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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Silcraft XTank2 Mobile Extremity Whirlpool System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission, by its nature, does not involve clinical studies with acceptance criteria, performance metrics, or ground truth establishment in the way typically seen for novel medical devices or AI algorithms.

Instead, the submission focuses on demonstrating equivalence in intended use, principles of operation, and technological characteristics to an already approved device. Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not applicable to this document.

Here's an explanation based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not present acceptance criteria or reported device performance in the context of a clinical study or performance-based evaluation against specific metrics. The "performance" is implicitly demonstrated through the comparison of its technical characteristics and intended use to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set or patient data was used in this type of submission. The evaluation is based on technical specifications and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth for a test set is not established in this type of regulatory submission. The FDA reviews the provided information for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is an extremity whirlpool system, not an AI algorithm. Therefore, an MRMC study or any assessment of AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm; it is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. Ground truth, in the context of clinical validation, is not relevant to this submission. The "ground truth" for the FDA's decision is whether the device is substantially equivalent to a predicate device based on its design, intended use, and operational principles.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is used.

9. How the ground truth for the training set was established

Not Applicable. No training set or ground truth establishment for a training set is relevant.

Summary Basis for the Finding of Substantial Equivalence (from the document):

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

In essence, for this 510(k) submission, the "acceptance criteria" are demonstrating substantial equivalence to a predicate device, and the "study" is the comparative analysis presented in the document itself.

Summary

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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: (616) 946-4221 Facsimile: (616) 946-1740

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

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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

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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,

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 Sign-Off)
Division of General Restorative Devices ic971592
510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optional Formal 1-2-96)

Regulation Number and Section

§ 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.