(298 days)
Not Found
No
The summary describes a physical repositioning device and does not mention any software, data processing, or AI/ML terms.
No.
The device is a repositioning device intended to prevent plagiocephaly, which aligns it more with a prophylactic or preventative device rather than a therapeutic one that treats an existing condition.
No
Explanation: The device is described as a "repositioning device to aid in the prevention of deformational (or positional) plagiocephaly." It does not detect, diagnose, or monitor a condition. Its purpose is preventative and positional, not diagnostic.
No
The device description clearly states it is a "form fitting infant beanie hat," which is a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This device is a physical beanie worn on the head.
- The intended use is for repositioning the infant's head, not for diagnosing any condition or analyzing biological samples.
- The device description clearly states it's a "form fitting infant beanie hat placed strategically on a baby's head." This is a physical intervention, not a diagnostic test.
The information provided about the device's function, intended use, and description all point to it being a physical medical device used for repositioning, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head
Indicated Patient Age Range
0-9 months of age
Intended User / Care Setting
over-the-counter
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)
The FDA has not established special controls or 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.
K062143, K060986, K051300, K041996
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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K082367
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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 | ||
| Wellington, CO 80549 | |||
| Phone Number: | (208) 316-5297 | ||
| Fax Number: | (208) 734-9941 | ||
| Contact Person: | Jane Y. Scott, M.D. | ||
| Chief Executive Officer | |||
| Jsco704@aol.com | |||
| Date Prepared: | June 10, 2009 | ||
| Device Trade or | |||
| Proprietary Name: | Infant Sleep Beanie | ||
| Device Common or | |||
| Usual Name: | Pediatric position holder | ||
| Classification: | Division of Anesthesiology, General Hospital, Infection Control and | ||
| Dental Devices | |||
| Panel: General Hospital and Personal Use Devices | |||
| Classification: 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 infant | ||
| beanie 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-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. | |||
| Technological | |||
| Characteristics: | The Infant Sleep Beanie is worn on the infant's head and therefore | ||
| the 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 is | |||
| easy to pack and change if soiled. | |||
| Performance Summary: | The FDA has not established special controls or standards for this | ||
| device. |
1
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.
2
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:
. 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