CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
Device Facts
| Record ID | K160921 |
|---|---|
| Device Name | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant |
| Applicant | Cs Medical, LLC |
| Product Code | PSW · Radiology |
| Decision Date | Nov 3, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K160921 · Nov 3, 2016 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | Cs Medical, LLC | Routine clinical use of TEE probes | Clinical in-use testing was performed on soiled TEE probes collected after routine clinical use to demonstrate the disinfection efficacy of the TD-100 system with TD-8 disinfectant. | Clinical In-Use Testing; Disinfection Efficacy; TEE Probes |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical In-Use Testing; Retrospective/Observational (In-use testing of routine clinical samples) | Soiled TEE probes from routine clinical use | Not applicable for this study | Complete kill of microorganisms after TEE probe processing |
Indications for Use
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
Device Story
The TD-100 Disinfector is an automated system for high-level disinfection of TEE ultrasound probes. The device operates as a closed system using single-use bottles of TD-5 (glutaraldehyde) or TD-8 (ortho-phthalaldehyde) disinfectant. The process involves loading a fresh disinfectant bottle, heating the solution to 38°-40°C, soaking the probe for 5 minutes, and performing a thorough rinse. The device prints a verification report confirming cycle success, time, and temperature. It is operated by trained qualified individuals in clinical environments. By automating the disinfection cycle and using single-use chemistry, the device eliminates the need for potency monitoring or daily solution testing, ensuring consistent disinfection and reducing potential exposure to chemical vapors for the operator. The system benefits patients by providing validated, repeatable high-level disinfection of semi-critical TEE probes.
Clinical Evidence
Bench testing and clinical in-use testing were performed. Bench testing confirmed sporicidal, tuberculocidal, bactericidal, fungicidal, and virucidal efficacy against organisms including Bacillus subtilis, Mycobacterium terrae, Staphylococcus aureus, and Poliovirus. Clinical in-use testing on soiled TEE probes processed in the TD-100 with TD-8 disinfectant demonstrated a complete kill of microorganisms. Biocompatibility testing per ISO 10993-5 confirmed the disinfectant is non-cytotoxic, non-irritant, and non-sensitizing.
Technological Characteristics
Automated disinfector for TEE probes; uses single-use TD-5 (1.7% glutaraldehyde) or TD-8 (0.3% ortho-phthalaldehyde) chemistry. Operates at 38°-40°C for 5 minutes. Includes integrated heating, rinsing, and printing verification. Software-controlled cycle. Materials tested for compatibility with TD-8. No activation or dilution required.
Indications for Use
Indicated for high-level disinfection of transesophageal (TEE) ultrasound probes in qualified clinical settings. Contraindicated for use with probes not approved by manufacturers for this system.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- CS Medical TD 100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305)
- Rapicide OPA-28® (K120306)
- Metricide OPA Plus (K070627 as Opaciden Solution)
- Cidex OPA (K030004)
Submission Summary (Full Text)
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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 with<br>TD-5® and TD-8® High<br>Level Disinfectants | TD 100 automated<br>disinfector with TD-5 and<br>TD-8 disinfectants | Diagnostic ultrasound<br>transducer (21 CFR<br>892.1570, Primary<br>Product Code ITX) |
### Legally Marketed Predicate Devices
- 1. CS Medical TD 100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) - Primary Predicate
- 2. Rapicide OPA-28® (K120306)
- 3. Metricide OPA Plus (K070627 as Opaciden Solution)
- 4. 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-level<br>disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| 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-level<br>disinfectant | Time | Temperature | Minimum Recommended<br>Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-8® | 5 minutes | 38°- 40°C | 0.3% ortho-phthalaldehyde |
