(213 days)
Not Found
No
The device description focuses on a chemical disinfection process with controlled parameters (time, temperature) and does not mention any computational analysis, pattern recognition, or learning algorithms.
No.
This device is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes, not for therapeutic use on patients.
No
The device is a disinfector, designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes, not to diagnose medical conditions.
No
The device description clearly outlines a physical hardware system (TD 100® disinfector) that performs a disinfection process using specific liquid disinfectants. While it likely contains software to control the process, it is not solely software.
Based on the provided text, the TD 100® disinfector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing high-level disinfection of Transesophageal (TEE) ultrasound probes. This is a process for sterilizing or disinfecting medical devices, not for performing tests on biological samples to diagnose or monitor a patient's condition.
- Device Description: The description details a system for cleaning and disinfecting probes using specific chemical disinfectants and a controlled process (heating, soaking, rinsing). This aligns with a device used for reprocessing medical equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or treatment decisions based on testing biological materials.
Therefore, the TD 100® disinfector falls under the category of a medical device used for reprocessing other medical devices, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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: 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
Product codes
PSW, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified individuals trained in its use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051305, K120306, K070627, K030004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 | ||
| TD-5® and TD-8® High | ||
| Level Disinfectants | TD 100 automated | |
| disinfector with TD-5 and | ||
| TD-8 disinfectants | Diagnostic ultrasound | |
| transducer (21 CFR | ||
| 892.1570, Primary | ||
| Product 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)
4
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
disinfectant | Time | Temperature | Minimum Recommended
Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-5® | 5 minutes | 38°-40°C | 1.7% glutaraldehyde |
5
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
disinfectant | Time | Temperature | Minimum Recommended
Concentration |
|----------------------------|-----------|-------------|--------------------------------------|
| TD-8® | 5 minutes | 38°- 40°C | 0.3% ortho-phthalaldehyde |
| Element | Proposed Device
TD 100® Disinfector
with TD-5® and TD-8®
High Level
Disinfectants | Predicate Device
TD 100®
Transesophageal
Probe Disinfector
and TD-5 High-
level Disinfectant
(K051305) | Predicate Device
Rapicide OPA-28®
(K120306) | Predicate Deice
Metricide OPA
Plus (K070627 As
Opaciden) | Predicate Deice
Cidex OPA
(K030004) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classifi-
cation
Name
(CFR;
Product
code) | Diagnostic ultrasound
transducer (21 CFR §
892.1570, Primary
Product Code - ITX) | Diagnostic
ultrasound
transducer (21
CFR § 892.1570,
Primary Product
Code - ITX) | Liquid chemical
germicide/high
level disinfectant
(21 CFR §
880.6885, Product
Code MED) | Liquid chemical
germicide/high
level disinfectant
(21 CFR §
880.6885, Product
Code MED) | Liquid chemical
germicide/high
level disinfectant
(21 CFR §
880.6885, Product
Code MED) |
| 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-8® disinfectants,
which are designed to
be used only with the
TD 100® disinfector.
The disinfectant
bottles cannot be
reused in the system.
TD-5® disinfectant is
intended for use as
single use high-level | The TD 100®
disinfector is
designed to
provide high-level
disinfection of
Transesophageal
(TEE) ultrasound
probes. The
system uses the
TD-5®
disinfectant, which
is designed to be
used only with the
TD 100. The
disinfectant bottles
cannot be reused
in the system. TD-
5® is intended for | Rapicide OPA-28 is
a high level
disinfectant solution
for reprocessing of
heat sensitive semi
critical medical
devices for which
sterilization is not
suitable. Rapicide
OPA-28 may be
used at or above its
minimum
recommended
concentration
(MRC) of 0.35%
OPA as determined
by Rapicide OPA-
28 test strips in | Metricide OPA Plus
(K070627 as
Opaciden) Solution
is a high level
disinfectant for
reprocessing heat-
sensitive medical
devices for which
sterilization is not
suitable, and when
used according to
the Directions for
Use. Metricide OPA
Plus (K070627 as
Opaciden) may be
used or reused at
or above its
Minimum
Recommended
Concentration
(MRC) of 0.3%, as | CIDEX OPA
Solution is intended
for use as a high
level disinfectant
for reprocessing
heat sensitive
medical devices.
CIDEX OPA
Solution can be
used in manual
systems (trays and
buckets) and
automated
endoscope
reprocessors. |
| Element | Proposed Device
TD 100® Disinfector
with TD-5® and TD-8®
High Level
Disinfectants | Predicate Device
TD 100®
Transesophageal
Probe Disinfector
and TD-5 High-
level Disinfectant
(K051305) | Predicate Device
Rapicide OPA-28®
(K120306) | Predicate Deice
Metricide OPA
Plus (K070627 As
Opaciden) | Predicate Deice
Cidex OPA
(K030004) |
| | 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 disinfectant
TD-5®
Time
5 minutes
Temperature
38° – 40°C
Minimum
Recommended
Concentration
1.7% glutaraldehyde
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. | use as a single
use high-level
disinfectant to be
used exclusively in
the TD 100® for
the high-level
disinfection of TEE
ultrasound probes.
