The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure 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, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

Device Description

The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral 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. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.

AI/ML Overview

The document describes the Maxtec MaxBlend 2+p, a medical device combining an air/oxygen blender, oxygen monitor, pressure monitor, and flowmeter. The 510(k) submission seeks substantial equivalence to existing predicate devices (Maxtec MaxBlend 2 - K161718 and MaxO2ME+p - K221734), particularly highlighting the addition of a pressure monitoring feature.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several performance aspects are implicitly derived from the comparative tables (Table 1 and 2) where the subject device's specifications are listed and compared to the predicate devices. The "Reported Device Performance" for the subject device is simply its stated characteristics, which are claimed to meet or be identical to the predicate device specifications, thereby meeting the acceptance criteria based on substantial equivalence.

Feature / Performance Aspect	Acceptance Criteria (from predicate devices)	Reported Device Performance (Maxtec MaxBlend 2+p)
Air/Oxygen Mixer Features
Gas Supply Type	Air / Oxygen	Air / Oxygen
Pressure	30 to 75 psi	30 to 75 psi
Mixed gas stability	± 1% oxygen	± 1% oxygen
Flow range of Blenders	Low flow model – 0-30 Lpm; High flow model – 0-100 Lpm	Low flow model – 0-30 Lpm; High flow model – 0-70 Lpm (Primary Predicate) / 0-100 Lpm (Secondary Predicate)
Pressure supply differential alarm	Air / oxygen pressure < 20 psi an alarm sounds	Air / oxygen pressure < 20 psi an alarm sounds
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 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	90% of final value in approx. 15 seconds at 23°C
Warm-up Time	None required	None required
High alarm range	16 – 100%	16 – 100%
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)	0-95% (non-condensing)
Expected use-life of sensor	1,500,000 O2% hours (approx. 2 years)	1,500,000 O2% hours (approx. 2 years)
Flowmeter Features
Accuracy	± 10% of indicated value when inlet pressure is 50 psi	± 10% of indicated value when inlet pressure is 50 psi
Flow meter ranges	0 – 3 Lpm, 0 – 15 Lpm, 0 – 30 Lpm, 0 – 70 Lpm (some predicates mention 0-100Lpm as well)	0 – 3 Lpm, 0 – 15 Lpm, 0 – 30 Lpm, 0 – 70 Lpm
Pressure Monitor Features	(Based on Secondary Predicate MaxO2 ME+p K221734)	(Maxtec MaxBlend 2+p)
Technology	Microprocessor controlled device	Microprocessor controlled device
Pressure sensor type	Solid-state pressure transducer	Solid-state pressure transducer
Pressure Measurement Range	-15 to +60 cmH2O	-15 to +60 cmH2O
Pressure Resolution	1 cmH2O	1 cmH2O
Display resolution	0.5 cm H2O	0.5 cm H2O
Total Accuracy	± 1 cmH2O	± 1 cmH2O
Low alarm range	1 - 30 cmH2O	1 - 30 cmH2O
High alarm range	1 - 60 cmH2O	1 - 60 cmH2O
Alarm delay	3 seconds (pressure only)	3 seconds (pressure only)
Zero calibration	Yes	Yes
Operating Temperature	15°C - 40°C, 0-95% RH	15°C - 40°C, 0-95% RH
Storage Temperature	-15°C - 50°C @ 95% RH	-15°C - 50°C @ 95% RH
Atmospheric Pressure	800 – 1013 mBars	800 – 1013 mBars
Power requirements	4x - AA alkaline batteries	4x - AA alkaline batteries
Battery Life	5000 hours	5000 hours

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states:

Non-clinical Testing: "We performed a number of tests to demonstrate that the proposed device performed as intended." It then lists several international standards that the device met. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily related to engineering and performance validation against standards rather than clinical data.
Clinical Testing: "No human clinical testing was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since "No human clinical testing was performed," and the primary testing involved adherence to international standards and non-clinical performance, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical testing would be the defined requirements and specifications within the cited standards.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set is mentioned, and the testing focuses on compliance with technical standards.

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

Not applicable. This device is a medical gas mixer and monitor, not an AI-assisted diagnostic or interpretation tool that would involve human readers or image analysis.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a hardware product with integrated monitoring capabilities. Its "standalone" performance is measured through its adherence to the technical specifications and international standards listed under "Non-clinical Testing." The document states: "In all cases the subject device met the standard requirements." This implicitly confirms standalone performance against established benchmarks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance specifications (e.g., oxygen accuracy, pressure accuracy, flow rates), the ground truth is based on metrological standards and calibrated equipment used in accordance with the listed international standards (e.g., ISO 80601-2-55, ISO 11195). For biocompatibility, the ground truth is established by adherence to ISO 10993 and ISO 18562 standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device with integrated sensors and controls, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, followed by 'ADMINISTRATION' in a smaller font size.

