(267 days)
EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).
The provided text describes the EOlife device, a medical device intended to assist healthcare professionals in manual ventilation during cardiopulmonary resuscitation (CPR) by measuring ventilatory flows and displaying visual guides on insufflated volume and ventilation frequency. The document is a 510(k) premarket notification by Archeon Medical to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a "Comparison of Technological Characteristics with Predicate Device" (Table 1) and a "Summary of Performance Testing" (Table 2). The most relevant section for acceptance criteria related to product performance is the "Measuring range and accuracy of ventilation values" and "Measuring range and accuracy of ventilation frequencies" within Table 1.
| Acceptance Criteria (from Subject Device) | Reported Device Performance and Discussion (from Subject Device, Predicate Device, and Discussion columns in Table 1) |
|---|---|
| Insufflated Volume (Vi): Operating range 50 to 2000 ml | Vi: Operating range 50 to 2000 ml RMSE: 15.7 ml |
| Tidal Volume (Vt): Operating range 0 to 2000 ml | Vt: Operating range 0 to 2000 ml RMSE: 40 ml |
| Ventilation Frequency: 1 to 60 bpm, ± 1 bpm | Ventilation Frequency: 1 to 60 bpm, ± 1 bpm |
| Real time emergency feedback: Based on 2020 AHA Guidelines | Comparison to Predicate: Both devices (EOlife and L770-CPR Resuscitation Timer) provide real-time feedback for manual ventilation quality during CPR. The predicate device uses 2005 AHA Guidelines, while EOlife uses 2020 AHA Guidelines. The discussion states this is "Same" because "Both devices were based on the current relevant AHA guideline in force." This implies that adhering to the most current guidelines is an acceptable performance characteristic. |
| Mechanical design and compatibility (with environment and resuscitator) | Bench Testing Summary: Verification of the mechanical design and compatibility of the device with its environment and with the manual resuscitator was performed. Comparison between features (mechanical design, assembly with patient interface and manual resuscitator, ventilation setting) and predicate device was done to demonstrate substantial equivalence. |
| Software functionality, safety, and effectiveness | Software Testing Summary: IEC 62304 testing met requirement of the standard. Software testing included design, development, verification, validation, and traceability. Verification and validation demonstrated that the software functions correctly as designed and operates the device according to device design specifications and requirements. |
| Usability/Human Factors | Usability Assessment Summary: Usability assessment was completed including critical tasks identification through use-based risk analysis, rounds of formative and summative testing according to IEC 62366-1 and FDA guidance. The study demonstrated that users were able to successfully and safely use the device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." Instead, it relies on non-clinical (bench) testing, usability testing, and comparison to a predicate device.
- Test Set Description: The "test set" in this context refers primarily to the testing conducted on the physical device and its software, rather than a dataset of patient cases.
- Sample Size:
- For the performance metrics (Vi, Vt, Freq), the specific number of tests or samples used to derive the RMSE values is not provided.
- For biocompatibility, electrical safety, EMC, battery, power supply, mechanical, and software testing, the sample size is also not explicitly stated. These types of tests typically involve a limited number of devices to demonstrate compliance with standards.
- For usability testing, "rounds of formative and summative testing" were performed, but the number of participants or test scenarios is not specified.
- Data Provenance: The testing was related to the device itself (hardware, software). No patient data is mentioned as being used for testing. The manufacturer, Archeon Medical, is based in Besançon, France. Therefore, the testing would presumably have been conducted there or by affiliated labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided as the submission focuses on non-clinical testing and comparison to a predicate device, not on diagnostic performance against human expert-established ground truth on a patient dataset. The "ground truth" for the device's measurements (volume, frequency) would be established by calibrated measurement equipment used in the bench testing.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no human expert-based ground truth or adjudication process described for clinical effectiveness. The assessment is against technical specifications and established standards through bench testing.
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. The submission explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." The device is positioned as an "adjunct tool" providing real-time feedback, not as an AI diagnostic tool that human readers would interpret. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance testing (bench testing) described in Table 2, specifically the "Accuracy assessment of the values measured and displayed by EOlife," can be considered a form of standalone performance assessment of the device's measurement capabilities. The software within the device operates autonomously to measure and display parameters ("algorithm only"). However, this is for measurement accuracy, not for a diagnostic or interpretive task that would typically be associated with "standalone AI performance" in imaging or other clinical decision support contexts. The device's primary function is to provide real-time guidance to a human user, making it inherently "human-in-the-loop" in its intended use.
