(57 days)
No
The summary describes a system for high-level disinfection of TEE probes using a specific disinfectant and a chemical indicator. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The software validation mentioned is standard for medical devices and does not indicate AI/ML.
No
This device is a high-level disinfector for TEE ultrasound probes, which are medical devices, but the disinfector itself does not have a direct therapeutic effect on a patient. It is used to prepare other medical devices for safe use.
No
The device is designed for the high-level disinfection of transesophageal (TEE) ultrasound probes, not for diagnostic purposes.
No
The device description clearly outlines a physical hardware system (TD 200 disinfector) that performs a physical process (heating, soaking, rinsing) using a chemical disinfectant (TD-12). While software is mentioned for validation, the core function and components are hardware and chemical.
Based on the provided information, the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant and QwikCheck™ Chemical Indicators is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is the high-level disinfection of Transesophageal (TEE) ultrasound probes. This is a process to reduce the number of viable microorganisms on a medical device, not to diagnose a disease or condition.
- Device Description: The description focuses on the mechanical and chemical process of disinfection, including heating, soaking, rinsing, and verification of the cycle. It does not describe any analysis of biological samples or substances from the human body for diagnostic purposes.
- Function of the Disinfectant and Indicators: The TD-12 disinfectant is a chemical agent used to kill microorganisms. The QwikCheck™ Chemical Indicators are used to verify the concentration of the disinfectant, ensuring the disinfection process is effective. These are tools used in the disinfection process itself, not for analyzing patient samples.
- 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.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays designed to detect specific analytes in biological samples.
The device is a medical device used for reprocessing other medical devices (TEE probes) to make them safe for reuse. While it plays a crucial role in patient care by preventing the spread of infection, its function is not diagnostic.
N/A
Intended Use / Indications for Use
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-Level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-12® | 3 minutes | 38°C | 1750 ppm peracetic acid |
QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
Product codes (comma separated list FDA assigned to the subject device)
PSW, MED, JOJ
Device Description
The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12 disinfectant. The TD 200 disinfector is for use only with TD-12 disinfectant. The TD-12 is for use only in the TD 200 disinfector. Thus, the TD 200 disinfector and TD-12 disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to at least 38°C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200 disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
TD-12® high level disinfectant and TD 200® disinfector is intended for use by 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)
Software Validation
All qualification activities defined in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant Verification and Validation Plan were successfully completed and provided documented evidence that the TD 200 consistently performs as intended. All data collected during test execution met the established acceptance criteria, was recorded on the data forms, and satisfactorily completed. The TD 200 Verification and Validation Summary Report and the associated qualification documents for the TD 200 detail the successful completion of all requirements of the TD 200 Master Verification and Validation Plan.
Electrical Safety Testing
The TD 200 Automated TEE Probe Disinfector withTD-12 High LevelDisinfectant has been investigated and passed all testing in accordance with UL 61010-1, 3rd Edition; Standard for Safety, Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements; Rev. April 29, 2016.
Biocompatibility
Under conditions of the study, TD-12 is not a sensitizer, nor an irritant and is non-cytotoxic. Transesophageal probes processed in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were evaluated for disinfectant residue. The analysis indicates that the level of residue on the TEE probes are not likely to have toxic effects on humans.
Material Compatibility
The materials used to construct the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were exposed to TD-12 disinfectant for a pre-determined period of time. There were no observable effects from exposure to TD-12 disinfectant on materials.
Compatibility Testing with TEE Probes
The TD 200 Automated TEE Probe Disinfector withTD-12 High Level Disinfectant should be used only with TEE probes which have been tested and approved by TEE probe manufacturers. Material Compatibility has been performed with GE, Philips and Siemens TEE probes. These probes did not have cosmetic nor functional deterioration. TD-12 probe compatibility testing was completed using a use-suspension of 3% w/v (approximately 3000ppm) PAA TD-12 at 38°C.
Performance Testing
TD-12 High Level Disinfectant vapor exposure studies were performed in a room with zero air exchanges and showed the main vapor management filter has capacity for 12 months of use. Automated Simulated use studies with TD-12 were conducted in the TD 200 disinfector. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.
Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant using standard operating parameters. In all cases, there was a complete kill of microorganisms after TEE probe processing.