December 4, 2023

Maxtec, LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bav Point Dr NE Saint Petersburg, Florida 33704

Re: K231895

Trade/Device Name: Maxtec MaxBlend2+p Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR, CCL, CAP Dated: October 31, 2023 Received: November 1, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231895

Device Name

Maxtec MaxBlend 2+p

Indications for Use (Describe)

The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure 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 healtheare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required.

This is not intended as a life-supporting device or life sustaining device.

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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1-Dec-23

Date Prepared:

Maxtec, Inc. 2305 South 1070 West Salt Lake City, UT 84119 Tel - 1-732-244-0010 x1151

Official Contact:	Rebecca Hudson - QARA
Submission Correspondent:	Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704
Proprietary or Trade Name:	Maxtec MaxBlend2+p
Classification CFR:	21 CFR 868.5330
Classification Code:	BZR
Classification Name:	Mixer, Breathing Gases, Anesthesia Inhalation
Classification CFR:	21 CFR 868.1720
Classification Code:	CCL
Classification Name:	Analyzer, Gas, Oxygen, Gaseous-Phase
Classification CFR:	21 CFR 868.2600
Classification Code:	CAP
Classification Name:	Monitor, Airway Pressure
Predicate Device:	Maxtec MaxBlend 2 - K161718
Secondary Predicate:	MaxO2ME+p -K221734

Device Description:

Indications for Use:

The Maxtec MaxBlend 2+p is designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure 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 or life sustaining device.

Patient Population:

Infant, pediatric, and adult patients for MaxBlend 2+p.

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Environments of use:

Hospital, sub-acute, and nursing-care facilities

We present the proposed device vs. the predicates in the Tables below.

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510(k) Summary Page 3 of 11 Table 1 Comparison of MaxBlend 2+p to Primary Predicate

