(367 days)
Not Found
No
The description focuses on the mechanical and pneumatic operation of the ventilator, with no mention of AI or ML capabilities for parameter adjustment, patient monitoring analysis, or other functions. The performance studies described are standard for ventilators and do not indicate the use of AI/ML.
Yes
The device is described as an "emergency and transport ventilation used for ventilation and oxygen inhalation" for patients where "spontaneous respiration has failed or is inadequate," which directly treats a physiological condition.
No
This device is an emergency and transport ventilator used for ventilation and oxygen inhalation, not for diagnosing medical conditions. It includes monitoring of airway pressure to ensure proper function during therapy, but this is not considered a diagnostic function.
No
The device description explicitly states it is an "electrical, pneumatically operated emergency and transport ventilator" and details hardware components like a compressed gas connection, adjusting knob, ventilation hose, patient valve, and alarm system.
Based on the provided information, the MEDUMAT Easy CPR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for emergency and transport ventilation, which is a life-support function performed directly on a patient.
- Device Description: The device description details a mechanical ventilator that delivers gas to the patient's lungs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body. The MEDUMAT Easy CPR operates directly on the patient to support respiration.
N/A
Intended Use / Indications for Use
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilation used for ventilation and oxygen inhalation with either a mask or tube.
Patient groups
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.
Users Qualified medical personnel only
Intended environments of use
· Mobile use for emergency medicine and primary care during emergency deployments
· During land or air transport or transfer between hospital rooms and departments
Product codes
BTL
Device Description
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator. Highly compressed medical oxygen is used as the ventilation gas; this is reduced to the necessary operating pressure via an external pressure reducer. The oxygen is supplied at the compressed gas connection. The ventilation parameters – frequency and tidal volume - are linked together and can be set using the adjusting knob on the device. The ventilation gas is transported to the patient through the ventilation hose via the patient valve and ventilation mask or via the tube. The lip membrane in the patient valve allows the patient exhalation of expiration gas. In order to monitor the patient, the device features continuous measurement of the airway pressure as well as a visual and audible alarm system.
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
Adults and children with a body weight of over 22 lbs (10 kg)
Intended User / Care Setting
Users: Qualified medical personnel only
Intended environments of use:
Mobile use for emergency medicine and primary care during emergency deployments
During land or air transport or transfer between hospital rooms and departments
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)
Various tests regarding EMC and electrical safety were conducted according to IEC 60601-1 Edition 3.1 (2012) and series standards to verify the safety and effectiveness of the MEDUMAT Easy CPR. These include the following:
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-1-8
- IEC 60601-1-12
As well as: - AIM 7351731
Performance Testing:
Several tests were conducted to verify the substantial equivalence between the MEDUMAT Easy CPR and the predicate device. Test reports show that MEDUMAT Easy CPR and the predicate device have the same ventilation mode characteristics. Furthermore, the test reports show that the performance of MEDUMAT Easy CPR is at least as good as the performance of the predicate device.
Test Items and Results:
- Verification of technical data of MEDUMAT Easy CPR: Passed
- Comparison of MMECPR and the predicate device Pneupac VR1 Standard:
- Characteristics of Demand Flow Mode:
- inspiration trigger: Passed
- expiration trigger: Passed
- flow: Passed
- Characteristics of Demand Flow Mode:
- Comparison of MMECPR and the predicate device Pneupac VR1 Standard:
- ventilation mode characteristics (IPPV): Passed
- ventilation mode characteristics (manual Mode): Passed
- Comparison of MMECPR and the predicate device Pneupac VR1 Standard:
- pressure limits: Passed
- Endurance and functional test of pressure relief valve / safety valve of MEDUMAT Esy CPR: Passed
- The inspiratory and expiratory respiratory resistances of Smith Medical's Pneupac VR1 are determined and compared with those of the Medumat Easy CPR under different operating conditions: Passed
Conclusion: Based on the validation testing performed and the information provided, the subject device MEDUMAT Easy CPR is substantially equivalent to the declared predicate.
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.
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
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Weinmann Emergency Medical Technology GmbH + Co. KG Kristin Ratschiller Team Leader QMS/ RA, Supply Chain + Quality Management Frohbösestraße 12 Hamburg, 22525 De
Re: K193191
Trade/Device Name: MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: October 22, 2020 Received: October 22, 2020
Dear Kristin Ratschiller:
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 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
1
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 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.
