HORIZONS HOT BIOPSY FORCEPS

K021706 · Horizons Intl. Corp. · KGE · Jun 21, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021706
• Device Name: HORIZONS HOT BIOPSY FORCEPS
• Applicant: Horizons Intl. Corp.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Horizons Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.

Device Story

Horizons Hot Biopsy Forceps; electrosurgical accessory used with flexible endoscopes. Device enables physician to grasp and dissect tissue samples during endoscopic procedures. Operates by delivering electrical current to tissue via forceps jaws; facilitates biopsy collection. Used in clinical settings by trained physicians. Provides mechanical grasping and electrosurgical cutting/coagulation capabilities; aids in diagnostic tissue sampling.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Electrosurgical accessory for flexible endoscopes; designed for tissue grasping and dissection. Class II device (21 CFR 876.4300).

Indications for Use

Indicated for use with flexible endoscopes for transendoscopic tissue dissection and grasping for biopsy purposes. Intended for prescription use only.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 1 2002

Mr. Rafic Saleh President Horizons International Corp. 287 Monterrey Street PONCE PR 00717-1376

Re: K021706

Trade/Device Name: Horizons Hot Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II

Product Code: 78 KGE Dated: May 14, 2002 Received: May 23, 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,

Nancy C. Brogdon

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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6.1 Indication for Use

## 510K INDICATION FOR USE STATEMENT

510(k) Number (if known): K021706

Horizons Hot Biopsy Forceps Device Name:

Horizons International Corp. Applicant Name:

Indications for Use:

Horizons Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.

Horizons International Corp.

Signature: Date: 6/18/02

Rafic Saleh - President

Prescription Use (Per 21 CFR 801.109)

David W. Legum

(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number

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## 510K STATEMENT OF SAFETY AND EFFECTIVENESS:

I certify, in my capacity as President of Horizons International Corporation, I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device is determined to be substantially equivalent. The information made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21CFR20.61.

Rafic Saleh - President

5/22/02

Date