(8 days)
Not Found
No
The device description and intended use focus on physical components (foam mattress, wedges) and mechanical positioning, with no mention of AI/ML terms, image processing, or data-driven algorithms.
No.
The device is indicated for prevention, not treatment, of a condition. Therefore, it is not a therapeutic device.
No
Explanation: The device is intended to prevent skull deformities by modifying sleeping positions, not to diagnose a medical condition.
No
The device description explicitly states it is a "fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges," indicating it is a physical hardware device, not software only.
Based on the provided information, the NightForm product is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NightForm's Function: The NightForm product is a physical device (a mattress and wedges) used externally to modify an infant's sleeping position. It does not involve testing any biological samples.
- Intended Use: The intended use is to prevent a physical condition (skull deformities) by altering sleeping posture, not to diagnose or detect a condition through laboratory analysis.
Therefore, the NightForm product falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly.
The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, known as deformational (or positional) plagiocephaly.
Product codes (comma separated list FDA assigned to the subject device)
FRP
Device Description
NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
0-9 months of age
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)
Performance Summary: FDA has not established special controls or performance standards for this device.
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.
Pedicraft Infant Reflux Wedge (K905629)
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.
0
Image /page/0/Picture/0 description: The image shows the text "Plastic Surgery Solutions, LLC". The text is white and the background is black. The text is centered in the image.
"Designer and marketer of NightForm infant positioning mattress"
APPLICANT INFORMATION A.
Submitter
Plastic Surgery Solutions, LLC 1150 N. 35th Avenue Suite 490 Hollywood, FL 33021
Submitter Contact Information
Phil Carter Phone: 954-648-6617 509-463-2465 Fax:
Submitter Registration Number (Owner/Operator): 9060469
Manufacturer:
JMB Products, Inc. 1401 Davey Road #750 Woodridge, IL 60517
Application date:
June 3, 2004
DEVICE NAME AND CLASSIFICATION B.
Infant sleep positioner Common Name:
Holder, Infant Position, Code FRP, CFR 880.5680 Classification Name:
NightForm™ Trade Name:
Class 1 Class:
Predicate Device:
The subject device is substantially equivalent to a predicate device Pedicraft Infant Reflux Wedge (K905629).
Device Description:
NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress
Image /page/0/Picture/24 description: The image shows the word "NightForm" in a bold, serif font. Below "NightForm" is the phrase "Infant Positioning Bed" in a smaller, sans-serif font. The text is black against a white background.
1
CO41696
Plastic Surgery Solutions, LLC
"Designer and marketer of NightForm infant pos
by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
Intended Use:
The device is intended to be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly.
Predicate Comparison
| Comparison | NightForm™ Infant Sleep
Positioner | Pedicraft Reflux Wedge
K 905629 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Application | Sleep positioning | Sleep positioning |
| Target Population | Infants 0-9 months | Infants |
| Purpose | To maintain the infant in sleep
positions that prevent deformational
plagiocephaly. | To maintain the infant in a sleeping
position which prevents gastro-
esophogeal reflux. |
| Materials | Fire retardant foams, fire-retardant
fabrics (treated cotton or poly/cotton
blend), mechanical hook& loop
fasteners, nylon zipper. | Foams, vinyl covering, fabric sling. |
Performance Summary: FDA has not established special controls or performance standards for this device.
Image /page/1/Picture/9 description: The image shows the word "NightForm" in a bold, sans-serif font. Below "NightForm" is the phrase "Infant Position rg Brd" in a smaller, less bold font. The text is black against a white background.
1150 N. 35th Avenue, Suite 490, Hollywood, Florida 33021
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
AUG - 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Plastic Surgery Solutions, LLC C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K041996
Trade/Device Name: NightFormTM, Infant Sleep Positioner Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: July 22, 2004 Received: July 26, 2004
Dear Mr. Devine:
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 referenced above and have acceminiosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the sixtration, 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 If your device is chasilional controls. Existing major regulations affecting (1 Wrt), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DTS Issuaires of that your device complies with other requirements mean that FDA nas made a doternand regulations administered by other Federal agencies. of the Act of ally I edelar bata suite suirements, including, but not limited to: registration r ou must comply with an also hove g (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lability systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality byovisions (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) I mis letter will anow you to objact inding of substantial equivalence of your device to a premiteted 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), IT you desire specific at rios for your as at (301) 594-4618 . 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 may obtain other generalacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chin-Lin, Ph.D.
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
Indications for Use
510(k) Number (if known): K041996_______________________________________________________________________________________________________________________________________
Device Name: __ NightFormTM, Infant Sleep Positioner |
Indications for Use:
The NightForm product is indicated for healthy infants 0-9 months to aid in the The Night of skull deformities that can rise from consistent back-sleeping postures, prevention of skan Geformational (or positional) plagiocephaly.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cetin Vur
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _ Kay196
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