(90 days)
Not Found
78 KPN
No
The device description and intended use focus on a simple conductive strip and audible alarm system, with no mention of AI/ML terms or functionalities.
No
The devices are designed to assist in toilet training and bedwetting solutions through alarms, rather than directly treating a medical condition or disease.
No
The devices are designed to assist with toilet training and bedwetting by using an alarm, not to diagnose a medical condition.
No
The device description explicitly mentions "Training parts, which has sewn in mylas conductive strips" and "Powered by a 9V battery," indicating physical hardware components are part of the device.
Based on the provided information, neither the Potty Pal nor the Forever Dry device is an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The descriptions clearly state that these devices are enuresis alarms. They work by detecting moisture (presumably urine) and triggering an audible alarm. This is a physical detection and alarm system, not a test performed on a biological sample in vitro.
- Intended Use: The intended uses are to assist in toilet training and address bedwetting, which are behavioral and physiological issues, not diagnostic procedures.
Therefore, these devices fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training.
Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.
Product codes
78 KPN
Device Description
The Forever Dry and Potty Pal consist of: Training parts, which has sewn in mylar conductive strips. The strips are connected to an audible alarm. Powered by a 9V battery.
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
child / toddlers
Intended User / Care Setting
parent or caregiver
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.2040 Enuresis alarm.
(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
100 14 197 01:59pm KENU TV & Fill ( 0 K
10 14 14 14 14 14 14 10 14 14 10 14 10 14 14 10 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 14 AVE: 1997 AUG 1 8 1997 K971855 Foreser Day is a nighting enwises device to aid in solving a childs
nightine bed wetting problems.
-
Potty Pal is a device to aid iن
accelerating the time required to
potty train a child. -
The Forever Dry and Potty Pal
consist of:
Training parts, which has sewn
in mylás conductive strips. The
strips are connected to an audible
alarm. Powered by a 9V battery
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is positioned in the center of the logo, and its wings extend outwards towards the text. The logo is simple and clean, and it effectively communicates the organization's name and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. D. Lynn Sheppard President DIGITAL APPLICATIONS 275 E. 300 S Santaquin, Utah 84655
AUG 1 8 1997
Re: K971855 Potty Pal and Forever-Dry Dated: April 12, 1997 Received: May 20, 1997 Regulatory class: II 21 CFR §876.2040/Product code: 78 KPN
Dear Mr. Sheppard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), 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 895. A 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 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 under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in yitre diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, 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/odrh/dsmamain.html"
Sincerely yours.
hJliau
Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ of _
510(k) Number (if known): 9178 55 Device Name: Po TTY PaL & FOREVER DRY
Indications For Use:
Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training.
Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doko Matling
(Division Sign-Off)
sional Reproductive, Abdon mal, ENT,
ad Radiological Devices
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_X
(Optional Format 1-2-96)