The TD-5® High
Level Disinfectant
and TD 100®
disinfector system
is intended for use
by qualified
individuals trained
in its use. | manual device
reprocessing with
an immersion time
of at least 10
minutes at a
minimum
temperature of
20°C for a reuse
period not to
exceed 28 days.
Rapicide OPA-28®
may also be used
in compatible
legally marketed
automatic
endoscope
reprocessors at or
above its MRC as
determined by
Rapicide OPA-28®
test strips with an
immersion time of
at least 5 minutes
at a minimum
temperature of
25°C for a reuse
period not to
exceed 28 days. | Metricide OPA Plus
(K070627 as
Opaciden) OPA
Reagent Strips, in
manual
reprocessing with
an immersion time
of at least 12
minutes at a
minimum of 20° C
(68° F), for a reuse
period not to
exceed 14 days.
Metricide OPA Plus
(K070627 as
Opaciden) may
also be used or
reused in a legally
marketed automatic
endoscope
reprocessor (that
can be set to a
minimum of 25° C),
at or above its
Minimum
Recommended
Concentration
(MRC), as
determined by
Metricide OPA
Plus (K070627 as
Opaciden) OPA
Reagent Strips,
with an immersion
time of at least 5
minutes at a
minimum of 25° C
(77° F), for a reuse
period not to
exceed 14 days. | |
| Element | Proposed Device
TD 100® Disinfector
with TD-5® and TD-8®
High Level
Disinfectants | Predicate Device
TD 100®
Transesophageal
Probe Disinfector
and TD-5 High-
level Disinfectant
(K051305) | Predicate Device
Rapicide OPA-28®
(K120306) | Predicate Deice
Metricide OPA
Plus (K070627 As
Opaciden) | Predicate Deice
Cidex OPA
(K030004) |
| | TD-8® disinfectant
should be used with
the following contact
conditions in TD
100®
disinfector:
High-level disinfectant
TD-8®
Time
5 minutes
Temperature
38° – 40°C
Minimum
Recommended
Concentration
0.3% ortho-
phthalaldehyde | | | | |
| Instrument
ation For
Automation | TD 100® with TD-5®
and TD-8® disinfector
is automated for single
use with only TD-5® or
TD-8® disinfectants.
The user initiates
automated cycle and
receives disinfection
verification ticket via
touchpad. Software
and user interface has
been modified as
compared to the
predicate TD 100®
(K051305) to facilitate
choice of TD-5® or
TD-8® disinfectants
and minor updates.
Other aspects of the
instrumentation are
identical to current TD
100® and TD-5®
device. | TD 100®
disinfector is
automated for
single use with
only TD-5®
disinfectant. The
user initiates
automated cycle
and receives
disinfection
verification ticket
via touchpad. | Rapicide OPA-28 is
indicated for
manual use and
use with
undesignated
(legally marketed)
automatic
reprocessors that
provide designated
contact conditions. | Metricide OPA Plus
(K070627 as
Opaciden)is
indicated for
manual use and
use with
undesignated
(legally marketed)
automatic
reprocessors that
provide designated
contact conditions. | Cidex OPA is
indicated for
manual use and
use with
undesignated
(legally marketed)
automatic
reprocessors that
provide designated
contact conditions. |
| Physical Properties | TD-8® | TD-5® | Rapicide OPA-
28 | Metricide OPA
Plus (As
Opaciden) | Cidex OPA |
| 510(k) Number | K160921 | K051305 | K120306 | K070627 (As
Opaciden) | K030004 |
| Clearance Date | TBD | 8/18/05 | 9/27/12 | 8/2/2007 | 2/27/2003 |
| Active Ingredients | Ortho-
phthalaldehyde
0.59% | Glutaraldehyde
2.65% | Ortho-
phthalaldehyde
0.575% | Ortho-
phthalaldehyde
0.6% | Ortho-
phthalaldehyde
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
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
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 |
| Use in Automated
Disinfector | Required | Required | Optional | Optional | Optional |
| Manual Use | No | No | Optional | Optional | Optional |
| Reusable Devices | TEE Probes
ONLY | TEE Probes
ONLY | Endoscopes | Endoscopes | Endoscopes |
| Disinfectant Temperature
Minimum | 38°C | 38°C | 25°C | 25°C | 25°C |
| Disinfectant Temperature
Maximum | 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®
6
...
7
,
8
Table C.1b: Comparative Table for TD-8
9
| Table C.1c: Comparative Table for TD-8, TD-5 | ||||||
|---|---|---|---|---|---|---|
| Test | Organism | TD-8 | ||||
| (Appendix 5) | TD-5 | Rapicide | ||||
| OPA-28 | ||||||
| (Appendix | ||||||
| A1.7) | Metricide | |||||
| OPA Plus | ||||||
| (K070627 as | ||||||
| Opaciden) | ||||||
| (Appendix |
- | Cidex OPA
(Appendix - |
| Sporicidal | Bacillus subtilis | 32.0 hrs at
37°C | 10 min at
21°C | 32 hrs at
25°C | 32 hrs at
25°C | 32 hrs at
25°C |
| Sporicidal | Clostridium
sporogenes | 32.0 hrs at
37°C | 10 min at
21°C | 32 hrs at
25°C | Not
performed | Not
performed |
| Tuberculocidal | Mycobacterium
terrae | 5.0 min at 37°C |