(39 days)
No
The document describes image processing and recording capabilities but does not mention AI or ML algorithms being used for analysis or interpretation.
No
The device is described as a "diagnostic system intended to be used to investigate pelvic floor disorders" by processing and recording images and videos. It does not perform any therapeutic function.
Yes
This device is explicitly described as a "diagnostic system intended to be used to investigate pelvic floor disorders" in the "Device Description" section. It processes and records images from ultrasound and video cameras to aid in evaluating medical conditions.
No
The device description explicitly states that the system includes "accessories (endoanal probe and video camera)" which are hardware components, making it a system that includes both software and hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The THD Procto Software System works with imaging modalities (ultrasound and video) that are applied to the body (endoanal ultrasound and anoscopy). It processes and records images of internal structures, but it does not analyze biological samples like blood, urine, or tissue biopsies.
- The intended use and device description clearly focus on imaging and image processing. The software's functions revolve around acquiring, processing, and displaying images and videos from the ultrasound probe and video camera.
Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The THD Procto Software 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
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, OUG, FWG
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 (endoanal probe and video camera), is able to be applied for:
- Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
- -Anoscopy 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; Durinq Anoscopy exams the THD Procto Software System records and displays images of the
anorectal channel with the aid of a dedicated video camera;
The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:
- Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
- . Endoanal Ultrasound Module, which manages:
- The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
- Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
- The examination report (medical history, comments, conclusions) and the printing O
- Anoscopy Exams module, which manages:
- Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
- Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
- The examination report (medical history, comments, conclusions) and the printing o
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoanal ultrasound, Anoscopy (video camera)
Anatomical Site
Pelvic region, anal canal, anorectal channel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
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
January 26, 2020
Image /page/0/Picture/1 description: The image shows 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 letters "FDA" in a square and the words "U.S. Food & Drug Administration".
THD SpA % Filippo Bastia CEO Via dell'Industria, 1 Correggio (RE) 42015 ITALY
Re: K193512
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, ITX, OUG, FWG Dated: December 16, 2019 Received: December 18, 2019
Dear Filippo Bastia:
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
1
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.
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
2
Indications for Use
510(k) Number (if known) K193512
Device Name THD Procto Software System
Indications for Use (Describe) The THD Procto Software 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
| 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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3
-
- General Information
Submitter :
- General Information
THD SpA Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371
Establishment Registration Number: 3006680097
Contact:
Filippo Bastia Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371 Email: requlatory@thdlab.com
Summary Preparation Date:
December 19, 2019
-
- Name & Classification
| Device Name: | THD Procto Software System | |
|---|---|---|
| Classification names | Regulation Name | Product Code |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic ultrasonic transducer | 892.1570 | ITX |
| Surgical camera and accessories | 878.4160 | FWG |
| Medical Device data system | 880.6310 | OUG |
CLASS:
ll
-
- Predicate Devices
The THD Procto Software System is substantially equivalent to the following device:
- Predicate Devices
| Applicant | Device name | 510(k) Number |
|---|---|---|
| Halo Medical | ||
| Technologies | CatalySt, MidCRYSTL, HALO | |
| Ultrasound System | K140899 | |
| Predicate device | ||
| Interson Corporation | Interson USB Ultrasound | |
| System | K163443 | |
| Reference device |
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 (endoanal probe and video camera), is able to be applied for:
- Device Description
-
Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
-
-Anoscopy 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; Durinq Anoscopy exams the THD Procto Software System records and displays images of the
anorectal channel with the aid of a dedicated video camera;
The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:
- Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
- . Endoanal Ultrasound Module, which manages:
- The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
- Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
- The examination report (medical history, comments, conclusions) and the printing O
- Anoscopy Exams module, which manages:
- Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
- Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
- The examination report (medical history, comments, conclusions) and the printing o
-
- 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 reqion 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
5
6. Comparison of technological characteristics with the predicate devices
| Proposed Device | Predicate device | Reference device | |
|---|---|---|---|
| Product Name | THD Procto Software | ||
| System | CatalySt, MidCRYSTL, HALO | ||
| Ultrasound System | Interson USB Ultrasound | ||
| System | |||
| Manufacturer | THD Spa | Halo Medical Technologies | Interson Corporation |
| 510(K) No. | / | K140899 | K163443 |
| Classification | |||
| • Regulation Name | Ultrasound Pulsed Echo Imaging | ||
| System | Ultrasound Pulsed Echo Imaging | ||
| System | Ultrasonic pulsed doppler imaging | ||
| system | |||
| • Regulation Number | 21 CFR 892.1560 | ||
| 21 CFR 892.1570 | |||
| 21 CFR 878.4160 | |||
| 21 CFR 880.6310 | 21 CFR 892.1560 | ||
| 21 CFR 892.1570 | 21 CFR 892.1550 | ||
| • Regulatory Class | II | II | II |
| • Product Code | IYO | IYO | IYN, |
| • Subsequent Product | |||
| Code | ITX, FWG, OUG | ITX | IYO, ITX |
| 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 a | |||
| resolution greater than 1.1 MPx | |||
| through USB protocol | "Catalyst" is a diagnostic ultrasound | ||
| system designed to be used for | |||
| investigating disorders of the pelvic | |||
| floor. | |||
| An ultrasonographic crystal within | |||
| the probe records images of the | |||
| organ, muscle, and tissue structures | |||
| of the pelvic region. | |||
| MidCRYSTL and HALO probes allow | |||
| for ultrasonography of | |||
| the following: |
- on the surface of the perineumn
and/or abdomen, - endocavity, by inserting the
endovaginal probe into the vagina,
and - endocavity, by inserting the
endoanal probe into the anal canal. | The Interson USB Ultrasound
System is intended for diagnostic
ultrasound imaging in B, color
Doppler, or Combined (B + Color)
modes. It is indicated for diagnostic
ultrasound imaging and fluid flow
analysis in the following
applications:
• Fetal/Obstetric
• Abdominal
• Pediatric
• Small Organ
• Musculo-skeletal
(conventional)
• Musculo-skeletal (superficial)
• Urology
• Gynecology
• Pelvic Floor
• Neuro-muscular
• Peripheral Vessel
The system is intended for use by
healthcare professionals |
| • Anatomical site | Anal canal | Perineum and/or abdomen, vagina,
anal canal | Every area in which ultrasonography is
required - it include anal canal using
the proper probe |
| Features | | | |
| • Configuration of the
system | Standalone software,
USB Endoanal probe and camera | Standalone software and
USB dedicated pelvic floor probes | Standalone software and
USB dedicated probes for different
applications |
| • 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 measure
distances and calculate angles | 2D measurement and
area measurement |
| • Commercial package | THD Proctostation or THD Procto
mobile | "Catalyst" diagnostic ultrasound
system | Unknown |