(90 days)
Not Found
No
The device description and lack of mentions of AI/ML, training/test sets, or performance metrics related to algorithmic analysis indicate no AI/ML is used.
Yes
The device is intended to provide relief from pain and discomfort due to hemorrhoids, which is a therapeutic purpose.
No
The device is intended to provide relief from pain and discomfort, not to diagnose a condition.
No
The device description clearly states that the Ice Baton is a physical, suppository-shaped medical device made of an applicator cover and applicator, which is filled with water and frozen. This indicates it is a hardware device, not software.
Based on the provided information, the Ice Baton is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Ice Baton's Function: The Ice Baton is a physical device applied externally to the body (to the hemorrhoid area) to provide pain relief through cryotherapy (cold therapy). It does not analyze any bodily specimens.
The description clearly states its intended use is for pain relief and discomfort, and its mechanism of action is based on applying cold to the affected area. This aligns with a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids.
Product codes
78 LKX
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hemorrhoid area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Page 1 of 2
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.
1
K012746
Page 2 of 2
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.
2
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.
3
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 | (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" (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 (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
4
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
12746
(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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