| Element | Proposed Device<br>TD 100® Disinfector<br>with TD-5® and TD-8®<br>High Level<br>Disinfectants | Predicate Device<br>TD 100®<br>Transesophageal<br>Probe Disinfector<br>and TD-5 High-<br>level Disinfectant<br>(K051305) | Predicate Device<br>Rapicide OPA-28®<br>(K120306) | Predicate Deice<br>Metricide OPA<br>Plus (K070627 As<br>Opaciden) | Predicate Deice<br>Cidex OPA<br>(K030004) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classifi-<br>cation<br>Name<br>(CFR;<br>Product<br>code) | Diagnostic ultrasound<br>transducer (21 CFR §<br>892.1570, Primary<br>Product Code - ITX) | Diagnostic<br>ultrasound<br>transducer (21<br>CFR § 892.1570,<br>Primary Product<br>Code - ITX) | Liquid chemical<br>germicide/high<br>level disinfectant<br>(21 CFR §<br>880.6885, Product<br>Code MED) | Liquid chemical<br>germicide/high<br>level disinfectant<br>(21 CFR §<br>880.6885, Product<br>Code MED) | Liquid chemical<br>germicide/high<br>level disinfectant<br>(21 CFR §<br>880.6885, Product<br>Code MED) |
| Indications<br>For Use | The TD 100®<br>disinfector is designed<br>to provide high-level<br>disinfection of<br>Transesophageal<br>(TEE) probes. The<br>system can use TD-5®<br>or TD-8® disinfectants,<br>which are designed to<br>be used only with the<br>TD 100® disinfector.<br>The disinfectant<br>bottles cannot be<br>reused in the system.<br>TD-5® disinfectant is<br>intended for use as<br>single use high-level | The TD 100®<br>disinfector is<br>designed to<br>provide high-level<br>disinfection of<br>Transesophageal<br>(TEE) ultrasound<br>probes. The<br>system uses the<br>TD-5®<br>disinfectant, which<br>is designed to be<br>used only with the<br>TD 100. The<br>disinfectant bottles<br>cannot be reused<br>in the system. TD-<br>5® is intended for | Rapicide OPA-28 is<br>a high level<br>disinfectant solution<br>for reprocessing of<br>heat sensitive semi<br>critical medical<br>devices for which<br>sterilization is not<br>suitable. Rapicide<br>OPA-28 may be<br>used at or above its<br>minimum<br>recommended<br>concentration<br>(MRC) of 0.35%<br>OPA as determined<br>by Rapicide OPA-<br>28 test strips in | Metricide OPA Plus<br>(K070627 as<br>Opaciden) Solution<br>is a high level<br>disinfectant for<br>reprocessing heat-<br>sensitive medical<br>devices for which<br>sterilization is not<br>suitable, and when<br>used according to<br>the Directions for<br>Use. Metricide OPA<br>Plus (K070627 as<br>Opaciden) may be<br>used or reused at<br>or above its<br>Minimum<br>Recommended<br>Concentration<br>(MRC) of 0.3%, as | CIDEX OPA<br>Solution is intended<br>for use as a high<br>level disinfectant<br>for reprocessing<br>heat sensitive<br>medical devices.<br>CIDEX OPA<br>Solution can be<br>used in manual<br>systems (trays and<br>buckets) and<br>automated<br>endoscope<br>reprocessors. |
| Element | Proposed Device<br>TD 100® Disinfector<br>with TD-5® and TD-8®<br>High Level<br>Disinfectants | Predicate Device<br>TD 100®<br>Transesophageal<br>Probe Disinfector<br>and TD-5 High-<br>level Disinfectant<br>(K051305) | Predicate Device<br>Rapicide OPA-28®<br>(K120306) | Predicate Deice<br>Metricide OPA<br>Plus (K070627 As<br>Opaciden) | Predicate Deice<br>Cidex OPA<br>(K030004) |
| | disinfectant to be used<br>exclusively in the TD<br>100® disinfector for<br>high-level disinfection<br>of TEE ultrasound<br>probes.<br>TD-5® high level<br>disinfectant and TD<br>100® disinfector<br>system are intended<br>for use by qualified<br>individuals trained in<br>its use.<br>TD-5® disinfectant<br>should be used with<br>the following contact<br>conditions in TD 100®<br>disinfector:<br>High-level disinfectant<br>TD-5®<br>Time<br>5 minutes<br>Temperature<br>38° – 40°C<br>Minimum<br>Recommended<br>Concentration<br>1.7% glutaraldehyde<br>TD-8® disinfectant is<br>intended for use as<br>single use high-level<br>disinfectant to be used<br>exclusively in the TD<br>100® disinfector for<br>high-level disinfection<br>of TEE ultrasound<br>probes.<br>TD-8® high level<br>disinfectant and TD<br>100® disinfector<br>system are intended<br>for use by qualified<br>individuals trained in<br>its use. | use as a single<br>use high-level<br>disinfectant to be<br>used exclusively in<br>the TD 100® for<br>the high-level<br>disinfection of TEE<br>ultrasound probes.