NIGHTFORM

K041996 · Plastic Surgery Solutions, LLC · FRP · Aug 3, 2004 · General Hospital

Device Facts

• Record ID: K041996
• Device Name: NIGHTFORM
• Applicant: Plastic Surgery Solutions, LLC
• Product Code: FRP · General Hospital
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5680
• Device Class: Class 1
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for 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.

Device Story

NightForm is an infant sleep positioner consisting of a fabric-covered polyurethane foam mattress and two adjustable, fabric-covered polyurethane wedges. The wedges attach to the mattress via hook-and-loop fasteners, allowing parents to modify the infant's supine sleeping position nightly. Used in the home environment by parents, the device aims to prevent deformational plagiocephaly by varying the infant's head position during sleep. It functions as a mechanical positioning aid; no electronic or software components are involved.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Materials: fire-retardant polyurethane foams, fire-retardant fabrics (treated cotton or poly/cotton blend), mechanical hook-and-loop fasteners, and nylon zipper. Form factor: mattress with adjustable wedges. No energy source, connectivity, or software.

Indications for Use

Indicated for healthy infants 0-9 months of age to aid in the prevention of skull deformities (deformational or positional plagiocephaly) resulting from consistent back-sleeping postures.

Regulatory Classification

Identification

A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.

Predicate Devices

• Pedicraft Infant Reflux Wedge (K905629)

Submission Summary (Full Text)

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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: [phone] 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.

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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

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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.

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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 [phone] . 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 [phone] or [phone] 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

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# 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

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