Brandon Blakely, PhD Assistant Director (Acting) DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193191
Device Name MEDUMAT Easy CPR
Indications for Use (Describe)
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilation used for ventilation and oxygen inhalation with either a mask or tube.
Patient groups
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.
Users Qualified medical personnel only
Intended environments of use
· Mobile use for emergency medicine and primary care during emergency deployments
· During land or air transport or transfer between hospital rooms and departments
| 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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Image /page/3/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in gray and features the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" is the phrase "medical technology" in smaller letters. There are two diagonal lines to the right of the word "WEINMANN".
K193191 - 510(k) Summary
Applicant
Company Name
Address
WEINMANN Emergency Medical Technology GmbH + Co. KG Frohbösestraße 12 22525 Hamburg Germany
Medical Technology GmbH + Co. KG
Not known yet - first application
QM-Systems + Regulatory Affairs
Establishment No.
Not known yet - first application
Kristin Ratschiller
Frohbösestraße 12 22525 Hamburg
+49 40 88 18 96-149
Germany
WEINMANN Emergency
Official contact person
Name Company Name
Address
Establishment No. Department
Phone Email
Subject device
Device Classification Name
510(k) number Device Name Applicant
Regulation Number Classification Product Code
Predicate device
Device Classification Name
510(k) number Device Name Applicant Regulation Number Classification Product Code Class
Ventilator, Emergency, Powered (Resuscitator) K193191 MEDUMAT Easy CPR WEINMANN Emergency Medical Technology GmbH + Co. KG 868.5925 BTL
Ventilator, Emergency, Powered (Resuscitator) K051322 Pneupac VR1 Standard Smiths Medical International, LTD. 868.5925 BTL ll
Section 005- 510(k) Summary K193191
510(k) Summary Product: MEDUMAT Easy CPR
4
Traditional 510(k) Notification 21 CFR 807.90(e)
Image /page/4/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in gray and features the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" is the phrase "medical technology" in smaller letters. There are two diagonal lines to the right of the word "WEINMANN".
Date of Submission Device Identification: Device Name
Common Name Model Number
2020-11-20
MEDUMAT Easy CPR Emergency and Transport Ventilator WM 20310/ WM 20330
Subject Device Classification:
Regulation Description Product Code C.F.R. Section Classification Panel Device Class
Powered Emergency Ventilator BTL 868.5925 Anesthesiology Devices Class II
Device Description:
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator. Highly compressed medical oxygen is used as the ventilation gas; this is reduced to the necessary operating pressure via an external pressure reducer. The oxygen is supplied at the compressed gas connection. The ventilation parameters – frequency and tidal volume - are linked together and can be set using the adjusting knob on the device. The ventilation gas is transported to the patient through the ventilation hose via the patient valve and ventilation mask or via the tube. The lip membrane in the patient valve allows the patient exhalation of expiration gas. In order to monitor the patient, the device features continuous measurement of the airway pressure as well as a visual and audible alarm system.
Indications for Use:
MEDUMAT EasyCPR is an electrical, pneumatically operated emergency and transport ventilator used for ventilation and oxygen inhalation with either a mask or tube.
Patient groups:
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.
Users:
Qualified medical personnel only
Intended environments of use :
- Mobile use for emergency medicine and primary care during emergency deployments
- During land or air transport or transfer between hospital rooms and departments
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Image /page/5/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in gray and features the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" are the words "medical technology" in a smaller font. There are two diagonal lines above the letters "M" and "A" in "WEINMANN".
Comparison of the Subject Device and the Predicate Device
The following table presents the comparison and brief discussion of technological characteristics, functions, and parameters of the identified predicate device and the proposed device.
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | MEDUMAT Easy CPR is an
electrical, pneumatically
operated emergency and
transport ventilator used for
ventilation and oxygen
inhalation with either a
mask or tube.
Patient groups:
Adults and children with a
body weight of over 22 lbs
(10 kg) where spontaneous
respiration has failed or is
inadequate.
