(213 days)
The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system.
TD-50 disinfectant is 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-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use.
TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
High-Level Disinfectant: TD-5®
Time: 5 minutes
Temperature: 38°C - 40°C
Minimum Recommended Concentration: 1.7% glutaraldehyde
TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes.
TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc.
TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
High-Level Disinfectant: TD-8®
Time: 5 minutes
Temperature: 38°C - 40°C
Minimum Recommended Concentration: 0.3% ortho-phthalaldehyde
The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents 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 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
The provided text is a 510(k) Summary for a medical device (TD-100 Disinfector with TD-5 and TD-88 High Level Disinfectants). It describes the device, its indications for use, and makes comparisons to predicate devices. However, the document does not contain the specific information requested in the prompt regarding an AI device, acceptance criteria tables with performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.
Instead, the document focuses on the disinfector's ability to achieve high-level disinfection, material compatibility, and stability in comparison to other disinfectants. The "acceptance criteria" presented are related to the effectiveness of the disinfectants against various microorganisms and operational parameters of the disinfection process (time, temperature, concentration).
Here's a breakdown of what is and is not in the provided text, in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- What is present: The document includes a table (Table C.1c) comparing the TD-8 and TD-5 disinfectants' performance against various organisms (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use) with predicate devices. The "performance" here is typically the contact time and temperature required to achieve the desired effect (e.g., kill the organism). It does not present a typical "acceptance criteria" table with a defined threshold and then the device's reported achievement against that threshold in the way an AI performance summary would.
- Missing: Specific quantitative acceptance criteria (e.g., "sensitivity must be >X%"). The table shows what the disinfectants achieve in terms of kill time/temperature.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing from the text: No sample sizes are provided for any of the microbial efficacy tests (e.g., number of replicates, number of devices tested).
- Missing from the text: No data provenance (country of origin, retrospective/prospective) is mentioned for the microbial efficacy studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable / Missing: This concept (experts establishing ground truth for a test set) is relevant for AI/diagnostic devices that interpret data (e.g., images). For a disinfectant device, the "ground truth" is established through laboratory microbiological testing (e.g., demonstrating reduction in colony-forming units). The document does not describe the laboratory personnel or their qualifications.
4. Adjudication Method for the Test Set:
- Not Applicable / Missing: Adjudication methods (like 2+1, 3+1) are for human review of data, typically in diagnostic studies. This is not mentioned for the disinfectant efficacy testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- Not Applicable: This type of study is for evaluating the impact of AI on human reader performance in diagnostic tasks. It is not relevant for a high-level disinfectant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This pertains to AI algorithm performance. The device is a disinfector, not an algorithm. The "standalone" performance here would be the device's ability to disinfect, which is what the microbial efficacy tests address.
7. The Type of Ground Truth Used:
- What is present: The "ground truth" for this device's performance is microbiological efficacy (kill of specified microorganisms) demonstrated through laboratory testing (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use). The "Clinical In-Use" section mentions "measurably complete kill of microorganisms" from "Wild-type from patients."
- Missing details: The specific methodologies for measuring kill (e.g., log reduction) are not detailed in this summary.
8. The Sample Size for the Training Set:
- Not Applicable / Missing: This concept is for AI/machine learning models. The device is a physical disinfector with chemical agents. There is no "training set" in this context. The development of the disinfectant formulation and system design would involve R&D and testing, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Missing: As above, there is no "training set" for this type of device.
Summary of what can be extracted, interpreted, and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
| Test | Organism | Acceptance Criteria (Inferred from Predicates & General HLD Standards) | Reported Device Performance (TD-8) |
|---|---|---|---|
| Sporicidal | Bacillus subtilis | Achieve kill/inactivation | 32.0 hrs at 37°C |
| Sporicidal | Clostridium sporogenes | Achieve kill/inactivation | 32.0 hrs at 37°C |
| Tuberculocidal | Mycobacterium terrae | Achieve kill/inactivation (typically 5-10 min) | 5.0 min at 37°C |
| Bactericidal | Staphylococcus aureus | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Bactericidal | Salmonella enterica | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Bactericidal | Pseudomonas aeruginosa | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Fungicidal | Trichophyton mentagrophytes | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Virucidal | Poliovirus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 37°C |
| Virucidal | Herpes Simplex Virus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Virucidal | Human Influenza Virus A | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Virucidal | Adenovirus Type 1 | Achieve kill/inactivation (typically 5 min) | 5.0 min at 25°C |
| Simulated Use | Mycobacterium terrae | Achieve kill/inactivation | 5.0 min at 37°C |
| Clinical In-Use | Wild-type from patients | Complete kill of microorganisms | Measurably complete kill |
- Note: The "Acceptance Criteria" column is inferred from the common requirements for high-level disinfectants and the performance of the predicate devices. The document explicitly states the "Minimum Recommended Concentration" (MRC) for TD-5 (1.7% glutaraldehyde) and TD-8 (0.3% ortho-phthalaldehyde) and the contact conditions (Time: 5 min, Temperature: 38°C - 40°C) as part of its claim.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size: Not specified in the provided text.
