THD

K070815 · G.F. S.R.L. · JAF · Jun 20, 2007 · Radiology

Device Facts

• Record ID: K070815
• Device Name: THD
• Applicant: G.F. S.R.L.
• Product Code: JAF · Radiology
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit. The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

Device Story

THD system facilitates Transanal Hemorrhoidal Dearterialization (THD). Components: THD Evolution Doppler device (8 MHz continuous wave Doppler detector, loudspeaker, light source) and THD Kit (proctoscope, sutures, needle holder, knot tightener). Physician uses Doppler probe to detect terminal branch of superior hemorrhoid artery; provides audible feedback via loudspeaker. Physician performs ligation of identified artery using proctoscope and provided surgical tools. Used in hospitals, clinics, and physician offices. Benefits include precise identification of hemorrhoidal arteries for targeted ligation, potentially improving surgical outcomes for second/third-degree hemorrhoids.

Clinical Evidence

Bench testing only. Acoustic output parameters (MI, Ispta3, Wo) measured and compared against FDA guidance limits for diagnostic ultrasound systems. Results confirm acoustic performance is within safe limits and equivalent to predicate devices.

Technological Characteristics

8 MHz continuous wave (CW) Doppler detector; includes loudspeaker and light source. Accessories: Doppler transducer, optical fibers, pneumatic foot pedal. Surgical kit includes proctoscope, sutures, needle holder, knot tightener. Standalone device. Sterilized surgical kit components.

Indications for Use

Indicated for surgical treatment of second and third degree hemorrhoids in adult patients. Used by physicians in clinical settings via prescription.

Regulatory Classification

Identification

A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• HEMO-DOP (K041915)
• DOPPLER GUIDED PROCTOSCOPE Model 500H (K052067)

Submission Summary (Full Text)

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K070815

# 510(k) Summary of Safety and Effectiveness for the THD

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

| 2.1. General Information | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GF S.r.l.<br>Via dell'Industria, 1<br>42015 - Correggio (RE)<br>Italy |
| Consultant: | Guido Bonapace<br>ISENET<br>Via Emilia, 418<br>40096 - San Lazzaro di Savena (BO)<br>Italy |
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Summary Preparation Date: | March 20, 2007 |
| 2.2. Names | |
| Device Name: | THD |
| Classification Name: | Nonfetal Ultrasonic monitor |
| Product Code: | JAF |
| Regulation number: | 892.1540 |

#### 2.3. Predicate Devices

The THD is substantially equivalent to the following devices:

| Applicant | Device name | 510(k) Number |
|-----------------------------------|---------------------------------------------|---------------|
| DWL-Electronische<br>Systeme GmbH | HEMO-DOP | K041915 |
| Multigon Industries, Inc. | DOPPLER GUIDED<br>PROCTOSCOPE Model<br>500H | K052067 |

CONFIDENTIAL

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## 2.4. Device Description

The THD consists of the THD Evolution Doppler Device and the THD Kit. The THD Evolution Doppler is a 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler must be used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation.

The THD Kit is a sterilized surgical kit comprised of a proctoscope, sutures, a needle holder and a knot tightener.

#### 2.5. Indications for Use

The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and a needle holder included in the THD Kit.

The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

### 2.6. Performance Data

The Acoustic output parameters measured for the THD Evolution are:

| | MI | Ispta₃<br>(mW/cm²) | Wo<br>(mW) |
|---------------|--------|--------------------|------------|
| Mean value | 0.027 | 232 | 15,633 |
| Standard Dev. | 0.0042 | 78 | 2,676 |
| Max Value: | 0.032 | 322 | 18,500 |

The results summarized in the table show that the THD Evolution is substantially equivalent in regards to acoustic performance to other devices legally marketed in United States and is below the upper limits recommended by the guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" September 30, 1997.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

G.F. S.r.L.. % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell President 5 Timber Lane North Reading, Massachusetts 01864

Re: K070815

Trade/Device Name: THD Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: II Product Code: JAF Dated: May 24, 2007 Received: May 29, 2007

JUN 2 0 2007

Dear Ms. O'Connell:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen O'Connell

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K 070815

Device Name: __ THD___________________________________________________________________________________________________________________________________________________________

Indications for Use:

The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit.

The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|------------------------------------------------|
| | AND/OR |
| | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| GF Srl 510(k)<br>THD | 510(k) Number. <span style="font-variant:small-caps;">CONFIDENTIAL</span> IL070815 | Page 8 |
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