(367 days)
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
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.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the MEDUMAT Easy CPR device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" for each performance metric in a table format with specific numerical targets. Instead, it states that various tests were conducted to "verify the safety and effectiveness" and that "the performance of MEDUMAT Easy CPR is at least as good as the performance of the predicate device." The "Test results" section for performance testing only indicates "Passed."
However, we can infer some criteria and reported performance from the comparison table and performance testing section.
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993 and ISO 18562 series standards | Passed (Non-cytotoxic, non-sensitizer, non-irritant, no systemic toxicity, exposures to particulates and VOCs unlikely to result in toxicological effects, no organic compounds identified as leachable) |
| EMC and Electrical Safety | Meet IEC 60601-1-2, -6, -8, -12 and AIM 7351731 standards | Passed |
| Ventilation Mode Characteristics (IPPV, Manual Mode) | Similar to predicate device (Pneupac VR1 Standard) | Passed |
| Demand Flow Mode (Inspiration Trigger, Expiration Trigger, Flow) | Similar to predicate device (Pneupac VR1 Standard) | Passed |
| Pressure Limits | Similar to predicate device (Pneupac VR1 Standard) | Passed (Differences noted but determined not to raise additional concerns) |
| Endurance and Functional Test of Pressure Relief Valve / Safety Valve | Functional operation and endurance | Passed |
| Inspiratory and Expiratory Respiratory Resistances | Comparable to predicate device (Pneupac VR1 Standard) across different operating conditions | Passed |
| Tidal Volume (Vt) Accuracy | ± 40 ml or ± 20% (the larger tolerance applies) | Stated as the tolerance; assumed to be met. (Predicate device has similar tolerances: ±15%) |
| Operating Conditions (Temperature, Air Pressure, Humidity) | Within specified ranges and similar to predicate device | Tested for the subject device; operating conditions are similar and tested. |
| Alerts (High Airway Pressure, Low Airway Pressure, Low gas supply, Low battery) | Functionality as specified | Present and stated to increase safety. (Predicate only has high airway pressure alarm). |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test set in terms of number of devices or data points used for each performance test.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer (Weinmann Emergency Medical Technology GmbH + Co. KG, Germany) or by testing labs on their behalf.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance tests appear to be engineering verification and validation against technical specifications and predicate device performance, rather than clinical studies requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. The performance testing described is objective, technical verification against standards and predicate device characteristics, not subjective assessment requiring adjudication by multiple experts.
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:
This is not applicable. The MEDUMAT Easy CPR is a hardware device (ventilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a ventilator, not an algorithm. Performance testing was done on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing can be considered:
- International Standards: For biocompatibility (ISO 10993, ISO 18562) and electrical safety/EMC (IEC 60601 series, AIM 7351731).
- Predicate Device Performance: For ventilation characteristics, pressure limits, demand flow mode, and respiratory resistances, the predicate device (Pneupac VR1 Standard) served as a benchmark for comparison.
- Internal Specifications/Design Requirements: For various technical data and functional tests.
8. The sample size for the training set:
This is not applicable. The MEDUMAT Easy CPR is a hardware medical device and does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.
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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
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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
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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
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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 deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac VR1 Standard(K051322) | Comparison | Discussion |
|---|---|---|---|---|
| Intended Use /Indications forUse | MEDUMAT Easy CPR is anelectrical, pneumaticallyoperated emergency andtransport ventilator used forventilation and oxygeninhalation with either amask or tube.Patient groups:Adults and children with abody weight of over 22 lbs(10 kg) where spontaneousrespiration has failed or isinadequate.Users:Qualified medicalpersonnel onlyIntended environments ofuseMobile use for•emergency medicineand primary careduring emergencydeployments | The Pneupac VR1 range arehand held portable, timecycled, gas powered generatorventilatory resuscitators thatare suitable for emergency andtransport use and will operatesafely in an MRI environmentup to 3 Tesla.They are designed for use byqualified medical caregivers,paramedics and other trainedpersonnel for the followingconditions:Pneupac VR1 Standard –Ventilatory resuscitatorintended for use on adults andchildren above a bodyweight of22 lb (10kg) with eitherrespiratorydistress/insufficiency or norespiratory function. | Similar | The subject device and the predicate deviceare intended to be used for similar medicalindications and have the same general purposeand operation modes. Both devices areintended to be used as emergency andtransport ventilators.One difference is that the predicate device isintended for use in an MRI environment. Thesubject device is not intended for MRIenvironment use and is not MRI safe.Since the subject device is not intended for MRIuse and is not labeled as MRI safe, noadditional concerns of safety are raised. |
