THD SLIDE ONE

K090009 · Thd Spa · JAF · Jan 28, 2009 · Radiology

Device Facts

• Record ID: K090009
• Device Name: THD SLIDE ONE
• Applicant: Thd Spa
• Product Code: JAF · Radiology
• Decision Date: Jan 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

System comprises THD Evolution Doppler device (8 MHz continuous wave Doppler detector, loudspeaker, light source) and THD Slide One Kit (proctoscope, needle holder, knot tightener, sutures, Doppler probe). Used for Transanal Hemorrhoidal Dearterialization (THD). Physician uses Doppler probe to detect terminal branches of superior hemorrhoid artery; audible feedback guides surgeon in performing arterial ligation using provided instruments. Used in hospitals, clinics, and physician offices. Benefits include Doppler-guided precision for hemorrhoid treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

• THD Slide (K081429)

Reference Devices

• THD Submission (K070815)

Submission Summary (Full Text)

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K 090009

THD Slide One

## THD S.p.A. SPECIAL 510(K) Notification

# 510(k) Summary for the THD Slide

JAN 2 8 2009

.

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

## 2.1. General Information

Submitter:

THD S.p.A. Via dell'Industria, 1 42015 - Correggio (RE) Italy

Guido Bonapace ISEMED srl

40026 Imola (BO)

Italy

Via Borgo Santa Cristina 12

Mob.phone: [phone] Telephone: [phone] Fax: [phone] Email: [e-mail]

Establishment Registration Number: 3006680097

Consultant:

Contact Person:

Contact Persons:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: [phone] Fax: [phone] Email: [e-mail]

Summary Preparation Date:

- 2.2. Names
Device Name: Classification Name: Product Code: Regulation number:

December 15, 2008

THD Slide One Nonfetal Ultrasonic monitor JAF 892.1540

### 2.3. Predicate Devices

CONFIDENTIAL

21

- -

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This Special 510(k) is related to the device modifications of the following devices:

| Applicant | Device name | 510(k) Number |
|------------|-------------|---------------|
| THD S.p.A. | THD Slide | K081429 |

### 2.4. Device Description

The THD Slide One consists of the THD Evolution Doppler device and the THD Slide One Kt. The THD Evolution Doppler device is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Slide One Kit is a sterilized surgical kit comprised of a proctoscope, needle holder, knot tightener, sutures and Doppler probe. The kits used for the surgical treatment could be the THD Slide One kit or one of the kits already cleared by THD/G.F .; the THD kit that was included in the THD Submission (K070815) or the THD Slide (K081429)

#### 2.5. Indications for Use

The THD Slide One 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 Doppler 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 Kits.

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

CONFIDENTIAL

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, official design.

#### Public Health Service

JAN 2 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

THD Spa % O'Connell Regulatory Consultants. Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K090009

Trade/Device Name: THD Slide One Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: II Product Code: JAF Dated: December 15, 2008 Received: January 2, 2009

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 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.

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## Page 2 - Ms. Maureen O'Connell

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance、 please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M. Millman

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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THD Slide One

THD S.D.A. SPECIAL 510(K) Notification

Indications for Use

510(k) Number (if known): K 0900009

THD Slide One

Device Name:

Indications for Use:

The THD Slide One 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 system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD proctoscope, sutures and a needle holder included in the THD Kits.

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR -

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of COREH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

CONFIDENTIAL Page 19

510(k) Number 09 0009