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.

Device Description

The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat placed strategically on a baby's head while lying awake, sleeping or during travel.

AI/ML Overview

This device, the "Infant Sleep Beanie," is a Class I medical device (pediatric position holder) and, as such, is exempt from stringent performance requirements typically associated with Class II or Class III devices. The submission explicitly states: "The FDA has not established special controls or standards for this device."

Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria are met is not applicable in this case. The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's how to address each point given the provided information:

Acceptance Criteria and Device Performance for Infant Sleep Beanie (K082367)

This device, classified as a Class I pediatric position holder, is exempt from specific performance-based acceptance criteria established by the FDA. Therefore, the device's acceptance is primarily based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting predefined numerical performance targets from a clinical trial. The provided submission does not contain a performance study with defined acceptance criteria.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not applicable. The FDA has not established special controls or standards for this Class I device. Acceptance is based on substantial equivalence to predicate devices, focusing on technological characteristics and intended use.	The device's "Performance Summary" section states: "The FDA has not established special controls or standards for this device." Therefore, no specific performance metrics or results from a performance study are reported in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission does not describe a performance study with a test set. This 510(k) is a premarket notification for a Class I device, which relies on demonstrating substantial equivalence to predicates rather than clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study or comparative effectiveness study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical pediatric position holder, not an algorithm, and therefore "standalone performance" in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established or used as there is no performance study described. The basis for marketing this device is its substantial equivalence to other legally marketed pediatric position holders.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.

Summary

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K082367
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Life Innovations
Limited Liability Company

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510(k) SUMMARY

JIJN 1 9 200


Submitter:	Life Innovations, LLC.
Address:	P.O. Box 148Wellington, CO 80549
Phone Number:	(208) 316-5297
Fax Number:	(208) 734-9941
Contact Person:	Jane Y. Scott, M.D.Chief Executive OfficerJsco704@aol.com
Date Prepared:	June 10, 2009
Device Trade orProprietary Name:	Infant Sleep Beanie
Device Common orUsual Name:	Pediatric position holder
Classification:	Division of Anesthesiology, General Hospital, Infection Control andDental DevicesPanel: General Hospital and Personal Use DevicesClassification: Class I (reserved)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 infantbeanie hat placed strategically on a baby's head while lying awake,sleeping or during travel.
Intended Use:	The Life Innovations Infant Sleep Beanie is an over-the-counterrepositioning device to aid in the prevention of deformational (orpositional) plagiocephaly arising from consistent back-sleepingpostures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.
TechnologicalCharacteristics:	The Infant Sleep Beanie is worn on the infant's head and thereforethe infant is unable to roll or turn away from the repositioning aid.The Infant Sleep Beanie can be used in all locations – car seat,bouncer, crib, floor stroller, etc. It is a convenient product that iseasy to pack and change if soiled.
Performance Summary:	The FDA has not established special controls or standards for thisdevice.

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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 (800) 638-2041 or (240) 276-3150 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

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

Regulation Number and Section

§ 880.5680 Pediatric position holder.

Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
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.(b)
Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.