MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

{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 ( <i>Select one or both, as applicable</i> ) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span> <span style="padding-right: 5px;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 ra@weinmann-emt.de 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 {5}------------------------------------------------ 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<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use /<br>Indications for<br>Use | MEDUMAT Easy CPR is an<br>electrical, pneumatically<br>operated emergency and<br>transport ventilator used for<br>ventilation and oxygen<br>inhalation with either a<br>mask or tube.<br>Patient groups:<br>Adults and children with a<br>body weight of over 22 lbs<br>(10 kg) where spontaneous<br>respiration has failed or is<br>inadequate.<br>Users:<br>Qualified medical<br>personnel only<br>Intended environments of<br>use<br>Mobile use for<br>•<br>emergency medicine<br>and primary care<br>during emergency<br>deployments | The Pneupac VR1 range are<br>hand held portable, time<br>cycled, gas powered generator<br>ventilatory resuscitators that<br>are suitable for emergency and<br>transport use and will operate<br>safely in an MRI environment<br>up to 3 Tesla.<br>They are designed for use by<br>qualified medical caregivers,<br>paramedics and other trained<br>personnel for the following<br>conditions:<br>Pneupac VR1 Standard –<br>Ventilatory resuscitator<br>intended for use on adults and<br>children above a bodyweight of<br>22 lb (10kg) with either<br>respiratory<br>distress/insufficiency or no<br>respiratory function. | Similar | The subject device and the predicate device<br>are intended to be used for similar medical<br>indications and have the same general purpose<br>and operation modes. Both devices are<br>intended to be used as emergency and<br>transport ventilators.<br>One difference is that the predicate device is<br>intended for use in an MRI environment. The<br>subject device is not intended for MRI<br>environment use and is not MRI safe.<br>Since the subject device is not intended for MRI<br>use and is not labeled as MRI safe, no<br>additional concerns of safety are raised. | | Feature | subject device<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | | | During land or air transport or transfer between hospital rooms and departments | | | | | | Contraindications:<br>None currently known. | | | | | | Possible side effects and<br>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<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | | | The device is not approved for the following applications:<br>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<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | | Excluded Envi-<br>ron-<br>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-<br>tions | None currently known. | Not specified | Identical | - | | Principle ope-<br>rator / intended<br>user | Qualified medical<br>personnel only | Medical personnel, paramedics<br>and ambulance technicians | Similar | Both subject device and predicate device are<br>only intended to be used by qualified medical<br>personnel. | | Dimensions | Height: 5.7 inch (145 mm)<br>Width: 3.9 inch (100 mm)<br>Depth: 3.5 inch (90 mm) | Height: 6.7 inch (170 mm)<br>Width: 3.7 inch (95 mm)<br>Depth: 3.9 inch (100 mm) | Different | The dimensions of the subject and the<br>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<br>the predicate device. With regards to the<br>intended use and organization of the device as<br>a mobile device, these differences will not have<br>any impact on the safety and effectiveness not<br>the operation and handling of the device. | | Feature | subject device<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | | Operational modes/Ventilation modes | | | Different | The subject device has the same<br>operational/ventilation modes as the predicate<br>device. Most of the specifications for these<br>modes are identical. The tidal volume and the<br>inspiration-expiration time ratio are similar, the<br>max. ventilation pressure setting range and the<br>relief pressure are different for the subject and<br>the predicate device, but no additional concerns<br>are introduced through that. In addition to this,<br>monitoring of the ventilation pressure is added<br>in compliance with the requirements of the<br>standard DIN EN 794-3:2009-12. | | Automatic vol-<br>ume controlled<br>ventilation | Yes | Yes | Identical | device. Most of the specifications for these<br>modes are identical. The tidal volume and the<br>inspiration-expiration time ratio are similar, the<br>max. ventilation pressure setting range and the<br>relief pressure are different for the subject and<br>the predicate device, but no additional concerns<br>are introduced through that. In addition to this,<br>monitoring of the ventilation pressure is added<br>in compliance with the requirements of the<br>standard DIN EN 794-3:2009-12. | | Manual volume<br>controlled venti-<br>lation | Yes | Yes | Identical | | | Demand flow<br>mode | Yes | Yes | Identical | | | Tidal Vol-<br>ume(Vt) | 65 to 950 ml | 150 to 1050 ml | Similar | | | Ventilation rate<br>(freq.) setting<br>range | 10 to 25 bpm | 10 to 25 bpm | Identical | | | Fixed combina-<br>tion of tidal vol-<br>ume and venti-<br>lation rate | Yes | Yes | Identical | | | Inspiratory-ex-<br>piratory time ra-<br>tio (I:E) | 1:2 (Vt ≤ 150 ml),<br>1:3 (Vt > 150 ml)<br>1:1 (manual mode) | 1:2 fixed in continuous mode<br>1:2 manual mode | Similar | | | Max. ventilation<br>pressure setting<br>range | 20 or 45 cmH2O | 40 cm H2O (standard)<br>60 cmH2O (optional) | Different | | | Relief pressure<br>(single fault) | max. 100 cmH2O | 40 cm H2O (standard)<br>60 cmH2O (optional) | Different | | | O2 concentra-<br>tion | 100% O2 | 100% O2 | Identical | | | Monitoring | Ventilation pressure<br>monitoring | None | Different | | | Feature | subject device<br>MEDUMAT Easy CPR<br>(K193191) | predicate device<br>Pneupac VR1 Standard<br>(K051322) | Comparison | Discussion | | Alarms | High Airway Pressure<br>Low Airway Pressure<br>Low gas supply<br>Low battery | High Airway Pressure | Different | Both, subject and predicate devices have an<br>alarm for high airway pressure, however, the<br>alarm generation differs. Furthermore, the<br>subject device has some additional alarms to<br>increase the safety of the device. | | Tidal volume<br>(Vt) accuracy | STP: 65 to 950 ml (± 40 ml<br>or ± 20%)<br>The larger tolerance<br>applies. | STP conditions: ±15% Vt (no-<br>air-Mix) | Similar | The comparison of the tidal volume<br>specifications shows that the tolerances for tidal<br>volume accuracy for the predicate device are<br>similar to the tolerances of the subject device. | | Supply gas | Medical oxygen | Medical oxygen | Identical | - | | Permitted op-<br>erating pres-<br>sure for oxy-<br>gen source | 40 to 87.0 psi (2.7 to 6.0<br>bar) | 40 to 150 psi (2.7 to 10,34 bar) | Similar | The lower inlet pressure levels of the predicate<br>and the subject device are identical, but the<br>upper inlet pressure limit differs. No additional<br>concerns of safety are introduced. | | Minimum nec-<br>essary flow of<br>oxygen source | 40 l/min | 65 l/min | Similar | The specifications of the subject device differ<br>from the specifications of the predicate device<br>with respect to the minimum required gas flow. | | Power supply | 3,6V lithium battery | None | Different | The predicate device is pneumatically driven<br>and does not need an internal battery. The<br>battery specifications for the subject device<br>have been tested. Therefore, no additional<br>concerns of safety are introduced. | | Operating conditions |…