KOZY COMFORT INFANT POSITIONER

K062143 · Alfred E Mann Inst. For Biomedical Engineering · FRP · Oct 24, 2006 · General Hospital

Device Facts

• Record ID: K062143
• Device Name: KOZY COMFORT INFANT POSITIONER
• Applicant: Alfred E Mann Inst. For Biomedical Engineering
• Product Code: FRP · General Hospital
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5680
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The device is intended for positioning infants 0-12 months of age to prevent a condition known as deformational plagiocephaly.

Device Story

Kozy Comfort™ Infant Positioner is a polyurethane-based device designed to support infants 0-12 months of age. It functions as a physical support to maintain infant positioning during sleep, specifically intended to prevent deformational plagiocephaly caused by consistent back-sleeping. The device is intended for over-the-counter use by caregivers in a home environment. It provides a stable surface or boundary to encourage varied head positioning, thereby reducing pressure on the infant's skull.

Clinical Evidence

No clinical data provided. FDA has not established special controls or performance standards for this device.

Technological Characteristics

Polyurethane-based infant positioner. Form factor designed for infant support. No electronic components, software, or energy sources.

Indications for Use

Indicated for healthy infants 0-12 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

• NightForm (K041996)
• Pedicraft Reflux Wedge (K905629)

Submission Summary (Full Text)

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K062143

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## 510(k) Summary

OCT 2 4 2006

| Applicant Name: | Alfred E. Mann Institute for Biomedical Engineering at the University of<br>Southern California |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1042 W. 36th Place, DRB 101<br>Los Angeles, CA 90089 |
| Contact Person: | Arman H. Nadershahi, Esq. |
| Telephone: | [phone] |
| Preparation Date: | July 24, 2006 |
| Device Trade Name: | Kozy Comfort™ Infant Positioner |
| Device Common Name: | Infant Sleep Positioner |
| Classification Name: | Holder, Infant Positioner, Code FRP, CFR 880.5680 |
| Class: | Class I |
| Predicate Device: | NightForm - 510(k) # K041996<br>Pedicraft Reflux Wedge - 510(k) # K905629 |
| Device Description: | Kozy Comfort™ Infant Positioner is a polyurethane based infant<br>positioner. |
| Intended Use: | The device is intended for positioning infants 0-12 months of age to<br>prevent a condition known as deformational plagiocephaly. |
| Performance Summary: | FDA has not established special controls or performance standards for<br>this device. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 4 2006

Mr. Arman H. Nadershahi Head of Legal Affairs Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California 1042 W. 36th Place, DRB 101 Los Angeles, California 90089

Re: K062143

Trade/Device Name: Kozy Comfort™ Infant Positioner Regulation Number: 21 CFR 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: July 24, 2006 Received: July 27, 2006

Dear Mr. Nadershahi:

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 indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Nadershahi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runoe

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): K062143

Device Name: Kozy Comfort™ Infant Positioner

Indications For Use:

The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chr. Win

1 Humber ._ / 462

Can-Off ion of Anesthesiology, General Hospical, on Control, Dental Devicesa

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