(233 days)
Not Found
Not Found
No
The description focuses on the mechanical and electrical functions of a patient positioning system and does not mention any AI or ML capabilities.
No.
The device is a patient positioning system used to elevate a patient's head and thorax during medical procedures like airway management and CPR, but it does not directly treat a disease or condition itself.
No
The device description clearly states its functions, such as elevating a patient's head and thorax during airway management, CPR, and patient transport. It acts as a positioning and support tool, not for diagnosing any medical condition.
No
The device description explicitly states it is an "electrically powered device" and a "cardiopulmonary back board," indicating it is a physical hardware device, not software only. The performance studies also include electrical and bench testing, further confirming its hardware nature.
Based on the provided information, the EleGARD™ Patient Positioning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EleGARD™ Function: The EleGARD™ is a physical device used to position a patient's body during medical procedures like airway management and CPR. It does not analyze any biological specimens.
- Intended Use: The intended use clearly describes a physical positioning system for patient support during various interventions.
- Device Description: The description focuses on the mechanical and electrical aspects of the device for positioning.
- Performance Studies: The performance studies mentioned (biocompatibility, electrical, bench testing) are related to the physical and functional aspects of the device, not the analysis of biological samples.
Therefore, the EleGARD™ Patient Positioning System falls under the category of a medical device used for patient support and positioning, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FOA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head and thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical personnel
Hospital and pre-hospital
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Subject device evaluated for Biocompatibility, Electrical, EMC, EMI, and Bench testing.
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: The proposed device was evaluated 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.
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.
Not Found
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.
Not Found
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
§ 880.6080 Cardiopulmonary resuscitation board.
(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.
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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)
Device Name
EleGARD™ Patient Positioning System
Indications for Use (Describe)
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.
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)
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FORM FDA 3881 (7/17) 443-6740 EF
Page 1 of 1
SC Publishing Services (301)
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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
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.
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.
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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
| | Proposed
EleGARD™ Patient
Positioning | Predicate
Head Up Platform |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Procode | FOA - cardiopulmonary resuscitation
board
CFR 880.6080 | FOA - cardiopulmonary resuscitation
board
CFR 880.6080 |
| Indications for Use | 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 | Intended to assist in elevating the head
and shoulders of a patient from a
supine position to approximately 30
degrees and may be used during
various procedures, i.e., airway
management 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 torso
via manual and electro-mechanical
lifting and hold in place | Manual mechanical means to elevate
the head and torso and hold in place |
| Performance | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-12
Cleaning of patient contacting surfaces
Compatibility of Lucas backplate
connection | Device was not electrical |
| 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 | 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 |
| Patient contacting
materials | Evaluated via ISO 10993-1 | Evaluated via ISO 10993-1 |
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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.