(231 days)
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No
The device description details a hydro-therapy chair with a blower motor and water jets, with no mention of AI or ML technologies.
Yes
The device is described as aiding in debridement of wounds, pain relief, cleansing of open wounds, and physical therapy, all of which are considered therapeutic uses.
No
The device's intended use is to aid in adding moisture, debridement, pain relief, cleansing, and physical therapy, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a chair, hydro-pad, suction cups, stable bar, hose, and blower motor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for physical therapy, wound care (adding moisture, debridement, cleansing), and pain relief. These are all external applications and treatments performed on the patient's body.
- Device Description: The device is a hydro-therapy chair that provides whirlpool therapy. It involves circulating water and air around the patient's body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly operates in vivo (on the body) for therapeutic and supportive purposes.
N/A
Intended Use / Indications for Use
the intended use of the device is to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.
Product codes
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Device Description
The Banks Hydro-Therapy Chair provides whirlpool therapy in the home so that patients do not require unnecessary hospitalization or require transportation to a hospital. The Banks Hydro-Chair comprises: a chair for supporting the patient, the chair may comprise a backrest, armrest, seat and frame; a hydro-pad, suction cups for removably fastening the chair to a bath tub, the lateral stability of the chair may be increased by a Stable Bar that is removably fastened to the backrest and a corresponding side wall of the bath in which the whirlpool therapy is taking place. The Hydropad is connected at the base of the Chair and the posterior opening of the Hydro-pad connects to a hose(typically rubberized tubing)) which is connected to a blower motor which exerts a powerful pressure of air circulating through the ports of the Hydro-pad.
Streams of water jet through the ports causing a swirling motion of the water in which the Hydro-pad is immersed. The Chair is also composed of a seat portion and the Chair is open so jets of water can reach the sacral, coccyx, rectum, groin and vaginal areas of the patient utilizing the Hydro-Therapy Chair. The seating and backing of the Chair are made of soft polyethylene material to prevent undue pressure to the skin during therapy. For handicapped and disabled persons, the arm frames of the Chair are easily removable. A more detailed description of the materials can be found in the drawings included in the "Attachments" section, section 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacral, coccyx, rectum, groin and vaginal areas
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
no assessment of performance data is necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(K) SUMMARY" AS REQUIRED BY 807.92(C)
Pursuant to 807.92(a)(1) David Banks 3411 Oakcrest Drive Shelby, NC 28150 704-487-1003
APR - 1 1996
Pursuant to 809.92(a)(2):
· Trade name - "Banks Hydro-Therapy Chair"
· Common name - Powered Sitz Bath
· Classification - Bath, Sitz, Powered, Class II device pursuant to 21 C.F.R. §890.5100
Pursuant to 809.92(a)(3) applicant claims substantial equivalence to legally marketed predicate device the Ferno-Washington, Inc. "Ferno-Ille-Hi-Lo, Jr.™". The predicate device is a mobile whirlpool bearing Registration No. K914125.
Pursuant to 809.92(a)(4), a description of the device is:
The Banks Hydro-Therapy Chair provides whirlpool therapy in the home so that patients do not require unnecessary hospitalization or require transportation to a hospital. The Banks Hydro-Chair comprises: a chair for supporting the patient, the chair may comprise a backrest, armrest, seat and frame; a hydro-pad, suction cups for removably fastening the chair to a bath tub, the lateral stability of the chair may be increased by a Stable Bar that is removably fastened to the backrest and a corresponding side wall of the bath in which the whirlpool therapy is taking place. The Hydropad is connected at the base of the Chair and the posterior opening of the Hydro-pad connects to a hose(typically rubberized tubing)) which is connected to a blower motor which exerts a powerful pressure of air circulating through the ports of the Hydro-pad.
Streams of water jet through the ports causing a swirling motion of the water in which the Hydro-pad is immersed. The Chair is also
1
composed of a seat portion and the Chair is open so jets of water can reach the sacral, coccyx, rectum, groin and vaginal areas of the patient utilizing the Hydro-Therapy Chair. The seating and backing of the Chair are made of soft polyethylene material to prevent undue pressure to the skin during therapy. For handicapped and disabled persons, the arm frames of the Chair are easily removable. A more detailed description of the materials can be found in the drawings included in the "Attachments" section, section 2.
Pursuant to 809.92(a)(5), the intended use of the device is to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.
Pursuant to 809.92(a)(6), basically, both the applicant's device("Banks Hydro-Therapy Chair") and the predicate device("Ferno-Washington, Inc.-Ille-Hi-Lo, Jr.™") agitate warm water to assist in the healing of patients requiring immersion in warm agitated water for such purposes as treatment of wounds, improvement of circulation, and relief of skin pain and discomfort.
Pursuant to 809.92(b)(1)-(3), applicant believes no assessment of performance data is necessary.
Pursuant to 809.92(d), applicant believes that no other information is necessary for 510(k) approval, but applicant will provide other information as reasonably required by the Food and Drug Administration.
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