(229 days)
No
The device description focuses on automated disinfection processes based on pre-set parameters (time, temperature, concentration) and does not mention any learning, adaptive, or data-driven decision-making components characteristic of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is designed for high-level disinfection of transesophageal (TEE) ultrasound probes, not for therapeutic use on a patient. It cleans medical devices, it does not treat medical conditions.
No
This device is designed for high-level disinfection of TEE ultrasound probes, not for diagnosing medical conditions.
No
The device description clearly describes a physical hardware device (TD 200® Automated TEE Probe Disinfector) that performs a physical process (heating, soaking, rinsing) using a chemical disinfectant (TD-12®). While there is mention of software validation, this is validation of the software controlling the hardware, not a standalone software device.
Based on the provided information, the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide 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 medical condition.
- Device Description: The description details a system for cleaning and disinfecting probes, involving heating, soaking, and rinsing. This aligns with device reprocessing, not in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases
- Using reagents or kits designed for in vitro testing
The device is clearly intended for the reprocessing of medical equipment (TEE probes) to prevent the spread of infection, which falls under the category of medical device sterilization/disinfection, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
- High-level disinfectant: TD-12®
- Time: 3 minutes
- Temperature: 38°C
- Minimum Recommended Concentration: 1.75% peracetic acid
Product codes (comma separated list FDA assigned to the subject device)
PSW, MED
Device Description
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12® disinfectant. The TD 200® disinfector is for use only with TD-12® disinfectant. The TD-12® is for use only in the TD 200® disinfector. Thus, the TD 200® disinfector and TD-12® disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200® disinfector. A fresh, unopened bottle of TD-12® disinfectant is loaded into the TD 200® disinfector. The TD 200® disinfector heats the TD-12® disinfectant to at least 38 C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200® disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200® disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Transesophageal (TEE) ultrasound probes (implies contact with esophagus/heart)
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:
- Study Type: Clinical In-Use Testing
- Sample Size: Not specified, but involved "soiled TEE probes"
- Key Results: In all cases, there was a complete kill of microorganisms after TEE probe processing.
Non-Clinical Testing:
- Software Validation:
- Study Type: Software Validation
- Key Results: All qualification activities were successfully completed, and documented evidence showed the TD 200® consistently performs as intended. All data collected met established acceptance criteria.
- Electrical Safety Testing:
- Study Type: Electrical Safety Testing
- Key Results: Investigated and passed all testing in accordance with UL 61010-1, 3rd Edition.
- Clinical In-Use Testing (repeated entry):
- Study Type: Clinical In-Use Testing
- Key Results: After routine clinical use, soiled TEE probes subjected to disinfection resulted in a complete kill of microorganisms.
- Biocompatibility:
- Study Type: Biocompatibility
- Key Results: TD-12® is not a sensitizer, nor an irritant and is non-cytotoxic. Residue levels on TEE probes are not likely to have toxic effects on humans.
- Material Compatibility:
- Study Type: Material Compatibility
- Key Results: No observable effects from exposure to TD-12® disinfectant on materials used to construct the TD 200®.
- Compatibility Testing with TEE Probes:
- Study Type: Compatibility Testing
- TEE Probes Tested: GE, Philips, and Siemens TEE probes.
- Conditions: TD-12® at 3% w/v (approximately 3000ppm) PAA at 38°C.
- Key Results: These probes did not have cosmetic nor functional deterioration. The device should only be used with TEE probes tested and approved by TEE probe manufacturers.
- Performance Testing:
- Study Type: Performance Testing (includes vapor exposure and automated simulated use studies)
- Key Results: Main vapor management filter has capacity for 12 months of use. In all automated simulated use studies with TD-12® in the TD 200®, there was a measurably complete kill of microorganisms after TEE probe processing. After routine clinical use with soiled TEE probes, there was a measurably complete kill of microorganisms.
