(301 days)
Models 2001, 3700D, 3600, and 3600XL: Full immersion bathing and hydromassage of the lower extremities of patients in a sitting position.
Models 2300 and 3300: Full immersion and hydromassage of patients in a sitting position.
Models 4300, 5300, 4400SS, and 5400SS: Full immersion bathing and hydromassage of patients in a reclining position.
Ten of the eleven models of the Silcraft Whirlpool System and all of the predicate devices consist primarily of the following components: (1) a tub; (2) a shower wand; (3) a control console; (4) a water temperature control; (5) a whirlpool motor; (6) multiple whirlpool jets; and (7) a built-in automatic or manual disinfection system. One models does not have a built-in disinfection system.
Each model of the Silcraft Whirlpool System and all of the predicate devices are labeled for use with one or more patient lift and/or transfer devices, including certain Silcraft transporters and lifts ("the Silcraft Patient Lift").
The provided text is a 510(k) premarket notification for the Silcraft Whirlpool System, seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would. Instead, the submission relies on demonstrating substantial equivalence based on similar intended use, principles of operation, and technological characteristics to legally marketed predicate devices.
Therefore, many of the requested sections (acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and ground truth establishment for training set) are not applicable to this type of regulatory submission.
Here's a breakdown of the information that can be extracted versus what is not present:
Information Present in the Document:
-
Acceptance Criteria and Reported Device Performance: This document does not establish specific acceptance criteria or report performance data as would be found in a clinical study of a novel device. The "acceptance criteria" here is effectively the demonstration of "substantial equivalence" to predicate devices based on intended use, principles of operation, and technological characteristics. The "reported device performance" is implicitly that it performs similarly to the predicate devices for bathing and hydromassage.
- Acceptance Criteria (Implicit): Substantially equivalent intended use, principles of operation, and technological characteristics to legally marketed predicate devices.
- Reported Device Performance (Implicit): Functions for bathing and hydromassage as existing whirlpool systems. Minor technological differences do not raise new questions of safety or effectiveness.
-
Sample Size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data. The "test set" in this context is the Silcraft Whirlpool System itself, being compared to predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.
-
Adjudication method: Not applicable. There was no adjudication process for a test set. The FDA reviews the submitted comparison to predicate devices.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a study comparing human reader performance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is a medical device, not an algorithm.
-
The type of ground truth used: Not applicable. There is no concept of "ground truth" in the context of a 510(k) submission based on substantial equivalence to existing hydrobaths. The "truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use.
-
The sample size for the training set: Not applicable. There is no training set mentioned or used.
-
How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The Silcraft Whirlpool System obtained regulatory clearance (K971593) by demonstrating substantial equivalence to several legally marketed predicate devices. The basis for this finding was the shared intended use (bathing and hydromassage), similar principles of operation, and similar technological characteristics as the predicate devices. The document explicitly states that "minor technological differences... do not raise any new questions of safety or effectiveness."
For the Silcraft Disinfectant, substantial equivalence was based on its EPA registration and compliance with relevant EPA and FDA guidance for general purpose disinfectants.
The submission does not involve clinical studies with acceptance criteria, test sets, or expert ground truths for performance evaluation of "device meets the acceptance criteria" in the way one might expect for a novel diagnostic or therapeutic device or AI algorithm. Instead, the "study" is implicitly the comparative analysis presented in the 510(k) submission, comparing the new device to existing, legally marketed devices.
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FEB 2 6 1998
510(k) SUMMARY FOR SILCRAFT CORPORATION'S SILCRAFT 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
(1) Silcraft Access 3700 Whirlpool System, Access 3600 Whirlpool System, Model 2001 Bather, Model 2300 Junior Sit Tub, Model 3300 Sit Tub, Model 4300 Supine Tub, Model 5300 Supine Maxi Tub, Model 4400SS Whirlpool System, and Model 5400SS Whirlpool System
(2) Silcraft Model 1800 Lift, Model 1850 Lift, Model 1400 Sling Lift; Venture Sling Lift, Venture II Sling Lift, Model 1300 Traverse Battery Operated Lift/Transfer System, and Model 1200 Traverse Battery Operated Lift/Transfer System
(3) Silcraft Disinfectant
Common or Usual Names
Whirlpool System Patient Lift and Transfer Device General Purpose Disinfectant
Classification Names
Immersion Hydrobath (21 C.F.R. § 890.5100) Non-AC-powered Patient Lift (21 C.F.R. § 880.5510) Medical Device Disinfectant (No classification regulation)
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Predicate Devices
- Grand Traverse Technologies, Inc.'s Freedom Bath; (1)
- Dutton-Lainson Company's Sanitas Whirlpool Bathing System; (2)
- Arjo-Century, Inc.'s Whirlpool Bathing System; (3)
- Arjo-Century, Inc.'s Height Adjustment Tank with Hygiene Chair; and (4)
- Setma, Inc.'s Setma VHT Bathing System (5)
Intended Use
All eleven models of the Silcraft Whirlpool System are intended to be used for hydromassage and bathing.