* Data Provenance: Not specified in the provided text. The studies appear to be laboratory-based efficacy tests ("Simulated Use," "Clinical In-Use").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not applicable as this is a disinfectant device, not an AI/diagnostic device involving expert interpretation. The "ground truth" is derived from direct microbial efficacy testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable for this type of device and study.
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 for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable in the AI sense. The microbial efficacy tests (Table C.1c) demonstrate the standalone performance of the disinfectant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Microbiological efficacy (kill/inactivation of various microorganisms) determined through laboratory testing and "Clinical In-Use" studies showing "measurably complete kill of microorganisms" from probes after routine clinical use.
8. The sample size for the training set
* Not applicable for this type of device.
9. How the ground truth for the training set was established
* Not applicable for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
CS Medical LLC Mr. Kendall Ashe Vice President 2179 East Lyon Station Road Creedmoor, North Carolina 27522
Re: K160921
Trade/Device Name: CS Medical TD-100 Disinfector with TD-50 and TD-88 High Level Disinfectants Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW Dated: October 3, 2016 Received: October 4, 2016
Dear Mr. Ashe:
This letter corrects our substantially equivalent letter of November 3, 2016.
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. 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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Page 2 – Mr. Ashe
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K 16092 I
Device Name
CS Medical TD-100® Disinfector with TD-5® and TD-88 High Level Disinfectant System
Indications for Use (Describe)
The TD 1000 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system.
TD-50 disinfectant is 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-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use.
TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
| High-Level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-5® | 5 minutes | 38°C - 40°C | 1.7% glutaraldehyde |
TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes.
TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc.
TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector:
| High-Level Disinfectant | TD-8® |
|---|---|
| Time | 5 minutes |
| Temperature | 38°C - 40°C |
| Minimum Recommended Concentration | 0.3% ortho-phthalaldehyde |
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)
| Prescription Use (Part 21
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K160921
510(k) Owner
CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 Phone 919-255-9472 Fax 919-528-3400
Contact Person
Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 Email kendallashe@csmedicalllc.com
Submission Prepared
November 3, 2016
| CS Medical Trade Name | Common Name | Classification Name |
|---|---|---|
| TD 100® Disinfector withTD-5® and TD-8® HighLevel Disinfectants | TD 100 automateddisinfector with TD-5 andTD-8 disinfectants | Diagnostic ultrasoundtransducer (21 CFR892.1570, PrimaryProduct Code ITX) |
Legally Marketed Predicate Devices
-
- CS Medical TD 100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) - Primary Predicate
-
- Rapicide OPA-28® (K120306)
-
- Metricide OPA Plus (K070627 as Opaciden Solution)
-
- Cidex OPA (K030004)
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Description of the CS Medical TD 100 Disinfector with TD-5 and TD-80 High Level Disinfectants
The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents 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 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
Indications for Use
The TD 100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) probes. The system can use TD-5% or TD-80 disinfectants. which are designed to be used only with the TD 100% disinfector. The disinfectant bottles cannot be reused in the system.
