | Yes | Same |
| ActivationRequired | Yes | Yes | Same |
| High-LevelDisinfectionClaim | Yes | Yes | Same |
| SterilizationClaim | No | No | Same |
| Maximum Re-Use Period | Single Use | Single Use | Same |
| PAA Test | Yes | Yes | Same |
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| Strip Available | |||
|---|---|---|---|
| Use inAutomatedDisinfector | Required | Required | Same |
| Manual Use | No | No | Same |
| DisinfectantTemperatureMinimum | 38°C | 38°C | Same |
| DisinfectionTime | 3 Minutes | 3 Minutes | Same |
Comparative Table between QwikCheck Chemical Indicators
| Element | QwikCheck ChemicalIndicator (proposeddevice) | QwikCheck ChemicalIndicator (device usedin conjunction withK192228) | Comparison |
|---|---|---|---|
| Classification Name(CFR; Product code) | Sterilization ProcessIndicator (21 C.F.R. §880.2800, product codeJOJ) | Sterilization ProcessIndicator (21 C.F.R. §880.2800, product codeJOJ) | Same |
| Indications for Usefor ChemicalIndicator | QwikCheck ChemicalIndicators are used priorto the disinfection cycleto ensure that thedisinfectant used isabove the minimumrecommendedconcentration (MRC) of1750ppm peracetic acid. | The QwikCheck™Chemical Indicator is aqualitative chemicalindicator dedicated foruse in determiningwhether theconcentration ofperacetic acid, the activeingredient in CSMedical's TD-12 Solution,is above or below theestablished MinimumRecommendedConcentration (MRC)according to the solutionmanufacturer. | Similar |
| Analyte | Peracetic acid in TD-12Solution | Peracetic acid in TD-12Solution | Same |
| Indicator Strip | 0.2" x 0.2" test paperattached to a plastichandle | 0.2" x 0.2" test paperattached to a plastichandle | Same |
| Indicator Agents | Starch and iodide | Starch and iodide | Same |
| Minimum Time ofColor Change | 30 seconds | 30 seconds | Same |
| Results | A test pad which issimilar in color to theFAIL color blockindicates the solution is ≤1750 ppm. If the color ofthe test pad is similar tothe PASS block, thesolution is > 1750 ppm | A test pad which issimilar in color to theFAIL color blockindicates the solution is ≤1750 ppm. If the color ofthe test pad is similar tothe PASS block, thesolution 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).
§ 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.