CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 by CS Medical LLC

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 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.

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-5 disinfectant. Each soiled TEE probe is pre-cleaned manually before insertion into the TD-100 disinfector. A fresh, unopened bottle of TD-5 disinfectant is loaded into the TD-100 disinfector. The TD-100 disinfector heats the TD-5 disinfectant to 38-40C, soaks the TEE probe at least fiveminutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. 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 disinfectant is used with each cycle no monitoring of the disinfectant's potency required, nor is there any requirement for daily testing of the disinfectant solution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CS Medical TD-100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Target Performance)	Reported Device Performance (Achieved)
High-Level Disinfection:	Simulated Use Testing: A 6-Log₁₀ reduction of M. terrae was achieved when disinfecting TEE probes dosed with artificial soil containing M. terrae.
Residual Disinfectant Toxicity:	Biocompatibility: Analysis indicated that the level of residue on the TEE probes following processing in the TD-100 using TD-5 is not likely to have toxic effects on humans. (Implicitly, the acceptance criterion is that there are no toxic levels of residue, and this was met).
Material Compatibility:	Material Compatibility: No observable adverse effects were seen on the materials used to construct the TD-100 after extended exposure to TD-5 High-level Disinfectant. (Implicitly, the acceptance criterion is no material degradation, and this was met).
Disinfectant Stability:	Stability: TD-5 High-level Disinfectant was tested and shown to be stable for a shelf life of one year. The concentration of the disinfectant at the end of 18 months of testing was well above the 1.7% minimum recommended concentration. (Implicitly, the acceptance criterion is stability for at least one year and maintaining minimum concentration, and this was met with exceedance on concentration over a longer period).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a numerical sample size for either the simulated use testing or the in-use clinical testing.

Simulated Use Testing: It states, "In all cases a 6-Log₁₀ reduction of M. terrae was achieved." This implies multiple tests were conducted, but the specific number is not provided.
In Use Testing: It states, "TEE Probes used in a clinical setting were examined. The probes were bioburden post cleaning and a new population of probes was examined for bioburden after disinfection. In all cases, there was a complete kill of microbes after disinfection." Again, "in all cases" implies multiple probes, but no specific number is given.

Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be retrospective for the "In Use Testing" as it refers to "probes used in a clinical setting" that were then examined. The "Simulated Use Testing" likely involved prospective testing in a lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The efficacy testing revolves around microbial reduction and absence of growth, which would typically involve laboratory analysis by microbiologists rather than interpretation by clinical experts like radiologists.

4. Adjudication Method for the Test Set:

Not applicable. The efficacy testing involves quantitative microbial reduction (Log reductions) and qualitative assessment of microbial kill, which are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This type of study was not conducted. The device is a high-level disinfectant system, not an AI-powered diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This classification doesn't directly apply because the device is a physical disinfectant system, not a software algorithm. However, the "Efficacy Testing" sections (Simulated Use and In Use Testing) demonstrate the standalone performance of the device system itself (TD-100 plus TD-5) in achieving high-level disinfection without human intervention during the disinfection cycle (after manual pre-cleaning and probe loading).

7. Type of Ground Truth Used:

Microbiological Culture/Counts: For efficacy testing, the ground truth was established by microbiological methods measuring the reduction of specific microorganisms (M. terrae for simulated use) and the complete kill of microbes (for in-use testing). This is a direct measurement of disinfection effectiveness.
Chemical Analysis: For biocompatibility (residue) and material compatibility, the ground truth would be chemical analysis of residue levels and visual/physical inspection for material degradation.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML product developed with a training set. The "development" would involve chemical formulation and engineering design, not data training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap each other.

Public Health Service

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. Ben Chemelli Vice President 3248 Lake Woodard Drive Raleigh, North Carolina 27604

Re: K051305

Trade/Device Name: CS Medical TD-100 Transesophageal Probe Disinfector, Model Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: PSW Dated: July 29, 2005 Received: August 1, 2005

Dear Mr. Chemelli:

This letter corrects our substantially equivalent letter of August 18, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chemelli

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 Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K051305

Device Name: TD-5 High Lével Disinfectant and TD-100 Transesophiageal Probe Disinfector

Indications For Use:

TD-5 is intended for 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.

TD-5 High Level Disinfectant should be used with the following contact conditions:

	Time	Temperature	MinimumRecommendedConcentration
High LevelDisinfection	5 Minutes	38-40°C	1.7%

The TD-5 High Level Disinfectant and TD-100 disinfector system is intended for use by qualified individuals trained in its use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Signature of CDRH, Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number $

Page 1 of 1

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AUG 1 8 2005

12 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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Contact:

CS Medical L.L.C.

3248 Lake Woodard Drive

Raleigh, NC 27604

Person:100 11 11 11 11------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Ben Chemelli
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------

Date Prepared: May 16, 2005

Device Name:

Trade name:

CS Medical TD-100 Transesophageal Probe Disinfector CS Medical TD-5 High-level Disinfectant

Classification:

Endoscope and Accessories. 21 C.F.R. § 876.1500.

High Level Liquid Chemical Disinfectant. 21 C.F.R. § 880.6885.

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Predicate Devices:

(1) Medivators DSD™ Disinfector For Flexible Endoscopes (K914145)
(2) Wavicide-01 (K914749)
(3) Medivators Rapicide™ 5 Minute High-Level Disinfectant (K993042)

The DSD system uses a High-level Disinfectant to reprocess reusable flexible endoscopes. It controls the environmental conditions (for example contact time with the disinfectant, temperature of the disinfectant and ninsing) necessary for effective disinfection of the device being processed.

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Device Description:

Intended Use:

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TD-5 is intended for 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.

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Efficacy Testing:

Simulated Use Testing: The High-level Disinfection capabilities of the TD-100 disinfector and TD-5 High-level Disinfectant were evaluated for efficacy in a simulated use environment. In all cases a 6-Logio reduction of M. terrae was achieved when disinfecting TEE probes that were dosed with artificial soil containing M. terrae.

In Use Testing: TEE Probes used in a clinical setting were examined. The probes were bioburden post cleaning and a new population of probes was examined for bioburden after disinfection. In all cases, there was a complete kill of microbes after disinfection.

Biocompatibility:

Transesophageal probes processed in the TD-100 using TD-5 were evaluated for disinfectant residue. The analysis indicates that the level of residue on the TEE probes in not likely to have toxic effects on humans.

. . . .. . . . . Material Compatibility:

. . . . . . .

The materials used to construct the TD-100 were exposed to TD-5 High-level Disinfectant for an extended period of time. There were no observable effects from exposure to TD-5.

... ... ... ... ... ... ... ... ... .. .. .. .. .. .. .. .. .. .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... Stability:

TD-5 High Level disinfectant has been tested and shown to be stable for a shelf life of one-year. The concentration of the disinfectant at the end of 18 months of testing is well about the 1.7% minimum recommended concentration.

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Conclusion:

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The information and data presented demonstrate substantial equivalence to the · predicate devices. The TD-100 and TD-5 are substantially equivalent to other legally marketed devices. ...

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CS Medical LLC 510(1) Premiarket Application for TD-100 Disinfoctor and TD-5 HLD

Regulation Number and Section

§ 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.