- Stability:
- Study Type: Stability
- Key Results: TD-12® high level disinfectant is stable for a shelf life of at least twelve (12) months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Disinfection Effectiveness: Complete kill of microorganisms (from clinical in-use and simulated use studies)
- Vapor Management Filter Capacity: 12 months (from vapor exposure studies)
- Disinfectant Stability: At least twelve (12) months shelf life
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 1, 2020
CS Medical L.L.C. Kendall Ashe Vice President and General Manager 2179 East Lyon Station Road Creedmoor, North Carolina 27522
Re: K192228
Trade/Device Name: TD 200® Disinfector with TD-12® High Level Disinfectant Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW, MED Dated: February 27, 2020 Received: February 27, 2020
Dear Kendall Ashe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192228
Device Name
TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant
Indications for Use (Describe)
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-level disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-12® | 3 minutes | 38°C | 1.75% peracetic acid |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
510(k) Owner CS Medical L.L.C. 2179 E. Lvon Station Road Creedmoor, North Carolina 27522 Phone 919-255-9472 Fax 919-528-3400
Contact Name Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Email: kendallashe@csmedicalllc.com
Submission Prepared 26-Feb-2020
CS Medical Trade Name TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant
Common Name TD 200®
Classification Name Diagnostic ultrasonic transducer (21 CFR 892.1570, Primary Product Code, PSW Secondary Product Code, MED
Legally Marketed Predicate Devices
- CS Medical TD 100® Transesophageal Probe Disinfector with TD-5® and TD-8® High 1. Level Disinfectants (K160921) - Primary Predicate
-
- Medivators Rapicide PA High Level Disinfectant (K082988)
Reference Device
- TD-8 High-Level Disinfectant (K160921) 1.
Description of the CS Medical TD 200® Automated Tee Probe Disinfector with TD-12® High Level Disinfectant
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12® disinfectant. The TD 200® disinfector is for use only with TD-12® disinfectant. The TD-12® is for use only in the TD 200® disinfector. Thus, the TD 200® disinfector and TD-12® disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200® disinfector. A fresh, unopened bottle of TD-12® disinfectant is loaded into the TD 200® disinfector. The TD 200® disinfector heats the TD-12® disinfectant to at least 38 C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200® disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 2008 K192228 Page 1 of 10
4
disinfector and dried according to the TEE probe manufacturer's instructions. The TD 2008 disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
Indications for Use Statement
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200% disinfector. The disinfectant bottles cannot be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-level disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-12® | 3 minutes | 38°C | 1.75% peracetic acid |
Technological Characteristics:
Table C1.a: Comparative Table for TD 200®
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Element | TD 200® Automated TEE | ||
| Probe Disinfector with TD- | |||
| 12® High Level Disinfectant | |||
| (K192228) | TD 100® | ||
| Transesophageal Probe | |||
| Disinfector and TD-5 | |||
| and TD-8 High- level | |||
| Disinfectant (K160921) | |||
| Classification | |||
| Name | |||
| (CFR; | |||
| Product | |||
| code) | Diagnostic ultrasonic | ||
| transducer (21 C.F.R. § | |||
| 892.1570, product code | |||
| PSW) | Diagnostic ultrasonic | ||
| transducer (21 C.F.R. § | |||
| 892.1570, product code | |||
| PSW) | Liquid chemical | ||
| sterilants/high level | |||
| disinfectant (21 CFR | |||
| §880.6885, Product | |||
| Code MED) | |||
| Indications for | |||
| use | The TD 200® Automated | ||
| TEE Probe Disinfector with | |||
| TD-12® High Level | |||
| Disinfectant is designed to | |||
| provide high-level | |||
| disinfection of | |||
| Transesophageal (TEE) | |||
| ultrasound probes. The | |||
| system can use TD-12® | |||
| disinfectant, which is | 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 | Rapicide PA High Level | ||
| Disinfectant is a | |||
| peracetic acid based, | |||
| two part disinfectant. | |||
| Part A contains the | |||
| active ingredients and | |||
| Part B contains | |||
| anticorrosive agents | |||
| and surfactants. Part A | |||
| and Part B are mixed in | |||
| designed to be used only | |||
| with the TD 200® | |||
| disinfector. The disinfectant | |||
| bottles cannot be reused in | |||
| the system. | disinfectant bottles cannot | ||
| be reused in the system. | |||
| TD-5 and TD8 | |||
| disinfectants are 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 and TD-8 | |||
| high level disinfectants | |||
| 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: | the machine and diluted | ||
| with water. |
The Minimum
Recommended
Concentration (MRC) of
Rapicide PA is 850 ppm
of peracetic acid. A test
strip is used to ensure
that the use solution is
above the MRC.
Rapicide PA High Level
Disinfectant is intended
for use with the
Advantage Plus
Endoscope
Reprocessing System to
provide high level
disinfection of
endoscopes when used
according to the
directions for use.
