(29 days)
Not Found
No
The summary describes image processing and data visualization but does not mention any AI or ML techniques being used for analysis, interpretation, or decision support.
No
The device is described as a "diagnostic system intended to be used to investigate pelvic floor disorders" and its functions include processing images, recording data, and displaying results, all of which are diagnostic rather than therapeutic actions.
Yes
The device description clearly states, "The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders." This purpose is further supported by its use in processing and recording images for evaluation, as well as displaying and recording physiological data for analysis.
No
The device description explicitly states that the THD Procto Software System is used "together with its accessories and devices (endoanal probe, video camera and THD Anopress)". This indicates that the system includes hardware components beyond just the software itself.
Based on the provided information, the THD Procto Software System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The THD Procto Software System processes images and data acquired directly from within the patient's body using probes and cameras inserted into the anal canal and anorectal tract. It does not analyze biological samples like blood, urine, or tissue biopsies.
- The intended use and device description focus on imaging and physiological measurements. The system is used for endoanal ultrasound, anoscopy, and anorectal manometry, all of which are in-vivo diagnostic procedures.
- There is no mention of analyzing biological samples. The inputs are ultrasound signals, video images, and pressure data.
Therefore, the THD Procto Software System falls under the category of a medical device used for in-vivo diagnostic imaging and physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The THD Procto Software System is a software that can be used:
• In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.
• In Anoscopy exams, in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with an adequate resolution and their subsequent processing.
• In anorectal manometry examinations, in order to view on a two-dimensional Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing)
· Follow the clinical history, possible follow-ups of a patients
Product codes (comma separated list FDA assigned to the subject device)
IYO, KLA, ITX, FWG, OUG
Device Description
The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:
- -Endoanal ultrasound (→ trans-rectal ultrasound / echography)
- Anoscopy exams
- -Manometry exams
During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; During Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camero;
During Manometry exams the THD Procto Software System allows the visualization and storage of patient data and examination results (anorectal manometry pressure values) as measured by THD Anopress device.
The different modules and associated hardware devices cannot interfere with each other neither can work simultaneously.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Video
Anatomical Site
Anal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained medical staff.
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)
Non clinical tests performed on the subject device
The software has been tested and validated according to the requirements of IEC 62304.
The device modification has been evaluated according to the following guidance documents:
- -Guidance for the Content of Premarket Submission for Software Contained in Medical Devices: Guidance for Industry and Staff - Issued on May 11, 2005
- -The Special 510(k) Program: Guidance for Industry and FDA staff – Issued on September 13, 2019
- -Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and FDA Staff – issued on October 25, 2017
In addition to performance data already documented with K193512, an integration test on the modified device has been performed in order to check the correct integration of the THD Procto Software, the subject device, with the THD Anopress device, verifying that the additional Manometry Module performs the expected functions and dialogues correctly with the THD Anopress device.
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.
Not Found
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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 agency's name, "U.S. Food & Drug Administration."
August 31, 2023
THD SpA Maurizio Pantaleoni Quality and Regulatory Manager Via dell'Industria, 1 Correggio, RE 42015 ITALY
Re: K211623
Trade/Device Name: THD Procto Software System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, KLA, ITX, FWG, OUG
Dear Maurizio Pantaleoni:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 24, 2021. Specifically, FDA is updating this SE Letter to remove secondary product code NSX as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Yanna Kang, OHT8: Office of Radiological Health, 301-796-6704, Yanna.Kang@fda.hhs.gov.
Sincerelv.
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director for Mammography and Ultrasound DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
June 24, 2021
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
THD SpA % Maurizio Pantaleoni Quality and Regulatory Manager Via dell'Industria, 1 Correggio, RE 42015 ITALY
Re: K211623
Trade/Device Name: THD Procto Software System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, KLA, ITX, FWG, OUG, NSX Dated: May 19, 2021 Received: May 26, 2021
Dear Maurizio Pantaleoni:
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 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
2
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 (QS) 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,
Michael D. O'Hara For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Device Name THD Procto Software System
Indications for Use (Describe)
The THD Procto Software System is a software that can be used:
• In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.
• In Anoscopy exams, in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with an adequate resolution and their subsequent processing.
• In anorectal manometry examinations, in order to view on a two-dimensional Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing)
· Follow the clinical history, possible follow-ups of a patients
| 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
General Information 1.