Attributes	Subject Device	Primary Predicate
	Maxtec MaxBlend 2+p	MaxBlend 2 K161718
Product Classification	Primary - BZR Secondary - CCLNew Secondary - CAP	Primary - BZRSecondary - CCL
Indications for Use	The Maxtec MaxBlend 2+p is designed to provide acontinuous air/oxygen gas mixture and to continuouslymonitor the concentration of oxygen and pressure beingdelivered to infant, pediatric, and adult patients. It is arestricted medical device intended for use by qualified, trainedpersonnel, under the direction of a physician, in professionalhealthcare settings, i.e., hospital, sub-acute, and nursing-carefacilities where the delivery and monitoring of air/oxygenmixtures is required.This is not intended as a life-supporting device or lifesustaining device.	The MaxBlend 2 and MaxBlend Lite are designed to providea continuous air/oxygen gas mixture and to continuouslymonitor the concentration of oxygen being delivered to infant,pediatric, and adult patients. It is a restricted medical deviceintended for use by qualified, trained personnel, under thedirection of a physician, in professional healthcare settings,i.e., hospital, sub-acute, and nursing-care facilities where thedelivery and monitoring of air/oxygen mixtures is required.This is not intended as a life supporting device.
New indication	Pressure monitoring	N/A See Table 2 for this feature
Environments of Use	Professional healthcare settings, i.e., hospital, sub-acute, andnursing-care facilities where the delivery and monitoring ofair/oxygen mixtures is required.	Professional healthcare settings, i.e., hospital, sub-acute, andnursing-care facilities where the delivery and monitoring ofair/oxygen mixtures is required.
	Not for use in MRI environments	Not for use in MRI environments
Patient Population	Infant, pediatric, and adult patients	Infant, pediatric, and adult patients
Components	Oxygen monitoringAir/Oxygen BlenderFlowmeterBleedAdding pressure feature	Oxygen monitoringAir/Oxygen BlenderNo FlowmeterBleed
Air/Oxygen Mixer Features
Blender	Blender isCareFusion / Bird - K883038 orBioMed Devices - K925982	Blender isCareFusion / Bird - K883038 orBioMed Devices - K925982
Gas Supply Type	Air / Oxygen	Air / Oxygen
Pressure	30 to 75 psi	30 to 75 psi
Attributes	Subject DeviceMaxtec MaxBlend 2+p	Primary PredicateMaxBlend 2 K161718
Mixed gas stability	+ 1% oxygen	+ 1% oxygen
Flow range of Blenders	Low flow model – 0-30 LpmHigh flow model – 0-70 Lpm	Low flow model – 0-30 LpmHigh flow model – 0-100 Lpm
Pressure supplydifferential alarm	Air / oxygen pressure must be < 20 psi an alarm sounds	Air / oxygen pressure must be < 20 psi an alarm sounds
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 measurementrange	0-100%	0-100%
Total Accuracy	±3% Actual oxygen level over full operating temperaturerange	±3% Actual oxygen level over full operating temperaturerange
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in approx. 15 seconds at 23°C
Warm-up Time	None required	None required
High alarm range	16 – 100%	16 – 100%
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)	0-95% (non-condensing)
Expected use-life of sensor	1,500,000 O2% hours (approx. 2 years)	1,500,000 O2% hours (approx. 2 years)
Flowmeter Features
Accuracy	+ 10% of indicated value when inlet pressure is 50 psi	+ 10% of indicated value when inlet pressure is 50 psi
Flow meter ranges	0 – 3 Lpm0 – 15 Lpm0 – 30 Lpm0 – 70 Lpm	0 – 3 Lpm0 – 30 Lpm0 – 70 Lpm0 – 100 Lpm
Attributes	Subject Device	Primary Predicate
	Maxtec MaxBlend 2+p	MaxBlend 2 K161718
Pressure Monitor Features (adding this feature)
Technology	Microprocessor controlled device	See Table 2
Pressure sensor type	Solid-state pressure transducer	See Table 2
Displayed information	Low pressure alarm setting	See Table 2
	High pressure alarm setting
	Alarm silence indicator
	Power supply indicator
	Average (mean) pressure
	Audible and visual alarm
Pressure Measurement	-15 to +60 cmH2O	See Table 2
Range
Pressure Resolution	1 cmH2O	See Table 2
Display resolution	0.5 cm H2O	See Table 2
Total Accuracy	+ 1 cmH2O	See Table 2
Low alarm range	1 - 30 cmH2O	See Table 2
High alarm range	1 - 60 cmH2O	See Table 2
Alarm delay	3 seconds (pressure only)	See Table 2
Zero calibration	Yes	See Table 2
System interface	Disposable tubing with filter and with or without Nafion	See Table 2
	connects to tee or face mask
Operating Temperature	15°C - 40°C, 0-95% RH	See Table 2
Storage Temperature	-15°C - 50°C @ 95% RH	See Table 2
Atmospheric Pressure	800 – 1013 mBars	See Table 2
Power requirements	4x - AA alkaline batteries	See Table 2
Battery Life	5000 hours	See Table 2
General Information
Standards	ANSI/AAMI/ES 60601-1	ANSI/AAMI/ES 60601-1
	IEC 60601-1-2	IEC 60601-1-2
	IEC 60601-1-8	IEC 60601-1-8
	ISO 80601-2-55	ISO 80601-2-55
	ISO 11195
Biocompatibility /Materials	Identical materials to K161718 and K221734	Externally communicating
in Gas Pathway		Tissue, Permanent duration
	Identical to K161718 and K221734	Materials of the Oxygen Sensor (K153659) and Blenders
		(K883038 and K925982) are identical
Attributes	Subject Device	Secondary Predicate
	Maxtec MaxBlend 2+p	MaxO2 ME+p K221734
Product Classification	Primary – BZR	Primary - CCL
	Secondary - CCL	Secondary - CAP
	New Secondary - CAP
Indications for Use	The Maxtec MaxBlend 2+p is designed to provide a	The MaxO2 ME+p is an oxygen monitor with integrated
	continuous air/oxygen gas mixture and to continuously	pressure monitoring intended for continuous monitoring of
	monitor the concentration of oxygen and pressure being	the concentration of oxygen and pressure being delivered to
	delivered to infant, pediatric, and adult patients. It is a	patients ranging from newborns to adults. It can be used in the
	restricted medical device intended for use by qualified, trained	hospital and sub-acute settings.
	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 or life
	sustaining device.
New indication	Adding Pressure monitoring	Cleared for pressure monitoring
Environments of Use	Professional healthcare settings, i.e., hospital, sub-acute, and	Hospital and sub-acute settings
	nursing-care facilities where the delivery and monitoring of
	air/oxygen mixtures is required.

