(29 days)
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
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.
The provided text is a 510(k) Pre-Market Notification for the THD Procto Software System. It focuses on administrative changes and design control activities related to the addition of a new "Manometry Module" to an already cleared software system. This type of submission (Special 510(k)) indicates that the device modification does not raise new questions of substantial equivalence.
Crucially, the document does not contain the detailed performance study results, acceptance criteria, or information about the ground truth establishment, expert review, or sample sizes for a clinical performance study related to an AI/ML component. The "Performance Data" section ([8]) states that "Non clinical tests performed on the subject device. The software has been tested and validated according to the requirements of IEC 62304." and mentions "an integration test on the modified device."
Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them, specifically relating to AI/ML performance, because such data is not present in this 510(k) document. This submission primarily focuses on the integration and functional verification of a new module.
Based on the provided text, the requested information cannot be found.
The document is a regulatory submission describing a software modification (addition of a manometry module) to an existing device, and it relies on non-clinical testing and conformity to standards like IEC 62304. It does not detail clinical performance studies for AI/ML components with human-in-the-loop performance, expert consensus on ground truth, or specific acceptance criteria for diagnostic accuracy.
The relevant section on "Performance Data" ([8]) explicitly states:
- "Non clinical tests performed on the subject device."
- "The software has been tested and validated according to the requirements of IEC 62304."
- "an integration test on the modified device has been performed in order to check the correct integration of the THD Procto Software... with the THD Anopress device, verifying that the additional Manometry Module performs the expected functions and dialogues correctly with the THD Anopress device."
This indicates fundamental functional and integration testing, not a clinical performance study with the metrics and details requested (e.g., AUC, sensitivity, specificity, expert consensus, MRMC studies, etc.).
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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
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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
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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
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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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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.
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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;
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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 SoftwareSystem | THD Procto SoftwareSystem | THD Anopress with THDSensyProbe |
| Manufacturer | THD S.p.a | THD S.p.a | THD S.p.a |
| 510(K) No. | K211623 | K193512 | K180135 |
| Classification | |||
| · Regulation Name | Ultrasound Pulsed EchoImaging System-Gastrointestinal motilitymonitoring system | Ultrasound Pulsed Echo ImagingSystem | Gastrointestinal motility monitoringsystem |
| · 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 ProductCode | KLA, ITX, FWG, OUG, NSX | ITX, FWG, OUG | NSX |
| Intended use | |||
| · Indications for use | The THD Procto Software System isa software that can be used:• In endoanal ultrasound (EAUS), inorder to help evaluate pelvic floordisorders by processing andrecording images of tissuestructures in the pelvic region withthe aid of a dedicated ultrasoundprobe. This is done by inserting theprobe into the anal canal, acquiringthe ultrasound signal and letting thesoftware process the image.· In Anoscopy exams in order torecord images and videos of theanorectal channel, which areacquired through a dedicated videocamera that provides images with anadequate resolution and theirsubsequent processing | The THD Procto Software System isa software that can be used:• In endoanal ultrasound (EAUS), inorder to help evaluate pelvic floordisorders by processing andrecording images of tissuestructures in the pelvic region withthe aid of a dedicated ultrasoundprobe. This is done by inserting theprobe into the anal canal, acquiringthe ultrasound signal and letting thesoftware process the image.· In Anoscopy exams in order torecord images and videos of theanorectal channel, which areacquired through a dedicated videocamera that provides images with aresolution greater than 1.1 MPxthrough USB protocol | |
| • In anorectal manometryexaminations, in order to view on atwo-dimensional Pressure/Timegraph the acquisition of the meanpressure signal transmitted by theTHD Anopress device andsubsequent processing (examinationreport and report printing)• Follow the clinical history, possiblefollow-ups of a patients | The THD Anopress device must beusedexclusively to assess the averagesphincter tone due to the pressureexerted by the muscles in the analcanal on the specially designed THDProbes. THD Anopress must only beused by appropriately trainedmedical staff.Furthermore, the THD SensyProbeenables evaluation of the rectalsensitivity and capacity and the ano-rectal inhibitory reflex throughconnection to a syringe and filling ofthe 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 SoftwareSystem | THD Procto SoftwareSystem | THD Anopress with THDSensyProbe |
| Manufacturer | THD S.p.a | THD S.p.a | THD S.p.a |
| 510(K) No. | K211623 | K193512 | K180135 |
| Technical Features | |||
| • Configuration of thesystem | Standalone software, USB Endoanalprobe and camera and possibility tocommunicate with the THDAnopress device with the specificBluetooth Dongle available in theTHD Anopress, to be inserted intothe USB port of the PC in order toallow the bluetoothconnectionbetween the PC and the THDAnopress | Standalone software,USB Endoanal probe and camera | - USB key containing Anopress SWdata acquisition software andSoftware - Manual- Bluetooth Dongle to be insertedinto the USB port of the PC toestablish the connection with theTHD 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 orTHD ProctoMobile | THD Proctostation orTHD ProctoMobile | - Manometer- Inflating system: pump (on THDAnopress main unit) for manometrytest and syringe for sensation test- Software on the THD Anopressdevice- Software on PC (optional)- Catheter (probe) :o with one sensitive balloon(membrane) located on theintroducer (THD PressProbe).Membrane is related to manometrytesto with one sensitive balloon(membrane) located on theintroducer and one larger balloonlocated in the most distal end (THDSensyProbe).Membrane is related to manometrytest, the larger balloon is related torectal sensation test |
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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
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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.
§ 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.