<br>The TD-5® High<br>Level Disinfectant<br>and TD 100®<br>disinfector system<br>is intended for use<br>by qualified<br>individuals trained<br>in its use. | manual device<br>reprocessing with<br>an immersion time<br>of at least 10<br>minutes at a<br>minimum<br>temperature of<br>20°C for a reuse<br>period not to<br>exceed 28 days.<br>Rapicide OPA-28®<br>may also be used<br>in compatible<br>legally marketed<br>automatic<br>endoscope<br>reprocessors at or<br>above its MRC as<br>determined by<br>Rapicide OPA-28®<br>test strips with an<br>immersion time of<br>at least 5 minutes<br>at a minimum<br>temperature of<br>25°C for a reuse<br>period not to<br>exceed 28 days. | Metricide OPA Plus<br>(K070627 as<br>Opaciden) OPA<br>Reagent Strips, in<br>manual<br>reprocessing with<br>an immersion time<br>of at least 12<br>minutes at a<br>minimum of 20° C<br>(68° F), for a reuse<br>period not to<br>exceed 14 days.<br>Metricide OPA Plus<br>(K070627 as<br>Opaciden) may<br>also be used or<br>reused in a legally<br>marketed automatic<br>endoscope<br>reprocessor (that<br>can be set to a<br>minimum of 25° C),<br>at or above its<br>Minimum<br>Recommended<br>Concentration<br>(MRC), as<br>determined by<br>Metricide OPA<br>Plus (K070627 as<br>Opaciden) OPA<br>Reagent Strips,<br>with an immersion<br>time of at least 5<br>minutes at a<br>minimum of 25° C<br>(77° F), for a reuse<br>period not to<br>exceed 14 days. | |
| Element | Proposed Device<br>TD 100® Disinfector<br>with TD-5® and TD-8®<br>High Level<br>Disinfectants | Predicate Device<br>TD 100®<br>Transesophageal<br>Probe Disinfector<br>and TD-5 High-<br>level Disinfectant<br>(K051305) | Predicate Device<br>Rapicide OPA-28®<br>(K120306) | Predicate Deice<br>Metricide OPA<br>Plus (K070627 As<br>Opaciden) | Predicate Deice<br>Cidex OPA<br>(K030004) |
| | TD-8® disinfectant<br>should be used with<br>the following contact<br>conditions in TD<br>100®<br>disinfector:<br>High-level disinfectant<br>TD-8®<br>Time<br>5 minutes<br>Temperature<br>38° – 40°C<br>Minimum<br>Recommended<br>Concentration<br>0.3% ortho-<br>phthalaldehyde | | | | |
| Instrument<br>ation For<br>Automation | TD 100® with TD-5®<br>and TD-8® disinfector<br>is automated for single<br>use with only TD-5® or<br>TD-8® disinfectants.<br>The user initiates<br>automated cycle and<br>receives disinfection<br>verification ticket via<br>touchpad. Software<br>and user interface has<br>been modified as<br>compared to the<br>predicate TD 100®<br>(K051305) to facilitate<br>choice of TD-5® or<br>TD-8® disinfectants<br>and minor updates.<br>Other aspects of the<br>instrumentation are<br>identical to current TD<br>100® and TD-5®<br>device. | TD 100®<br>disinfector is<br>automated for<br>single use with<br>only TD-5®<br>disinfectant. The<br>user initiates<br>automated cycle<br>and receives<br>disinfection<br>verification ticket<br>via touchpad. | Rapicide OPA-28 is<br>indicated for<br>manual use and<br>use with<br>undesignated<br>(legally marketed)<br>automatic<br>reprocessors that<br>provide designated<br>contact conditions. | Metricide OPA Plus<br>(K070627 as<br>Opaciden)is<br>indicated for<br>manual use and<br>use with<br>undesignated<br>(legally marketed)<br>automatic<br>reprocessors that<br>provide designated<br>contact conditions. | Cidex OPA is<br>indicated for<br>manual use and<br>use with<br>undesignated<br>(legally marketed)<br>automatic<br>reprocessors that<br>provide designated<br>contact conditions. |
| Physical Properties | TD-8® | TD-5® | Rapicide OPA-<br>28 | Metricide OPA<br>Plus (As<br>Opaciden) | Cidex OPA |
| 510(k) Number | K160921 | K051305 | K120306 | K070627 (As<br>Opaciden) | K030004 |
| Clearance Date | TBD | 8/18/05 | 9/27/12 | 8/2/2007 | 2/27/2003 |
| Active Ingredients | Ortho-<br>phthalaldehyde<br>0.59% | Glutaraldehyde<br>2.65% | Ortho-<br>phthalaldehyde<br>0.575% | Ortho-<br>phthalaldehyde<br>0.6% | Ortho-<br>phthalaldehyde<br>0.55% |
| 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 Recommended<br>Concentration (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 Disinfection<br>Claim | 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…