	Not for use in MRI environments	Not for use in MRI environments
Patient Population	Infant, pediatric, and adult patients	Newborns to adults
Components	Oxygen monitoring	Oxygen monitoring
	Air/Oxygen Blender
	Flowmeter
	Bleed
	Pressure monitoring	Pressure Monitoring
Pressure Monitoring Features (adding this feature)
Technology	Microprocessor controlled device	Microprocessor controlled device
Pressure sensor type	Solid-state pressure transducer	Solid-state pressure transducer
Displayed information	Low pressure alarm setting	Low pressure alarm setting
	High pressure alarm setting	High pressure alarm setting
	Alarm silence indicator	Alarm silence indicator
	Power supply indicator	Power supply indicator
Attributes	Subject DeviceMaxtec MaxBlend 2+p	Secondary PredicateMaxO2 ME+p K221734
	Average (mean) pressureAudible and visual alarm	Average (mean) pressureAudible and visual alarm
Pressure MeasurementRange	-15 to +60 cmH2O	-15 to +60 cmH2O
Pressure Resolution	1 cmH2O	1 cmH2O
Display resolution	0.5 cm H2O	0.5 cm H2O
Total Accuracy	+ 1 cmH2O	+ 1 cmH2O
Low alarm range	1 - 30 cmH2O	1 - 30 cmH2O
High alarm range	1 - 60 cmH2O	1 - 60 cmH2O
Alarm delay	3 seconds (pressure only)	3 seconds (pressure only)
Zero calibration	Yes	Yes
System interface	Disposable tubing with filter and with or without Nafionconnects to tee or face mask	Disposable tubing with filter and with or without Nafionconnects to tee or face mask
Operating Temperature	15°C - 40°C, 0-95% RH	15°C - 40°C, 0-95% RH
Storage Temperature	-15°C - 50°C @ 95% RH	-15°C - 50°C @ 95% RH
Atmospheric Pressure	800 – 1013 mBars	800 – 1013 mBars
Power requirements	4x - AA alkaline batteries	4x - AA alkaline batteries
Battery Life	5000 hours	5000 hours
Oxygen Monitor Features
Oxygen measurementrange	0-100%	0-100%
Oxygen Resolution	0.1%	0.1%
Accuracy and Linearity	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale
Total Accuracy	±3% Actual oxygen level over full operating temperaturerange	±3% Actual oxygen level over full operating temperaturerange
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in approx. 15 seconds at 23°C
Warm-up Time	None required	None required
High alarm range	16 - 100%	16 - 100%
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)
Atmospheric Pressure	800 – 1013 mBars	800 – 1013 mBars
Humidity	0-95% (non-condensing)	0-95% (non-condensing)
Power requirements	4x - AA Alkaline batteries	4x - AA Alkaline batteries
Attributes	Subject Device	Secondary Predicate
	Maxtec MaxBlend 2+p	MaxO2 ME+p K221734
Battery Life	Approx. 5000 hours, typical use	Approx. 5000 hours, typical use
Low Battery Indications	Battery indicator on LCD display	Battery indicator on LCD display
Sensor Type	Maxtec MAX-550E galvanic fuel cell	Maxtec MAX-550E galvanic fuel cell
Expected use-life of sensor	1,500,000 O2% hours (approx.. 2 years)	1,500,000 O2% hours (approx.. 2 years)
Alarm Systems	High/Low alarms, flashing yellow LEDs	High/Low alarms, flashing yellow LEDs
	Nominal 975 Hz audio buzzer (IEC 60601-1-8)	Nominal 975 Hz audio buzzer (IEC 60601-1-8)
Low Oxygen Alarm Range	15% - 99% (>1% lower than high alarm)	15% - 99% (>1% lower than high alarm)
High Oxygen Alarm Range	16% - 100% (>1% higher than low alarm)	16% - 100% (>1% higher than low alarm)
Accuracy	Exact to display alarm value	Exact to display alarm value
Accessories	Diverter	Diverter
	Tee adapter (15 mmm x 22 mm fittings)	Tee adapter (15 mmm x 22 mm fittings)
	Pressure monitoring line	Pressure monitoring line
	Mounting brackets	Mounting brackets
	DC power adapter	DC power adapter
Air/Oxygen Mixer Features
Blender	Blender is	Not applicable see Table 1
	CareFusion / Bird - K883038 or
	BioMed Devices - K925982
Gas Supply Type	Air / Oxygen	Not applicable see Table 1
Pressure	30 to 75 psi	Not applicable see Table 1
% Oxygen Control	21 - 100%	Not applicable see Table 1
	Accuracy + 3%
Mixed gas stability	+ 1% oxygen	Not applicable see Table 1
Flow range of Blenders	Low flow model - 0-30 Lpm	Not applicable see Table 1
	High flow model - 0-100 Lpm
Pressure supply	Air / oxygen pressure must be < 20 psi an alarm sounds	Not applicable see Table 1
differential alarm
Pressure Drop	< 6 psi @ 50 psi	Not applicable see Table 1
Bleed flow	3-13 Lpm at 50 psi depending upon model	Not applicable see Table 1
Flowmeter Features
Accuracy	+ 10% of indicated value when inlet pressure is 50 psi	Not applicable see Table 1
Flow meter ranges	0 – 3 Lpm	Not applicable see Table 1
	0 - 15 Lpm
	0 - 30 Lpm
	0 - 70 Lpm
Attributes	Subject DeviceMaxtec MaxBlend 2+p	Secondary PredicateMaxO2 ME+p K221734
General Information
Standards	ANSI/AAMI/ES 60601-1IEC 60601-1-2 with RFIDIEC 60601-1-8ISO 80601-2-55ISO 11195	ANSI/AAMI/ES 60601-1IEC 60601-1-2AIM RFIDIEC 60601-1-8ISO 80601-2-55
BiocompatibilityMaterials in Gas Pathway	Identical to K161718 and K221734Materials of the Oxygen Sensor (K153659) and PressureMonitoring (K221734)	Materials of the Oxygen Sensor (K153659) and PressureMonitoring (K221734)Materials tested to applicable ISO 10993-1 and ISO 18562-1requirements

