TORNADO ROTATABEL SNARE AND POLYP CATCHER

K083049 · Horizons Intl. Corp. · FDI · Dec 23, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K083049
• Device Name: TORNADO ROTATABEL SNARE AND POLYP CATCHER
• Applicant: Horizons Intl. Corp.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Dec 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.

Device Story

The Horizons Rotatable Snare and Polyp Catcher TORNADO™ is an endoscopic accessory used by gastroenterologists during endoscopic procedures. The device consists of a snare mechanism designed to capture polyps within the gastrointestinal tract. It is used in conjunction with an electrosurgical unit to perform polypectomy, allowing for the simultaneous removal and collection of the tissue. The device is operated by a physician under endoscopic visualization to ensure precise targeting of the polyp. By enabling both excision and retrieval in a single procedure, the device streamlines the workflow for the clinician and facilitates the removal of polyps for subsequent pathological examination, potentially benefiting the patient by reducing procedure time and the need for multiple instrument exchanges.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an endoscopic electrosurgical accessory. It features a rotatable snare mechanism for tissue capture and a collection component. It is designed for use with standard endoscopic equipment and electrosurgical generators. Materials and sterilization methods are consistent with standard endoscopic surgical instruments.

Indications for Use

Indicated for the electrosurgical removal and collection of polyps from the gastrointestinal tract under endoscopic visualization in patients requiring polypectomy.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rafic Saleh, President Horizons International Corporation P.O. Box 213-3006 Zona Franca Metro Barreal De Heredia COSTA RICA

DEC 2 3 2008

Re: K083049

Trade/Device Name: Horizons Rotatable Snare and Polyp Catcher TORNADO™ Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: December 8, 2008 Received: December 10, 2008

Dear Mr. Saleh:

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.

{1}------------------------------------------------

## Page 2

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.

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## 510K INDICATION FOR USE STATEMENT

## 510(k) Number (if known): K083049

:

| Device Name: | Horizons Rotatabel Snare and Polyp Catcher TORNADOTM |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Name: | Horizons International Corp. |
| Indications for Use: | Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is<br>intended to Electrosurgically Remove and collect Polyps from the<br>Gastro Intestinal Tract Under Endoscopic Visualization. |

Horizons International Corp.

Signature:

100 - 100 -

Rafic Saleh – President

Date: Date: Date: Date:

Prescription Use
(Per 21 CFR 801.109)

: 上一篇:

:

:

1

·

: 上一篇: 上一篇:

. . . . .

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -083049