NIGHTFORM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "Plastic Surgery Solutions, LLC". The text is white and the background is black. The text is centered in the image. "Designer and marketer of NightForm infant positioning mattress" #### APPLICANT INFORMATION A. #### Submitter Plastic Surgery Solutions, LLC 1150 N. 35th Avenue Suite 490 Hollywood, FL 33021 Submitter Contact Information Phil Carter Phone: 954-648-6617 509-463-2465 Fax: #### Submitter Registration Number (Owner/Operator): 9060469 Manufacturer: JMB Products, Inc. 1401 Davey Road #750 Woodridge, IL 60517 Application date: June 3, 2004 #### DEVICE NAME AND CLASSIFICATION B. Infant sleep positioner Common Name: Holder, Infant Position, Code FRP, CFR 880.5680 Classification Name: NightForm™ Trade Name: Class 1 Class: ## Predicate Device: The subject device is substantially equivalent to a predicate device Pedicraft Infant Reflux Wedge (K905629). ### Device Description: NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress Image /page/0/Picture/24 description: The image shows the word "NightForm" in a bold, serif font. Below "NightForm" is the phrase "Infant Positioning Bed" in a smaller, sans-serif font. The text is black against a white background. {1}------------------------------------------------ CO41696 **Plastic Surgery Solutions, LLC** "Designer and marketer of NightForm infant pos by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly. ### Intended Use: The device is intended to be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly. ## Predicate Comparison | Comparison | NightForm™ Infant Sleep<br>Positioner | Pedicraft Reflux Wedge<br>K 905629 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Application | Sleep positioning | Sleep positioning | | Target Population | Infants 0-9 months | Infants | | Purpose | To maintain the infant in sleep<br>positions that prevent deformational<br>plagiocephaly. | To maintain the infant in a sleeping<br>position which prevents gastro-<br>esophogeal reflux. | | Materials | Fire retardant foams, fire-retardant<br>fabrics (treated cotton or poly/cotton<br>blend), mechanical hook& loop<br>fasteners, nylon zipper. | Foams, vinyl covering, fabric sling. | Performance Summary: FDA has not established special controls or performance standards for this device. Image /page/1/Picture/9 description: The image shows the word "NightForm" in a bold, sans-serif font. Below "NightForm" is the phrase "Infant Position rg Brd" in a smaller, less bold font. The text is black against a white background. 1150 N. 35th Avenue, Suite 490, Hollywood, Florida 33021 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Public Health Service AUG - 3 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Plastic Surgery Solutions, LLC C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548 Re: K041996 Trade/Device Name: NightFormTM, Infant Sleep Positioner Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: July 22, 2004 Received: July 26, 2004 Dear Mr. Devine: 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 referenced above and have acceminiosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the sixtration, 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 If your device is chasilional controls. Existing major regulations affecting (1 Wrt), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Devine Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DTS Issuaires of that your device complies with other requirements mean that FDA nas made a doternand regulations administered by other Federal agencies. of the Act of ally I edelar bata suite suirements, including, but not limited to: registration r ou must comply with an also hove g (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lability systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality byovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to objact inding of substantial equivalence of your device to a premiteted 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), IT you desire specific at rios for your as at (301) 594-4618 . 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 may obtain other generalacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours, Chin-Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): ___K041996__________________________________________________________________________________________________________________________________________ Device Name: __ NightFormTM, Infant Sleep Positioner | Indications for Use: The NightForm product is indicated for healthy infants 0-9 months to aid in the The Night of skull deformities that can rise from consistent back-sleeping postures, prevention of skan Geformational (or positional) plagiocephaly. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Cetin Vur (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: _ Kay196 Page 1 of 1