No clinical in-use testing was performed with the QwikCheck chemical indicators as no clinical in-use testing was performed with the predicate chemical indicators so this testing is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2023
CS Medical LLC Kendall Ashe Vice President, General Manager 2179 East Lyon Station Rd Creedmoor, North Carolina 27522
Re: K233049
Trade/Device Name: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW, MED, JOJ Dated: September 25, 2023 Received: September 25, 2023
Dear Kendall Ashe:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233049
Device Name
TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with OwikCheck™ Chemical Indicators
Indications for Use (Describe)
The TD 2008 Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 2008 disinfector. The disinfectant be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-Level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-12® | 3 minutes | 38°C | 1750 ppm peracetic acid |
OwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
K233049
510(k) Owner CS Medical L.L.C. 2179 E. Lyon Station Road Creedmoor, North Carolina 27522 Phone 919-255-9472 Fax 919-528-3400
Contact Name Kendall Ashe Vice President and General Manager, CS Medical, LLC 2179 E. Lyon Station Road Creedmoor. North Carolina 27522 Email: kendallashe@csmedicalllc.com
Submission Prepared 25-Sept-2023
CS Medical Trade Name TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators
Common Name TD 200 disinfector TD-12 disinfectant and QwikCheck chemical indicator
Classification Name Diagnostic ultrasonic transducer (21 CFR 892.1570, Primary Product Code. PSW Secondary Product Code, MED, JOJ
Legally Marketed Predicate Devices
-
TD 200/TD-12 disinfector/disinfectant system (K192228) - Primary Predicate
-
IBT Scientific Peracid Test (K964264)
Description of the CS Medical TD 200® Disinfector with TD-12® High Level Disinfectant and QwikCheck™ Indicator
The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12 disinfectant. The TD 200 disinfector is for use only with TD-12 disinfectant. The TD-12 is for use only in the TD 200 disinfector. Thus, the TD 200 disinfector and TD-12 disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to at least 38°C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200 disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cvcle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
5
TD 200, TD-12, and QwikCheck Indications for Use Statement:
The TD 200® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.
TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.
TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.
TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:
| High-level Disinfectant | Time | Temperature | Minimum Recommended Concentration |
|---|---|---|---|
| TD-12® | 3 minutes | 38°C | 1750 ppm peracetic acid |
QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750 ppm peracetic acid.
Comparative Table for Indications for Use
| Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|
| Element | TD 200 Disinfector with TD- | ||
| 12 High-Level disinfectant | |||
| with QwikCheck Chemical | |||
| Indicator | TD 200 Disinfector with TD- | ||
| 12 High-Level Disinfectant | |||
| 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) | Same | ||
| Indications for | |||
| Use | The TD 200 disinfector is | ||
| designed to provide high- | |||
| level disinfection of | |||
| Transesophageal (TEE) | |||
| ultrasound probes. The | |||
| system can use TD-12 | |||
| disinfectant, which is | |||
| designed to be used only | |||
| with the TD 200 disinfector. | |||
| The disinfectant bottles | |||
| cannot be reused in the | |||
| system. | |||
| TD-12 disinfectant is | |||
| intended for use as single | |||
| use high-level disinfectant | |||
| to be used exclusively in the | The TD 200 disinfector is | ||
| designed to provide high- | |||
| level disinfection of | |||
| Transesophageal (TEE) | |||
| ultrasound probes. The | |||
| system can use TD-12 | |||
| disinfectant, which is | |||
| designed to be used only | |||
| with the TD 200 disinfector. | |||
| The disinfectant bottles | |||
| cannot be reused in the | |||
| system. | |||
| TD-12 disinfectant is | |||
| intended for use as single | |||
| use high-level disinfectant | |||
| to be used exclusively in the | Same |
6
| 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: | 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 (MRC) 1750
ppm Peracetic Acid | High-level Disinfectant TD-
12
Time - 3 Minutes
Temperature - 38°C
Minimum Recommended
Concentration (MRC) 1.75%
Peracetic Acid |
| QwikCheck Chemical
Indicators are used prior to
