Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electronic components for gas mixing, flow control, and oxygen monitoring with alarms. There is no mention of AI or ML algorithms for data analysis, prediction, or decision-making.

Therapeutic

Yes
The device is intended 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 functions as an "oxygen delivery device," indicating a direct involvement in patient care through the delivery of a therapeutic gas mixture.

Diagnostic

No
The device is described as an oxygen delivery device incorporating an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter. It is used to provide and monitor a continuous air/oxygen gas mixture for patients. While it monitors oxygen concentration, its primary function is delivering and regulating gas mixtures, not diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that the MaxBlend family of blenders are "oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly." This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is 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." This describes a device that interacts with the patient's respiratory system by delivering and monitoring gases, not a device that performs tests on biological samples in vitro (outside the body).
Device Description: The description details an "oxygen delivery device" that incorporates a blender, monitor, and flowmeter. These components are all involved in the delivery and monitoring of gases for respiration, not in the analysis of biological specimens.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic purposes based on analyzing biological samples
- Measurement of analytes in biological fluids

The device is clearly intended for direct patient care related to respiration and gas delivery, which falls under the category of a therapeutic or monitoring medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

BZR, CCL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

infant, pediatric, and adult patients.

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical Testing:

Electrical safety and EMC testing and Mechanical and Environmental conditions
- Utilized standards: 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
- Accuracy and alarm performance
General Performance Test Report ISO11195 related to Standalone Blenders and ISO 15002:2008 - Flowmeter
- Testing included applicable elements of the standard for blenders: Reverse Gas flow, Leakage to Atmosphere, Accuracy of operation, Gas supply failure, Marking
- Flowmeter accuracy, Leak test, environmental and mechanical conditions
Operating and Storage Environment Report
- Testing at high and low temperatures and humidity conditions
Cleaning Durability
- Durability of marking on the device was tested with standard cleaning wipes and disinfectants
Packaging Validation
- Testing of packaging per ISTA 2A
MaxBlend Family Response Time Report
- Evaluation of the oxygen sensor response time to changes in %O2
Oxygen Compatibility Report ISO15001
- Testing of component materials in the gas pathway for oxygen compatibility
Usability Study Report
- Performed usability testing to healthcare professionals

Key Results: In all cases the proposed device passed or meets the acceptance criteria.

Key Metrics

Not Found

Predicate Device(s)

Bird, Sentry Blender – K973646

Reference Device(s)

K153659, K883038, K925982

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

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.

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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) Summary
October 27, 2016
Page 1 of 6 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact: | Bruce Brierley
President
Maxtec LLC
2305 South 1070 West
Salt Lake City, Utah 84119
Tel – 385-549-8070 |
| Applicant Contact: | Paul Dryden
ProMedic, LLC |
| Proprietary or Trade Name: | MaxBlend 2
MaxBlend Lite |
| Common/Usual Name: | Mixer, Breathing Gases, Anesthesia Inhalation |
| Classification Name: | 21 CFR 868.5330
Breathing Gas Mixer |
| Product Code:
Additional Product Code: | BZR, Class II
CCL, Class II |
| Predicate Device: | Bird, Sentry Blender – K973646 |
| Reference Devices: | K153659 – Maxtec MaxO2ME
K883038 - CareFusion / Bird - Blender
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
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.	Bird Sentry Blender is designed to provide a continuous
air/oxygen gas mixture 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
institutional environments where delivery and monitoring of
air/oxygen mixtures is required.
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.

Not for use in MRI environments | Institutional (healthcare settings) environments where the
delivery and monitoring of air/oxygen mixtures is required

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.