Maxtec MaxBlend2+p

K231895 · Maxtec, LLC · BZR · Dec 4, 2023 · Anesthesiology

Device Facts

• Record ID: K231895
• Device Name: Maxtec MaxBlend2+p
• Applicant: Maxtec, LLC
• Product Code: BZR · Anesthesiology
• Decision Date: Dec 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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 Story

Maxtec MaxBlend 2+p integrates air/oxygen blender, battery-powered oxygen/pressure monitor, and adjustable flowmeter into single assembly. Device receives medical-grade air and oxygen inputs; blender provides precise mixing; flowmeter controls delivery rate. Oxygen monitor uses galvanic fuel cell (MAX-550E) to measure concentration; solid-state transducer monitors airway pressure. Used in professional healthcare settings by trained personnel. Output displayed on LCD; includes audible/visual alarms for oxygen concentration and pressure limits. Assists clinicians in managing gas delivery; benefits patients by ensuring precise oxygen concentration and pressure monitoring.

Clinical Evidence

No clinical data. Bench testing only, including AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55, and ISO 11195. Biocompatibility of patient-contacting materials (disposable pressure tubing) leveraged from secondary predicate (K221734) per ISO 10993 and ISO 18562 standards.

Technological Characteristics

Microprocessor-controlled device. Components: air/oxygen blender, flowmeter, galvanic fuel cell oxygen sensor (MAX-550E), solid-state pressure transducer. Power: 4x AA alkaline batteries. Connectivity: standalone. Standards: ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55, ISO 11195. Materials: identical to predicates K161718/K221734.

Indications for Use

Indicated for infant, pediatric, and adult patients requiring continuous air/oxygen gas mixture delivery and monitoring of oxygen concentration and airway pressure. Intended for use by qualified, trained personnel under physician direction in professional healthcare settings (hospitals, sub-acute, nursing-care). Not for life-support/life-sustaining use.

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Predicate Devices

• Maxtec MaxBlend 2 (K161718)
• MaxO2 ME+p (K221734)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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<br>ProMedic, LLC<br>131 Bay Point Dr NE<br>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<br>New Secondary - CAP | Primary - BZR<br>Secondary - CCL |
| Indications for Use | The Maxtec MaxBlend 2+p is designed to provide a<br>continuous air/oxygen gas mixture and to continuously<br>monitor the concentration of oxygen and pressure being<br>delivered to infant, pediatric, and adult patients. It is a<br>restricted medical device intended for use by qualified, trained<br>personnel, under the direction of a physician, in professional<br>healthcare settings, i.e., hospital, sub-acute, and nursing-care<br>facilities where the delivery and monitoring of air/oxygen<br>mixtures is required.<br><br>This is not intended as a life-supporting device or life<br>sustaining device. | The MaxBlend 2 and MaxBlend Lite are designed to provide<br>a continuous air/oxygen gas mixture and to continuously<br>monitor the concentration of oxygen being delivered to infant,<br>pediatric, and adult patients. It is a restricted medical device<br>intended for use by qualified, trained personnel, under the<br>direction of a physician, in professional healthcare settings,<br>i.e., hospital, sub-acute, and nursing-care facilities where the<br>delivery and monitoring of air/oxygen mixtures is required.<br><br>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, and<br>nursing-care facilities where the delivery and monitoring of<br>air/oxygen mixtures is required. | Professional healthcare settings, i.e., hospital, sub-acute, and<br>nursing-care facilities where the delivery and monitoring of<br>air/oxygen mixtures is required. |
| | 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 monitoring<br>Air/Oxygen Blender<br>Flowmeter<br>Bleed<br>Adding pressure feature | Oxygen monitoring<br>Air/Oxygen Blender<br>No Flowmeter<br>Bleed |
| Air/Oxygen Mixer Features | | |
| Blender | Blender is<br>CareFusion / Bird - K883038 or<br>BioMed Devices - K925982 | Blender is<br>CareFusion / Bird - K883038 or<br>BioMed Devices - K925982 |
| Gas Supply Type | Air / Oxygen | Air / Oxygen |
| Pressure | 30 to 75 psi | 30 to 75 psi |
| Attributes | Subject Device<br>Maxtec MaxBlend 2+p | Primary Predicate<br>MaxBlend 2 K161718 |
| Mixed gas stability | + 1% oxygen | + 1% oxygen |
| Flow range of Blenders | Low flow model – 0-30 Lpm<br>High flow model – 0-70 Lpm | Low flow model – 0-30 Lpm<br>High flow model – 0-100 Lpm |
| Pressure supply<br>differential 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 measurement<br>range | 0-100% | 0-100% |
| Total Accuracy | ±3% Actual oxygen level over full operating temperature<br>range | ±3% Actual oxygen level over full operating temperature<br>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<br>0 – 15 Lpm<br>0 – 30 Lpm<br>0 – 70 Lpm | 0 – 3 Lpm<br>0 – 30 Lpm<br>0 – 70 Lpm<br>0 – 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…