(85 days)
No
The device description and intended use focus solely on the physical structure and function of a transport device for babies. There is no mention of any computational analysis, data processing, or features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a transport solution for babies, similar to a stretcher, and does not provide any treatment or therapeutic action. Its purpose is solely for conveyance.
No
Explanation: The device is described as a transport incubator or stretcher for conveying babies, not for diagnosing medical conditions. There is no mention of it analyzing any data or performing any diagnostic functions.
No
The device description explicitly details physical components such as a carbon fiber shell, foam lining, transparent shields, vacuum mattress, and straps, indicating it is a hardware device for transporting infants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "convey a baby to or from a medical facility, between facilities or between departments within a single medical facility." This describes a device used for transportation and support, not for performing tests on samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description details a physical container designed for transporting a baby, focusing on features like the shell, lining, shields, mattress, and straps. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in the body.
- Diagnostic or monitoring purposes based on sample analysis.
Therefore, the Baby Pod is a medical device used for patient transport, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Material components in contact with the baby have been evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6900 Hand-carried stretcher.
(a)
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.(b)
Classification. Class I (general controls). The device 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 also exempt from the current good manufacturing practice requirements of the quality system 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
APR 2 2 2003
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.
1
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.
2
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 (301) 594-4618. 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/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
3
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