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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from Maxtec, LLC, regarding their MaxBlend 2 and MaxBlend Lite devices. It aims to demonstrate substantial equivalence to a predicate device, the Bird Sentry Blender (K973646), and references other cleared devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender).

Here's an analysis based on your request, highlighting that this document outlines non-clinical testing for a medical device that mixes and monitors breathing gases, not a typically AI-powered diagnostic imaging device. Therefore, many of the requested categories (like MRMC studies, roles of experts for ground truth, sample sizes for training/test sets for AI models, etc.) are not applicable or are addressed differently in the context of hardware device performance testing.

Acceptance Criteria and Device Performance (Non-Clinical/Hardware)

The acceptance criteria are primarily based on meeting the performance specifications of the predicate device and established standards for medical devices of this type. The "reported device performance" is generally stated as "passed" or "meets the acceptance criteria" for various tests.

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Predicate / Standards Equivalent)	Reported Device Performance (MaxBlend 2 and MaxBlend Lite)
Indications for Use	Continuous air/oxygen gas mixture, monitor O2 concentration for infant, pediatric, adult patients in institutional settings; not life supporting.	Continuous air/oxygen gas mixture, continuously monitor O2 concentration for infant, pediatric, adult patients in professional healthcare settings (hospital, sub-acute, nursing-care facilities); not life supporting.
Environments of Use	Institutional (healthcare settings), Not for MRI.	Professional healthcare settings (hospital, sub-acute, nursing-care facilities), Not for MRI.
Patient Population	Infant, pediatric, and adult patients.	Infant, pediatric, and adult patients.
Weight	2 kg	2.4 kg
Power source of oxygen monitor	2 x AA Alkaline batteries	4 x AA Alkaline batteries
Gas Supply Type	Air / Oxygen, 30 to 75 psi	Air / Oxygen, 30 to 75 psi
% Oxygen Control	21 - 100%, Accuracy ± 3%	21 - 100%, Accuracy ± 3%
Mixed Gas Stability	± 1% oxygen	± 1% oxygen
Flow Range of Blenders	Low flow: 0-30 Lpm; High flow: 0-100 Lpm.	Low flow: 0-30 Lpm; High flow: 0-100 Lpm.
Pressure Supply Differential Alarm	Air / oxygen pressure < 20 psi alarms sounds.	Air / oxygen pressure < 20 psi alarms sounds.
Pressure Drop	≤ 6 psi @ 50 psi	≤ 6 psi @ 50 psi
Bleed Flow	3-13 Lpm at 50 psi depending on model.	3-13 Lpm at 50 psi depending on model.
Oxygen Measurement Range	0-100%	0-100%
Total Accuracy (Oxygen)	+3% Actual oxygen level over full operating temperature range.	+3% Actual oxygen level over full operating temperature range.
Response Time (Oxygen Monitor)	< 20 seconds	90% of final value in approx. 15 seconds at 23°C (meets/exceeds criterion).
Warm-up Time	None required.	None required.
High Alarm Range (Oxygen)	18 - 99%	16 - 100% (broader range, considered equivalent as it allows broader control and is set by clinician).
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	0-100% (non-condensing)	0-95% (non-condensing) (slight difference, but likely acceptable for intended environment).
Expected Use-Life of Sensor	750,000 O2% hours	1,500,000 O2% hours (approx. 2 years) (superior to predicate, identical to reference device).
Flowmeter Accuracy	Typically ± 10% of indicated value.	± 10% of indicated value when inlet pressure is 50 psi.
Flow Meter Ranges	0-30 Lpm for Low flow; 0-100 Lpm for High flow (user discretion).	0-3 Lpm, 0-30 Lpm, 0-70 Lpm, 0-100 Lpm (broader range tested, at user's discretion, accuracy is the same).
Standards Compliance	Tested to older versions of equivalent standards (e.g., electrical safety).	ANSI/AAMI/ES 60601-1, IEC 60601-1-2, ISO 80601-2-55, IEC 60601-1-8, ISO11195, ISO 15002:2008, ISO15001. (Indicates compliance with current standards).
Biocompatibility (Materials in Gas Pathway)	Materials externally communicating, tissue (permanent), no humidified gases.	Externally communicating, tissue (permanent), no humidified gases. VOC and PM2.5 testing performed and passed. Materials identical to cleared Maxtec products and blenders.
Cleaning Durability	[Implied standard durability]	Durability of marking tested with standard cleaning wipes/disinfectants. (Passed)
Packaging Validation	[Implied standard validation]	Testing per ISTA 2A. (Passed)
Usability	[Implied safe and effective use]	Usability testing performed with healthcare professionals. (Passed)

Overall Conclusion found in the document: "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)."

Regarding the AI/Diagnostic-Specific Questions (Not Directly Applicable to this Hardware Device but Addressed for Completeness):

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

Not Applicable in the AI/ML sense. This submission relates to physical device performance and safety testing. The "test set" would refer to devices manufactured and subjected to various non-clinical engineering and performance tests (e.g., electrical safety, EMC, accuracy, durability, environmental conditions, etc.). The sample size for these tests is not explicitly stated in terms of a "data set" but rather implies a sufficient number of representative devices for engineering validation.
Data Provenance: The testing was conducted by or on behalf of Maxtec, LLC, in the USA (Salt Lake City, Utah). It's "prospective" in the sense that the new devices were built and tested to meet pre-defined criteria, not a retrospective analysis of patient data.

