(154 days)
Vichy Shower is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Vichy Shower." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed.
However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML device evaluation. The Vichy Shower is a hydrotherapy device, not an AI/ML-driven diagnostic or treatment device, therefore, the requested information is not applicable to this submission.
To clarify, the prompt asks for details typically found in submissions for AI/ML-enabled medical devices, which require extensive clinical validation studies to demonstrate safety and effectiveness. The Vichy Shower falls under a different regulatory pathway where substantial equivalence to existing devices is the primary criterion for market clearance, and typically does not involve the types of studies described in the prompt.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | | 1998
Ms. Joyce M. Duquette · Fritz Companies, Inc. Representing Bouvier Hydro Inc. 100 Walnut Street, Suite 20 P.O. Box 2874 Champlain, New York 12919
Re: K980909 Trade Name: Vichy Shower Regulatory Class: II Product Code: ILJ Dated: April 14, 1998 Received: June 15, 1998
Dear Ms. Duquette:
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 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. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Joyce M. Duquette
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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/dsmamain.html".
Sincerely yours,
Stephen Edwards
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K980909 |
|---|---|
| Device Name: | Vichy Shower |
Indications For Use:
-JUL.29.1998 -- 11:4422-""
Vichy Shower is used in hydrotherapy to relieve pain and itching
and and and in the healing process of inflamed and trauminated Vichy Shower is used in hydrotherapy to relieve parn and traumatized
and as an aid in the healing process of inflamed and traumated Vichy Shower 1s Used Timber of intribution of Creations
and as an aid in the healing process of intribution of contaminated
tissue, and it serves as a setting for removal of tissue .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NOT WRIDE of CDRH, Office of Device Evaluation (ODE)
Stuptim Rhodes
General Restorative De
OR
Over-The-Counter Use X__
• • •
Prescription Use (Per 21 CFR 801.109)
(Optional Forms: 1-2-96)
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.