(301 days)
Not Found
Not Found
No
The device description lists standard hydromassage components and does not mention any AI/ML terms or functionalities.
Yes
The device is intended for "hydromassage treatment of the user's extremities," which is a therapeutic application.
No
Explanation: The device is described as providing "hydromassage treatment" and its components support this function (tank, jets, motor). There is no mention of it collecting or analyzing data for diagnostic purposes.
No
The device description clearly lists multiple hardware components, including a tank, motor, jets, and pumps, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Hydromassage treatment of the user's extremities." This is a physical therapy or therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details components related to a whirlpool system for physical therapy (tank, jets, motor, etc.). None of the components are related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic purposes or providing information about a disease or condition based on sample analysis.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ILJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
User's extremities (arm, elbow, wrist, ankles or feet)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ferno's Ferno IIIe Hi-Lo Jr. Whirlpool System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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FEB 2 6 1998
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
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
2
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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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
coll
(Division Sign-Off)
Division of General Restorative Devices ic971592
510(k) Number
Prescription Use (Per 21 CFR 801.109)
..
OR
Over-The-Counter Use X
(Optional Formal 1-2-96)