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

Not Applicable in the AI/ML sense. Ground truth for device performance is established by engineering specifications, international and national standards (e.g., ISO, IEC, ANSI/AAMI), and comparison to a legally marketed predicate device.
Qualifications of Experts: The experts are likely engineers, quality assurance personnel, and regulatory affairs professionals involved in device design, manufacturing, and testing, potentially with input from clinical users for usability studies. Their qualifications would be in engineering, quality management systems (QMS), and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set:

Not Applicable in the AI/ML sense. Device performance testing involves objective measurements against a standard or specification. There isn't an "adjudication" process like a clinical expert consensus on an image. Test results either pass or fail the predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, not done. This is a hardware device focused on gas mixing and oxygen monitoring, not a diagnostic imaging AI algorithm that assists human readers. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable as an "algorithm only" study. The core components (oxygen monitor and blender) are "standalone" in function (they perform their tasks independently) and their performance was evaluated by integrating them into the MaxBlend family. The document states "The major components... 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."

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:
- Engineering specifications and design requirements.
- Performance characteristics of the legally marketed predicate device (Bird Sentry Blender - K973646).
- Compliance with recognized industry standards (e.g., ISO, IEC, ANSI/AAMI).
- Comparison to previously cleared reference devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender) which contribute components to the MaxBlend family.
- Objective physical measurements and test results (e.g., accuracy of oxygen control, response time, flow rates, pressure, etc.).

8. The Sample Size for the Training Set:

Not Applicable in the AI/ML sense. There is no "training set" for an AI model. This is a hardware device.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable in the AI/ML sense. No training set exists.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K161718

Device Name

MaxBlend 2 and MaxBlend Lite

Indications for Use (Describe)

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)

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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	510(k) SummaryOctober 27, 2016Page 1 of 6
Sponsor Contact:	Bruce BrierleyPresidentMaxtec LLC2305 South 1070 WestSalt Lake City, Utah 84119Tel – 385-549-8070
Applicant Contact:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	MaxBlend 2MaxBlend Lite
Common/Usual Name:	Mixer, Breathing Gases, Anesthesia Inhalation
Classification Name:	21 CFR 868.5330Breathing Gas Mixer
Product Code:Additional Product Code:	BZR, Class IICCL, Class II
Predicate Device:	Bird, Sentry Blender – K973646
Reference Devices:	K153659 – Maxtec MaxO2MEK883038 - CareFusion / Bird - BlenderK925982 - BioMed Devices - Blender

Device Description:

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

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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).

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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 acontinuous air/oxygen gas mixture and to continuously monitorthe concentration of oxygen being delivered to infant, pediatric,and adult patients. It is a restricted medical device intended foruse by qualified, trained personnel, under the direction of aphysician, in professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities where the delivery andmonitoring of air/oxygen mixtures is required. This is notintended as a life supporting device.	Bird Sentry Blender is designed to provide a continuousair/oxygen gas mixture to infant, pediatric, and adult patients. Itis a restricted medical device intended for use by qualified,trained personnel under the direction of a physician ininstitutional environments where delivery and monitoring ofair/oxygen mixtures is required.
Environments of Use	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	Institutional (healthcare settings) environments where thedelivery and monitoring of air/oxygen mixtures is requiredNot for use in MRI environments
Patient Population	Infant, pediatric, and adult patients	Infant, pediatric, and adult patients
Components	Oxygen monitoringAir/Oxygen BlenderFlowmeterBleed	Oxygen monitoringAir/Oxygen BlenderNo FlowmeterBleed
Weight	2.4 kg	2 kg
Power source of oxygenmonitor	4 x AA Alkaline batteries	2 x AA Alkaline batteries
Air/Oxygen Mixer Features
Blender	Blender isCareFusion / Bird - K883038 orBioMed Devices – K925982	Bird provided blender
Gas Supply Type	Air / Oxygen30 to 75 psi	Air / Oxygen30 to 75 psi
% Oxygen Control	21 - 100%Accuracy ± 3%	21 - 100%Accuracy ± 3%
Mixed gas stability	± 1% oxygen	± 1% oxygen
Flow range of Blenders	Low flow model – 0-30 LpmHigh flow model – 0-100 Lpm	Low flow model – 0-30 LpmHigh flow model – 0-100 Lpm
Pressure supply differentialalarm	Air / oxygen pressure must be < 20 psi an alarm sounds	Air / oxygen pressure must be < 20 psi an alarm sounds
Attributes	Subject DeviceMaxBlend 2 and MaxBlend Lite	PredicateBird 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 measurementrange	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 functiontypically ± 10% of indicated value
Flow meter ranges	0 – 3 Lpm0 - 30 Lpm0 - 70 Lpm0 - 100 Lpm	0 - 30 Lpm for Low flow0 - 100 Lpm for High flowRange is at the discretion of the user
General Information
Standards	ANSI/AAMI/ES 60601-1IEC 60601-1-2	Tested to older versions of the equivalent standards
Materials in Gas Pathway	Externally communicatingTissue, Permanent durationNo exposure to humidified gasesVOC and PM2.5Materials of the Oxygen Sensor (K153659) and Blenders(K883038 and K925982) are identicalMaterials of the flowmeter and connecting manifold tested viaVOC and PM2.5	Externally communicatingTissue, Permanent durationNo exposure to humidified gases

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510(k) Summary October 20, 2016

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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.

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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.

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).