| Feature | subject deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac VR1 Standard(K051322) | Comparison | Discussion |
| During land or air transport or transfer between hospital rooms and departments | ||||
| Contraindications:None currently known. | ||||
| Possible side effects andcomplications: 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 deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac 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 deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac 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 / intendeduser | Qualified medicalpersonnel only | Medical personnel, paramedicsand ambulance technicians | Similar | Both subject device and predicate device areonly intended to be used by qualified medicalpersonnel. |
| 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 thepredicate 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 thanthe predicate device. With regards to theintended use and organization of the device asa mobile device, these differences will not haveany impact on the safety and effectiveness notthe operation and handling of the device. |
| Feature | subject deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac VR1 Standard(K051322) | Comparison | Discussion |
| Operational modes/Ventilation modes | Different | The subject device has the sameoperational/ventilation modes as the predicatedevice. Most of the specifications for thesemodes are identical. The tidal volume and theinspiration-expiration time ratio are similar, themax. ventilation pressure setting range and therelief pressure are different for the subject andthe predicate device, but no additional concernsare introduced through that. In addition to this,monitoring of the ventilation pressure is addedin compliance with the requirements of thestandard DIN EN 794-3:2009-12. | ||
| Automatic vol-ume controlledventilation | Yes | Yes | Identical | device. Most of the specifications for thesemodes are identical. The tidal volume and theinspiration-expiration time ratio are similar, themax. ventilation pressure setting range and therelief pressure are different for the subject andthe predicate device, but no additional concernsare introduced through that. In addition to this,monitoring of the ventilation pressure is addedin compliance with the requirements of thestandard DIN EN 794-3:2009-12. |
| Manual volumecontrolled venti-lation | Yes | Yes | Identical | |
| Demand flowmode | Yes | Yes | Identical | |
| Tidal Vol-ume(Vt) | 65 to 950 ml | 150 to 1050 ml | Similar | |
| Ventilation rate(freq.) settingrange | 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 mode1:2 manual mode | Similar | |
| Max. ventilationpressure settingrange | 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 pressuremonitoring | None | Different | |
| Feature | subject deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac VR1 Standard(K051322) | Comparison | Discussion |
| Alarms | High Airway PressureLow Airway PressureLow gas supplyLow battery | High Airway Pressure | Different | Both, subject and predicate devices have analarm for high airway pressure, however, thealarm generation differs. Furthermore, thesubject device has some additional alarms toincrease the safety of the device. |
| Tidal volume(Vt) accuracy | STP: 65 to 950 ml (± 40 mlor ± 20%)The larger toleranceapplies. | STP conditions: ±15% Vt (no-air-Mix) | Similar | The comparison of the tidal volumespecifications shows that the tolerances for tidalvolume accuracy for the predicate device aresimilar 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 6.0bar) | 40 to 150 psi (2.7 to 10,34 bar) | Similar | The lower inlet pressure levels of the predicateand the subject device are identical, but theupper inlet pressure limit differs. No additionalconcerns of safety are introduced. |
| Minimum nec-essary flow ofoxygen source | 40 l/min | 65 l/min | Similar | The specifications of the subject device differfrom the specifications of the predicate devicewith respect to the minimum required gas flow. |
| Power supply | 3,6V lithium battery | None | Different | The predicate device is pneumatically drivenand does not need an internal battery. Thebattery specifications for the subject devicehave been tested. Therefore, no additionalconcerns of safety are introduced. |
| Operating conditions | Similar | The operating conditions are similar and testedfor the subject device. | ||
| Temperaturerange | -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 withoutcondensation | 40-95% relative humidity | Similar | |
| Feature | subject deviceMEDUMAT Easy CPR(K193191) | predicate devicePneupac VR1 Standard(K051322) | Comparison | Discussion |
| Connectors | Similar | Patient connections and compressed gasconnections are identical between subject and | ||
| Patient connec-tion at patientvalve | 15 mm internal taperedconnector22 mm external taperedconnector | 15 mm internal taperedconnector22 mm external taperedconnector | Identical | predicate device. The patient valve resistancediffers slightly. |
| Compressedgas connection | External thread CGA 1240(9/16" DISS connection) | 9/16" DISS connection | Identical | |
| Patient valve re-sistance | Inspiration: <6 cmH2O at 30l/min to 60 l/minExpiration: <6 cmH2O at 30l/min to 60 l/min | < 4.5 mbar at 50 l/min< 3.0 mbar at 50 l/min | Different | |
| Degree of pro-tection againstdust and water | IP54protection against theingress of dust and splashwater from all sides | IP 56 | Different | The protection against contact and dust depositis identical between the predicate and thesubject device, but the protection against theingress of water is higher for the predicatedevice since this device has no electricalcomponents. Nevertheless, the minimumrequired protection class is fulfilled and thedevices are considered substantially equivalent. |
Section 005- 510(k) Summary K193191
510(k) Summary Product: MEDUMAT Easy CPR
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Image /page/6/Picture/1 description: The image shows the logo for WEINMANN medical technology. The word "WEINMANN" is in large, bold, gray letters. Below that, in smaller gray letters, are the words "medical technology."
