(335 days)
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No
The device description focuses on UV-C dose monitoring and control using optical sensors and software to ensure a predefined dose is achieved. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The software's function is described as deterministic based on sensor readings and pre-defined parameters.
No
This device is for high-level disinfection of ultrasound probes, not for treating patients.
No
The device is a high-level disinfection system for ultrasound probes, not a diagnostic device. It functions to clean medical equipment rather than to diagnose conditions.
No
The device description clearly states it is an automated medical device consisting of a sealed disinfection chamber, UV-C lamps, reflective walls, and optical sensors (photodiodes). While software is used for control and monitoring, the core function and components are hardware-based.
Based on the provided information, the Chronos® device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to achieve high-level disinfection of the surfaces of ultrasound probes. This is a process applied to a medical device (the ultrasound probe) to reduce microbial contamination, not a test performed on a biological sample to diagnose a condition or provide information about a patient's health.
- Device Description: The device description clearly states its function is to provide UV-C disinfection of ultrasound probes within an enclosed chamber. It monitors UV-C dose and ensures the disinfection cycle is completed. This is a physical/chemical process applied to an external object.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.). IVDs are designed to perform tests on such samples.
- Performance Studies: The performance studies focus on the device's ability to kill microorganisms on the probe surfaces (log reduction, microbicidal potency, etc.), not on the accuracy or reliability of a diagnostic test.
In summary, the Chronos® is a medical device used for reprocessing (disinfecting) other medical devices (ultrasound probes). It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chronos® is indicated for use in a healthcare environment to achieve a high-level disinfection of surfaces of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.
Product codes (comma separated list FDA assigned to the subject device)
SCS
Device Description
The Germitec Chronos® device is intended to provide Ultraviolet C (UV-C) chemical-free highlevel disinfection (HLD) of ultrasound probes within an enclosed disinfection chamber. As defined in FDA Guidance - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, found at https://www.fda.gov/media/80265/download, HLD is a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores. The subject device is intended for use in health care facilities by trained personnel. The Chronos® is an automated medical device consisting of a sealed disinfection chamber, incorporating multiple UV-C lamps and reflective walls. UV-C dose is identified as the only critical determinant of the effectiveness of the disinfection cycle.
The software is used to determine achievement of the disinfection total dose and acceptance of the automated HLD cycle. The total dose delivered to the surface of each ultrasound probe undergoing. the disinfection process is continuously monitored by two optical sensors, UV-C sensitive photodiodes. The control system continuously takes readings from the sensors, tracks progress of the ongoing disinfection cycle, and terminates the disinfection cycle when the cycle-controlling photodiodes indicate that the pre-defined UV-C dose has been achieved. Additionally, the device utilizes an independent cycle monitoring step through the use of a third UV-C photodiode. This independent probe is used to verify that the pre-defined UV-C HLD dose has been delivered.
Onto each ultrasound probe for which compatibility has been validated, a ring is placed onto the ultrasound cable. This ring is used to set the probe into the proper position within the chamber, as well as to include an identifier barcode. This barcode is read by the Chronos® software, and provides identification of both the appropriate disinfection dose as well as traceability for the ultrasound probe undergoing disinfection. The encoding of the barcode to each specific probe model and installation of the ring on each probe can only be performed by an authorized service representative from Germitec.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare environment, trained personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
UV-C Hierarchy of Resistance: Performance testing showed that the most resistant microorganism tested was Aspergillus brasiliensis.
Potency Testing: Testing documented that the device has microbicidal potency against sporicidal, bactericidal, fungicidal, mycobactericidal, and virucidal organisms, including Bacillus subtilis, Deinococcus radiodurans, Mycobacterium terrae, Candida auris, and Poliovirus Type 1, among others.
Simulated Use Testing: Demonstrated that the Chronos® can reliably and consistently achieve a > 6 log reduction of Bacillus subtilis (surrogate microorganism) on worst-case ultrasound probes over a range of challenging geometries.
Optical Verification on Worst-Case Probes: Demonstrated that the minimum effective dose (MED) of (b)(4) mJ/cm2 UV-C exposure was received at all geometrically worst-case locations on selected probes following automated disinfection cycles.
In-Use Testing: Demonstrated the achievement of HLD on clinical used transvaginal, transrectal, and external ultrasound probes.
UV-C Leak Test: Performance testing showed that UV-C leakage remained
N/A
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DE NOVO CLASSIFICATION REQUEST FOR GERMITEC CHRONOS
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Ultraviolet radiation disinfection chamber device. An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.
NEW REGULATION NUMBER: 21 CFR 880.6511
CLASSIFICATION: Class II
PRODUCT CODE: SCS
BACKGROUND
DEVICE NAME: Germitec Chronos®
SUBMISSION NUMBER: DEN230067
DATE DE NOVO RECEIVED: October 3, 2023
SPONSOR INFORMATION:
Germitec 19 Rue Vauban 33000 Bordeaux, France
INDICATIONS FOR USE
Chronos® is indicated for use in a healthcare environment to achieve a high-level disinfection of surfaces of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.
