VAGABOND SOFT RESTRAINT SYSTEM by EMERGENT INNOVATIONS, LTD.

Yagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride.

Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport.

Vagabond for Panoose Application: The papose application is necessary for the pediatric patients who require emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an and for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed.

Yagabond for bed restraint: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called the "Vagabond Soft Restraint System." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical trial or performance evaluation.

However, based on the nature of the document, we can infer some aspects and highlight what information is missing.

What the document tells us (and what it doesn't):

The document grants substantial equivalence to a predicate device, which means the FDA has determined the new device is as safe and effective as a legally marketed device. This process typically relies on comparing the new device's design, materials, and intended use to an existing, approved device, rather than requiring extensive new performance studies against specific acceptance criteria.

Response to your questions based on the provided document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or mechanical stress limits). The acceptance criterion implicitly met is "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a legally marketed device.
- Reported Device Performance: The document does not report specific device performance metrics resulting from a study. It only describes the "Indications For Use" for which the device is considered substantially equivalent. These indications describe how it's meant to be used, implying it performs adequately for these uses, but without quantitative data.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not mention any specific test set sample size or data provenance for a study demonstrating performance. The 510(k) process primarily involves comparing the new device to a predicate, and often relies on bench testing, previous clinical data for the predicate, or design specifications rather than a new large-scale clinical trial for every submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. As no specific test set or clinical study is detailed, the establishment of ground truth by experts is not discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. There is no mention of a test set or an adjudication method.
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:
- This is not applicable. The "Vagabond Soft Restraint System" is a physical restraint device, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as the device is a physical restraint system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Since there's no mention of a specific performance study in this document, there's no information on the type of ground truth used. The "ground truth" for a physical restraint device would typically relate to its mechanical integrity, durability, and effectiveness in securing patients according to established safety standards, which are usually assessed through engineering tests and comparison to predicate devices, not clinical outcomes data in the same way as a diagnostic device.
The sample size for the training set:
- This is not applicable. The device is a physical restraint system, not an AI model requiring a training set.
How the ground truth for the training set was established:
- This is not applicable. The device is a physical restraint system.

In summary: The provided document is a regulatory clearance letter, not a scientific study report. It confirms the "Vagabond Soft Restraint System" is substantially equivalent to a legally marketed predicate device for various indications, but it does not detail the specific performance studies, acceptance criteria, or methodological aspects that would be present in a research paper. These types of details are usually contained in the 510(k) submission itself, which is a much larger and more technical document.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 1999

Mr. Duane R. Elliott Emergent Innovations, Ltd. P.O. Box 40773 46240 Indianapolis, Indiana

Re: K982178 Vagabond Soft Restraint System Trade Name: Requlatory Class: I Product Code: FMQ October 27, 1998 Dated: October 29, 1998 Received:

Dear Mr. Elliott:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Elliott

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known) __ K-982178 Vagabond Soft Restraint System Device Name:___

Indications For Use:

(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)

(Division Sign-Off)

Division of Dental Infection Control,

and General Hospital Devices

510(k) Number	K982178
---------------	---------

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Indications For Use

510(k) Number (if known)______________________________________________________________________________________________________________________________________________________ Vagabond Soft Restraint System Device Name:

Indications For Use:

... . .

Yagabond for bed restraint:_This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺳﺎ

Over-The-Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices

510(k) Number __

Regulation Number and Section

§ 880.6760 Protective restraint.

(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(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.