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510(k) Summary Page 4 of 11

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510(k) Summary Page 5 of 11

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510(k) Summary Page 6 of 11

Table 2 Comparison of the proposed device vs. the Secondary Predicate MaxO2 ME+p

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510(k) Summary Page 7 of 11

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510(k) Summary Page 8 of 11

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510(k) Summary Page 9 of 11

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510(k) Summary Page 10 of 11

Substantial Equivalence Discussion and Conclusion

As discussed the only new feature is the pressure monitoring feature. All other features and performance are identical to the primary and secondary predicates, we will only discuss the pressure monitoring feature being added to the subject device.

Indications for Use

The subject device, Maxtec MaxBlend 2+p.is adding the cleared feature of measuring and monitoring pressure including the disposable accessory lines. This is similar to the secondary predicate K221734 – Maxtec – MaxO2 ME+p.

However, for product classification purposes we have compared to subject device to the primary predicate which has the same primary indications for use with the added pressure monitoring feature. The primary predicate, K161718 is the MaxBlend 2 which is an air/gas blender with oxygen monitoring.

Environment of Use

The subject device, MaxBlend 2+p has similar environments of use when compared to the primary predicate K161718 Maxtec - MaxBlend 2. There is no difference in the use environments and adding the pressure monitoring feature which has been cleared for the same use environments would raise different concerns of safety or effectiveness.

Population

The subject device, Maxtec MaxBlend 2+p has similar patient population as the primary predicate, K161718 Maxtec -MaxBlend 2. While the secondary predicate has been cleared with the pressure monitoring for newborn to adults, the subject device and its primary predicate have been cleared for infants, pediatrics and adults. The addition of the pressure monitoring feature remains within the same patient population as the secondary predicate.

Performance Specifications

The subject device, Maxtec MaxBlend 2+p, has similar performance specifications for the blender and oxygen monitoring features as the primary predicate, K161718 - Maxtec MaxBlend 2 and the pressure monitoring performance specifications as the secondary predicate, K221734 – Maxtec MaxO2 ME+p.

Non-clinical Testing

We performed a number of tests to demonstrate that the proposed device performed as intended. Testing includes:

AAMI ANSI ES 60601-1: 2005 +A1: 2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020 Collateral standard: Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1-8: 2012 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 80601-2-55: 2018 Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 11195:2018 Gas mixers for medical use

In all cases the subject device met the standard requirements. Biocompatibility

The only new patient contacting materials are the disposable pressure tubing which are identical to the secondary predicate, K221734 - Maxtec MaxO2 ME+p. There are no changes in materials or patient contact type. These materials were evaluated in K221734 and included:

ISO 10993-5:2009 Cytotoxicity ●
ISO 10993-10:2010 Sensitization and Irritation ●

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510(k) Summary Page 11 of 11

ISO 10993-11:2017 - Material Mediated Pyrogenicity
ISO 10993-18:2020 Chemical Characterization with a Toxicological Risk Assessment ●
ISO 18562-2:2017 - Particulate Material
ISO 18562-3:2017 VOC with Toxicological Risk Assessment ●

The patient contacting materials were found to be safe for the intended population and indications for use.

Animal

No animal testing was performed.

Clinical

No human clinical testing was performed.

Conclusion

We have performed a comparison of specifications in the above tables and found the proposed addition of the pressure monitoring feature to the subject device to be equivalent to the predicates.

Regulation Number and Section

§ 868.5330 Breathing gas mixer.

(a)
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.(b)
Classification. Class II (performance standards).