(91 days)
Not Found
No
The description focuses on a chemical disinfection process with controlled temperature and soak time, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a disinfector for medical equipment (ultrasound probes), not a device that provides therapy to a patient.
No
The device is a disinfector and disinfectant system, not a diagnostic device. Its purpose is to provide high-level disinfection of TEE ultrasound probes, which is a sterilization or cleaning function, not a diagnostic one.
No
The device description clearly outlines a physical hardware system (TD-100 disinfector) that performs a disinfection process using a specific liquid disinfectant (TD-5). It involves heating, soaking, and rinsing, which are hardware-driven functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use of the TD-100 disinfector and TD-5 disinfectant system is to disinfect medical devices (TEE ultrasound probes). Disinfection is a process applied to medical devices to reduce the number of viable microorganisms.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Function: The TD-100 system's function is to clean and disinfect the TEE probe itself, not to analyze a sample taken from a patient.
The system is a medical device used in the process of preparing other medical devices for use on patients. It does not perform any diagnostic testing on patient samples.
N/A
Intended Use / Indications for Use
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.
Product codes
PSW
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,
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 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.
1
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
2
Indications for Use
510(k) Number: K051305
Device Name: TD-5 High Lével Disinfectant and TD-100 Transesophiageal Probe Disinfector
Indications For Use:
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.
TD-5 High Level Disinfectant should be used with the following contact conditions:
| | Time | Temperature | Minimum
Recommended
Concentration |
|----------------------------|-----------|-------------|-----------------------------------------|
| High Level
Disinfection | 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
3
AUG 1 8 2005
12 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ので、この後の時間があります。 この時間には、 この時、 、 、 、 、 、 、 、 、 、 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
..............................................................................................................................................................................
4
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,
Intended Use:
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.
のです。 この時間のお店は、 もちろん、 しかし、 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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.
..............................................................................................................................................................................
5
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.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
6
Conclusion:
. . . . . . . . . . . . . . . . . ... ... ... .. .. .. .. .. .. .. .. ..
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. ...
. ............................................................................................................................................................................
CS Medical LLC 510(1) Premiarket Application for TD-100 Disinfoctor and TD-5 HLD
40