(267 days)
P160022/S013,K051279
No
The description focuses on measuring ventilation parameters and providing real-time feedback based on established guidelines (AHA 2020). There is no mention of AI, ML, or any learning algorithms. The device appears to be a sensor-based system with embedded software for calculation and display, not incorporating adaptive or learning capabilities.
No
The device is intended to measure ventilatory flows and provide feedback to healthcare professionals to ensure adequate ventilation during CPR, rather than directly treating a condition itself. It's a monitoring and guidance tool for a therapeutic procedure.
No
The device measures ventilatory flows and displays visual guides and parameters to ensure adequate ventilation during CPR. It provides real-time feedback on ventilation quality based on established guidelines. Its purpose is to guide and ensure proper ventilation, not to diagnose a medical condition.
No
The device description explicitly states that EOlife is composed of an electronic control unit, a removable and rechargeable battery pack, and a single-use flow sensor (FlowSense), in addition to embedded software. This indicates the presence of hardware components beyond just software.
Based on the provided information, the EOlife device is not an IVD (In Vitro Diagnostic).
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.
- EOlife's Function: EOlife measures and displays ventilation parameters (flow, volume, frequency) during manual resuscitation. It interacts with the air being moved into and out of the patient's lungs, but it does not analyze any biological samples from the patient's body.
- Intended Use: The intended use clearly states it's for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guides on volume and frequency. This is a physiological measurement related to breathing mechanics, not a diagnostic test performed on a biological sample.
Therefore, EOlife falls under the category of a medical device used for monitoring and guiding a physiological process (ventilation) rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BTM
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Healthcare professionals
- Prehospital care
- Emergency transport
- Hospital environment
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
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.
Biocompatibility: ISO 18562-1, -2 and -3 testing met requirements for breathing gas pathways: indirect patient contact (contact with airflow), limited exposure (
§ 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).
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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
1
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
2
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 with | ||
| emergency manual | |||
| resuscitation devices to | |||
| measure ventilatory flows and | |||
| display visual guide on the | |||
| insufflated volume, tidal | |||
| volume, and ventilation | |||
| frequency to ensure adequate | |||
| ventilation of adult | |||
| cardiopulmonary arrest patient | |||
| during cardiopulmonary | |||
| resuscitation (CPR) performed | |||
| by healthcare professionals. | The L770-CPR Resuscitation | ||
| Timer gives an audible and | |||
| visual guide to the proper | |||
| inspiratory time and (BPM) | |||
| breaths per minute during | |||
| emergency manual ventilation. | |||
| Il displays the actual inspiratory | |||
| time, (BPM) breaths per | |||
| minute, and peak airway | |||
| pressure. | Same | ||
| The devices are all intended | |||
| to be used as an adjunct tool | |||
| to the manual resuscitator to | |||
| measure the manual | |||
| ventilation and provide real | |||
| time feedback to the user. | |||
| Intended | |||
| use/Claimed | |||
| functionalities | Measurement, display and real | ||
| time guidance of manual | |||
| ventilation quality | Measurement, display and real | ||
| time guidance of manual | |||
| ventilation quality | Same | ||
| Situation of use | CPR | CPR | Same |
| Intended patient | Adult cardiopulmonary arrest | ||
| patient | Adult and child | ||
| cardiopulmonary arrest patient | Partial | ||
| Subject device is not intended | |||
| for child, however there is no | |||
| impact on substantial | |||
| equivalence or safety and | |||
| performance of the device. | |||
| The intended use patient to | |||
| adult only is supported by the | |||
| reference device Real BVM | |||
| Help (P160022/S013) which is | |||
| also only intended for adult | |||
| cardiopulmonary arrest | |||
| patients | |||
| Ventilation interface | Mask or endotracheal tube (ET) | ||
| or supraglottic airways (SGA) | |||
| device | Mask only | Partial | |
| The interface with ET tube or | |||