the disinfection cycle to
ensure that the disinfectant
used is above the minimum
recommended
concentration (MRC) of
1750ppm peracetic acid. | |
Comparison of Proposed TD 200 Device to Primary Predicate TD 200 Device
| Features | Proposed Device
TD 200® Automated
TEE Probe
Disinfector with TD-
12® High Level
Disinfectant with
QwikCheck Chemical
Indicator | Predicate Device
TD 200® Automated
TEE Probe
Disinfector with TD-
12® High Level
Disinfectant
(K192228) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------|
| The system shall utilize a
disinfectant that has at least a
one-year shelf life from the
date of manufacture. | Yes | Yes | Same |
| Single-use disinfectants only | Yes | Yes | Same |
| User hazard to disinfectant
contact reduced by bottle
loading system | Yes | Yes | Same |
| The system shall provide a
disinfection cycle that has a
disinfectant contact time, at
least 180 seconds and
disinfects at 38°C | Yes | Yes | Same |
| Disinfectant residues shall be
rinsed until the disinfectant
residue is below a
toxicologically significant
level. | Yes | Yes | Same |
| Reduced height of machine
for easy load of TEE probe | Yes | Yes | Same |
| Machine serial number, lot
number of disinfectant, probe
number, and operator number
on output ticket | Yes | Yes | Same |
| Minimal footprint, secured to
wall for stability | Yes | Yes | Same |
| Design | | | |
| Intended Use | Automated high-level
disinfection of TEE
probes | Automated high-level
disinfection of TEE
probes | Same |
| Manual Pre-cleaning | Yes | Yes | Same |
| Operating principles | Peracetic Acid high-
level disinfection | Peracetic Acid high-
level disinfection | Same |
| Process monitors | Digital display
screen, printout | Digital display
screen, printout | Same |
| Software/firmware control | Yes | Yes | Same |
| Performance claims | High-level
disinfection | High-level
disinfection | Same |
| Provides high-level
disinfection for heat-sensitive
TEE probes | Yes | Yes | Same |
| Uses PAA-based
disinfectants | Yes | Yes | Same |
| Automated disinfection cycle | Yes | Yes | Same |
| Disinfection process with
success/failure print out. | Yes | Yes | Same |
| User hazard to vapor
exposure controlled by vapor
management system utilizing
air circulation and activated
carbon filtration | Yes | Yes | Same |
| The system shall be
controlled by a
microcontroller processor. | Yes | Yes | Same |
| The system shall provide a
built-in printer. | Yes | Yes | Same |
| Specifications | | | |
| Dedicated Disinfectants for
use with the device | Peracetic acid
(TD-12) | Peracetic acid
(TD-12) | Same |
| Disinfectant Minimum
Recommended Concentration | 1750 ppm Peracetic
Acid | 1.75% Peracetic Acid | Same |
| 110 VAC | Yes | Yes | Same |
| Potable Water Inlet | Yes | Yes | Same |
| User hazard to vapor
exposure controlled by
vapor management
system utilizing air
circulation and filtration
with no room air
circulation required | Yes | Yes | Same |
| Use a chemical indicator | Yes | Yes | Same |
7
8
Comparison of Proposed TD 12 Device to Primary Predicate TD 12 Device
| Physical
Properties | Proposed Device
TD-12 | Predicate Device
TD-12 (K192228) | Comparison |
|--------------------------------------------------|---------------------------------------|---------------------------------------|------------|
| Active
Ingredients | 0.30%
peracetic acid | 0.30%
peracetic acid | Same |
| Inert
Ingredients | 99.7% | 99.7% | Same |
| Water-Based
Liquid | No | No | Same |
| pH Value | 8.5 – 9.0 | 8.5 – 9.0 | Same |
| Buffer System | Sodium Carbonate and
Sulfamic Acid | Sodium Carbonate and
Sulfamic Acid | Same |
| Minimum
Recommended
Concentration
(MRC) | 1750 ppm | 1.75% | Same |
| Dilution
Required | Yes | Yes | Same |
| Activation
Required | Yes | Yes | Same |
| High-Level
Disinfection
Claim | Yes | Yes | Same |
| Sterilization
Claim | No | No | Same |
| Maximum Re-
Use Period | Single Use | Single Use | Same |
| PAA Test | Yes | Yes | Same |
9
| Strip Available | |||
|---|---|---|---|
| Use in | |||
| Automated | |||
| Disinfector | Required | Required | Same |
| Manual Use | No | No | Same |
| Disinfectant | |||
| Temperature | |||
| Minimum | 38°C | 38°C | Same |
| Disinfection | |||
| Time | 3 Minutes | 3 Minutes | Same |
Comparative Table between QwikCheck Chemical Indicators
| Element | QwikCheck Chemical
Indicator (proposed
device) | QwikCheck Chemical
Indicator (device used
in conjunction with
K192228) | Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification Name
(CFR; Product code) | Sterilization Process
Indicator (21 C.F.R. §
880.2800, product code
JOJ) | Sterilization Process
Indicator (21 C.F.R. §
880.2800, product code
JOJ) | Same |
| Indications for Use
