(204 days)
Not Found
No
The summary describes a physical vest with a foam wedge and does not mention any computational or data-driven components that would suggest AI/ML.
Yes
The device is intended to aid in the prevention of skull deformities (deformational plagiocephaly), which is a medical condition, making it a therapeutic device.
No
The device is described as an aid in the prevention of skull deformities, not for diagnosing them. It positions a foam wedge to direct the head and prevent consistent pressure on one spot.
No
The device description clearly states it is a "sleeveless vest, with a pocket on the back for an insertable foam wedge," indicating it is a physical, hardware-based device.
Based on the provided information, the Robin Hood Vest ™ 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Robin Hood Vest ™ Function: The Robin Hood Vest ™ is a physical device worn by an infant to alter their sleeping position and prevent skull deformities. It does not involve testing any biological samples.
The device description and intended use clearly indicate a physical intervention, not a diagnostic test performed on biological material.
N/A
Intended Use / 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.
Product codes
FRP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull
Indicated Patient Age Range
0-15 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)
Nightform -- 510(k) # K041996
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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 Street |
| San Jose, CA 95112 | |
| Contact Person: | Connie DeWitt |
| President | |
| 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 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. | |
| Intended 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. | |
| CONCLUSIONS: | Based on the foregoing and other information in this |
| application, Kamber Corporation believes that the Robin |
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Z+2
Hood Vest is substantially equivalent to its claimed predicate under conditions of intended use.
:
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 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.
3
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
4
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)