TD-58 disinfectant is 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% high level disinfectant 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:
| High-leveldisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| TD-5® | 5 minutes | 38°-40°C | 1.7% glutaraldehyde |
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TD-8® disinfectant is 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-8® high level disinfectant and TD 100® disinfector system are 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-leveldisinfectant | Time | Temperature | Minimum RecommendedConcentration |
|---|---|---|---|
| TD-8® | 5 minutes | 38°- 40°C | 0.3% ortho-phthalaldehyde |
| Element | Proposed DeviceTD 100® Disinfectorwith TD-5® and TD-8®High LevelDisinfectants | Predicate DeviceTD 100®TransesophagealProbe Disinfectorand TD-5 High-level Disinfectant(K051305) | Predicate DeviceRapicide OPA-28®(K120306) | Predicate DeiceMetricide OPAPlus (K070627 AsOpaciden) | Predicate DeiceCidex OPA(K030004) |
|---|---|---|---|---|---|
| Classifi-cationName(CFR;Productcode) | Diagnostic ultrasoundtransducer (21 CFR §892.1570, PrimaryProduct Code - ITX) | Diagnosticultrasoundtransducer (21CFR § 892.1570,Primary ProductCode - ITX) | Liquid chemicalgermicide/highlevel disinfectant(21 CFR §880.6885, ProductCode MED) | Liquid chemicalgermicide/highlevel disinfectant(21 CFR §880.6885, ProductCode MED) | Liquid chemicalgermicide/highlevel disinfectant(21 CFR §880.6885, ProductCode MED) |
| IndicationsFor Use | The TD 100®disinfector is designedto provide high-leveldisinfection ofTransesophageal(TEE) probes. Thesystem can use TD-5®or TD-8® disinfectants,which are designed tobe used only with theTD 100® disinfector.The disinfectantbottles cannot bereused in the system.TD-5® disinfectant isintended for use assingle use high-level | The TD 100®disinfector isdesigned toprovide high-leveldisinfection ofTransesophageal(TEE) ultrasoundprobes. Thesystem uses theTD-5®disinfectant, whichis designed to beused only with theTD 100. Thedisinfectant bottlescannot be reusedin the system. TD-5® is intended for | Rapicide OPA-28 isa high leveldisinfectant solutionfor reprocessing ofheat sensitive semicritical medicaldevices for whichsterilization is notsuitable. RapicideOPA-28 may beused at or above itsminimumrecommendedconcentration(MRC) of 0.35%OPA as determinedby Rapicide OPA-28 test strips in | Metricide OPA Plus(K070627 asOpaciden) Solutionis a high leveldisinfectant forreprocessing heat-sensitive medicaldevices for whichsterilization is notsuitable, and whenused according tothe Directions forUse. Metricide OPAPlus (K070627 asOpaciden) may beused or reused ator above itsMinimumRecommendedConcentration(MRC) of 0.3%, as | CIDEX OPASolution is intendedfor use as a highlevel disinfectantfor reprocessingheat sensitivemedical devices.CIDEX OPASolution can beused in manualsystems (trays andbuckets) andautomatedendoscopereprocessors. |
| Element | Proposed DeviceTD 100® Disinfectorwith TD-5® and TD-8®High LevelDisinfectants | Predicate DeviceTD 100®TransesophagealProbe Disinfectorand TD-5 High-level Disinfectant(K051305) | Predicate DeviceRapicide OPA-28®(K120306) | Predicate DeiceMetricide OPAPlus (K070627 AsOpaciden) | Predicate DeiceCidex OPA(K030004) |
| disinfectant to be usedexclusively in the TD100® disinfector forhigh-level disinfectionof TEE ultrasoundprobes.TD-5® high leveldisinfectant and TD100® disinfectorsystem are intendedfor use by qualifiedindividuals trained inits use.TD-5® disinfectantshould be used withthe following contactconditions in TD 100®disinfector:High-level disinfectantTD-5®Time5 minutesTemperature38° – 40°CMinimumRecommendedConcentration1.7% glutaraldehydeTD-8® disinfectant isintended for use assingle use high-leveldisinfectant to be usedexclusively in the TD100® disinfector forhigh-level disinfectionof TEE ultrasoundprobes.TD-8® high leveldisinfectant and TD100® disinfectorsystem are intendedfor use by qualifiedindividuals trained inits use. | use as a singleuse high-leveldisinfectant