The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.

AI/ML Overview

The provided text is a 510(k) summary for the "Head Bed™ Infant Sleep Positioner." This document establishes substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include information about the performance claims (e.g., sensitivity, specificity, accuracy) that would be evaluated in such a study.

The document details the device description, intended use, and a comparison to a predicate device ("NightForm™ Infant Sleep Positioner"). It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on substantial equivalence based on design, materials, and intended use, not on specific performance metrics or clinical study results demonstrating efficacy or safety beyond the predicate.
Sample size used for the test set and the data provenance: Not applicable as no performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
Adjudication method for the test set: Not applicable as no performance study is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it's a physical infant positioner.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used: Not applicable as no performance study is described.
The sample size for the training set: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable as no performance study is described, and this is a physical device, not a machine learning model.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria. Such a study would typically be required for devices making new performance claims or those classified differently.

Summary

{0}------------------------------------------------

Kα60986

page 1 of 2

510(k) Summary

JUL 1 1 2006

Applicant Information

Submitter

Contact information

Steven H. Warnock, M.D., P.C. 9829 S. 1300 E. Suite 200 Sandy, UT 84094

Steven Warnock, M.D. Phone: 801-571-2020 Fax: 801-571-6899 email: swarnockmd(a)yahoo.com

Submitter Registration Number: K060986

Device Name and Classification:

Common Name:	Infant Sleep Positioner
Classification Name:	Holder, Infant Position, Code FRP, CFR 880.5680
Trade Name:	Head Bed™
Class:	Class 1

Device Description:

Intended Use:

Deformational plagiocephaly is an abnormal flattening of the infant's head resulting from lying in one position. Some medical conditions predispose infants to this condition. Frequent changes in head position can help prevent or correct deformational plagiocephly. The Head Bed device is intended for use as an infant sleep positioner. The Head Bed device is used to position the head so as to aid in the prevention of deformational plagiocephaly. It is intended for use in infants less than 6 months of age or in those infants who cannot roll from back to front. The device is placed on the mattress, around the head to control head position. This selective positioning of the head allows some control over the forces that create flattening of the head.

Predicate Device:

The subject device is substantially equivalent to a predicate device NightForm Infant Sleep Positioner.

{1}------------------------------------------------

KUCO980

ﻴﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ 2010 C

Predicate Comparison:

Comparison	Head Bed™ Positioner	NightForm™ Infant Sleep Positioner
Application	Sleep positioning	Sleep positioning
Target population	Infants 0-6 months	Infants 0-9 months
Purpose	To maintain infant sleep position for prevention of deformational plagiocephaly.	To maintain infant sleep position for prevention of deformational plagiocephaly.
Materials	Fire-resistant foam and a fire retardant fabric cover with Velcro closure.	Fire-retardant foam and fabric (cotton or poly/cotton blend), mechanical hook & loop fasteners, nylon zipper.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2006

Dr. Steven H. Warnock President Steven H. Warnock, M.D. 9829 South 1300 East, Suite 200 Sandy, Utah 84094

Re: K060986

Trade/Device Name: Head Bed™ Infant Positioner Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: March 6, 2006 Received: March 18, 2006

Dear Dr. Warnock:

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 (first the indications for use stated in the enclosure) to legally marketed predicate devices may keted 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 gremeral 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 Codc of Federal Regulations, Title 21, Parts 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 -Dr. Warnock

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Cure Salion for
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}------------------------------------------------

K06 0986

Indications For Use

510(k) Number (if known): K060986

Head Bed™ infant positioner Device Name:

Indications For Use:

The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

for Hach

Sign-Off)
n of Anesthesiology, General Hospital,
won Control, Dental Devices
0906

i, humbat: K. D.C.R.C.

Page 1 of

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.