MaxBlend 2, MaxBlend Lite
Device Facts
| Record ID | K161718 |
|---|---|
| Device Name | MaxBlend 2, MaxBlend Lite |
| Applicant | Maxtec, LLC |
| Product Code | BZR · Anesthesiology |
| Decision Date | Oct 27, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5330 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
Device Story
MaxBlend 2 and MaxBlend Lite are integrated oxygen delivery systems combining an air/oxygen blender, battery-powered oxygen monitor, and adjustable flowmeter. MaxBlend 2 is a single assembly; MaxBlend Lite is a module attachable to existing compatible blenders. Devices receive medical-grade air and oxygen (30-75 psi) as input. The blender mixes gases; the flowmeter controls delivery rate; the oxygen monitor measures concentration and provides user-selectable high/low alarms. Operated by qualified personnel in professional healthcare settings. Output is a mixed gas stream and visual concentration display. Clinicians use output to adjust oxygen therapy, ensuring patient receives prescribed concentration. Benefits include integrated monitoring and delivery for improved safety and convenience. Not for life support or MRI use.
Clinical Evidence
Bench testing only. No human clinical testing performed. Testing included electrical safety (ANSI/AAMI/ES IEC 60601-1), EMC (IEC-EN 60601-1-2), gas monitor standards (ISO 80601-2-55), blender/flowmeter performance (ISO 11195, ISO 15002), oxygen compatibility (ISO 15001), usability studies, and biocompatibility (VOC/PM2.5 testing).
Technological Characteristics
Integrated air/oxygen blender, flowmeter, and oxygen monitor. Powered by 4x AA alkaline batteries. Gas pathway materials tested for biocompatibility (ISO 10993-1). Standards: ANSI/AAMI/ES 60601-1, IEC 60601-1-2, ISO 80601-2-55. Connectivity: Standalone. Sterilization: Not specified (components are finished goods).
Indications for Use
Indicated for infant, pediatric, and adult patients requiring continuous air/oxygen gas mixture delivery and monitoring in professional healthcare settings (hospital, sub-acute, nursing-care). No contraindications.
Regulatory Classification
Identification
A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
Predicate Devices
- Bird, Sentry Blender (K973646)
Reference Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
Maxtec, LLC c/o Paul Dryden Consultant 2305 South 1070 West Salt Lake City, Utah 84119
Re: K161718
Trade/Device Name: MaxBlend 2, MaxBlend Lite Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR, CCL Dated: September 27, 2016 Received: September 28, 2016
Dear Paul Dryden:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known)
#### K161718
#### Device Name
#### MaxBlend 2 and MaxBlend Lite
Indications for Use (Describe)
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
{3}------------------------------------------------
| | 510(k) Summary<br>October 27, 2016<br>Page 1 of 6 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact: | Bruce Brierley<br>President<br>Maxtec LLC<br>2305 South 1070 West<br>Salt Lake City, Utah 84119<br>Tel – 385-549-8070 |
| Applicant Contact: | Paul Dryden<br>ProMedic, LLC |
| Proprietary or Trade Name: | MaxBlend 2<br>MaxBlend Lite |
| Common/Usual Name: | Mixer, Breathing Gases, Anesthesia Inhalation |
| Classification Name: | 21 CFR 868.5330<br>Breathing Gas Mixer |
| Product Code:<br>Additional Product Code: | BZR, Class II<br>CCL, Class II |
| Predicate Device: | Bird, Sentry Blender – K973646 |
| Reference Devices: | K153659 – Maxtec MaxO2ME<br>K883038 - CareFusion / Bird - Blender<br>K925982 - BioMed Devices - Blender |
# Device Description:
The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms.
The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.
#### Indications for Use:
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities where the
{4}------------------------------------------------
# 510(k) Summarv
October 27, 2016
#### Page 2 of 6
delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
#### Patient Population
The MaxBlend may be used on equipment where the patient population is infant, pediatric, and adult patients.
