INFANT SLEEP BEANIE

K082367 · Life Innovations, LLC · FRP · Jun 12, 2009 · General Hospital

Device Facts

• Record ID: K082367
• Device Name: INFANT SLEEP BEANIE
• Applicant: Life Innovations, LLC
• Product Code: FRP · General Hospital
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5680
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Indications for Use

The Life Innovations Infant Sleep Beanie is an over-the-counter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.

Device Story

Infant Sleep Beanie is a form-fitting hat worn by infants; designed to aid in the prevention of deformational plagiocephaly by facilitating repositioning during sleep or rest. Device is used in various settings including cribs, car seats, bouncers, and strollers. It is intended for use with healthy, non-ambulating infants aged 0-9 months. The device functions as a physical positioner to prevent the infant from rolling or turning away from the desired position. It is an over-the-counter product intended for use by caregivers.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Form-fitting beanie hat; wearable design; non-powered; mechanical positioning aid.

Indications for Use

Indicated for healthy, non-ambulating infants 0-9 months of age to aid in the prevention of deformational (positional) plagiocephaly caused by consistent back-sleeping.

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

• Kozy Comfort™ Infant Positioner (K062143)
• Head Bed™ Infant Positioner (K060986)
• Robin Hood Vest™ (K051300)
• Nightform™ Infant Sleep Positioner (K041996)

Submission Summary (Full Text)

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K082367
1 of 1

Life Innovations
Limited Liability Company

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### 510(k) SUMMARY

# JIJN 1 9 200

| | | | JUN 12 2009 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|
| Submitter: | Life Innovations, LLC. | | |
| Address: | P.O. Box 148<br>Wellington, CO 80549 | | |
| Phone Number: | [phone] | | |
| Fax Number: | [phone] | | |
| Contact Person: | Jane Y. Scott, M.D.<br>Chief Executive Officer<br>[e-mail] | | |
| Date Prepared: | June 10, 2009 | | |
| Device Trade or<br>Proprietary Name: | Infant Sleep Beanie | | |
| Device Common or<br>Usual Name: | Pediatric position holder | | |
| Classification: | Division of Anesthesiology, General Hospital, Infection Control and<br>Dental Devices<br>Panel: General Hospital and Personal Use Devices<br>Classification: Class I (reserved)<br>Classification Code: FRP | | |
| Predicate Device(s): | Kozy Comfort™ Infant Positioner | K062143 | |
| | Head Bed™ Infant Positioner | K060986 | |
| | Robin Hood Vest™ | K051300 | |
| | Nightform™ Infant Sleep Positioner | K041996 | |
| Device Description: | The Life Innovations Infant Sleep Beanie is a form fitting infant<br>beanie hat placed strategically on a baby's head while lying awake,<br>sleeping or during travel. | | |
| Intended Use: | The Life Innovations Infant Sleep Beanie is an over-the-counter<br>repositioning device to aid in the prevention of deformational (or<br>positional) plagiocephaly arising from consistent back-sleeping<br>postures. The Infant Sleep Beanie is intended for healthy, non-<br>ambulating infants 0-9 months of age. | | |
| Technological<br>Characteristics: | The Infant Sleep Beanie is worn on the infant's head and therefore<br>the infant is unable to roll or turn away from the repositioning aid.<br>The Infant Sleep Beanie can be used in all locations – car seat,<br>bouncer, crib, floor stroller, etc. It is a convenient product that is<br>easy to pack and change if soiled. | | |
| Performance Summary: | The FDA has not established special controls or standards for this<br>device. | | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## IUN 1 2 2009

Jane Y. Scott, M.D. Chief Executive Officer Life Innovations, LLC P.O. Box 148 Wellington, Colorado 80549

Re: K082367

Trade/Device Name: Infant Sleep Beanie Regulation Number: 21 CFR 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: June 10, 2009 Received: June 10, 2009

Dear Dr. Scott:

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 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- Dr. Scott

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Anthony 29. master for

Susan Runner, D.D.S., M.A. Acting Director . . . Division of Anesthesiology, General Hospital, . Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

K082367

. Infant Sleep Beanie

The Life Innovations Infant Sleep Beanie is an over-thecounter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KO82367

Life Innovations, LLC Revised February, 2009