(17 days)
Not Found
Not Found
No
The summary describes a bath for patients and explicitly states that AI, DNN, or ML are not mentioned.
No
The device is described as a bath for hygiene purposes, which does not constitute a therapeutic function.
No
The device is described as a "Cascade Bath" intended for bathing patients, which is a therapeutic/care function, not a diagnostic one.
No
The intended use describes a physical bath for bathing patients, which is a hardware device, not software.
Based on the provided information, the Cascade Bath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for bathing patients and residents. This is a physical care activity, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: While the description is "Not Found," the intended use clearly indicates a device for bathing, which is not a diagnostic function.
- No Mention of Diagnostic Activities: There is no mention of analyzing samples, detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Cascade Bath does not fit this description.
N/A
Intended Use / Indications for Use
The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
Product codes
ILJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel in nursing homes, hospitals, and assisted living facilities.
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2001
Penner Manufacturing Inc. c/o Brian R. Biersach Project Engineer Conformity Assessment Services Underwriters Laboratories Inc.® 333 Pfingsten Road Northbrook, Illinois 60062-2096
Re: K012057
Trade Name: Cascade Bath Model 6900 Regulation Number: 890.5100 Regulatory Class: II Product Code: ILJ Dated: June 27, 2001 Received: July 2, 2001
Dear Mr. Biersach:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your beceived is substantially equivalent (for the indications for use above und we nave actering marketed predicate devices marketed in interstate commerce stated in the energially to tegally manates of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (ree). Tou may) alercrors, arovisions of the Act include requirements for annual provisions of the Feel - Notes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt valy in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mspections, the Food and in regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have roopense to your y the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Brian R. Biersach
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonthoution. The I Drivination for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific diagnostic devices), please contact the Office of Compliance at additionally 60911 o ditionally, for questions on the promotion and advertising of your device, (2017) 594-4639 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Bmt dlleetno or
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
2
Attachment Ib
Page 1 of 1
KO12054
New application 510(k) Number (if known):
Cascade Bath Device Name:
Indications For Use:
·
The Cascade Bath is intended for bathing patients and/or The Cascade bath ID Incons, hospitals, and assisted living These baths are to be given by trained facilities. personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Oplional Fornial 1-2-96)
Rsmtheleeehnspon cm
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K012057