ROBIN HOOD VEST

K051300 · Kamber Corporation · FRP · Dec 8, 2005 · General Hospital

Device Facts

• Record ID: K051300
• Device Name: ROBIN HOOD VEST
• Applicant: Kamber Corporation
• Product Code: FRP · General Hospital
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5680
• Device Class: Class 1
• Attributes: Pediatric

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.

Device Story

The Robin Hood Vest™ is a sleeveless garment designed for infants to wear during sleep. It features a back pocket containing an insertable foam wedge. The device functions by positioning the foam wedge under the infant to direct the head's resting position, preventing the head from consistently resting on the same spot. This mechanical positioning aims to reduce the risk of deformational (positional) plagiocephaly in healthy infants. The device is intended for over-the-counter use by caregivers in a home environment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use.

Technological Characteristics

Sleeveless vest with insertable foam wedge. Mechanical positioning device. No energy source, software, or electronic components.

Indications for Use

Indicated for healthy infants aged 0-15 months to aid in the prevention of deformational (positional) plagiocephaly caused by consistent back-sleeping postures.

Regulatory Classification

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.

Predicate Devices

• Nightform (K041996)

Submission Summary (Full Text)

{0}------------------------------------------------

05/300

1 of 2

### 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<br>San Jose, CA 95112 |
| Contact Person: | Connie DeWitt<br>President |
| Telephone: | [phone] (telephone)<br>[phone] (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)<br>Product Code: FRP |
| Predicate Device: | Nightform -- 510(k) # K041996 |
| Device Description: | The Robin Hood Vest ^™ is a sleeveless vest, with a pocket<br>on the back for an insertable foam wedge, that an infant<br>wears while sleeping. The device positions a foam wedge<br>under the infant during sleep to direct the head so that it<br>does not always rest on the same spot. |
| Intended Use: | The Robin Hood Vest ^™ is intended for use in healthy infants<br>aged 0-15 months to aid in the prevention of skull<br>deformities that can arise from consistent back-sleeping<br>postures, the condition known as deformational (or<br>positional) plagiocephaly. |
| CONCLUSIONS: | Based on the foregoing and other information in this<br>application, Kamber Corporation believes that the Robin |

{1}------------------------------------------------

K051300

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 [phone]. 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 [phone] or [phone] 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)

K051302