Submitter :
THD SpA Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371
Establishment Registration Number: 3006680097
Contact:
Maurizio Pantaleoni Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371 Email: regulatory@thdlab.com
Summary Preparation Date: May 19, 2021
2. Name & Classification
Device Name: THD Procto Software System
Classification name: Ultrasound Pulsed Echo Imaging System
Classification regulation number: 892.1560
Primary Product Code: IYO
Additional Product Codes: KLA, ITX, FWG, OUG, NSX
CLASS: II
3. Predicate Devices
THD Procto Software System covered by this Special 510(k) is substantially equivalent to the following devices
| Applicant | Device name | 510(k) Number |
|---|---|---|
| THD S.p.A | THD Procto Software System | K193512 |
| THD S.p.A | THD Anopress with THD SensyProbe | K180135 |
The device modification is related to the THD Procto Software System, already cleared by the Agency with K193512. K193512 is then the primary predicate device for this device modification.
5
THD SPA SPECIAL 510(K) NOTIFICATION
The modified device consists in the addition of a new module to the THD Procto Software (namely the Manometry Module) that can communicate with the hardware device THD Anopress during the execution of anorectal manometry exams. THD Anopress is cleared by the Agency with K180135.
In the initial design of THD Anopress device, a dedicated software, named Anopress SW, was developed in order to allow the Bluetooth communication with THD Anopress device during anorectal manometry exams for patient and examination data storage.
Device modification of THD Procto Software System aims to provide a single software suite able to interface with different hardware devices commonly used in the proctology field, through the management of separate and independent modules, by integrating the Anopress SW in the THD Procto Software with an additional independent module, named Manometry Module.
The main features of the Manometry Module are summarized below:
- Communication with THD Anoperss device through USB Dongle Bluetooth technology
- . When THD Anopress device is connected and the manometry exam is in progress, the Manometry Module allows the acquisition of the patient manometric data provided by the THD Anopress hardware device and subsequent visualization on a two-dimensional Pressure/Time graph
- . Post processing elaboration by the operator of the acquired two-dimensional Pressure/Time graph with the possibility to change the positioning and size of the time intervals defining the manoeuvres performed by the patient
- Examination reporting (anamnesis, comments, conclusions) and report printing ●
The previous existing modules, e.g. Launcher, Endoanal Ultrasound (EAUS) and Anoscopy modules, are not affected by this device modification.
4. Device Description
The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:
- -Endoanal ultrasound (→ trans-rectal ultrasound / echography)
- Anoscopy exams ।
- -Manometry exams
During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; During Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camero;
6
During Manometry exams the THD Procto Software System allows the visualization and storage of patient data and examination results (anorectal manometry pressure values) as measured by THD Anopress device.
The different modules and associated hardware devices cannot interfere with each other neither can work simultaneously.
5. Indications for Use
The THD Procto Software System is a software that can be used:
- In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by o processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.
- In Anoscopy exams in order to record images and videos of the anorectal channel, o which are acquired through a dedicated video camera that provides images with an adequate resolution and their subsequent processing.
- In anorectal manometry examinations, in order to view on a two-dimensional o Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing)
- Follow the clinical history, possible follow-ups of a patients o
6. Design Control Activities
The device modification is related to the addition of a new module to the THD Procto Software already cleared by the Agency with K193512, namely the Manometry Module. This new module interfaces with the hardware device THD Anopress, cleared by the Agency with K180135. The new Manometry module keeps the same features and functionalities of the Anopress SW that is the initial software application designed to communicate with the THD Anopress device during manometry exams.
The design control activities performed on the modified devices aimed to the verification of the new features in relation to the risk analysis in order to assess the impact of this device modification, in compliance with the IEC62304, that is the standard normally used by THD to manages the development of its Software.
After verification and validation activities no unacceptable residual risks emerged from the risk analysis and all verification and validation activities performed on the subject modified device provided results conform to the required specifications.
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7. Comparison of technological characteristics with the predicate devices
| Proposed Device | Primary Predicate device | Secondary Predicate device | |
|---|---|---|---|
| Product Name | THD Procto Software | ||
| System | THD Procto Software | ||
| System | THD Anopress with THD | ||
| SensyProbe | |||
| Manufacturer | THD S.p.a | THD S.p.a | THD S.p.a |
| 510(K) No. | K211623 | K193512 | K180135 |
| Classification | |||
| · Regulation Name | Ultrasound Pulsed Echo | ||
| Imaging System |
Gastrointestinal motility
monitoring system | Ultrasound Pulsed Echo Imaging
System | Gastrointestinal motility monitoring
system |
| · Regulation Number | 21 CFR 892.1560 | 21 CFR 892.1560 | 21 CFR 876.1725 |
| · Regulatory Class | II | II | II |
| · Primary Product Code | IYO | IYO | KLA |
| · Subsequent Product
Code | KLA, ITX, FWG, OUG, NSX | ITX, FWG, OUG | NSX |
| Intended use | | | |
| · Indications for use | The THD Procto Software System is
a software that can be used:
• In endoanal ultrasound (EAUS), in
order to help evaluate pelvic floor
disorders by processing and
recording images of tissue
structures in the pelvic region with
the aid of a dedicated ultrasound
probe. This is done by inserting the
probe into the anal canal, acquiring
the ultrasound signal and letting the
software process the image.
