(29 days)
No
The summary describes an electrically powered patient positioning system and does not mention any AI or ML capabilities, image processing, or data analysis related to AI/ML.
No.
Explanation: The device is described as a "patient positioning system" that helps elevate a patient's head and thorax during various procedures like airway management and CPR. Its function is to facilitate medical procedures rather than directly treating a disease or condition itself.
No
The EleGARD Patient Positioning System is described as a cardiopulmonary board that elevates a patient's head and thorax for procedures like airway management and CPR. Its function is to position the patient and facilitate medical interventions, not to obtain diagnostic information or analyze medical data.
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.
Based on the provided information, the EleGARD™ Patient Positioning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- EleGARD's 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 supporting and elevating a patient's head and thorax.
- Device Description: The description focuses on its function as a backboard and its ability to position the patient.
- Lack of IVD Indicators: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on biological tests.
Therefore, the EleGARD™ falls under the category of a medical device used for patient support and positioning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EleGARD™ Patient Positioning System (EleGARD) 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 System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
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.
There are several different CPR methods which use a back board, stretcher or bed, e.g., manual CPR, manual CPR Adjuncts, and with the Defibtech Chest Compression System and ARM XR backplate or with the LUCAS Chest Compression System as previously cleared under K191689.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's head and thorax
Indicated Patient Age Range
Adults and children, not including infants and neonates.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing Summary
- Biocompatibility of Materials: Not Found
- Electrical, EMC, EMI testing: Testing was performed for K191689. The modification has not effect on this performance. K191689 included testing per ANSI/AAMI/ES 60601-1 and IEC 60601-1-2, and the device performed as intended and met the requirements.
- Bench testing: Testing and verification was performed to evaluate the ability to connect the Defibtech ARM XR backplate with the EleGARD™. This testing included Patient Position, connection to Optional Associate Equipment, Carrying, a review of any different Risk Mitigation, there were none, and the ability to fit within the EleGARD™ and that the placement of the Defibtech ARM XR backplate can be attached to the main ARM XR unit. Upon completion of the tests, it was found to meet its performance requirements.
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
§ 880.6080 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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July 29, 2022
AdvancedCPR Solutions LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K221901
Trade/Device Name: EleGARD Regulation Number: 21 CFR 880.6080 Regulation Name: Cardiopulmonary Resuscitation Board Regulatory Class: Class I Product Code: FOA Dated: June 28, 2022 Received: June 30, 2022
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 mediation-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,
David Wolloscheck, Ph.D. For Payal Patel 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221901
Device Name
EleGARD™ Patient Positioning System
Indications for Use (Describe)
The EleGARD™ Patient Positioning System (EleGARD) 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 System or ARM XR Automated Chest Compressor, and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(k) Summary
| Date Prepared: | 28-Jul-22 |
|---|---|
| AdvancedCPR Solutions LLC | |
| 5201 Eden Ave., Suite 300 | |
| Edina, MN 55436 | |
| Tel – 763.259.3722 | |
| Official Contact: | Philip Faris - CEO |
| Proprietary or Trade Name: | EleGARD™ Patient Positioning System |
| Common/Usual Name: | Cardiopulmonary board |
| Classification Name: | FOA - Cardiopulmonary resuscitation board (21 |
| CFR 880.6080) | |
| Predicate Device: | K191689 - AdvancedCPR Solutions LLC |
| Reference Device | K211289 - Defibtech RMU 2000 |
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.
There are several different CPR methods which use a back board, stretcher or bed, e.g., manual CPR, manual CPR Adjuncts, and with the Defibtech Chest Compression System and ARM XR backplate or with the LUCAS Chest Compression System as previously cleared under K191689.
Indications for Use:
The EleGARD™ Patient Positioning System (EleGARD) 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 System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
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. Specifically, when used with the automated compression systems the population is limited to adults and when not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
4
510(k) Summary
Contraindications:
It is recommended that EleGARD™ no be used under the following conditions:
- It is recommended that EleGARD™ no be used under the following conditions:
•- If the patient weighs more than 350 pounds .
