The EleGARD™ Patient Positioning System is cardiopulmonary board which may elevate a patient's head and thorax including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS Chest Compression Systems; and patient transport.

Device Description

The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques.

The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient.

It may be used with the patient lying flat or may elevate the patient's thorax and head. The device would be used in emergency conditions when healthcare professionals need to: provide airway management, perform CPR with manual / hand compressions, adjunctive manual CPR devices, and a LUCAS mechanical compression device, perform manual bag / mask ventilation, and transport a patient.

AI/ML Overview

The provided document describes the EleGARD™ Patient Positioning System, a cardiopulmonary board, and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device and outlines various performance tests conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments
Biocompatibility	ISO 10993-1	Evaluated via Cytotoxicity, Sensitization, and Irritation testing.	The document states "Testing included by Cytotoxicity, Sensitization and Irritation" and implies successful evaluation.
Electrical Safety	ANSI/AAMI/ES 60601-1	Proposed device met the requirements of the standards.	"ES160601-1" is mentioned in the bench testing section as covered.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Proposed device met the requirements of the standards.
Safety for EMS Environments	IEC 60601-1-12	Proposed device met the requirements of the standards.
Functional Performance	Raising and lowering the device to specified positions.	"The proposed device was tested for functional performance of raising and lowering the device to the specified positions."	Implies successful performance, though no specific metrics are given.
Software Verification	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	Software verification was completed.	Implies successful verification.
System Verification	(Implied as part of overall system functionality)	System verification was completed.	Implies successful verification.
Compatibility of Lucas Backplate Connection	Not explicitly stated, but implies proper mechanical and functional compatibility.	Testing was completed for "compatibility of the backplate connection."	Implies successful compatibility.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for any of the tests. The studies conducted are primarily bench testing and evaluations against recognized standards (e.g., ISO, IEC). There is no mention of patient data (retrospective or prospective) being used in these performance tests. The provenance of any data beyond the specific test standards and internal evaluations is not detailed.

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

This information is not provided in the document. The performance data described relates to engineering and material testing standards, not clinical evaluation requiring expert consensus on ground truth.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth, which is not the type of study detailed here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is focused on evaluating the performance of diagnostic algorithms, often with AI assistance, in a clinical setting involving human readers and interpretation of images/data. The EleGARD™ is a patient positioning system, and its evaluation focuses on mechanical, electrical, and material safety and functionality, not diagnostic accuracy or AI assistance for human readers.

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

This is not applicable as the EleGARD™ Patient Positioning System is a physical medical device, not an algorithm that performs a diagnostic or analytical function. Therefore, a standalone algorithm performance study was not conducted.

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

For the engineering and material safety tests described, the "ground truth" is established by adherence to the specified international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12). Compliance with these standards serves as the benchmark for acceptable performance. There is no mention of clinical outcomes data, expert consensus, or pathological findings being used as ground truth for these studies.

8. The sample size for the training set

This is not applicable. The EleGARD™ is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable for the same reasons above; there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 13, 2020

Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutions c/o Paul Dryden Manager ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K191689

Trade/Device Name: EleGARD Patient Positioning System Regulation Number: 21 CFR 880.6080 Regulation Name: Cardiopulmonary Resuscitation Board Regulatory Class: Class I. reserved Product Code: FOA, Dated: January 14, 2020 Received: January 15, 2020

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K191689

Device Name

EleGARD™ Patient Positioning System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17) 443-6740 EF

Page 1 of 1

SC Publishing Services (301)

{3}------------------------------------------------

510(k) Summary K191689

Date Prepared: 13-Feb-2020

I Submitter

Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutions
5201 Eden Ave., Suite 300
Edina, MN 55436
Tel – 763.259.3722

Submitter Contact:	Philip Tetzlaff, CTO
Submission Correspondent:	Paul Dryden, ProMedic, LLC

II Device

Proprietary or Trade Name:	EleGARD™ Patient Positioning System
Common/Usual Name:	Cardiopulmonary resuscitation board
Classification Name:	Cardiopulmonary resuscitation board (21CFR 880.6080)
Regulatory Class:	I
Product Code:	FOA

III Predicate Device

	Minnesota Resuscitation (now AdvancedCPR Solutions)Heads Up Platform - Class I exempt, FOA, 21CFR 880.6080
--	----------------------------------------------------------------------------------------------------------------

IV Device Description

V Indications for Use

The EleGARD™ Patient Positioning System is a cardiopulmonary board which may elevate a patient's head and thorax: including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS Chest Compression Systems; and patient transport.

