THD Procto Software System

K193512 · Thd Spa · IYO · Jan 26, 2020 · Radiology

Device Facts

• Record ID: K193512
• Device Name: THD Procto Software System
• Applicant: Thd Spa
• Product Code: IYO · Radiology
• Decision Date: Jan 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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

Device Story

Diagnostic system for pelvic floor disorders; utilizes dedicated endoanal ultrasound probe and video camera. Inputs: ultrasound signals from probe; video/images from camera via USB. Software processes signals into 2D echographic images/videos; enables real-time or post-processing (notes, zoom, measurements). Outputs: recorded images, videos, and examination reports (medical history, conclusions, printing). Used in clinical settings by healthcare professionals. System comprises three modules: Medical Report (database management), Endoanal Ultrasound, and Anoscopy Exams. Facilitates clinical decision-making through visualization and documentation of anorectal/pelvic structures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Standalone software running on COTS Windows OS. Interfaces with USB-based endoanal ultrasound probe and video camera (>1.1 MPx). Functions include 2D image processing, distance/area/angle measurements, and report generation. Class II device.

Indications for Use

Indicated for patients requiring evaluation of pelvic floor disorders via endoanal ultrasound or anorectal channel examination via anoscopy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CatalySt, MidCRYSTL, HALO Ultrasound System (K140899)

Reference Devices

• Interson USB Ultrasound System (K163443)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size: 12pt;"><b> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12pt;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

*"An agency may not conduct or sponsor, and a person is not required to respond to a collection of*

not conduct or sponsor, and a person is not required to respond to, a collection of An agency may information unless it displays a currently valid OMB number."

{3}------------------------------------------------

- 1. General Information
Submitter :

THD SpA Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. [phone] Fax [phone]

## Establishment Registration Number: 3006680097

Contact:

Filippo Bastia Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. [phone] Fax [phone] Email: [e-mail]

Summary Preparation Date:

December 19, 2019

- 2. 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

- 3. Predicate Devices
The THD Procto Software System is substantially equivalent to the following device:

| Applicant | Device name | 510(k) Number |
|------------------------------|------------------------------------------------|-----------------------------|
| Halo Medical<br>Technologies | CatalySt, MidCRYSTL, HALO<br>Ultrasound System | K140899<br>Predicate device |
| Interson Corporation | Interson USB Ultrasound<br>System | K163443<br>Reference device |

{4}------------------------------------------------

- 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:

- 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
- 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 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<br>System | CatalySt, MidCRYSTL, HALO<br>Ultrasound System | Interson USB Ultrasound<br>System |
| Manufacturer | THD Spa | Halo Medical Technologies | Interson Corporation |
| 510(K) No. | / | K140899 | K163443 |
| Classification | | | |
| • Regulation Name | Ultrasound Pulsed Echo Imaging<br>System | Ultrasound Pulsed Echo Imaging<br>System | Ultrasonic pulsed doppler imaging<br>system |
| • Regulation Number | 21 CFR 892.1560<br>21 CFR 892.1570<br>21 CFR 878.4160<br>21 CFR 880.6310 | 21 CFR 892.1560<br>21 CFR 892.1570 | 21 CFR 892.1550 |
| • Regulatory Class | II | II | II |
| • Product Code | IYO | IYO | IYN, |
| • Subsequent Product<br>Code | ITX, FWG, OUG | ITX | IYO, ITX |
| Intended use | | | |
| • Indications for use | The THD Procto Software System is<br>a software that can be used:<br>• In endoanal ultrasound (EAUS), in<br>order to help evaluate pelvic floor<br>disorders by processing and<br>recording images of tissue<br>structures in the pelvic region with<br>the aid of a dedicated ultrasound<br>probe. This is done by inserting the<br>probe into the anal canal, acquiring<br>the ultrasound signal and letting the<br>software process the image.<br>• In Anoscopy exams in order to<br>record images and videos of the<br>anorectal channel, which are<br>acquired through a dedicated video<br>camera that provides images with a<br>resolution greater than 1.1 MPx<br>through USB protocol | "Catalyst" is a diagnostic ultrasound<br>system designed to be used for<br>investigating disorders of the pelvic<br>floor.<br>An ultrasonographic crystal within<br>the probe records images of the<br>organ, muscle, and tissue structures<br>of the pelvic region.<br>MidCRYSTL and HALO probes allow<br>for ultrasonography of<br>the following:<br>1) on the surface of the perineumn<br>and/or abdomen,<br>2) endocavity, by inserting the<br>endovaginal probe into the vagina,<br>and<br>3) endocavity, by inserting the<br>endoanal probe into the anal canal. | The Interson USB Ultrasound<br>System is intended for diagnostic<br>ultrasound imaging in B, color<br>Doppler, or Combined (B + Color)<br>modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow<br>analysis in the following<br>applications:<br>• Fetal/Obstetric<br>• Abdominal<br>• Pediatric<br>• Small Organ<br>• Musculo-skeletal<br>(conventional)<br>• Musculo-skeletal (superficial)<br>• Urology<br>• Gynecology<br>• Pelvic Floor<br>• Neuro-muscular<br>• Peripheral Vessel<br>The system is intended for use by<br>healthcare professionals |
| • Anatomical site | Anal canal | Perineum and/or abdomen, vagina,<br>anal canal | Every area in which ultrasonography is<br>required - it include anal canal using<br>the proper probe |
| Features | | | |
| • Configuration of the<br>system | Standalone software,<br>USB Endoanal probe and camera | Standalone software and<br>USB dedicated pelvic floor probes | Standalone software and<br>USB dedicated probes for different<br>applications |
| • Software platform | Commercial off-the-<br>shelf operating system<br>(Windows) | Commercial off-the-<br>shelf operating system<br>(Windows) | Commercial off-the-<br>shelf operating system<br>(Windows) |
| • Measurement function | 2D measurement: distances,<br>area and angle measurement | 2D measure<br>distances and calculate angles | 2D measurement and<br>area measurement |
| • Commercial package | THD Proctostation or THD Procto<br>mobile | "Catalyst" diagnostic ultrasound<br>system | Unknown |