VANNA BATHING SYSTEM

K993872 · Vancare, Inc. · ILJ · Feb 16, 2000 · Physical Medicine

Device Facts

• Record ID: K993872
• Device Name: VANNA BATHING SYSTEM
• Applicant: Vancare, Inc.
• Product Code: ILJ · Physical Medicine
• Decision Date: Feb 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2

Intended Use

The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.

Device Story

VÄNNA Bathing System is a hydro-bath device used in clinical settings (hospitals, nursing homes, assisted living) for patient hygiene. It functions as a bathing tub equipped with temperature sensors and read-out indicators to monitor water temperature. Operated by facility staff, the device provides a controlled environment for patient bathing. The primary benefit is the maintenance of patient cleanliness and hygiene to support infection control. The system utilizes standard hydro-bath technology, with updated temperature monitoring components to improve reliability compared to legacy systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on historical use of similar hydro-bath technology and bench-level comparison of components.

Technological Characteristics

Hydro-bath system; includes integrated temperature sensors and digital temperature read-out indicators. Designed for institutional use. No specific materials or connectivity standards disclosed.

Indications for Use

Indicated for bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities to maintain a clean and healthy environment and prevent disease spread.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Century Bathing System
• Sanitas Bathing System
• Smart Tub

Submission Summary (Full Text)

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FEB 1 6 2000

Image /page/0/Picture/1 description: The image shows a logo for VANCARE inc. The logo consists of a large, stylized letter V on the left, with the text "VANCARE inc." to the right of the V. Below the text is the location "Aurora, NI 68818 1103".

K993872

## 510k Summary

The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise. Also the intended use of these devices is very similar.

In summary and conclusion the VÄNNA Bathing System is "substantially equivalent" to the Century Bathing System, Sanitas Bathing System and the Smart Tub as to pre-market notification purposes. We respectfully request the FDA's concurrence with this conclusion.

This pre-market notification and its enclosures are being submitted in triplicate. Please do not hesitate to contact us if you have any questions or need additional information.

Sincerely,

Kuklats

James A. Vanderheiden President

JVA/gd Enclosures

[phone]

FAX [phone]

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2000

Mr. James A. Vanderheiden President VANCARE, Inc. 1515 1st Street Aurora, Nebraska 68818

Re: K993872 Trade Name: VANNA Bathing System Regulatory Class: II Product Code: ILJ Dated: January 28, 2000 Received: January 31, 2000

Dear Mr. Vanderheiden

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 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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## Page 2 – Mr. James A. Vanderheiden

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Mark A Mulhausen

James E. Dillard III Acting 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) : K993872 DEVICE NAME : VANNA Bathing System INDICATIONS FOR USE:

The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.

Mark A. Mulhausen

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K993872

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format 1-2.