Rapicide PA should be
used under the following
contact conditions: | |
| 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. | High-level disinfectant
TD-5
Time - 5 minutes
Temperature - 38° to
40°C
Minimum Recommended
Concentration
1.7% glutaraldehyde | Time - 5 minutes
Temperature – 30°
Minimum
Recommended
Concentration (MRC)
850ppm | |
| TD-12® high level
disinfectant and TD 200®
disinfector is 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
TD-8
Time - 5 minutes
Temperature - 38° to
40°C
Minimum Recommended
Concentration | | |
| 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 (MRC)
1.75% Peracetic Acid | | | |
| | 0.3% ortho-
phthalaldehyde | | |
| Instrumentati
on For
Automation | TD 200® Automated TEE
Probe Disinfector with TD-
12® High Level Disinfectant
is automated for single use
with only TD-12®
disinfectant. The user
initiates the automated
cycle via touchpad and
receives disinfection
verification ticket. Software
has been modified as
compared to the predicate
TD 100 (K160921) to
facilitate the only choice of
TD-12® disinfectant. Other
aspects of the
instrumentation are
identical to current TD 100
with TD-5 and TD-8 devices. | TD 100 with TD-5 or TD-8
disinfectors is automated
for single use with only
TD-5 or TD-8
disinfectants. The user
initiates the automated
cycle via touchpad and
receives disinfection
verification ticket. | Rapicide PA is
indicated for manual
use and use with
undesignated (legally
marketed) automatic
reprocessors that
provide designated
contact conditions. |
5
6
Comparison of Proposed Device to Primary Predicate Device
| | Proposed
Device | Predicate
Device | Predicate
Device | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------|
| | TD 200®
Automated TEE
Probe
Disinfector with
TD-12® High
Level
Disinfectant
(K192228) | TD 100®
Transesophage
al Probe
Disinfector and
TD-5 and TD-8
High- level
Disinfectant
(K160921) | Rapicide
PA
(K082988) | |
| Features | | | | |
| The system shall utilize a
disinfectant that has at least a
one year shelf life from the
date of manufacture. | Yes | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Yes | Same |
| User hazard to disinfectant
contact reduced by bottle
loading system | Yes | Yes | N/A | Same |
| The system shall provide a
disinfection cycle that has a
disinfectant contact time, at
least 180 seconds and
disinfects at 38°C | Yes | No | N/A | TD-12 has a
shorter
disinfection
time vs TD 100 |
| Disinfectant residues shall be
rinsed until the disinfectant
residue is below a
toxicologically significant
level. | Yes | Yes | N/A | Same |
| Machine number, lot number
of disinfectant, probe number,
operator number on output
ticket | Yes | Yes | N/A | Same |
| Design | | | | |
| Intended Use | Automated high-
level disinfection
of TEE probes | Automated
high-level
disinfection of
TEE probes | High-level
disinfection
of
endoscope
s | Same |
| Manual Pre-cleaning | Yes | Yes | Yes | Same |
| Operating principles | Peracetic Acid
high-level
disinfection | Aldehyde high-
level
disinfection | Peracetic
Acid high-
level
disinfection | Same (TD-12
and Rapicide
PA) |
| Process monitors | Digital display
screen, printout | Digital display
screen, printout | N/A | Same |
| Software/firmware control | Yes | Yes | N/A | Same |
| Performance claims | High-level
disinfection | High-level
disinfection | High-level
disinfection | Same |
| Provides high-level
disinfection for heat-sensitive
TEE probes | Yes | Yes | Yes | Same |
| Uses PAA-based
disinfectants | Yes | No | Yes | Same (TD-12
and Rapicide
PA) |
| Automated disinfection cycle | Yes | Yes | N/A | Same |
| Disinfection process with
success/failure print out. | Yes | Yes | N/A | Same |
| User hazard to vapor
exposure controlled by vapor