#### Contraindications
There are no contraindications.
#### Environments of Use
Professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities, where the delivery and monitoring of air/oxygen mixtures is required.
#### Substantial Equivalence
This section discusses how one can find the MaxBlend Family substantially equivalent to the predicate Bird Sentry Blender (K973646).
#### Indications for Use
Table 1 outlines the indications for use for both devices are similar, namely to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is not intended as a life supporting device.
#### Discussion:
One can find the subject device substantially equivalent to the predicate Bird Sentry Blender (K973646). There are no differences which raise any different questions of safety and effectiveness.
#### Environment of Use
The environments of use are similar. The predicate device uses the term "institutional setting", we have clarified this to be professional healthcare settings.
#### Discussion:
One can find the proposed device substantially equivalent to the predicate Bird Sentry Blender (K973646). There are no differences which raise any different questions of safety and effectiveness.
#### Population
The patient population is infant to adult patients which is identical to the predicate.
#### Discussion:
There are no differences which raise any different questions of safety and effectiveness.
#### Performance Specifications
The major components of the MaxBlend Family, i.e. oxygen monitoring and blender, are comprised of devices which have already been cleared for the identical indications for use, population, and environment of use. Integrating them into a single assembly for user convenience does not alter their performance. The performance specifications for the blender, oxygen monitor and their combination can be found substantially equivalent to the Bird Sentry Blender (K973646).
#### Discussion:
There are no differences between the predicate and the reference devices which would raise any different questions of safety and effectiveness. One can find the proposed device substantially equivalent to the predicate Bird Sentry Blender (K973646).
{5}------------------------------------------------
# 510(k) Summary
October 27, 2016
| Attributes | Subject Device | Predicate |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MaxBlend 2 and MaxBlend Lite | Bird Sentry Blender (K973646) |
| Indications for Use | The MaxBlend 2 and MaxBlend Lite are designed to provide a<br>continuous air/oxygen gas mixture and to continuously monitor<br>the concentration of oxygen being delivered to infant, pediatric,<br>and adult patients. It is a restricted medical device intended for<br>use by qualified, trained personnel, under the direction of a<br>physician, in professional healthcare settings, i.e., hospital, sub-<br>acute, and nursing-care facilities where the delivery and<br>monitoring of air/oxygen mixtures is required. This is not<br>intended as a life supporting device. | Bird Sentry Blender is designed to provide a continuous<br>air/oxygen gas mixture to infant, pediatric, and adult patients. It<br>is a restricted medical device intended for use by qualified,<br>trained personnel under the direction of a physician in<br>institutional environments where delivery and monitoring of<br>air/oxygen mixtures is required. |
| Environments of Use | Professional healthcare settings, i.e., hospital, sub-acute, and<br>nursing-care facilities where the delivery and monitoring of<br>air/oxygen mixtures is required.<br><br>Not for use in MRI environments | Institutional (healthcare settings) environments where the<br>delivery and monitoring of air/oxygen mixtures is required<br><br>Not for use in MRI environments |
