POTTY PAL AND FOREVER-DRY

K971855 · Digital Applications, Inc. · KPN · Aug 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971855
• Device Name: POTTY PAL AND FOREVER-DRY
• Applicant: Digital Applications, Inc.
• Product Code: KPN · Gastroenterology, Urology
• Decision Date: Aug 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.2040
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device consists of training pants with sewn-in conductive strips connected to an audible alarm powered by a 9V battery. Used by parents or caregivers to assist toddlers with toilet training or nighttime enuresis. When moisture is detected by the conductive strips, the circuit closes, triggering the audible alarm to alert the user/caregiver. Intended for home use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Consists of training pants with integrated conductive strips, 9V battery-powered audible alarm circuit. Simple moisture-sensing electrical circuit.

Indications for Use

Indicated for toddlers requiring assistance with daytime toilet training (Potty Pal) or nighttime bedwetting (Forever Dry).

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{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.

2. Potty Pal is a device to aid iن
accelerating the time required to
potty train a child.

3. 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

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## 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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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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)