(89 days)
The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly
Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.
The provided 510(k) summary for the "Kozy Comfort™ Infant Positioner" (K062143) does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.
The document states: "FDA has not established special controls or performance standards for this device." This indicates that the device was approved based on substantial equivalence to predicate devices, rather than through a performance study against specific acceptance criteria.
Therefore, for each of your requested points, the answer is that the information is not available in the provided text.
Here's a breakdown based on your request, explicitly stating why the information is not present:
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A table of acceptance criteria and the reported device performance
- Not available. The document states no special controls or performance standards exist for this Class I device. As such, no defined acceptance criteria are presented, nor is there a study reporting performance against such criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No performance study is mentioned or referenced.
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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 available. No performance study requiring expert adjudication or ground truth establishment is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No performance study or test set requiring adjudication is described.
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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 available. This device is an infant positioner, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not available. This device is an infant positioner, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. No performance study requiring ground truth is described.
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The sample size for the training set
- Not available. No training set is applicable or described for this type of device.
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How the ground truth for the training set was established
- Not available. No training set or ground truth establishment is applicable or described.
In summary, the provided 510(k) summary is for a Class I medical device (infant positioner) that was cleared based on substantial equivalence to existing predicate devices, without the need for performance studies against specific acceptance criteria. Therefore, the information you requested about performance studies, data, and ground truth is not part of this 510(k) submission.
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510(k) Summary
OCT 2 4 2006
| Applicant Name: | Alfred E. Mann Institute for Biomedical Engineering at the University ofSouthern California |
|---|---|
| Address: | 1042 W. 36th Place, DRB 101Los Angeles, CA 90089 |
| Contact Person: | Arman H. Nadershahi, Esq. |
| Telephone: | (213) 740-8271 |
| Preparation Date: | July 24, 2006 |
| Device Trade Name: | Kozy Comfort™ Infant Positioner |
| Device Common Name: | Infant Sleep Positioner |
| Classification Name: | Holder, Infant Positioner, Code FRP, CFR 880.5680 |
| Class: | Class I |
| Predicate Device: | NightForm - 510(k) # K041996Pedicraft Reflux Wedge - 510(k) # K905629 |
| Device Description: | Kozy Comfort™ Infant Positioner is a polyurethane based infantpositioner. |
| Intended Use: | The device is intended for positioning infants 0-12 months of age toprevent a condition known as deformational plagiocephaly. |
| Performance Summary: | FDA has not established special controls or performance standards forthis device. |
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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2006
Mr. Arman H. Nadershahi Head of Legal Affairs Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California 1042 W. 36th Place, DRB 101 Los Angeles, California 90089
Re: K062143
Trade/Device Name: Kozy Comfort™ Infant Positioner Regulation Number: 21 CFR 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: July 24, 2006 Received: July 27, 2006
Dear Mr. Nadershahi:
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 such 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 – Mr. Nadershahi
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/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runoe
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
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Indications For Use
510(k) Number (if known): K062143
Device Name: Kozy Comfort™ Infant Positioner
Indications For Use:
The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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)
Chr. Win
1 Humber ._ / 462
Can-Off ion of Anesthesiology, General Hospical, on Control, Dental Devicesa
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§ 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.