| Patient Population | Infant, pediatric, and adult patients | Infant, pediatric, and adult patients |
| Components | Oxygen monitoring<br>Air/Oxygen Blender<br>Flowmeter<br>Bleed | Oxygen monitoring<br>Air/Oxygen Blender<br>No Flowmeter<br>Bleed |
| Weight | 2.4 kg | 2 kg |
| Power source of oxygen<br>monitor | 4 x AA Alkaline batteries | 2 x AA Alkaline batteries |
| Air/Oxygen Mixer Features | | |
| Blender | Blender is<br>CareFusion / Bird - K883038 or<br>BioMed Devices – K925982 | Bird provided blender |
| Gas Supply Type | Air / Oxygen<br>30 to 75 psi | Air / Oxygen<br>30 to 75 psi |
| % Oxygen Control | 21 - 100%<br>Accuracy ± 3% | 21 - 100%<br>Accuracy ± 3% |
| Mixed gas stability | ± 1% oxygen | ± 1% oxygen |
| Flow range of Blenders | Low flow model – 0-30 Lpm<br>High flow model – 0-100 Lpm | Low flow model – 0-30 Lpm<br>High flow model – 0-100 Lpm |
| Pressure supply differential<br>alarm | Air / oxygen pressure must be < 20 psi an alarm sounds | Air / oxygen pressure must be < 20 psi an alarm sounds |
| Attributes | Subject Device<br>MaxBlend 2 and MaxBlend Lite | Predicate<br>Bird Sentry Blender (K973646) |
| Pressure Drop | ≤ 6 psi @ 50 psi | ≤ 6 psi @ 50 psi |
| Bleed flow | 3-13 Lpm at 50 psi depending upon model | 3-13 Lpm at 50 psi depending upon model |
| Oxygen Monitor Features | | |
| Oxygen measurement<br>range | 0-100% | 0-100% |
| Total Accuracy | +3% Actual oxygen level over full operating temperature range | +3% Actual oxygen level over full operating temperature range |
| Response Time | 90% of final value in approx. 15 seconds at 23°C | < 20 seconds |
| Warm-up Time | None required | None required |
| High alarm range | 16 - 100% | 18 - 99% |
| Operating Temperature | 15°C - 40°C (59°F – 104°F) | 15°C - 40°C (59°F – 104°F) |
| Storage Temperature | -15°C - 50°C (5°F – 122°F) | -15°C - 50°C (5°F – 122°F) |
| Humidity | 0-95% (non-condensing) | 0-100% (non-condensing) |
| Expected use-life of sensor | 1,500,000 O2% hours (approx.. 2 years) | 750,000 O2% hours |
| Flowmeter Features | | |
| Accuracy | ± 10% of indicated value when inlet pressure is 50 psi | Flowmeter is added by user and is required to function<br>typically ± 10% of indicated value |
| Flow meter ranges | 0 – 3 Lpm<br>0 - 30 Lpm<br>0 - 70 Lpm<br>0 - 100 Lpm | 0 - 30 Lpm for Low flow<br>0 - 100 Lpm for High flow<br>Range is at the discretion of the user |
| General Information | | |
| Standards | ANSI/AAMI/ES 60601-1<br>IEC 60601-1-2 | Tested to older versions of the equivalent standards |
| Materials in Gas Pathway | Externally communicating<br>Tissue, Permanent duration<br>No exposure to humidified gases<br>VOC and PM2.5<br>Materials of the Oxygen Sensor (K153659) and Blenders<br>(K883038 and K925982) are identical<br>Materials of the flowmeter and connecting manifold tested via<br>VOC and PM2.5 | Externally communicating<br>Tissue, Permanent duration<br>No exposure to humidified gases |
{6}------------------------------------------------
# 510(k) Summary October 20, 2016
{7}------------------------------------------------
# 510(k) Summary
October 20, 2016 Page 5 of 6
# Non-clinical Testing
We performed a number of tests to demonstrate that the proposed device performed as intended. Testing and a brief summary follow.
- Electrical safety and EMC testing and Mechanical and Environmental conditions .
- o We utilized the following standards to evaluate the electrical safety of the device
- ISO 80601-2-55 Gas monitors .