Users:
Qualified medical
personnel only
Intended environments of
use
Mobile use for
•
emergency medicine
and primary care
during emergency
deployments | The Pneupac VR1 range are
hand held portable, time
cycled, gas powered generator
ventilatory resuscitators that
are suitable for emergency and
transport use and will operate
safely in an MRI environment
up to 3 Tesla.
They are designed for use by
qualified medical caregivers,
paramedics and other trained
personnel for the following
conditions:
Pneupac VR1 Standard –
Ventilatory resuscitator
intended for use on adults and
children above a bodyweight of
22 lb (10kg) with either
respiratory
distress/insufficiency or no
respiratory function. | Similar | The subject device and the predicate device
are intended to be used for similar medical
indications and have the same general purpose
and operation modes. Both devices are
intended to be used as emergency and
transport ventilators.
One difference is that the predicate device is
intended for use in an MRI environment. The
subject device is not intended for MRI
environment use and is not MRI safe.
Since the subject device is not intended for MRI
use and is not labeled as MRI safe, no
additional concerns of safety are raised. |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| | During land or air transport or transfer between hospital rooms and departments | | | |
| | Contraindications:
None currently known. | | | |
| | Possible side effects and
complications: Undesirable effects on the cardiovascular system (e.g. reduction of cardiac output, reduction of venous return flow) Drying out of the airways Overinflation of the lung tissue (lung rupture) Overinflation of the stomach during mask ventilation (e.g. aspiration of stomach contents) Exclusions and restrictions of intended use | | | |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| | The device is not approved for the following applications:
Operation for long-term ventilation in excess of 24 hours Operation in hyperbaric chambers Operation in combination with magnetic resonance scanners (MRI, NMR, NMI) | | | |
| Operating principle /Control mechanism | Time cycled, volume controlled, pressure limited flow generator | Time cycled, volume controlled, pressure limited flow generator. | Similar | The operating principles of the subject device and the predicate device are identical and only differ slightly in wording and underlying control mechanisms. Both devices are oxygen driven. |
| Patient population | Adults and children above a bodyweight of 22 lb (10 kg) | Adults and children above a bodyweight of 22 lb (10 kg) | Identical | - |
| Environment of use | Mobile use for emergency medicine and primary care during emergency deployments During land or air transport or transfer between hospital rooms and departments | Inside and outside hospital in emergency situations and for intra- and interhospital transport and for operation in an MRI environment up to 3 Tesla. | Different | As an additional feature, the predicate device is suitable for the operation in an MRI up to 3 Tesla. The use in an MRI or a hyperbaric chamber is excluded in the IFU for the subject device. |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| Excluded Envi-
ron-
ment of use | Operation in hyperbaric chambers Operation in combination with magnetic resonance scanners (MRI, NMR, NMI) | No information about the use in a hyperbaric chamber available MRI environment not excluded | Different | - |
| Contraindica-
tions | None currently known. | Not specified | Identical | - |
| Principle ope-
rator / intended
user | Qualified medical
personnel only | Medical personnel, paramedics
and ambulance technicians | Similar | Both subject device and predicate device are
only intended to be used by qualified medical
personnel. |
| Dimensions | Height: 5.7 inch (145 mm)
Width: 3.9 inch (100 mm)
Depth: 3.5 inch (90 mm) | Height: 6.7 inch (170 mm)
Width: 3.7 inch (95 mm)
Depth: 3.9 inch (100 mm) | Different | The dimensions of the subject and the
predicate device differ slightly. |
| Weight | 1.5 lbs (0.7 kg) | 0.9 lbs (0.42 kg) | Similar | The weight of the subject device is higher than
the predicate device. With regards to the
intended use and organization of the device as
a mobile device, these differences will not have
any impact on the safety and effectiveness not
the operation and handling of the device. |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| Operational modes/Ventilation modes | | | Different | The subject device has the same
