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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "Baby Pod." This document is a premarket notification for a Class I device and focuses on establishing substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria often seen in Class II/III devices or AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (like acceptance criteria for performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance with metrics like sensitivity/specificity, or detailed ground truth methodologies) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in text)	Reported Device Performance
Materials in contact with the baby must be biocompatible.	Evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible.
Device must be substantially equivalent to WEEVAC 6 Infant Evacuation Stretcher (K902521) in terms of intended use and similar indications for use.	Determined to be substantially equivalent based on intended use, indications for use, and characterization of technological differences (materials, configuration) which are more contemporary but biocompatible.

2. Sample size used for the test set and the data provenance:

Not applicable/Not Provided: This submission focuses on substantial equivalence based on design characteristics and material biocompatibility, not performance metrics derived from a test set of data or patient outcomes. There is no mention of a "test set" in the context of clinical or performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not Provided: No clinical "ground truth" or expert review of a test set is mentioned. The ground truth for biocompatibility would be established by laboratory testing against ISO standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not Provided: No test set requiring adjudication by experts is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable: This device is a pediatric carrier-stretcher accessory, not an AI or imaging device. Therefore, no MRMC study or AI assistance is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable: This is a physical medical device, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Biocompatibility Standards: For the specified acceptance criteria, the "ground truth" for material safety relied on ISO-10993 recognized test methods for biocompatibility.
Predicate Device Comparison: The determination of "substantial equivalence" served as the primary "ground truth" or benchmark for this type of submission, comparing the new device's features, intended use, and indications to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable/Not Provided: No training set is involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" described in this 510(k) submission is primarily a comparison to a predicate device and biocompatibility testing.

Predicate Device Comparison: The "Baby Pod" was compared to the WEEVAC 6 Infant Evacuation Stretcher (K902521). The study aimed to demonstrate that the Baby Pod has the "same intended use and similar indications for use." The minor technological differences (materials of construction and configuration) were characterized and deemed "more contemporary" but "biocompatible," ensuring they did not raise new questions of safety or effectiveness. This comparison facilitated the substantial equivalence determination by the FDA.
Biocompatibility Testing: "Material components in contact with the baby have been evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible." This testing directly addressed the safety aspect of the materials used in the device.

In essence, for a Class I device seeking 510(k) clearance, the "study" is often an engineering and design comparison combined with relevant safety testing (like biocompatibility), rather than a clinical trial or performance evaluation using patient data.

Summary

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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 (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

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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 _____________________________________________________________________________________________________________________________________________________________

Over -The-Counter Use

(Optional Format 1-2-96)

Patricia Ciacente

nesthesiology, General Hosi

510(k) Number: K030283

510(k) Submission: Baby Pod

Regulation Number and Section

§ 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.