· In Anoscopy exams in order to
record images and videos of the
anorectal channel, which are
acquired through a dedicated video
camera that provides images with an
adequate resolution and their
subsequent processing | The THD Procto Software System is
a software that can be used:
• In endoanal ultrasound (EAUS), in
order to help evaluate pelvic floor
disorders by processing and
recording images of tissue
structures in the pelvic region with
the aid of a dedicated ultrasound
probe. This is done by inserting the
probe into the anal canal, acquiring
the ultrasound signal and letting the
software process the image.
· In Anoscopy exams in order to
record images and videos of the
anorectal channel, which are
acquired through a dedicated video
camera that provides images with a
resolution greater than 1.1 MPx
through USB protocol | |
| | • In anorectal manometry
examinations, in order to view on a
two-dimensional Pressure/Time
graph the acquisition of the mean
pressure signal transmitted by the
THD Anopress device and
subsequent processing (examination
report and report printing)
• Follow the clinical history, possible
follow-ups of a patients | | The THD Anopress device must be
used
exclusively to assess the average
sphincter tone due to the pressure
exerted by the muscles in the anal
canal on the specially designed THD
Probes. THD Anopress must only be
used by appropriately trained
medical staff.
Furthermore, the THD SensyProbe
enables evaluation of the rectal
sensitivity and capacity and the ano-
rectal inhibitory reflex through
connection to a syringe and filling of
the balloon on the probe with air. |
| · Anatomical site | Anal canal | Anal canal | Anorectal tract |
| | Proposed Device | Primary Predicate device | Secondary Predicate device |
| Product Name | THD Procto Software
System | THD Procto Software
System | THD Anopress with THD
SensyProbe |
| Manufacturer | THD S.p.a | THD S.p.a | THD S.p.a |
| 510(K) No. | K211623 | K193512 | K180135 |
| Technical Features | | | |
| • Configuration of the
system | Standalone software, USB Endoanal
probe and camera and possibility to
communicate with the THD
Anopress device with the specific
Bluetooth Dongle available in the
THD Anopress, to be inserted into
the USB port of the PC in order to
allow the bluetooth
connection
between the PC and the THD
Anopress | Standalone software,
USB Endoanal probe and camera | - USB key containing Anopress SW
data acquisition software and
Software - Manual
- Bluetooth Dongle to be inserted
into the USB port of the PC to
establish the connection with the
THD Anopress. |
| • Software platform | Commercial off-the-
shelf operating system
(Windows) | Commercial off-the-
shelf operating system
(Windows) | Commercial off-the-
shelf operating system
(Windows) |
| • Measurement function | 2D measurement: distances,
area and angle measurement | 2D measurement: distances,
area and angle measurement | |
| • Commercial package | THD Proctostation or
THD ProctoMobile | THD Proctostation or
THD ProctoMobile | - Manometer - Inflating system: pump (on THD
Anopress main unit) for manometry
test and syringe for sensation test - Software on the THD Anopress
device - Software on PC (optional)
- Catheter (probe) :
o with one sensitive balloon
(membrane) located on the
introducer (THD PressProbe).
Membrane is related to manometry
test
o with one sensitive balloon
(membrane) located on the
introducer and one larger balloon
located in the most distal end (THD
SensyProbe).
Membrane is related to manometry
test, the larger balloon is related to
rectal sensation test |
8
8. Performance Data
Non clinical tests performed on the subject device
The software has been tested and validated according to the requirements of IEC 62304.
The subject device modification has been evaluated according to the following guidance documents:
- -Guidance for the Content of Premarket Submission for Software Contained in Medical Devices: Guidance for Industry and Staff - Issued on May 11, 2005
- -The Special 510(k) Program: Guidance for Industry and FDA staff – Issued on September 13, 2019
- -Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and FDA Staff – issued on October 25, 2017
9
THD SPA SPECIAL 510(K) NOTIFICATION
In addition to performance data already documented with K193512, an integration test on the modified device has been performed in order to check the correct integration of the THD Procto Software, the subject device, with the THD Anopress device, verifying that the additional Manometry Module performs the expected functions and dialogues correctly with the THD Anopress device.
8. Conclusions
In light of evidences summarized above and based on classification, intended use, technological characteristics and performance data, the subject device is substantially equivalent to the primary predicate device K193512 for Medical Report (Launcher), Endoanal Ultrasound (EAUS) and Anoscopy modules.