BABY POD

K030283 · Prism Enterprises, Inc. · FPP · Apr 22, 2003 · General Hospital

Device Facts

• Record ID: K030283
• Device Name: BABY POD
• Applicant: Prism Enterprises, Inc.
• Product Code: FPP · General Hospital
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6900
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

Device Story

Baby Pod is a pediatric carrier/stretcher accessory used to transport infants between or within medical facilities. The device consists of a lightweight carbon fiber outer shell lined with shock-absorbent foam, featuring transparent shields for infant observation. It includes a patient-positioning vacuum mattress, stretcher-fixing straps for securing the device during transport, and safety straps to secure the infant. The device is operated by healthcare personnel. It provides a protective, stable environment for the infant during transit, minimizing physical impact through its shock-absorbent design.

Clinical Evidence

Bench testing only. Biocompatibility of materials in contact with the infant was evaluated in accordance with ISO-10993 standards.

Technological Characteristics

Carbon fiber outer shell; shock-absorbent foam inner lining; transparent viewing shields; patient-positioning vacuum mattress; stretcher and safety straps. Materials are biocompatible per ISO-10993.

Indications for Use

Indicated for the transport of infants between or within medical facilities.

Regulatory Classification

Identification

A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

Predicate Devices

• WEEVAC 6 Infant Evacuation Stretcher (K902521)

Reference Devices

• TransWarmer warmer mattress (K934631)

Submission Summary (Full Text)

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## APR 2 2 2003

K030283

# 510(k) Summary

Submitted by:

| Company Name: | Prism Enterprises LP |
|-----------------|------------------------|
| Address: | 6952 Fairgrounds Pkwy. |
| | San Antonio, TX 78238 |
| Telephone: | 1-800-648-9822 |
| Fax: | 210-520-7463 |
| CONTACT PERSON: | Barb Wills |
| DATE PREPARED: | 01-22-03 |

| TRADE NAME: | Baby Pod |
|--------------|----------------------------------------|
| COMMON NAME: | pediatric carrier- stretcher accessory |

SUBSTANTIALLY EQUIVALENT TO: The Baby Pod is substantially equivalent to WEEVAC 6 Infant Evacuation Stretcher (K902521). The TransWarmer® warmer mattress, an accessory used with the Baby Pod, was previously cleared for market (K934631.) The Baby Pod has the same intended use and similar indications for use as the predicate device. The minor technological differences (materials of construction and configuration) are more contemporary than those of the WEEVAC 6, but are well characterized and materials in contact with the baby are biocompatible.

DESCRIPTION of the DEVICE: Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.

#### INDICATIONS FOR USE:

Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

#### SUMMARY of TESTING:

Material components in contact with the baby have been evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with two snakes entwined around it.

Public Health Service

APR 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Prism Enterprise, Incorporated C/O Ms. Elaine Duncan Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560

Re: K030283

Trade/Device Name: Baby Pod Regulation Number: 880.6900 Regulation Name: Hand-carried Stretcher Regulatory Class: I Product Code: FPP Dated: January 22, 2003 Received: January 27, 2003

Dear Ms. Duncan:

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 - Ms. Duncan

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 (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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Susan Roeser

Susan Runner, DDS, MA Interim 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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510(k) Number (if known)_11030283

Device Name:

### Indications for Use:

Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

> (Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over -The-Counter Use

(Optional Format 1-2-96)

Patricia Ciacente

nesthesiology, General Hosi

510(k) Number: K030283

510(k) Submission: Baby Pod