| SGA device is supported by | |||
| both reference devices (Real | |||
| BVM Help P160022/S013 and | |||
| Exhalometer K051279) which | |||
| may be used with mask or ET | |||
| tube or SGA device | |||
| Design | Portable electronic control unit | ||
| including sensors, an embedded | |||
| software that contains | |||
| algorithms and a screen to | |||
| display information to the user | Portable electronic control unit | ||
| including sensors, an embedded | |||
| software that contains | |||
| algorithms and a screen to | |||
| display information to the user | Same | ||
| Materials | Plastic material | Plastic material | Same |
| - | Subject device | Predicate device | Discussion |
| Measurement | |||
| technology | Flowmeter | Manometer | Different |
| Type of sensor and resulting | |||
| measured ventilation | |||
| parameters are different due | |||
| to the evolution of AHA | |||
| guidelines which recommend | |||
| now to control the volume of | |||
| air administered to the | |||
| patient. There is no impact on | |||
| substantial equivalence or | |||
| safety and performance of the | |||
| device. | |||
| Using flowmeter technology | |||
| for the sensor is supported by | |||
| both reference devices (Real | |||
| BVM Help P160022/S013 and | |||
| Exhalometer K051279) which | |||
| both use flowmeter sensors | |||
| Ventilation | |||
| parameters display | Ventilation frequency (Freq in | ||
| cycle/min) | |||
| Insufflated volume (Vi in mL) | |||
| Tidal volume (Vt in mL) | Ventilation frequency (Freq in | ||
| breath/min) | |||
| Airway pressure (pressure in cm | |||
| H2O) | |||
| Inspiratory time (Ti in s) | Partial | ||
| Type of sensor and resulting | |||
| measured ventilation | |||
| parameters are different due | |||
| to the evolution of AHA | |||
| guidelines which recommend | |||
| now to control the volume of | |||
| air administered to the | |||
| patient. There is no impact on | |||
| substantial equivalence or | |||
| safety and performance of the | |||
| device | |||
| The ventilation parameters | |||
| displays are supported by the | |||
| reference devices: Real BVM | |||
| Help (P160022/S013) displays | |||
| the insufflated volume (Vi) | |||
| then converted into the tidal | |||
| volume (Vt) and the | |||
| Exhalometer (K051279) | |||
| displays the exhaled volume | |||
| (Ve) converted into the tidal | |||
| volume (Vt) | |||
| Ventilation modes | - | ||
| 30:2 | |||
| Continuous | - | ||
| 30:2 | |||
| Continuous | Same | ||
| Real time emergency | |||
| feedback | 2020 AHA (American Heart | ||
| Association) Guidelines for | |||
| Cardiopulmonary Resuscitation | |||
| and Emergency Cardiovascular | |||
| Care, Part 3: Adult Basic and | |||
| Advanced Life Support | 2005 AHA (American Heart | ||
| Association) Guidelines for | |||
| Cardiopulmonary Resuscitation | |||
| and Emergency Cardiovascular | |||
| Care, Part 3: Adult Basic and | |||
| Advanced Life Support | Same | ||
| Both devices were based on | |||
| the current relevant AHA | |||
| guideline in force | |||
| - | Subject device | Predicate device | Discussion |
| (lithium) | (Alkaline) | Both devices (Real BVM Help | |
| P160022/S013 and | |||
| Exhalometer K051279) are | |||
| powered with a battery using | |||
| different technologies. There | |||
| is no impact on substantial | |||
| equivalence or safety and | |||
| performance of the device. | |||
| The use of a lithium battery is | |||
| supported by both reference | |||
| devices which use a lithium | |||
| battery | |||
| Intended user | Healthcare professionals | Emergency medical team | Same |
| Emergency medical team are | |||
| healthcare professionals | |||
| Environment of use | - Prehospital care |
- Emergency transport
- Hospital environment | - Emergency transport
- Hospital environment | Partial
Predicate device is not
intended for prehospital care
(outdoor environment
conditions), but subject
device is certified for this type
of environment. There is no
impact on substantial
equivalence or safety and
performance of the device.
Prehospital care environment
is supported by the reference
device Real BVM Help
(P160022/S013) which may
be used in the same
environment. |
| Measuring range and
accuracy of
ventilation values | Vi: Operating range 50 to 2000
ml
RMSE = 15.7 ml
Vt: Operating range 0 to 2000
ml
RMSE = 40 ml | Ti: ± 10%
Air pressure: 60 cm H2O
maximum
± 5% | Same
The order of magnitude of the
measuring accuracy of the
ventilation parameters is the
same |
| Measuring range and
accuracy of
ventilation
frequencies | 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/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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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 ( |