operational/ventilation modes as the predicate
device. Most of the specifications for these
modes are identical. The tidal volume and the
inspiration-expiration time ratio are similar, the
max. ventilation pressure setting range and the
relief pressure are different for the subject and
the predicate device, but no additional concerns
are introduced through that. In addition to this,
monitoring of the ventilation pressure is added
in compliance with the requirements of the
standard DIN EN 794-3:2009-12. |
| Automatic vol-
ume controlled
ventilation | Yes | Yes | Identical | device. Most of the specifications for these
modes are identical. The tidal volume and the
inspiration-expiration time ratio are similar, the
max. ventilation pressure setting range and the
relief pressure are different for the subject and
the predicate device, but no additional concerns
are introduced through that. In addition to this,
monitoring of the ventilation pressure is added
in compliance with the requirements of the
standard DIN EN 794-3:2009-12. |
| Manual volume
controlled venti-
lation | Yes | Yes | Identical | |
| Demand flow
mode | Yes | Yes | Identical | |
| Tidal Vol-
ume(Vt) | 65 to 950 ml | 150 to 1050 ml | Similar | |
| Ventilation rate
(freq.) setting
range | 10 to 25 bpm | 10 to 25 bpm | Identical | |
| Fixed combina-
tion of tidal vol-
ume and venti-
lation rate | Yes | Yes | Identical | |
| Inspiratory-ex-
piratory time ra-
tio (I:E) | 1:2 (Vt ≤ 150 ml),
1:3 (Vt > 150 ml)
1:1 (manual mode) | 1:2 fixed in continuous mode
1:2 manual mode | Similar | |
| Max. ventilation
pressure setting
range | 20 or 45 cmH2O | 40 cm H2O (standard)
60 cmH2O (optional) | Different | |
| Relief pressure
(single fault) | max. 100 cmH2O | 40 cm H2O (standard)
60 cmH2O (optional) | Different | |
| O2 concentra-
tion | 100% O2 | 100% O2 | Identical | |
| Monitoring | Ventilation pressure
monitoring | None | Different | |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| Alarms | High Airway Pressure
Low Airway Pressure
Low gas supply
Low battery | High Airway Pressure | Different | Both, subject and predicate devices have an
alarm for high airway pressure, however, the
alarm generation differs. Furthermore, the
subject device has some additional alarms to
increase the safety of the device. |
| Tidal volume
(Vt) accuracy | STP: 65 to 950 ml (± 40 ml
or ± 20%)
The larger tolerance
applies. | STP conditions: ±15% Vt (no-
air-Mix) | Similar | The comparison of the tidal volume
specifications shows that the tolerances for tidal
volume accuracy for the predicate device are
similar to the tolerances of the subject device. |
| Supply gas | Medical oxygen | Medical oxygen | Identical | - |
| Permitted op-
erating pres-
sure for oxy-
gen source | 40 to 87.0 psi (2.7 to 6.0
bar) | 40 to 150 psi (2.7 to 10,34 bar) | Similar | The lower inlet pressure levels of the predicate
and the subject device are identical, but the
upper inlet pressure limit differs. No additional
concerns of safety are introduced. |
| Minimum nec-
essary flow of
oxygen source | 40 l/min | 65 l/min | Similar | The specifications of the subject device differ
from the specifications of the predicate device
with respect to the minimum required gas flow. |
| Power supply | 3,6V lithium battery | None | Different | The predicate device is pneumatically driven
and does not need an internal battery. The
battery specifications for the subject device
have been tested. Therefore, no additional
concerns of safety are introduced. |
| Operating conditions | | | Similar | The operating conditions are similar and tested
for the subject device. |
| Temperature
range | -4° to 122° F (-20 °C to
+50 °C) | -0,4°F to 122°F (-18°C to +50°
C) | Similar | |
| Air pressure | 62 kPa to 110 kPa | 70 kPa to 110kPa | Similar | |
| Humidity | Max. 95% RH without
condensation | 40-95% relative humidity | Similar | |
| Feature | subject device
MEDUMAT Easy CPR
(K193191) | predicate device
Pneupac VR1 Standard
(K051322) | Comparison | Discussion |
| Connectors | | | Similar | Patient connections and compressed gas
connections are identical between subject and |
| Patient connec-
tion at patient
valve | 15 mm internal tapered
connector
22 mm external tapered
connector | 15 mm internal tapered
connector
22 mm external tapered
connector | Identical | predicate device. The patient valve resistance
differs slightly. |
| Compressed
gas connection | External thread CGA 1240
(9/16" DISS connection) | 9/16" DISS connection | Identical | |
| Patient valve re-
sistance | Inspiration: