(10 days)
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Not Found
No
The document describes a bath for patients and does not mention any AI or ML capabilities.
No
The "Intended Use / Indications for Use" section explicitly states, "The Pacific Bath will not be marketed for therapeutic or other medical uses."
No
The 'Intended Use' specifically states, "The Pacific Bath will not be marketed for therapeutic or other medical uses." Diagnosis is a medical use.
No
The device description clearly states "Pacific Recumbent Height Adjustable Bath," indicating a physical bathing apparatus, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bathing patients and residents, which is a physical care activity, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Recumbent Height Adjustable Bath," which is a piece of equipment for bathing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly intended for patient hygiene and comfort, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.
Product codes
ILJ
Device Description
Pacific Recumbent Height Adjustable Bath
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained personnel only; nursing homes, hospitals, and assisted living facilities
Description of the training set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s)
Not Found
Reference Device(s)
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized stripes or lines, possibly representing an eagle or a similar emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 5 2004
Penner Manufacturing, Inc. C/o Ms. Chantel Carson Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062-2092
Re: K040772
Trade/Device Name: Pacific Recumbent Height Adjustable Bath Regulation Number: 21 CFR 890.5100 Regulation Name: Immersion hydrobath Regulatory Class: II Product Code: ILJ Dated: March 24, 2004 Received: March 26, 2004
Dear Ms. Carson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Ms. Chantel Carson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.
Mark N Millam
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Pacific Recumbent Height Adjustable Bath Device Name:
Indications For Use:
The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Milliken
and Neurologic
Page 1 of
5100 Number K040772