HEMORRELIEF DEVICE

K973590 · A.Stein - Regulatory Affairs Consulting · LKX · Feb 5, 1998 · GU

Device Facts

• Record ID: K973590
• Device Name: HEMORRELIEF DEVICE
• Applicant: A.Stein - Regulatory Affairs Consulting
• Product Code: LKX · GU
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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 Story

Hemorrelief is a cryotherapy device for hemorrhoid treatment. Device applies controlled cold to affected area to alleviate symptoms including pain, itching, inflammation, and bleeding. Intended for over-the-counter use by patients. Mechanism relies on therapeutic cooling to provide symptomatic relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cryotherapy device; utilizes controlled cold treatment for therapeutic effect. No electronic, software, or complex mechanical components described.

Indications for Use

Indicated for patients suffering from hemorrhoids to provide relief of pain, itching, inflammation, and bleeding.

Submission Summary (Full Text)

{0}------------------------------------------------

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

1 - 12 - 12 - 1 - 1 - 1 - 1 -

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

{1}------------------------------------------------

## Indications for Use Statement

.

.. ..

( <

ﺴﺮ

Page 1 of 1

-

17

.

| 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)

| | <div> Dober R Silling </div> (Division Sign-Off) <div>Division of Reproductive, Abdominal, ENT, and Radiological Devices </div> <div>510(k) Number K973590</div> |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Prescription Use (Per 21 C.F.R. 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
|------------------------------------------------------|----|-------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------|----|-------------------------------------------------------------------------------------------------------------------|