Section 005- 510(k) Summary K193191
510(k) Summary Product: MEDUMAT Easy CPR
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Image /page/7/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 above the letter "M" in "WEINMANN."
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Image /page/8/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in a sans-serif font and is gray in color. The word "WEINMANN" is in large letters, and the words "medical technology" are in smaller letters below. There are two diagonal lines above the second "N" in "WEINMANN".
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Image /page/9/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. To the right of the word "WEINMANN" are two diagonal lines.
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Image /page/11/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in a sans-serif font and is a dark gray color. The word "WEINMANN" is on the top line, and the words "medical technology" are on the bottom line. There are two diagonal lines above the second "N" in WEINMANN.
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Summary of Peformance Testing
Biocompatibility
A biological evaluation was performed on the MEDUMAT Easy CPR that included several tests on the ISO 10993 and the ISO 18562 series of standards – for details please refer to the following table:
| Test Item | AppliedStand-ards | Standard Title | Test result |
|---|---|---|---|
| Cytotoxicity | ISO10993-5:2009 | Biological evaluation of medicaldevices—Part 5: Tests for in-vitro cytotoxicity | considered as "non-cytotoxic" to the sub-confluent monolayer of L-929 mouse fibro-plast cells |
| Sensitization | ISO10993-10:2010 | Biological evaluation of medicaldevices - Part 10: Tests for irrita-tion and skin sensitization | polar and non-polar extracts of the testitem were "non-sensitizer" to the skin ofthe guinea pigs under the experimentalconditions employed. |
| Irritation | ISO10993-10:2010 | Biological evaluation of medicaldevices - Part 10: Tests for irrita-tion and skin sensitization | polar and non—polar extracts of test item,were "non-irritant" to the skin of New Zea-land white rabbits under the experimentalconditions and the dose employed as perthe ISO 10993 Part 10:2010(E). |
| acute syste-mic toxicity | ISO10993-11:2017 | Biological evaluation of medicaldevices — Part 11: Tests forsystemic toxicity | no mortality or evidence of systemic tox-icity from the extracts injected into mice |
| Emissions ofparticulatematter | ISO18562-2:2017 | Biocompatibility evaluation ofbreathing gas pathways inhealthcare applications - Part 2:Tests for emissions of particulatematter | Therefore, it is concluded that exposuresto particulates and VOCs, as released fromthe Medumat Easy CPR, are unlikely to re-sult in toxicological effects. |
| Emission ofVolatile Or-ganic Com-pounds | ISO18562-3:2017 | Biocompatibi/ity evaluation ofbreathing gas pathways inhealthcare applications - Part 3:Test for emission of volatile or-ganic compounds (VOCs) | |
| Test Item | AppliedStand-ards | Standard Title | Test result |
| leachable | ISO18562-4:2017 | Biocompatibility evaluation ofbreathing gas pathways inhealthcare applications – Part 4:Tests for leachables in conden-sate | No organic compounds were identified inthe WEINMANN patient valve tested forthis study using the GC/MSD and ICP-MSextraction methods presented in this re-port. |
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EMC and electrical safety
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 l
- 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 Item | Test result | |
|---|---|---|
| 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• expiration trigger• flow | Passed | |
| Comparison of MMECPR and the predicate device Pneupac VR1 Standard:• ventilation mode characteristics (IPPV)• ventilation mode characteristics (manual Mode) | Passed | |
| Comparison of MMECPR and the predicate device Pneupac VR1 Standard:• pressure limits | Passed | |
| Section 005- 510(k) SummaryK193191 | 510(k) SummaryProduct: MEDUMAT Easy CPR | Page 5-11 |
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Image /page/14/Picture/1 description: The image shows the logo for WEINMANN medical technology. The logo is in gray and features the company name in bold, uppercase letters. Below the company name, in a smaller font, is the phrase "medical technology."
| Test Item | Test result |
|---|---|
| Endurance and functional test of pressure relief valve / safety valve of MEDUMAT EsyCPR | Passed |
| The inspiratory and expiratory respiratory resistances of Smith Medical's Pneupac VR1are determined and compared with those of the Medumat Easy CPR under different op-erating 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.
§ 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).