management system utilizing
air circulation and activated
carbon filtration | Yes | Yes | N/A | Same |
| The system shall be designed
to utilize a modular
electronics controller box. | Yes | Yes | N/A | Same |
| The system shall be
controlled by a
microcontroller processor. | Yes | Yes | N/A | Same |
| The system shall provide a
built-in printer. | Yes | Yes | N/A | Same |
| Specifications | | | | |
| Dedicated Disinfectants for
use with the device | Peracetic acid
(TD-12) | Glutaraldehyde
(TD-5); Ortho-
phthalaldehyde
(TD-8) | Rapicide PA
peracetic
acid | Same (TD-12
and Rapicide
PA) |
| Disinfectant Minimum
Recommended Concentration | 1.75% Peracetic
Acid (TD-12) | 1.7%
glutaraldehyde
(TD-5)
0.3% ortho-
phthalaldehyde
(TD-8) | 850 ppm
peracetic
acid | Similar (TD-12
and Rapicide
PA) |
| 110 VAC | Yes | Yes | N/A | Same |
| Potable Water Inlet | Yes | Yes | N/A | Same |
7
8
The technological differences between the high-level disinfection phase of the Proposed Device (TD 200) K192228 and Predicate Device (TD 100) K160921 are small except for the type of high-level disinfectants. The differences between TD-12 and Rapicide PA are small except for the Minimum Recommended Concentration (MRC), which are similar. Both devices, TD 200 and TD 100, achieve the same high-level disinfection of TEE probes using the same technological methods. Both TD-12 and Rapicide PA are peracetic acid high-level disinfectants which achieve high-level disinfection useful for the disinfection of TEE and Endoscopy probes. Both Proposed (TD-12) and Predicate (Rapicide PA) devices have similar physical properties (Table C1.b) and disinfection properties (Table C1.c).
| Physical
Properties | Proposed
Device | Reference
Device | Predicate Device | Comparison |
|------------------------|------------------------|-------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | TD-12® | TD-8 | Rapicide PA | |
| 510(k) Number | K192228 | K160921 | K082988 | |
| Active Ingredients | 3.0%
peracetic acid | 0.59% Ortho-
phthaladehyde | Part A - 22%
hydrogen peroxide
and 5%
peroxyacetic acid
Part B - 4% | Similar (TD-12
and Rapicide
PA) |
| Inert Ingredients | 97.0% | 99.41% | Part A - 73%
Part B – 95.7% | TD-12, TD-8,
and Rapicide
PA have
different inert
ingredients |
| Water-Based
Liquid | No | Yes | Yes | Same after
hydration of
TD-12 |
| pH Value | 8.5 – 9.0 | 7.45 – 7.55 | 0.4±.3 Part A
11.4 - 12.4 Part B
Combined Part A
and B is 4.2 | TD-12, TD-8,
and Rapicide
PA have
different pH
values |
Table C1.b: Comparative Table (Physical Properties) for TD-12®, TD-8®, Rapicide PA
9
| Buffer System | Sodium
Carbonate and
Sulfamic Acid | Phosphates | Trisodium
Phosphate | TD-12, TD-8,
and Rapicide
PA have
different
buffer system |
|--------------------------------------------------|------------------------------------------|------------|------------------------|-----------------------------------------------------------------------|
| Minimum
Recommended
Concentration
(MRC) | 1.75% | 0.3% | 850 ppm | TD-12 and
Rapicide PA
have different
MRC |
| Dilution Required | Yes | No | Yes | Same (TD-12
and Rapicide
PA) |
| Activation
Required | Yes | No | Yes | Same (TD-12
and Rapicide
PA) |
| High-Level
Disinfection Claim | Yes | Yes | Yes | Same |
| Sterilization
Claim | No | No | No | Same |
| Maximum Re-Use
Period | Single Use | Single Use | 28 Days | Same (TD-12
and TD-8).
Rapicide PA
not single use. |
| PAA Test Strip
Available | Yes | No | Yes | Same (TD-12
and Rapicide
PA) |
| Use in Automated
Disinfector | Required | Required | Optional | Same (TD-12
and TD-8).
Optional
Rapicide PA |
| Manual Use | No | No | Optional | Same (TD-12
and TD-8).
Optional
Rapicide PA |
| Disinfectant
Temperature
Minimum | 38°C | 38°C | 30°C | Same (TD-12
and TD-8).