Principles of Operation
The principles of operation of the all models of the Silcraft Whirlpool System and the predicate are very similar. First, patients access these tubs by means of certain patient transport and lift devices; in certain models, ambulatory patients enter these devices through a door in the side of the tub. Second, once the patient is comfortably position in a seated or reclining in the Silcraft tub or a predicate device's tub, the attendant (or the patient in certain models of the Silcraft Whirlpool System and a couple of the predicate devices) adjusts the valves on the control console to set the volume and temperature of the water flowing into the tub or shower. Third, the attendant (or the patient in certain models of the Silcraft Whirlpool System and a couple of the predicate devices) operates the whirlpool feature of the device by adjusting one or more aeration switches or knobs on the control panel. The attendant (or the patient in certain models of the Silcraft Whirlpool System and a couple of the predicate devices) then manually adjust both the direction of the whirlpool jets by turning them. Fourth, patients exit the Silcraft Whirlpool System's or the predicate devices' tubs by means of the same patient transport and lift devices thev used to enter the tubs or by simply exiting the tub through the tub door in certain models. Fifth, the attendant cleans and disinfects the tub using the devices' built-in disinfection system.
Technical Characteristics
Ten of the eleven models of the Silcraft Whirlpool System and all of the predicate devices consist primarily of the following components: (1) a tub; (2) a shower wand; (3) a control console; (4) a water temperature control; (5) a whirlpool motor; (6) multiple whirlpool jets; and (7) a built-in automatic or manual disinfection system. One models does not have a built-in disinfection system.
Each model of the Silcraft Whirlpool System and all of the predicate devices are labeled for use with one or more patient lift and/or transfer devices, including certain Silcraft transporters and lifts ("the Silcraft Patient Lift"). The
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Silcraft Patient Lift and the legally marketed lifts are intended be used to transport patients from the bed to the bath and vice versa and to lift them into and out of the tub. Any minor technological differences between the Silcraft Patient Lifts, most of which are exempt from 510(k) requirements, and legally marketed lifts do not raise any new questions of safety or effectiveness.
The labeling for the models of the Silcraft Whirlpool System that have built-in disinfection systems state that Silcraft Disinfectant should be used to disinfect the devices. This general purpose disinfectant is registered with the Environmental Protection Agency ("EPA"). For this reason, the Silcraft Disinfectant device is substantially equivalent to reference products FDA has on file.
Summary Basis for the Finding of Substantial Equivalence
The safety and effectiveness of the Silcraft Whirlpool System is based on the long history of use of hydrobaths with very similar technological characteristics. The Silcraft Whirlpool System and all of the predicate have the same intended use: bathing and hydromassage. The various models of the Silcraft Whirlpool System also have very similar principles of operation and technological characteristics as the predicate devices. Moreover, the minor technological differences between the Silcraft Whirlpool System and the predicate devices, namely the number of valves on their control consoles, certain components of their disinfection systems and different features of the lifts which they are labeled for use with, do not raise any new questions of safety or effectiveness. Thus, each model of the Silcraft Whirlpool System is substantially equivalent to the predicate devices.
All of the Silcraft Patient Lifts are exempt from 510(k) requirements because they are non-AC-powered lifts. Nevertheless, these patient lifts are substantially equivalent to legally marketed lifts with which the predicate devices are labeled for use because they have the same intended use, similar principles of operation and technological characteristics. Any minor differences in their technological characteristics do not raise any new questions of safety or effectiveness.
The BA a egistered Silerate Disinfect ant is substantial equivalent, to other general purpose disinfectants hy virtue of its EPA registration and compliance with BPA and Tandum of danderstanding cogarding liquid chamicale germicides and TDA syuidance documents regarding general purpose disinfectants of and-bydrobath 6mm
3
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
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
Re: K971592 XTank2 Mobile Extremity Whirlpool System K971593 Silcraft Whirlpool System Regulatory Class: II Product Code: ILJ February 11, 1998 Dated: 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. ਬ 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 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. concerning your devices 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 - Mr. Howard M. Holstein
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA acberrood in your bial equivalence of your devices to legally marketed predicate devices results in a classification for marketed producted as 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 ene regaracton chercleda, "... EFR 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,
Colton M. Witten, Ph.D.
Celta M. Witten, Ph.D., M.D. 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):
Silcraft Whirlpool System Device Name:
Indications For Use:
Models 2001, 3700D, 3600, and 3600XL: Full immersion bathing and hydromassage of the lower extremities of patients in a sitting position.
Models 2300 and 3300: Full immersion and hydromassage of patients in a sitting position.
Models 4300, 5300, 4400SS, and 5400SS: Full immersion bathing and hydromassage of patients in a reclining position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRR, Office of
A. Odeda
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 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.