for Chemical
Indicator | QwikCheck Chemical
Indicators are used prior
to the disinfection cycle
to ensure that the
disinfectant used is
above the minimum
recommended
concentration (MRC) of
1750ppm peracetic acid. | The QwikCheck™
Chemical Indicator is a
qualitative chemical
indicator dedicated for
use in determining
whether the
concentration of
peracetic acid, the active
ingredient in CS
Medical's TD-12 Solution,
is above or below the
established Minimum
Recommended
Concentration (MRC)
according to the solution
manufacturer. | Similar |
| Analyte | Peracetic acid in TD-12
Solution | Peracetic acid in TD-12
Solution | Same |
| Indicator Strip | 0.2" x 0.2" test paper
attached to a plastic
handle | 0.2" x 0.2" test paper
attached to a plastic
handle | Same |
| Indicator Agents | Starch and iodide | Starch and iodide | Same |
| Minimum Time of
Color Change | 30 seconds | 30 seconds | Same |
| Results | A test pad which is
similar in color to the
FAIL color block
indicates the solution is ≤
1750 ppm. If the color of
the test pad is similar to
the PASS block, the
solution is > 1750 ppm | A test pad which is
similar in color to the
FAIL color block
indicates the solution is ≤
1750 ppm. If the color of
the test pad is similar to
the PASS block, the
solution is > 1750 ppm | Same |
10
The only one difference between the subject and predicate devices is a change of supplier of the QwikCheck Chemical Indicator.
Summary of Non-Clinical Testing
Software Validation
All qualification activities defined in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant Verification and Validation Plan were successfully completed and provided documented evidence that the TD 200 consistently performs as intended. All data collected during test execution met the established acceptance criteria, was recorded on the data forms, and satisfactorily completed. The TD 200 Verification and Validation Summary Report and the associated qualification documents for the TD 200 detail the successful completion of all requirements of the TD 200 Master Verification and Validation Plan.
Electrical Safety Testing
The TD 200 Automated TEE Probe Disinfector withTD-12 High LevelDisinfectant has been investigated and passed all testing in accordance with UL 61010-1, 3rd Edition; Standard for Safety, Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements; Rev. April 29, 2016.
Biocompatibility
Under conditions of the study, TD-12 is not a sensitizer, nor an irritant and is non-cytotoxic. Transesophageal probes processed in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were evaluated for disinfectant residue. The analysis indicates that the level of residue on the TEE probes are not likely to have toxic effects on humans.
Material Compatibility
The materials used to construct the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant were exposed to TD-12 disinfectant for a pre-determined period of time. There were no observable effects from exposure to TD-12 disinfectant on materials.
Compatibility Testing with TEE Probes
The TD 200 Automated TEE Probe Disinfector withTD-12 High Level Disinfectant should be used only with TEE probes which have been tested and approved by TEE probe manufacturers. Material Compatibility has been performed with GE, Philips and Siemens TEE probes. These probes did not have cosmetic nor functional deterioration. TD-12 probe compatibility testing was
completed using a use-suspension of 3% w/v (approximately 3000ppm) PAA TD-12 at 38°C.
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Performance Testing
TD-12 High Level Disinfectant vapor exposure studies were performed in a room with zero air exchanges and showed the main vapor management filter has capacity for 12 months of use. Automated Simulated use studies with TD-12 were conducted in the TD 200 disinfector. In all cases there was a measurably complete kill of microorganisms after TEE probe processing.
Clinical In-Use Testing
After routine clinical use, soiled TEE probes were subjected to disinfection in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant using standard operating parameters. In all cases, there was a complete kill of microorganisms after TEE probe processing.
No clinical in-use testing was performed with the QwikCheck chemical indicators as no clinical in-use testing was performed with the predicate chemical indicators so this testing is not applicable.
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant with QwikCheck Chemical Indicators is as safe, as effective, and performs as well as or better than the legally marketed predicate device CS Medical TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant (K192228).