{4}------------------------------------------------

Patient Population:

Patients who may benefit from elevation of the head and neck, including those patients in need of airway management, elevation of the head, and those undergoing CPR.

Contraindications:

It is recommended that EleGARD™ not be used under the following conditions:

When it is not possible to position the patient safely or correctly on the EleGARD™ .
If the patient weighs more than 350 pounds

Environments of Use:

Hospital and pre-hospital

VII Comparison of Technological Characteristics and Performance with the Predicate

Table 1 - Table of the Similarities and Differences of Predicate vs. Proposed Device

	ProposedEleGARD™ PatientPositioning	PredicateHead Up Platform
Procode	FOA - cardiopulmonary resuscitationboardCFR 880.6080	FOA - cardiopulmonary resuscitationboardCFR 880.6080
Indications for Use	The EleGARD™ Patient PositioningSystem is cardiopulmonary boardwhich may elevate a patient's headand thorax including during airwaymanagement; during manual CPR,manual CPR adjuncts, CPR with theLUCAS Chest Compression Systems;and patient transport	Intended to assist in elevating the headand shoulders of a patient from asupine position to approximately 30degrees and may be used duringvarious procedures, i.e., airwaymanagement procedures, CPR, etc.
Prescriptive	Trained medical personnel	Trained medical personnel
Environments of use	Hospital and pre-hospital	Hospital and pre-hospital
Technology	Method to elevate the head and torsovia manual and electro-mechanicallifting and hold in place	Manual mechanical means to elevatethe head and torso and hold in place
Performance	IEC 60601-1IEC 60601-1-2IEC 60601-1-12Cleaning of patient contacting surfacesCompatibility of Lucas backplateconnection	Device was not electrical
Contraindications	It is recommended that EleGARD™not be used under the followingconditions:• When it is not possible to positionthe patient safely or correctly on theEleGARD• If the patient weighs more than 350pounds	It is recommended that EleGARD™not be used under the followingconditions:• When it is not possible to positionthe patient safely or correctly on theEleGARD• If the patient weighs more than 350pounds
Patient contactingmaterials	Evaluated via ISO 10993-1	Evaluated via ISO 10993-1

{5}------------------------------------------------

Substantial Equivalence Rationale

The EleGARD™ is viewed as substantially equivalent to the predicate device because:

Indications -

. Both the EleGARD™ and predicate device are designed to elevate a patient's head and thorax during airway management, various modalities of CPR and patient transport. The differences in the indications is that the subject device can be used with the LUCAS chest compression system. Performance testing was completed to support this change in indication.

Environment of Use -

All devices have the same environments of use: hospital and pre-hospital to be used by trained medical personnel

Technology -

The technology is to stabilize the body position and to elevate the patient's head and . thorax during CPR. The positions of the head and thorax are similar but the means to elevate is different between the proposed EleGARD™ and the predicate Head Up Platform.
The difference is electro-mechanical elevations vs. manual elevation. The practical nature of having electro-mechanical assistance in place of manual mechanical spring strut to elevate the patient when needed has been evaluated and does not raise any new concerns for safety or effectiveness that are not typical of other electro-mechanical devices.

VIII Performance Data

Biocompatibility of Materials -

The patient contacting materials of the EleGARD™ have been evaluated according to ISO 10993-1. Testing included by Cytotoxicity, Sensitization and Irritation.

Electrical, EMC, EMI testing -

We have evaluated the proposed device per ANSI/AAMI/ES 60601-1. IEC 60601-1-2, and IEC 60601-1-12.

The proposed device met the requirements of the standards.

Bench testing -

The proposed device was tested for functional performance of raising and lowering the device to the specified positions; Electrical safety ( ES160601-1); EMC (IEC60601-1-2); and Safety for use in EMS environments (IEC 60601-1-12), software verification and system verification (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and compatibility of the backplate connection.

IX Conclusion

The sponsor has demonstrated through performance testing, design and features to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.6080 Cardiopulmonary resuscitation board.

Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
Identification. A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.(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.