7. The Type of Ground Truth Used:
- For the measurement accuracy of volume and frequency values during bench testing, the ground truth would be established by precision laboratory instruments and simulated ventilation profiles (e.g., using a test lung and a ventilator simulator with known, calibrated outputs).
- For biocompatibility, electrical safety, EMC, mechanical, and software validation, the ground truth is compliance with international consensus standards (e.g., ISO, IEC, UN).
- For usability, the ground truth is the successful and safe completion of critical tasks by users as assessed in human factors testing.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The EOlife device is described as having "an embedded software that contains algorithms," but the document does not indicate that these algorithms (for measuring ventilatory flows and providing guidance) were developed using machine learning or required a "training set" of data in the typical sense. It appears to be based on programmed logic and physics models rather than statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 18, 2023
Archeon % Catherine Gloster President Gloster Biomedical International LLC 577 North Hope Ave Santa Barbara, California 93110
Re: K221841
Trade/Device Name: EOlife Regulation Number: 21 CFR 868.5915 Regulation Name: Ventilator, Emergency, Manual (Resuscitator) Regulatory Class: Class II Product Code: BTM Dated: February 10, 2023 Received: February 13, 2023
Dear Catherine Gloster:
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
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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); 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 (QS) 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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221841
Device Name EOlife
Indications for Use (Describe)
EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Sponsor: Archeon Medical Device: EOlife®
K221841/S001 Appendix 1 - Page 1
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Image /page/3/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a dark green sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "ARCHEON" is a red square with a white line running through it, forming the letter "H".
510(k) Summary
l. SUBMITTER
| Date prepared: | March 18, 2023 |
|---|---|
| Company name: | Archeon Medical |
| Company address: | 2 Chemin des Aiguillettes |
| 25000 Besançon | |
| FRANCE | |
| Contact person: | Ms. Valentine Oqda, Quality and Regulatory Affairs |
| Director | |
| Ph: +33-3-81-66-23-80 |
II. DEVICE
Trade name: EOlife Common name: EOlife Classification name : Manual Emergency Ventilator(21 CFR 868.5915) Device class: Class 2 Product code: BTM
III. PREDICATE DEVICE
This submission establishes the substantial equivalence of the EOlife device to the predicate device:
-
. L770-CPR Resuscitation Timer, K062080 (Allied Healthcare Products) (BTM, 21 CFR 868.5915)
The following two reference devices were also used to support the substantial equivalence: -
Real BVM Help, P160022/S013 (Zoll) (MKJ, 21 CFR 870.5310) ●
-
. Exhalometer, K051279 (Caldyne) (BZK, 21 CFR 868.1850)
DEVICE DESCRIPTION IV.
EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR).
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Image /page/4/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "ARCHEON" is a red square with a white line running through it. The white line appears to be a stylized version of the letter "H".
EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient.
EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense.
EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient).
During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).
INDICATIONS FOR USE V.
EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE VI.
EOlife is substantially equivalent to its predicate device. Some of the device characteristics are supported by the reference devices.
The Table 1 provides a comparison between EOlife and its predicate device.
