MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM

K030315 · Ultroid, LLC · KNS · Feb 27, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030315
• Device Name: MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
• Applicant: Ultroid, LLC
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, IV.

Device Story

Ultroid Hemorrhoid Management System is an endoscopic electrosurgical unit used by physicians for coagulative hemostatic therapy of internal hemorrhoids. Device delivers electrical current to target tissue to induce coagulation. Used in clinical settings; operated by physicians. Provides therapeutic benefit by managing hemorrhoidal symptoms through targeted tissue coagulation.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Endoscopic electrosurgical unit and accessories. Classified under 21 CFR 876.4300, Product Code KNS. Operates via electrical current for tissue coagulation.

Indications for Use

Indicated for coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, and IV in patients requiring physician-administered treatment.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

Mr. Ronald R. Newton Manager Ultroid™, LLC 2230 Damon Road CARSON CITY NV 89701

Re: K030315

Trade/Device Name: Ultroid™ Hemorrhoid Management System Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: January 25, 2003 Received: January 30, 2003

Dear Mr. Newton:

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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K030315

## 1.2 Statement of Indication for Use

Ultroid, LLC 2230 Damon Rd. Carson City, NV 89701

## Statement of Indications for Use

The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III , IV.

R. U. Nystrom

Ronald R. Newton Manager January 25, 2003

Premarket Notification [510(K)]

**Prescription Use**
(Per 21 CFR 801.109)

Vancey C. Broadon

(Division Sig 510(k) N