(78 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.
ANUICE -COLD PACK, PLASTIC APPLICATO MEDICAL GRADE - NON-CHOMICA
The provided text is a 510(k) clearance letter from the FDA for a device called "ANUICE -COLD PACK, PLASTIC APPLICATOR, MEDICAL GRADE - NON-CHEMICAL". It details the regulatory approval process but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval notice, not a study report.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 JUL
Mr. Jorge Caballero President Cryotherapy Pain Relief Products, Inc. 272 N.W. 106 Terrace Pembroke Pines, FL 33026
Re: K981428 Anu Ice Dated: April 14, 1998 Received: April 20, 1998 Unclassified/Procode: 78 LKX
Dear Mr. Caballero:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Mr. Jorge Caballero
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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Rahur R ratting 1
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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510(k) Number (if known):_ 长981428
Device Name: Device ANUICE -COLD PACK, PLASTIC APPLICATO MEDICAL GRADE - NON-CHOMICA
Indications For Use:
The device use is the treatment of hemorrhoids by oplying it directly to the swollen he morrhoidal Tissues. By applying colo to the fissue, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satlung/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
N/A