LIMITATIONS
The Germitec Chronos® is intended to be marketed for Over-The-Counter (OTC) use.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS
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DEVICE DESCRIPTION
The Germitec Chronos® device is intended to provide Ultraviolet C (UV-C) chemical-free highlevel disinfection (HLD) of ultrasound probes within an enclosed disinfection chamber. As defined in FDA Guidance - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, found at https://www.fda.gov/media/80265/download, HLD is a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores. The subject device is intended for use in health care facilities by trained personnel. The Chronos® is an automated medical device consisting of a sealed disinfection chamber, incorporating multiple UV-C lamps and reflective walls. UV-C dose is identified as the only critical determinant of the effectiveness of the disinfection cycle.
The software is used to determine achievement of the disinfection total dose and acceptance of the automated HLD cycle. The total dose delivered to the surface of each ultrasound probe undergoing. the disinfection process is continuously monitored by two optical sensors, UV-C sensitive photodiodes. The control system continuously takes readings from the sensors, tracks progress of the ongoing disinfection cycle, and terminates the disinfection cycle when the cycle-controlling photodiodes indicate that the pre-defined UV-C dose has been achieved. Additionally, the device utilizes an independent cycle monitoring step through the use of a third UV-C photodiode. This independent probe is used to verify that the pre-defined UV-C HLD dose has been delivered.
Image /page/1/Picture/3 description: The image shows a medical device with a user interface panel on the left side. On the right side, there is a probe holder and barcode reader opening, a disinfection chamber, and a door. The device appears to be designed for disinfecting medical probes and reading barcodes.
Pictures of Chronos® - Door Closed (left) and Door Open (right):
Onto each ultrasound probe for which compatibility has been validated, a ring is placed onto the ultrasound cable. This ring is used to set the probe into the proper position within the chamber, as well as to include an identifier barcode. This barcode is read by the Chronos® software, and
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provides identification of both the appropriate disinfection dose as well as traceability for the ultrasound probe undergoing disinfection. The encoding of the barcode to each specific probe model and installation of the ring on each probe can only be performed by an authorized service representative from Germitec.
Image /page/2/Picture/1 description: The image shows a barcode reader and its components. The top left image shows the front view of the barcode reader, with labels pointing to the window, barcode sticker, ring, and probe cable. The top right image shows a side view of the barcode reader, with a label pointing to the barcode reader opening. The bottom image shows a close-up view of the ring receptacle and the ring, with labels pointing to each component.
Barcode ring location:
SUMMARY OF BENCH STUDIES
REPROCESSING, STERILITY AND SHELF-LIFE
The Germitec Chronos® is provided non-sterile and does not require additional reprocessing or sterilization. The device requires regular maintenance in order to continue to function as intended.
Annual preventive maintenance activities are defined for general system checks, device cleaning (internal and external components), calibration of optical sensors (UV-C photodiodes) and replacement of the ventilation filter. Additionally, the UV-C lamps must be replaced on a two-year interval, or every 100 hours of cumulative use, whichever comes first. The software provides an indication to the operator of UV-C lamp usable life remaining.
BIOCOMPATIBILITY
The Germitec Chronos® device is designed to provide liquid-free, high-level disinfection of reusable ultrasound probes using UV-C as the germicidal agent. Since UV-C does not remain on the ultrasound probe following completion of an HLD cycle, there is no indirect contact with the patient or personnel conducting HLD reprocessing. The sponsor has
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provided an evaluation of the surface materials of representative ultrasound probes following exposure to the UV-C disinfection cycle. Biocompatibility risk evaluation and testing has been conducted in accordance with the FDA 2020 Biocompatibility Guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," found at https://www.fda.gov/media/142959/download
SOFTWARE & CYBERSECURITY
The Germitec Chronos® device incorporates a software-based control system used to control and monitor the delivery of UV-C dose required for high level disinfection of reusable ultrasound probes. The control system includes an ultrasound probe identifying system that captures key information about the probe, using a barcode reader, to link it to each disinfection. In addition to controlling the HLD cycle, the Chronos® device software controls system operation, ensures that the device is operating as expected, and communicates potential cycle errors to the user, as well as providing warnings about system status, condition, and reminders regarding preventive maintenance. The software testing was conducted as per FDA guidance document, "Content of premarket submissions for Device Software Functions, " found at https://www.fda.gov/media/153781/download.
Cybersecurity testing was conducted as per FDA guidance documents. "Cybersecurity in Medical Devices: Ouality System Considerations and Content of Premarket Submissions" found at https://www.fda.gov/media/119933/download, and "Postmarket Management of Cybersecurity in Medical Devices, " at https://www.fda.gov/media/95862/download.
ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY
Electromagnetic Compatibility (EMC) of the Chronos® device has been evaluated in accordance with IEC 61326-1, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements, and IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
Electrical safety testing of the Chronos® device was completed in accordance with IEC 61010-1. Safety requirement for electrical equipment for measurement, control and laboratory use. Part 1: General requirements and IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-040: Particular requirement for sterilizers and washer-disinfectors used to treat medical materials. Testing has been successfully completed per the referenced standards. including electrical, mechanical resistance to shock/impact, and mechanical safety testing.
PERFORMANCE TESTING - BENCH
The sponsor conducted the following performance tests to support that the device can achieve its intended use:
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UV-C Hierarchy of Resistance .
Performance testing has been conducted to support a side-by-side evaluation of microorganism UV-C resistance. Each microorganism was tested at a series of varying UV-C doses in the Chronos® device. For the purposes of hierarchy testing, a panel of microorganisms was selected which represented a combination of organisms currently used as surrogates for other HLD processes or organisms reported to be particularly resistant to UV-C in literature. The panel of microorganisms included in UV-C resistance hierarchy testing included bacterial spores, bacteria, mycobacteria, yeast/molds (spores) and Trichomaceae family (spore forming molds). A hierarchy of UV-C resistance was determined for the Chronos® device. Based on the results obtained, the most resistant microorganism tested was Aspergillus brasiliensis, of the Trichomaceae family (spore forming molds).
Potency Testing .
The Chronos® device was tested for potency using the standard array of microbicidal testing to support device efficacy. Modified testing was developed to demonstrate microbicidal potency for the device as there exists no current standard method in place for UV-C disinfection processes. Potency testing was conducted to demonstrate sporicidal, bactericidal, fungicidal, mycobactericidal and virucidal efficacy of the device. Microbicidal potency testing included the following microorganisms.
| Microbicidal Activity | Organisms Challenged |
|---|---|
| Sporicidal | Bacillus subtilis |
| Bacillus pumilus | |
| Clostridium sporogenes | |
| Bactericidal | Deinococcus radiodurans |
| Salmonella enterica | |
| Staphylococcus aureus | |
| Pseudomonas aeruginosa | |
| Paraburkholderia fungorum | |
| Mycobactericidal | Mycobacterium terrae |
| Mycobacterium bovis | |
| Mycobacterium avium | |
| Fungicidal | Candida auris |
| Candida albicans | |
| Trichophyton mentagrophyte (spore form) | |
| Virucidal | Poliovirus Type 1 |
| Adenovirus Type 5 | |
| Murine Norovirus | |
| Vaginal Herpes | |
| Polyomavirus | |
| HPV16 / HPV18 |
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| Sporicidal Activity | Organisms Challenged |
|---|---|
| Trichomaceae family (spore forming molds) | Aspergillus brasiliensis |
| Penicillium polonicum (spore form) |
Based on the testing documentation provided, the results support the determination of microbicidal potency for the device.
● Simulated Use Testing
Simulated use testing was conducted over a range of worst-case ultrasound probes to demonstrate that the Chronos® can reliably and consistently achieve a > 6 log reduction of the surrogate microorganism (Bacillus subtilis) following exposure to the disinfection cycle. Based on the completed hierarchy of resistance testing and the results of potency testing, Bacillus subtilis was identified as the most resistant bacterial spore and determined to be the most appropriate for use in Simulated Use testing. Representative transvaginal and transrectal (mucous membrane contacting), and external (skin contacting) ultrasound probes were selected based on their geometric complexity and difficulty to consistently achieve UV HLD.
For each probe, the three worst-case locations were identified based on difficulty for UV-C exposure to penetrate and therefore posed the greatest challenge to microbial inactivation. For each of these worst-case locations, a > 6 log microbial reduction was demonstrated for the worst-case ultrasound probes over a range of challenging geometries.
Optical Verification on Worst-Case Probes .
Worst-case ultrasound probes and associated "cold spot" locations on each probe, underwent optical verification studies to demonstrate that each location received the minimum effective dose (MED) of (b)(4) |mJ/cm2 UV-C exposure. All optical measurements at these geometrically worst-case locations were shown to receive the MED following exposure to the Chronos® device automated disinfection cycles.
In-Use Testing .
Ultrasound probes used in a clinical setting were subjected to the Chronos® automated high level disinfection cycles. Transvaginal and transrectal probes were used with single use probe protective sheath and gel. Transvaginal and transrectal probes were cleaned using cleaning solutions routinely used by hospital. External probes were used without a sheath and only underwent a dry wipe prior to exposure in the Chronos® system. In-Use testing demonstrated the achievement of HLD on these clinical used ultrasound probes.
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UV-C Leak Test .
The sponsor has conducted performance testing to support to demonstrate that the chamber door prevents UV-C leakage from the disinfection chamber during a routine disinfection cycle. Documentation was provided to show that the amount of UV-C leakage remained