XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM

K971592 · The Silcraft Corp. · ILJ · Feb 26, 1998 · Physical Medicine

Device Facts

• Record ID: K971592
• Device Name: XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
• Applicant: The Silcraft Corp.
• Product Code: ILJ · Physical Medicine
• Decision Date: Feb 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silcraft XTank2 Mobile Extremity Whirlpool System ("the Silcraft XTank") and Ferno's Ferno IIIe Hi-Lo Jr. Whirlpool System ("Ferno IIIe") are intended to be used for hydromassage of the user's extremities.

Device Story

Mobile extremity whirlpool system for hydromassage; used in clinical or home settings. Attendant fills tank with water; adjusts height for user comfort; user immerses extremity (arm, elbow, wrist, ankle, or foot). Attendant operates aeration control valve to provide whirlpool effect; turns off valve post-treatment. Cleaning involves adding disinfectant to tank; circulating through internal system via aeration valve or power drain; draining via power or manual drain. Device consists of tank, fill hose, base with castors, handle, control console, whirlpool motor, jets, and drain pump. Provides therapeutic hydromassage to affected extremities.

Clinical Evidence

No clinical data. Safety and effectiveness based on long history of use of hydrobaths with similar technological characteristics and bench-level comparison to predicate device.

Technological Characteristics

Components: water tank, fill hose, base with castors, handle, control console, whirlpool motor, whirlpool jets, power drain pump, manual drain. Energy source: electrical (AC power). Connectivity: none. Sterilization: manual cleaning/disinfection protocol. No software or automated algorithms.

Indications for Use

Indicated for hydromassage treatment of user's extremities. No specific age, gender, or disease state contraindications provided.

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

• Ferno IIIe Hi-Lo Jr. Whirlpool System (K971592)

Submission Summary (Full Text)

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FEB 2 6 1998

K971592

# 510(k) SUMMARY FOR SILCRAFT CORPORATION'S SILCRAFT XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM

Submitter's Name, Address, Telephone Number, And Contact Person

Silcraft Corporation 528 Hughes Drive Traverse City, MI 49686

Contact: Lee Dunsirn Silcraft Corporation Phone: [phone] Facsimile: [phone]

## Date Prepared

May 1, 1997

### Proprietary Name of the Devices

Silcraft XTank2 Mobile Extremity Whirlpool System

### Common or Usual Names

Extremity Whirlpool System

### Classification Names

Immersion Hydrobath (21 C.F.R. § 890.5100)

### Predicate Device

Ferno's Ferno IIIe Hi-Lo Jr. Whirlpool System

### Intended Use

The Silcraft XTank? Mobile Extremity Whirlpool System ("the Silcraft XTank") and Ferno's Ferno IIIe Hi-Lo Jr. Whirlpool System ("Ferno IIIe") are intended to be used for hydromassage of the user's extremities.

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## Principles of Operation

The principles of operation of the Silcraft XTank2 and the Ferno IIIe are very similar. First, the user or the attendant (hereinafter "attendant" will refer to both the user and the attendant) moves the device to the water source. Second, the attendant fills the tank with water from a separate water source. Third, the attendant moves the device to the user comes to the device. Fourth, the attendant adjust the height of the device so that is at a comfortable height for the user to soak his or her extremity while he or she is sitting next to the tank. Fifth, the user places the part of his or her body to be treated, i.e., his or arm, elbow, wrist, ankles or feet in the tank. Sixth, the attendant turns the aeration on/off valve to the "on" position. Seventh, the attendant turns the aeration control valve to the desired setting, if aeration is desired. Eighth, the user soaks the affected extremity in the tank. Ninth, the attendant turns the aeration on/off valve to the "off" position when the treatment is completed. Thus, both devices have the same nine step treatment procedures.

Once treatment is completed, the attendant adds disinfectant to the tank. Next, the attendant turns the Silcraft XTank"s aeration valve or the Ferno IIIe's power drain to the "on" position to circulate the disinfectant and water through the device's internal system and the interior of the tank following the cleaning and disinfection instructions in the device's operator's manual. The attendant then turns off the aeration or power drain. Finally, the attendant drains the tank using the device's power drain and/or manual drain. Thus, the Silcraft XTank"s and the Ferno IIIe's cleaning and disinfection procedures also are very similar.

## Technical Characteristics

The Silcraft XTank2 and the Ferno IIIe have very similar technological characteristics. Each of these device primarily consists of the following components: (1) a tank to be filled with water; (2) a fill hose; (3) a base with four castors or wheels: (4) a handle to lift the device: (5) a control console; (6) a whirlpool motor: (7) whirlpool jets; (8) a power drain pump; (9) a manual drain and handle; and (10) a power supply cord.

## Summary Basis for the Finding of Substantial Equivalence

The safety and effectiveness of the Silcraft XTank2 is based on the long history of use of hydrobaths with very similar technological characteristics. The Silcraft XTank2 and the 510(k) cleared Ferno IIIe have the same intended use and very similar principles of operation and technological characteristics. Moreover, the minor technological differences between the Silcraft XTank2 and the Ferno IIIe, namely the Silcraft XTank"s use castors instead of wheels, the additional ¼ horsepower of the device's whirlpool motor, its four additional whirlpool jets, and its electrical requirement of 5 more volts, do not raise any new questions of safety or

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effectiveness. Thus, the Silcraft XTank" is substantially equivalent to the Ferno IIIe.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1998

Mr. Howard M. Holstein Hogan & Hartson Representing Silcraft Corporation 555 Thirteenth Street, NW Washington, DC 20004-1109

K971592 Re: XTank Mobile Extremity Whirlpool System K971593 Silcraft Whirlpool System Regulatory Class: II Product Code: ILJ Dated: February 11, 1998 February 12, 1998 Received:

Dear Mr. Holstein:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 Requlation (QS) 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 In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. 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 requlations.

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Page 2 - Mr. Howard M. Holstein

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

C. Calvin M. Whitten, Ph. D.

Ph.D., M.D. Celta M. Witten ! Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Number (if known):

XTank2 Mobile Extremity Whirlpool System Device Name:_

## Indications For Use:

Hydromassage treatment of the user's extremities

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices ic971592
510(k) Number

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use X

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