HEMORRELIEF DEVICE

• K Number: K973590
• Device Name: HEMORRELIEF DEVICE
• Manufacturer: A. STEIN - REGULATORY AFFAIRS CONSULTING
• Date Cleared: 1998-02-05 ( 136 days)
• Product Code: LKX
• Regulation Number: N/A
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a device called "Hemorrelief" and its corresponding Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not include the specifics of a study or performance metrics. Therefore, I cannot generate the requested information based on the input.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 1998

Y-Tech Quality Products, Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consultant Regulatory Affairs Consulting, Inc. P.O.B. 454 Ginot Shomron, 44853 ISRAEL

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Re: K973590 Hemorrelief Dated: December 17, 1997 Received: December 29, 1997 Unclassified/Procode: 78 LKX

Dear Ms. Stein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Modical Devices that have been reclassified in accordance with the provisions of the Federal Pood, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device to 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 and additionally 809.10 for in yitte diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h. William Liu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

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510(k) Number (if known):	K973590
Device Name:	Hemorrelief
Indications for use:	The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Dober R Silling (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973590
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Prescription Use (Per 21 C.F.R. 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
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Regulation Number and Section

N/A