(204 days)
The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.
The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Robin Hood Vest™, which is a pediatric position holder. It declares the device's substantial equivalence to a predicate device based on its intended use and description, but it does not detail any performance studies, acceptance criteria, or specific data about the device's effectiveness or accuracy in preventing skull deformities.
Therefore, I cannot provide the requested table and information about a study based on the given text.
Summary of what cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory submission and substantial equivalence, not performance metrics.
- Sample size used for the test set and the data provenance: Not present. No test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
- Adjudication method for the test set: Not present. No test set or adjudication is mentioned.
- 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 relevant or present. This device is a physical pediatric position holder, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant or present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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APPENDIX E
510(k) SUMMARY Robin Hood Vest™ Kamber Corporation
This 510(k) summary of safety and effectiveness for the Robin Hood Vest™ is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Kamber Corporation |
|---|---|
| Address: | 104 S. 16 th StreetSan Jose, CA 95112 |
| Contact Person: | Connie DeWittPresident |
| Telephone: | (408) 286-6956 (telephone)(408) 228-8423 (fax) |
| Preparation Date: | May 2005 |
| Device Trade Name: | Robin Hood Vest ™ |
| Common Name: | Pediatric Position Holder |
| Classification Name: | Pediatric Position Holder (see 21 C.F.R. § 880.5680)Product Code: FRP |
| Predicate Device: | Nightform -- 510(k) # K041996 |
| Device Description: | The Robin Hood Vest ™ is a sleeveless vest, with a pocketon the back for an insertable foam wedge, that an infantwears while sleeping. The device positions a foam wedgeunder the infant during sleep to direct the head so that itdoes not always rest on the same spot. |
| Intended Use: | The Robin Hood Vest ™ is intended for use in healthy infantsaged 0-15 months to aid in the prevention of skulldeformities that can arise from consistent back-sleepingpostures, the condition known as deformational (orpositional) plagiocephaly. |
| CONCLUSIONS: | Based on the foregoing and other information in thisapplication, Kamber Corporation believes that the Robin |
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Hood Vest is substantially equivalent to its claimed predicate under conditions of intended use.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 2005
Kamber Corporation C/O Mr. David J. Bloch ReedSmith 1301 K Street, North West Suite 1100-East Tower Washington, D.C. 20005-3373
Re: K051300
Trade/Device Name: Robin Hood Vest™ Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: I Product Code: FRP Dated: October 31, 2005 Received: November 1, 2005
Dear Mr. Bloch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rows 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 merslate conmisered prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives 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 approvisions of the Act. The general controls provisions of the Act include controls provisions or 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 (1 Wry, it may of sacross to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of tountish further announcements concerning your device in the Eederal Register.
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Page 2 - Mr. Bloch
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 moan that 1 DA mas made a detess and regulations administered by other Federal agencies. of the Act of ally 1 oderal bakes as a requirements, including, but not limited to: registration T ou must comply with an are reserting (21 CFR Part 801); good manufacturing practice allu fisung (21 ℃FR Part 067), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajon 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) This letter will and in yourse organ finding of substantial equivalence of your device to a premarket notification: - The PD : 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), If you desire specific acrite to pliance at (240) 276-0115. Also, please note the regulation i 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 other gener general 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,
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
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K051300
(06)
TAB C
510(k) Number: K051300
Device Name: Robin Hood Vest™
INDICATIONS FOR USE:
The Robin Hood Vest™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.
Prescription Use
OR
Over-the-Counter Use ____X
(Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.