(142 days)
The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.
Not Found
The provided text is an FDA 510(k) clearance letter for a device called "anucure," which is intended for the treatment of hemorrhoids by applying cold to the tissue.
This document does not contain any information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a study report.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based solely on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002-
MAY - 3 2012
Mr. Jorge Caballero President Cryotherapy Products Inc. 1804 S.W. 81st . TERRACE DAVIE FL 33324
Re: K113660
Trade/Device Name: anucure Regulation Number: None Regulation Name: Device, Thermal, Hemorrhoids Regulatory Class: Unclassified Product Code: LKX Dated: March 11, 2012 Received: March 22, 2012
Dear Mr. Caballero:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 that I Drinas made a and regulations administered by other Federal agencies. You must or any I vacturers and the Act's requirements, including, but not limited to: registration and listing Configure and the Act 5 requirements, more 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/ucm084411.htm
Sincerely yours,
Benjamin R. Fisher, Ph.D.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use:
510(k) Number (if known): K 113660
Device Name: anucure
Indications for use:
The device use is the treatment of hemorrhoids by applying it directly to the swollen
Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap
section is used for the treatment of external hemorrhoids and the tube section for the treatment
of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the
rectum.
AND/OR Over-The-Counter Use X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Harold Reiner
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113660
Concurrence of CDRH, Office of Device Evaluation (ODE)
N/A