Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard medical device functionalities like gas blending, flow control, monitoring, and alarms, with no mention of AI or ML.

Therapeutic

No
The device is described as an "oxygen delivery device" that "provides a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure." While it delivers a substance, its primary stated function is mixing and monitoring, rather than directly treating a condition or restoring health. The text specifically states, "This is not intended as a life-supporting device or life sustaining device."

Diagnostic

No

The device is an oxygen delivery device that monitors oxygen concentration and pressure. It does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an oxygen delivery device incorporating hardware components such as an air/oxygen blender, battery-powered monitor, and adjustable flowmeter.

IVD (In Vitro Diagnostic)

Based on the provided information, the Maxtec MaxBlend 2+p is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device is for providing and monitoring a continuous air/oxygen gas mixture delivered to patients (infant, pediatric, and adult). This is a direct interaction with the patient's respiratory system.
Device Description: The description details an oxygen delivery device that blends gases and monitors oxygen concentration and pressure of the delivered gas. It does not mention analyzing samples taken from the body (like blood, urine, tissue, etc.).
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on analysis of biological samples.

The Maxtec MaxBlend 2+p is a medical device used for delivering and monitoring respiratory gases directly to a patient, which falls under a different category of medical devices than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

BZR, CCL, CAP

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.

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

qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:
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
Key results: 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 ●
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 ●
Key results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Maxtec MaxBlend 2 - K161718, MaxO2ME+p -K221734

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

CareFusion / Bird - K883038, BioMed Devices - K925982

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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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 Dryden
ProMedic, LLC
131 Bay Point Dr NE
St. 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:

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.

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 - CCL
New Secondary - CAP	Primary - BZR
Secondary - CCL
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. | 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.