Rapicide PA
has lower Min
Temp |
| Disinfection Time | 3 Minutes | 5 Minutes | 5 Minutes | Similar |
Table C1.c: Comparative Table (Test Organism) for TD-12®, TD-8, Rapicide PA
| Test | Proposed Device | Reference Device | Predicate Device | Comparison |
|---|---|---|---|---|
| Organism | ||||
| TD-12® | TD-8 | Rapicide PA | ||
| Sporicidal | 5.0 hrs at | 32.0 hrs at | Total Kill | Same |
| Bacillus subtilis | 37°C | 37°C | ||
| Sporicidal | 5.0 hrs at | 32.0 hrs at | Total Kill | Same |
| Clostridium | 37°C | 37°C | ||
| sporogenes |
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| Tuberculocidal
Mycobacterium
| terrae | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
|---|---|---|---|---|
| Bactericidal | ||||
| Staphylococcus | ||||
| aureus | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| Bactericidal | ||||
| Salmonella | ||||
| enterica | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| Bactericidal | ||||
| Pseudomonas | ||||
| aeruginosa | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| Fungicidal | ||||
| Trichophyton | ||||
| mentagrophytes | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
| Virucidal | ||||
| Poliovirus Type | ||||
| 1 | 3.0 min at 37°C | 5.0 min at 37°C | Complete | |
| Inactivation for | ||||
| Polio Virus Type 2 | Same (TD-12 | |||
| and TD-8). | ||||
| Type 2 for | ||||
| Rapicide PA | ||||
| Virucidal | ||||
| Herpes Simplex | ||||
| Virus Type 1 | 3.0 min at 37°C | 5.0 min at 25°C | Complete | |
| Inactivation | Same | |||
| Virucidal | ||||
| Human | ||||
| Influenza Virus | ||||
| A | 3.0 min at 37°C | 5.0 min at 25°C | Not performed | Same (TD-12 |
| and TD-8) | ||||
| Virucidal | ||||
| Adenovirus | ||||
| Type 1 | 3.0 min at37°C | 5.0min at 25°C | Not performed | Same (TD-12 |
| and TD-8) | ||||
| Simulated Use | ||||
| Mycobacterium | ||||
| terrae | 3.0 min at 37°C | 5.0 min at 37°C | >6 log Reduction | Same |
| Clinical In-Use | ||||
| Wild-type from | ||||
| patients | 3.0 min at 37°C | 5.0 min at 37°C | Total Kill | Same |
Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant using standard operating parameters. In all cases, there was a complete kill of microorganisms after TEE probe processing.
Non-Clinical Testing
Software Validation
All qualification activities defined in the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant Verification and Validation Plan were successfully completed and provided documented evidence that the TD 200® consistently performs as intended. All
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data collected during test execution met the established acceptance criteria, was recorded on the data forms, and satisfactorily completed. The TD 200® Verification and Validation Summary Report and the associated qualification documents for the TD 200® detail the successful completion of all requirements of the TD 200® Master Verification and Validation Plan.
Electrical Safety Testing
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant has been investigated and passed all testing in accordance with UL 61010-1. 3rd Edition: Standard for Safety, Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements: Rev. April 29, 2016.
Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant using standard operating parameters. In all cases, there was a complete kill of microorganisms after TEE probe processing.
Biocompatibility
Under conditions of the study, TD-12® is not a sensitizer, nor an irritant and is non-cytotoxic. Transesophageal probes processed in the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant were evaluated for disinfectant residue. The analysis indicates that the level of residue on the TEE probes are not likely to have toxic effects on humans.
Material Compatibility
The materials used to construct the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant were exposed to TD-12® disinfectant for a pre-determined period of time. There were no observable effects from exposure to TD-12® disinfectant onmaterials.
Compatibility Testing with TEE Probes
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant should be used only with TEE probes which have been tested and approved by TEE probe manufacturers. Material Compatibility has been performed with GE, Philips and Siemens TEE probes. These probes did not have cosmetic nor functional deterioration. TD-12® probe compatibility testing was completed using a use-suspension of 3% w/v (approximately 3000ppm) PAA TD-12® at 38°C.
Performance Testing
Disinfectant (TD-12®) vapor exposure studies were performed in a room with zero air exchanges and showed the main vapor management filter has capacity for 12 months of use. Automated Simulated use studies with TD-12® were conducted in the TD 200® disinfector. In all cases there was a measurably complete kill of microorganisms after TEE probe processing. After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200® disinfector with TD-12® disinfectant with standard operating parameters. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.
Stability
TD-12® high level disinfectant has been tested and shown to be stable for a shelf life of at least twelve (12) months.
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Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrates that the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is as safe, as effective, and performs as well as or better than the legally marketed predicate device Medivators Rapicide PA High Level Disinfectant (K082988).