| - | Subject device | Predicate device | Discussion |
|---|---|---|---|
| Manufacturer | ARCHEON | Allied Healthcare Products | / |
| Device Name | EOlife | L770-CPR Resuscitation Timer | / |
| - | Subject device | Predicate device | Discussion |
| 510(K) Number | K221841 | K062080 | / |
| Regulation Number | 21 CFR 868.5915 | 21 CFR 868.5915 | / |
| Classification | Class II | Class II | / |
| Classification name | Manual Emergency Ventilator | Manual Emergency Ventilator | / |
| Indications for Use | EOlife is intended for use withemergency manualresuscitation devices tomeasure ventilatory flows anddisplay visual guide on theinsufflated volume, tidalvolume, and ventilationfrequency to ensure adequateventilation of adultcardiopulmonary arrest patientduring cardiopulmonaryresuscitation (CPR) performedby healthcare professionals. | The L770-CPR ResuscitationTimer gives an audible andvisual guide to the properinspiratory time and (BPM)breaths per minute duringemergency manual ventilation.Il displays the actual inspiratorytime, (BPM) breaths perminute, and peak airwaypressure. | SameThe devices are all intendedto be used as an adjunct toolto the manual resuscitator tomeasure the manualventilation and provide realtime feedback to the user. |
| Intendeduse/Claimedfunctionalities | Measurement, display and realtime guidance of manualventilation quality | Measurement, display and realtime guidance of manualventilation quality | Same |
| Situation of use | CPR | CPR | Same |
| Intended patient | Adult cardiopulmonary arrestpatient | Adult and childcardiopulmonary arrest patient | PartialSubject device is not intendedfor child, however there is noimpact on substantialequivalence or safety andperformance of the device.The intended use patient toadult only is supported by thereference device Real BVMHelp (P160022/S013) which isalso only intended for adultcardiopulmonary arrestpatients |
| Ventilation interface | Mask or endotracheal tube (ET)or supraglottic airways (SGA)device | Mask only | PartialThe interface with ET tube orSGA device is supported byboth reference devices (RealBVM Help P160022/S013 andExhalometer K051279) whichmay be used with mask or ETtube or SGA device |
| Design | Portable electronic control unitincluding sensors, an embeddedsoftware that containsalgorithms and a screen todisplay information to the user | Portable electronic control unitincluding sensors, an embeddedsoftware that containsalgorithms and a screen todisplay information to the user | Same |
| Materials | Plastic material | Plastic material | Same |
| - | Subject device | Predicate device | Discussion |
| Measurementtechnology | Flowmeter | Manometer | DifferentType of sensor and resultingmeasured ventilationparameters are different dueto the evolution of AHAguidelines which recommendnow to control the volume ofair administered to thepatient. There is no impact onsubstantial equivalence orsafety and performance of thedevice.Using flowmeter technologyfor the sensor is supported byboth reference devices (RealBVM Help P160022/S013 andExhalometer K051279) whichboth use flowmeter sensors |
| Ventilationparameters display | Ventilation frequency (Freq incycle/min)Insufflated volume (Vi in mL)Tidal volume (Vt in mL) | Ventilation frequency (Freq inbreath/min)Airway pressure (pressure in cmH2O)Inspiratory time (Ti in s) | PartialType of sensor and resultingmeasured ventilationparameters are different dueto the evolution of AHAguidelines which recommendnow to control the volume ofair administered to thepatient. There is no impact onsubstantial equivalence orsafety and performance of thedeviceThe ventilation parametersdisplays are supported by thereference devices: Real BVMHelp (P160022/S013) displaysthe insufflated volume (Vi)then converted into the tidalvolume (Vt) and theExhalometer (K051279)displays the exhaled volume(Ve) converted into the tidalvolume (Vt) |
| Ventilation modes | -30:2Continuous | -30:2Continuous | Same |
| Real time emergencyfeedback | 2020 AHA (American HeartAssociation) Guidelines forCardiopulmonary Resuscitationand Emergency CardiovascularCare, Part 3: Adult Basic andAdvanced Life Support | 2005 AHA (American HeartAssociation) Guidelines forCardiopulmonary Resuscitationand Emergency CardiovascularCare, Part 3: Adult Basic andAdvanced Life Support | SameBoth devices were based onthe current relevant AHAguideline in force |
| - | Subject device | Predicate device | Discussion |
| (lithium) | (Alkaline) | Both devices (Real BVM HelpP160022/S013 andExhalometer K051279) arepowered with a battery usingdifferent technologies. Thereis no impact on substantialequivalence or safety andperformance of the device.The use of a lithium battery issupported by both referencedevices which use a lithiumbattery | |
| Intended user | Healthcare professionals | Emergency medical team | SameEmergency medical team arehealthcare professionals |
| Environment of use | - Prehospital care- Emergency transport- Hospital environment | - Emergency transport- Hospital environment | PartialPredicate device is notintended for prehospital care(outdoor environmentconditions), but subjectdevice is certified for this typeof environment. There is noimpact on substantialequivalence or safety andperformance of the device.Prehospital care environmentis supported by the referencedevice Real BVM Help(P160022/S013) which maybe used in the sameenvironment. |
| Measuring range andaccuracy ofventilation values | Vi: Operating range 50 to 2000mlRMSE = 15.7 mlVt: Operating range 0 to 2000mlRMSE = 40 ml | Ti: ± 10%Air pressure: 60 cm H2Omaximum± 5% | SameThe order of magnitude of themeasuring accuracy of theventilation parameters is thesame |
| Measuring range andaccuracy ofventilationfrequencies | 1 to 60 bpm± 1 bpm | Unknown measuring range± 1 bpm | Same tolerance |
Table 1: Substantial equivalence with predicate device
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Image /page/5/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a sans-serif font, with the "H" being stylized as a white line within a red square. Below the word "ARCHEON" is the word "MEDICAL" in a smaller font.