Environments of Use:
Hospital and pre-hospital
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510(k) Summary
Table 1 - Table of the Similarities and Differences of Predicate vs. Proposed Device
| Proposed | Predicate | Comments | |
|---|---|---|---|
| EleGARD™ Patient Positioning System with Defibtech | EleGARD™ Patient Positioning Systems with | ||
| ARM XR backplate | LUCAS backplate | ||
| K191689 | |||
| Procode / Classification / | |||
| CFR | FOA - cardiopulmonary board | ||
| CFR 880.6080 | FOA - cardiopulmonary board | ||
| CFR 880.6080 | Similar | ||
| Indications for Use | The EleGARD™ Patient Positioning System (EleGARD) 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 System or ARM XR Automated Chest | |||
| Compressor; and patient transport. EleGARD is indicated for | |||
| adults only when used with the LUCAS Chest Compression | |||
| System or the ARM XR Automated Chest Compressor. When | |||
| not used with an automated compression system, EleGARD | |||
| can be used for adults and children, not including infants and | |||
| neonates. | 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 | Similar | ||
| Prescriptive | Trained medical personnel | Trained medical personnel | Similar |
| Environments of use | Hospital and pre-hospital | Hospital and pre-hospital | Similar |
| Technology | Method to elevate the head and torso via manual and electro- | ||
| mechanical lifting and hold in place | Method to elevate the head and torso via manual | ||
| and electro-mechanical lifting and hold in place | Similar | ||
| Used with Automatic | |||
| Compression / | |||
| Decompression Systems | Yes, adding Dibetech ARM XR® | Yes with LUCAS | Similar, but different |
| Automatic Compression / | |||
| Decompression Systems | |||
| Performance | From K191689 | ||
| IEC 60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-1-12 | |||
| Cleaning | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-12 | |||
| Cleaning | Similar | ||
| 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 | Similar |
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Substantial Equivalence Rationale and Discussion of Differences
The EleGARD™ is viewed as substantially equivalent to the predicate device because:
Indications -
The EleGARD™ is designed to elevate a patient's head and thorax during airway management, various modalities of CPR and patient transport.
Discussion - The indications for use are similar to the predicate K191689 and within the intended use of the accessory backplate of the reference K211289. The patient population was clarified in the indications for to be consistent with and without use of automatic compression systems. There were no differences between the predicate and subject device.
Environment of Use -
All devices have the same environments of use: hospital to be used by trained medical personnel
Discussion - The environments of use and personnel are similar to the predicate device.
Technology -
The technology is to stabilize the body position and to elevate the patient's head and thorax during CPR. The positioning of the head and thorax is similar to the predicate. The only modification is the option of using the Defibtech ARM XR backplate, K211289, for the LUCAS backplate to connect to the applicable device.
Discussion – There is no change in technology between the proposed device and the predicate and the option of the Defibtech ARM XR backplate is similar to that of the LUCAS backplate. There are no technological differences in the backplates and their use with the EleGARD™ that would raise different risk concerns.
Non-clinical Testing Summary
Biocompatibility of Materials -
There are no direct patient contacting materials of the EleGARD™
Discussion - The sponsor offers 2 different coverings, one is identical to K191689 and the other has supportive ISO 10993-1 testing.
Electrical, EMC, EMI testing -
Testing was performed for K191689. The modification has not effect on this performance. K191689 included testing per ANSI/AAMI/ES 60601-1 and IEC 60601-1-2, and the device performed as intended and met the requirements.
Bench testing -
Testing and verification was performed to evaluate the ability to connect the Defibtech ARM XR backplate with the EleGARD™. This testing included Patient Position, connection to Optional Associate Equipment, Carrying, a review of any different Risk Mitigation, there were none, and the ability to fit within the EleGARD™ and that the placement of the Defibtech ARM XR backplate can be attached to the main ARM XR unit.
Discussion - Upon completion of the tests, it was found to meet its performance requirements.
Substantial Equivalence Conclusion -
The proposed addition of the Defibtech ARM XR backplate does not raise different questions of safety compared to the predicate and thus can be found substantially equivalent.