(136 days)
Not Found
Not Found
No
The summary describes a cryotherapy device for hemorrhoids and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
Yes
The device is intended to provide treatment for the relief of pain, itching, inflammation, and bleeding of hemorrhoids, which directly addresses a health condition.
No
Explanation: The "Intended Use" states that the device is for "treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy," indicating a therapeutic rather than diagnostic purpose.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components for cryotherapy.
Based on the provided information, the Hemorrelief device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat hemorrhoids through cryotherapy. This is a therapeutic treatment applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly indicates a therapeutic device.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hemorrelief device's function falls outside of this definition.
N/A
Intended Use / 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).
Product codes
78 LKX
Device Description
Hemorrelief
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 (301) 594-4613. Additionally, for question 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/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
.
.. ..
( Dober R Silling (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973590 |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Prescription Use (Per 21 C.F.R. 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------------------ | ---- | ------------------------------------------------------------------------------------------------------------------- |