PEDO CUSH PEDO CUDDLE

K972446 · Cavity Free Kids, Inc. · FMQ · Nov 13, 1997 · General Hospital

Device Facts

• Record ID: K972446
• Device Name: PEDO CUSH PEDO CUDDLE
• Applicant: Cavity Free Kids, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.

Device Story

Pedo Cush Pedo Cuddle is a combination restraint and cushion system for pediatric dental patients. The device consists of a main body restraint with flaps and hook-and-loop fasteners to secure the torso, a headpiece, and a cushion with an arcuate indentation for the buttocks, enclosed in a pillowcase with leg-securing flaps. The system uses adhesive material to maintain position on a standard dental chair. Operated by dental professionals in a clinical setting, the device physically restricts patient movement to prevent injury during procedures. By controlling side-to-side and up-and-down motion, it allows the clinician to perform dental work on uncooperative or fearful children safely. The device is designed to be comfortable for the patient while providing the clinician with a stable environment for treatment.

Clinical Evidence

Clinical performance was evaluated through observation of over 1,000 pediatric patients with behavior ranging from uncooperative and fearful to hysterically out-of-control. The device successfully managed patient movement, allowing dental procedures to be performed safely. No specific statistical metrics (e.g., p-values, CIs) were reported; evidence is based on clinical utility and successful management of patient motion in a dental office setting.

Technological Characteristics

Restraint system comprising soft cloth wrap with non-slip rubber backing and hook-and-loop closures. Includes foam cushion enclosed in hospital ticking vinyl and cotton outer jacket. Attaches to standard dental chairs via straps and adhesive backing. Non-electronic, mechanical device. Sterilization via laundering and bleaching.

Indications for Use

Indicated for pediatric patients requiring restraint during dental treatment to prevent injury from sudden or unsafe movement. For use under dentist supervision only.

Regulatory Classification

Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Predicate Devices

• Olympic Papoose Board

Submission Summary (Full Text)

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K972446

NOV 1 3 1997

## Summary:

| • Submitter's name: | Cavity Free Kids |
|---------------------|---------------------------------|
| Address: | 1224 Arcade St.<br>St. Paul, MN |
| Telephone: | 612-774-0583 |
| Fax Number: | 612-793-0967 |
| Contact person: | Dr. Vacharee S. Peterson |
| Summary prepared: | May 16, 1997 |
| • Trade Name: | Pedo Cush Pedo Cuddle |
| Common Name: | Protective Restraint |

- Identification of legally marketed device to which equivalency is claimed: Olympic ● Papose Board, manufactured by Olympic Medical Co. Seattle, WA.
## Description of Pedo Cush Pedo Cuddle:

A combination restraint and cushion for securing a pediatric patient in a dental chair, said combination comprising; a restraint comprising a main body portion which has a plurality of flaps attached thereto, each of said flaps having hook and loop fasteners affixed thereto, such that said flaps can be positioned and fastened around said patient to hold said patients torso in position a plurality of strings (straps) for tying said restraint around said dental chair and a headpiece which fits around the top of said dental chair, said restraint having adhesive material affixed to the back thereof to hold said restraint in position on said dental chair, and a cushion having an arcuste indentation at its top end to hold said petient's buttooks in position, said cushion being enclosed in a pillowcase having an adhesive material affixed to the underside thereof in order to maintain said cushion in position on said dental chair, said pillowcase having a plurality of flaps attached thereto, said flaps each having hook and loop fasteners affixed thereto such that said flaps can be positioned and fastened around said patient's legs to hold them in position. Pedo Cush Pedo Cuddle is covered by U.S. Patent N. 5,425, 381 and is described in more detail therein.

## Intended use:

To protect both patient and clinician from sudden and unsafe patient movement.

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## Comparison of technological characteristics:

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| | Pedo Cush Pedo Cuddle | Papoose Board |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Design | Wrap and Cushion, each<br>having flaps with Velcro<br>closures | Wrap with Velcro closures;<br>board and head stabilizer<br>can be added |
| Materials | Wrap (including flaps,<br>straps, and headpiece) made<br>of soft cloth with non-slip-<br>rubber backing, has Velcro<br>closures. Foam cushion<br>enclosed in hospital ticking<br>vinyl inserted in cotton<br>outer jacket | Mesh fabric wrap with<br>Velcro closures. Vinyl-<br>covered board, plastic head<br>stabilizer. |
| Performance | Controls side-to-side and<br>up-and -down motion of<br>patient in dental chair.<br>Tested on over 1,000 child<br>patients with behavior<br>ranging from uncooperative<br>and fearful to hysterically<br>out-of-control;<br>successfully managed the<br>patients to allow dental<br>procedures to be performed. | Controls side-to-side and<br>up-and-down motion of<br>patient in dental chair.<br>Currently on market. |
| Sterility: | Jacket can be laundered and<br>bleached. | Same |
| Safety: | Secures patient firmly and<br>comfortable in dental chair. | Same |
| Anatomical sites: | Secures patient's torso and<br>legs | Same |
| Human factors: | Comfortable and relaxing<br>for patient | Same |
| Compatibility with other<br>devices: | Can be used with any<br>standard dental chair | Same |
| Where used: | Dental office | Same |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Vacharee S. Peterson Cavity Free Kids, Incorporated 1224 Arcade Street St. Paul, Minnesota 55106

K972446 Re : Pedo Cush Pedo Cuddle Trade Name: Regulatory Class: I Product Code: ISMO October 9, 1997 Dated: October-14, 1997 --Received:

Dear Dr. Peterson:

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 indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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

NOV 1 3 1007

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Page 2 - Dr. Peterson

through 542 of the Act for devices under the Electronic Chrough Jaz Or the notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deberraco in formalence of your device to a legally Finding or babbancear or coults in a classification for your markets 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to 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/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

ರ್ವಾ

.Enclosure

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K972446

Indications For Use

| \$10(k) Number (if known) | K972446 |
|---------------------------|-----------------------|
| Device Name: | PEDO CUSH PEDO CUDDLE |

Indications For Use:Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.

OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF MERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Crescenti

(D) === Sigr "><< Divis and Or Controller Control. and Garnral Hispital Device 972446 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 4

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)