- . ANSI/AAMI/ES IEC 60601-1 - Electrical safety
- MaxBlend 2 IEC-EN 60601-1-2 – EMC
- . MaxBlend Lite IEC-EN 60601-1-2 - EMC
- IEC 60601-1-8 Alarms ●
- 0 Accuracy and alarm performance
- . General Performance Test Report ISO11195 related to Standalone Blenders and ISO 15002:2008 - Flowmeter
- o This testing included applicable elements of the standard for blenders which include Reverse Gas flow, Leakage to Atmosphere, Accuracy of operation, Gas supply failure, Marking
- Flowmeter accuracy, Leak test, environmental and mechanical conditions o
- Operating and Storage Environment Report ●
- Testing at high and low temperatures and humidity conditions o
- . Cleaning Durability
- o Durability of marking on the device was tested with standard cleaning wipes and disinfectants
- Packaging Validation
- o Testing of packaging per ISTA 2A
- MaxBlend Family Response Time Report
- Evaluation of the oxygen sensor response time to changes in %O2 o
- Oxygen Compatibility Report ISO15001
- Testing of component materials in the gas pathway for oxygen compatibility o
- . Usability Study Report
- o Performed usability testing to healthcare professionals
#### Discussion:
In all cases the proposed device passed or meets the acceptance criteria. One can find the proposed device substantially equivalent to the predicate Bird Sentry Blender (K973646).
# Biocompatibility - Materials
All materials have been utilized and cleared under previous Maxtec products and the Blenders have also been cleared for the identical intended use. We did perform VOC and PM2s testing for the "system" and for the other components we have provided a Material Certification statement.
Per G95-1 and ISO 10993-1:2009, these materials would be considered as:
- Externally communicating
- Tissue contact ●
- Duration of Use permanent (> 30 days) ●
There are no materials in the gas pathway which are in contact with humidified gases. The materials in the gas pathway are only on the fresh gas delivery side of the equipment.
{8}------------------------------------------------
# 510(k) Summary
#### October 20, 2016
#### Page 6 of 6
The Blenders are 510(k) cleared and there is no modification or change in the materials. Maxtec purchased the blenders as finished product from the respective manufacturers. The manifold and flowmeter are the only components add to complete the "system".
- . We did perform Biocompatibility testing:
- o Gas emission VOC testing with a risk assessment of any identified chemical
- . No identifiable VOCs were detected
- 0 Particulate Matter (PM25)
- Collected particulate was less than the acceptable standard .
Animal - No animal testing was performed.
Clinical - No human clinical testing was performed.
#### Discussion of Differences
There are few differences between the subject device and the predicate. They are:
- High / Low oxygen concentration alarms ●
- o The predicate has a range of 18 99% oxygen and the subject device 16 100%.
- The subject device has the identical alarm range as the reference MaxO2ME o (K153659) which has similar indications for use, population, and environment of use.
- The difference in range allows for broader control. Alarms are for the o convenience of the clinician and are set by the clinician.
- Pressure Drop for the blenders. Both the subject and predicate Bird Sentry (K973646) have the same specification of less than 60 psi but one is measured at 10 Lpm and the other at 40 Lpm. This specification however is identical for the Blender that has been used and cleared, so the concern of any differences is addressed through the reference blender having the identical specification of the subject device.
- . Sensor expected use-life. While the expected use-life of the sensor is different between the subject device and the predicate; the expected use-life is identical to the reference MaxO2ME (K153659) incorporated into the MaxBlend family.
- Flow meter ranges. Current standalone blenders require a flowmeter to be attached in order to function. The available flowmeters that can be attached range from 200 cc/min to 100 lpm. The proposed device has been tested with a variety of flowmeter ranges: 0-3 lpm, 0-30 Lpm, 0-70 Lpm, and 0-100 Lpm. The accuracy of the flowmeters is the same +/- 10% of indicated value. The different possible flowmeter ranges is at the discretion of the user for their particular use. So long as the flowmeter range is matched to the blender range these differences do not raise any different questions of safety and effectiveness.
The differences between the predicate and the subject device are addressed when we compare the subject device to the reference devices. As noted the subject device incorporates these components in the integrated system and thus is similar to the combination of the oxygen monitor and the blender.
#### Substantial Equivalence Conclusion -
It is sponsor's opinion that the MaxOnME oxygen analyzer based upon the comparative testing is substantially equivalent to the predicate device.
