ICE BATON

K012746 · Behive, Ltd. · LKX · Nov 14, 2001 · GU

Device Facts

• Record ID: K012746
• Device Name: ICE BATON
• Applicant: Behive, Ltd.
• Product Code: LKX · GU
• Decision Date: Nov 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Ice Baton is intended to provide relief for pain and discomfort due to hemorrhoids.

Device Story

Ice Baton is a suppository-shaped medical device for hemorrhoid pain relief. User fills applicator with water, replaces cover, and freezes. Once frozen, user removes cover and applies device to hemorrhoid area until ice melts or relief is achieved. Device is disposable. Intended for patient self-use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Suppository-shaped applicator and cover. Operates via thermal cooling (ice). User-filled with water. Disposable. No electronic components or software.

Indications for Use

Indicated for relief of pain and discomfort due to hemorrhoids in patients requiring topical cooling therapy.

Predicate Devices

• AnuIce (K981428)

Submission Summary (Full Text)

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K012746

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# 510(k) Summary for Behive Ltd Ice Baton

NOV 1 4 2001

#### 1. SPONSOR

Behive Ltd 308 Abbey Road Popley 4 Basingstoke Hants England

Graham Holland Contact Person: 44 0 1256 326990 Telephone:

Date Prepared: August 15, 2001

#### DEVICE NAME 2.

Ice Baton Proprietary Name: Hemorrhoid Device Common/Usual Name: Classification Name: Thermal Hemorrhoid Device

#### 3. PREDICATE DEVICES

Cryotherapy Pain Relief Products, Inc. - AnuIce - K981428

#### DEVICE DESCRIPTION 4.

The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomfort due to hemorrhoids. The Ice Baton consists of an applicator cover and applicator. During use, the cover is removed and the Ice Baton applicator is filled with bottled or drinking water. The applicator cover is placed back on the Ice Baton and excess water is removed. The Ice Baton is placed in the user's freezer until frozen.

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K012746
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After the Ice Baton is removed from the freezer, the applicator cover is removed and the Ice Baton is applied to the target hemorrhoid area. It is maintained on that area until the ice has melted or relief is felt. The Ice Baton is a disposable device.

#### INTENDED USE ર્જ

The Ice Baton is intended to provide relief for pain and discomfort due to hemorrhoids.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Behive Ltd Ice Baton and the Cryotherapy Pain Relief Products, Inc. AnuIce are both intended for the same purpose, to provide relief for the pain and discomfort due to hemorrhoids by cooling the hemorrhoids.

The Ice Baton and AnuIce devices are similar in design and characteristics. Both devices include an applicator/tube and cap. The Ice Baton is filled with water The Ice Baton is a whereas the AnuIce is prefilled with a coolant solution. disposable device and the AnuIce is a reusable device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 4 2001

Behive Ltd. c/o Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

# Re: K012746

Trade/Device Name: Behive Ltd. Ice Baton Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LKX Dated: August 15, 2001 Received: August 16, 2001

# Dear Ms. McNamara-Cullinane:

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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## Page 2

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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K012746

510(k) Number (if known):

NOV 1 4 2001

Device Name: Ice Baton

Indications For Use:

The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Device

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Behive Ltd 510(k) Ice Baton

August 15, 2001

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