HORIZONS REUSABLE POLYPECTOMY SNARES

K022268 · Horizons Intl. Corp. · FDI · Oct 25, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022268
• Device Name: HORIZONS REUSABLE POLYPECTOMY SNARES
• Applicant: Horizons Intl. Corp.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polypectomy Snares are used for cutting of polyps.

Device Story

Horizons Reusable Polypectomy Snares are endoscopic electrosurgical accessories designed for the excision of polyps. The device is operated by a physician during endoscopic procedures. It functions by delivering electrosurgical energy to a wire loop (snare) to cut tissue. The device is reusable, requiring appropriate sterilization between uses. It is intended for use in clinical settings where endoscopic polypectomy is performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable electrosurgical snare for endoscopic use. Operates as an accessory to an electrosurgical unit. Materials and design consistent with standard endoscopic polypectomy snares.

Indications for Use

Indicated for the cutting of polyps in patients undergoing endoscopic procedures.

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)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 5 2002

Mr. Rafic Saleh President Horizons International Corp. 287 Monterrey Street P.O. Box 7273 Ponce PUERTO RICO 00732-7273 Re: K022268

Trade/Device Name: Horizons Reusable Polypectomy Snares Regulation Number: 21 CFR 8876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 FDI and KNS Dated: October 14, 2002 Received: October 16, 2002

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 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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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Пример Сводки

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indication for Use 6.1

# 510K INDICATION FOR USE STATEMENT

510(k) Number (if known):

*K02268*

Horizons Reusable Polypectomy Snares Device Name:

Horizons International Corp. Applicant Name:

Indications for Use:

Polypectomy Snares are used for cutting of polyps.

Horizons International Corp.

Signature: ***_***_

Rafic Saleh - President

Date: 7/10/02

Prescription Use
(Per 21 CFR 801.109)

David A. Higgins