to beused exclusively inthe TD 100® forthe high-leveldisinfection of TEEultrasound probes.The TD-5® HighLevel Disinfectantand TD 100®disinfector systemis intended for useby qualifiedindividuals trainedin its use. | manual devicereprocessing withan immersion timeof at least 10minutes at aminimumtemperature of20°C for a reuseperiod not toexceed 28 days.Rapicide OPA-28®may also be usedin compatiblelegally marketedautomaticendoscopereprocessors at orabove its MRC asdetermined byRapicide OPA-28®test strips with animmersion time ofat least 5 minutesat a minimumtemperature of25°C for a reuseperiod not toexceed 28 days. | Metricide OPA Plus(K070627 asOpaciden) OPAReagent Strips, inmanualreprocessing withan immersion timeof at least 12minutes at aminimum of 20° C(68° F), for a reuseperiod not toexceed 14 days.Metricide OPA Plus(K070627 asOpaciden) mayalso be used orreused in a legallymarketed automaticendoscopereprocessor (thatcan be set to aminimum of 25° C),at or above itsMinimumRecommendedConcentration(MRC), asdetermined byMetricide OPAPlus (K070627 asOpaciden) OPAReagent Strips,with an immersiontime of at least 5minutes at aminimum of 25° C(77° F), for a reuseperiod not toexceed 14 days. | ||
| Element | Proposed DeviceTD 100® Disinfectorwith TD-5® and TD-8®High LevelDisinfectants | Predicate DeviceTD 100®TransesophagealProbe Disinfectorand TD-5 High-level Disinfectant(K051305) | Predicate DeviceRapicide OPA-28®(K120306) | Predicate DeiceMetricide OPAPlus (K070627 AsOpaciden) | Predicate DeiceCidex OPA(K030004) |
| TD-8® disinfectantshould be used withthe following contactconditions in TD100®disinfector:High-level disinfectantTD-8®Time5 minutesTemperature38° – 40°CMinimumRecommendedConcentration0.3% ortho-phthalaldehyde | |||||
| Instrumentation ForAutomation | TD 100® with TD-5®and TD-8® disinfectoris automated for singleuse with only TD-5® orTD-8® disinfectants.The user initiatesautomated cycle andreceives disinfectionverification ticket viatouchpad. Softwareand user interface hasbeen modified ascompared to thepredicate TD 100®(K051305) to facilitatechoice of TD-5® orTD-8® disinfectantsand minor updates.Other aspects of theinstrumentation areidentical to current TD100® and TD-5®device. | TD 100®disinfector isautomated forsingle use withonly TD-5®disinfectant. Theuser initiatesautomated cycleand receivesdisinfectionverification ticketvia touchpad. | Rapicide OPA-28 isindicated formanual use anduse withundesignated(legally marketed)automaticreprocessors thatprovide designatedcontact conditions. | Metricide OPA Plus(K070627 asOpaciden)isindicated formanual use anduse withundesignated(legally marketed)automaticreprocessors thatprovide designatedcontact conditions. | Cidex OPA isindicated formanual use anduse withundesignated(legally marketed)automaticreprocessors thatprovide designatedcontact conditions. |
| Physical Properties | TD-8® | TD-5® | Rapicide OPA-28 | Metricide OPAPlus (AsOpaciden) | Cidex OPA |
| 510(k) Number | K160921 | K051305 | K120306 | K070627 (AsOpaciden) | K030004 |
| Clearance Date | TBD | 8/18/05 | 9/27/12 | 8/2/2007 | 2/27/2003 |
| Active Ingredients | Ortho-phthalaldehyde0.59% | Glutaraldehyde2.65% | Ortho-phthalaldehyde0.575% | Ortho-phthalaldehyde0.6% | Ortho-phthalaldehyde0.55% |
| Inert Ingredients | 99.41% | 97.35% | 99.425% | 99.4% | 99.45% |
| Water-Based Liquid | Yes | Yes | Yes | Yes | Yes |
| pH Value | 7.45 - 7.55 | 5.9 - 6.8 | 7.5-8.0 | 7.0-7.8 | 7.2-7.8 |
| Buffer System | Phosphates | Phosphates | Not Published | Phosphates | Phosphates |
| Minimum RecommendedConcentration (MRC) | 0.3% | 1.7% | 0.35% | 0.3% | 0.3% (MEC) |
| Dilution Required | No | No | No | No | No |
| Activation Required | No | No | No | No | No |
| High-Level DisinfectionClaim | Yes | Yes | Yes | Yes | Yes |
| Sterilization Claim | No | No | No | No | No |
| Maximum Re-Use Period | Single Use | Single Use | 28 Days | 14 Days | 14 Days |
| OPA Test Strip Available | No | No | Yes | Yes | Yes |
| Use in AutomatedDisinfector | Required | Required | Optional | Optional | Optional |
