K Number
K023706
Device Name
ULTROID HEMORRHOID MANAGEMENT SYSTEM
Manufacturer
Date Cleared
2003-01-14

(71 days)

Product Code
Regulation Number
876.4300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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, III, III, IV.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a coagulative therapy system, which is generally a non-AI technology.

Yes
The device is intended for "coagulative hemostatic therapy of internal hemorrhoids," indicating its use in treating a medical condition.

No
The device is described as a "Hemorrhoid Management system" intended for "coagulative hemostatic therapy," which indicates a therapeutic rather than a diagnostic function.

No

The device description is not found, but the intended use describes a "system" for "coagulative hemostatic therapy," which strongly implies a hardware component is involved in delivering the therapy.

Based on the provided information, the Ultroid Hemorrhoid Management system is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Ultroid System Function: The description states the Ultroid system is intended for "coagulative hemostatic therapy of internal hemorrhoids." This indicates a therapeutic device that directly treats a condition within the body, rather than analyzing a sample taken from the body.
  • Lack of IVD Indicators: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.

Therefore, the Ultroid Hemorrhoid Management system is a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / 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, II, III, IV.

Product codes

78 KNS

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician use only.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
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.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2003

Dated: October 31, 2002 Received: November 4, 2002

Re: K023706

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

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

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 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 the letter:

8xx.1xxx(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 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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K023706
page 1 of 1

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.

Ronald D. Nystrom
(2-10-2002

Ronald R. Newton Manager November 22, 2002

Premarket Notification [510(K)] Number K023706

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Sypion

(Division Sign-Off) Division of Reproductive, Al and Radiological Devi 510(k) Number

Ultroid Special 510(k) Modification

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