(92 days)
NightForm Infant Sleep Positioner
Not Found
No
The device description is purely mechanical and there is no mention of AI, ML, or any computational processing.
No.
The device is indicated for prevention, not for treatment or therapy.
No
Explanation: The device is indicated to aid in the prevention of deformational plagiocephaly, not to diagnose it.
No
The device description clearly states it is a physical foam cushion, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Head Bed Function: The Head Bed™ is a physical device designed to position an infant's head externally. It does not involve testing any biological samples.
- Intended Use: The intended use is to aid in the prevention of deformational plagiocephaly by providing physical support and positioning.
The description clearly indicates a physical support device, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.
Product codes (comma separated list FDA assigned to the subject device)
FRP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
Indicated Patient Age Range
Infants less than 6 months of age or in those infants who cannot roll from back to front.
Infants aged 0-6 months.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NightForm Infant Sleep Positioner
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5680 Pediatric position holder.
(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.
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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:
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.
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
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.
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
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