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Image /page/6/Picture/0 description: The image shows the logo for Archeon Medical. The word "ARCHEON" is written in a dark green sans-serif font, with the "H" being stylized as a white line drawing within a red square. Below the word "ARCHEON" is the word "MEDICAL" in a smaller, lighter font.
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Image /page/7/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a simple, sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "ARCHEON" is a red square with a white stylized "H" inside, with a curved line going through the middle of the H.
VII. PERFORMANCE DATA
Data provided in this submission indicate that the basic functional characteristics of EOlife are substantially equivalent to those of the predicate device. Test data also demonstrated
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Image /page/8/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a simple, sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "ARCHEON" is a red square with a stylized "H" in white. The logo is clean and modern, and the red square adds a pop of color.
that the device is safe and effective and works according to its indications for use as well as meeting the requirements of the device's design specifications.
Non-clinical testing:
Bench testing related to software, biocompatibility, and performance including applicable consensus standards were conducted on EOlife, demonstrating the design meeting the specifications and the substantial equivalence of EOlife with the predicate device. Table 2 provides a summary of the non-clinical testing performed with EOlife.
| Performance Testing | Summary |
|---|---|
| Biocompatibility | ISO 18562-1, -2 and -3 testing met requirements for breathing gas pathways:indirect patient contact (contact with airflow), limited exposure (<2 hours)ISO 10993-1 testing: surface contact for limited duration (<24 hours) |
| Electrical safety | IEC 60601-1 testing met requirements of the standard |
| Electromagneticcompatibility | IEC 60601-1-2 testing met requirements of the standard |
| Lithium battery | Certified according to IEC 62133-2 and UN 383 and UL 1642 |
| Power supply | Certified according to EN IEC 61204-3 and EN 62368-1 |
| Mechanical testing | IEC 60601-1-12 testing met requirements of the standardISO 5356-1 testing met requirements for conical connection of anesthetic andrespiratory equipment |
| Software | IEC 62304 testing met requirement of the standard.Software testing included software design, development, verification,validation, and traceability. Verification and validation demonstrated that thesoftware functions correctly as designed and operates the device according tothe device design specifications and requirements. |
| Performance Testing –Bench | Bench testing was performed to evaluate the performance of EOlife and todemonstrate the design meets the specifications.Bench testing included:- Verification of the mechanical design and compatibility of the device with itsenvironment and with the manual resuscitator,- Accuracy assessment of the values measured and displayed by EOlife- Comparison between features (mechanical design, assembly with patientinterface and manual resuscitator, ventilation setting), measurementtechnologies and displayed values/visual interface and ventilationfeedback/guidance of EOlife and predicate device to demonstrate thesubstantial equivalence. |
| Performance Testing –Usability/Human factors | Usability assessment was completed for EOlife including critical tasksidentification through use-based risk analysis, rounds of formative andsummative testing according to IEC 62366-1 and 'Applying Human Factors andUsability Engineering to Medical Devices' FDA guidance. The study demonstratedthat users were able to successfully and safely use the device. |
Table 2: Summary of Performance Testing
Clinical performance testing:
The subject EOlife did not require clinical studies to support substantial equivalence.
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Image /page/9/Picture/0 description: The image shows the logo for Archeon Medical. The logo consists of the word "ARCHEON" in a dark teal sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "ARCHEON" is a red square with a white stylized "H" in the center.
VIII. CONCLUSION
Based on the comparison of the indications for use of EOlife, the proposed device and the predicate, and on the results of nonclinical testing, ARCHEON considers EOlife to be substantially equivalent to the predicate device.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).