| Manual Use | No | No | Optional | Optional | Optional |
| Reusable Devices | TEE ProbesONLY | TEE ProbesONLY | Endoscopes | Endoscopes | Endoscopes |
| Disinfectant TemperatureMinimum | 38°C | 38°C | 25°C | 25°C | 25°C |
| Disinfectant TemperatureMaximum | 40°C | 40°C | No Limit | No Limit | No Limit |
| Disinfection Time | 5 Minutes | 5 Minutes | 5 Minutes | 5 Minutes | 5 Minutes |
Table C.1a: Comparative Table for TD 100®
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Table C.1b: Comparative Table for TD-8
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| Table C.1c: Comparative Table for TD-8, TD-5 | ||||||
|---|---|---|---|---|---|---|
| Test | Organism | TD-8(Appendix 5) | TD-5 | RapicideOPA-28(AppendixA1.7) | MetricideOPA Plus(K070627 asOpaciden)(Appendix9) | Cidex OPA(Appendix9) |
| Sporicidal | Bacillus subtilis | 32.0 hrs at37°C | 10 min at21°C | 32 hrs at25°C | 32 hrs at25°C | 32 hrs at25°C |
| Sporicidal | Clostridiumsporogenes | 32.0 hrs at37°C | 10 min at21°C | 32 hrs at25°C | Notperformed | Notperformed |
| Tuberculocidal | Mycobacteriumterrae | 5.0 min at 37°C | < 1 min at37° | Notperformed | 5 min at25°C | 5 min at25°C |
| Bactericidal | Staphylococcusaureus | 5.0 min at 37°C | 10 min at25°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Bactericidal | Salmonellaenterica | 5.0 min at 37°C | 10 min at25°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Bactericidal | Pseudomonasaeruginosa | 5.0 min at 37°C | 10 min at25°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Fungicidal | Trichophytonmentagrophytes | 5.0 min at 37°C | 10 min at25°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Virucidal | Poliovirus Type1 | 5.0 min at 37°C | 5 min at 25°C(type 2) | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Virucidal | Herpes SimplexVirus Type 1 | 5.0 min at 25°C | 5 min at 25°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Virucidal | HumanInfluenza VirusA | 5.0 min at 25°C | Notperformed | Notperformed | 5 min at25°C | 5 min at25°C |
| Virucidal | AdenovirusType 1 | 5.0 min at 25°C | Notperformed | Notperformed | 5 min at25°C* | 5 min at25°C * |
| Simulated Use | Mycobacteriumterrae | 5.0 min at 37°C | 5 min at 37°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
| Clinical In-Use | Wild-type frompatients | 5.0 min at 37°C | 5 min at 37°C | 5 min at 25°C | 5 min at25°C | 5 min at25°C |
Table C. 1c. Comparative Table for TD-8. TD-5
- Adenovirus Type 2 tested
Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 100% disinfector with TD-80 disinfectant with standard operating parameters. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.
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Biocompatibility
Under the conditions of the study. TD-80 is not a sensitizer, nor an irritant and is non-cytotoxic.
Material Compatibility
The materials used to construct the TD 100 disinfector were exposed to TD-8 disinfectant for a pre-determined period of time. There were no observable effects from exposure to TD-80 disinfectants on materials.
Compatibility Testing with TEE Probes
The TD 100 Disinfector, TD-50 and TD-80 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 model 6VT-D TEE probes. Residues from these probes exhibited a slight cytotoxic effect per ISO 10993-5 and did not have visible probe deterioration.
Stability
TD-8® High Level Disinfectant has been tested and shown to be stable for a shelf life of 12 months. The concentration of the disinfectant at the end of 12 months of testing is well above the 0.3% minimum recommended concentration.
Conclusions
It is the conclusion of the CS Medical Scientific and Management team that the preponderance of evidence supports the designation of the TD 100% Disinfector with TD-50 and TD-80 High Level Disinfectants under consideration here (K160921) as substantially equivalent to the predicate TD 100° Disinfector with TD-5®, Rapicide OPA-28, Metrex Plus OPA (K070627 as Opaciden) and Cidex OPA.
§ 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.