Who is the manufacturer of Maxtec MaxO2 ME+p?

Maxtec, LLC filed the 510(k) submission for Maxtec MaxO2 ME+p (K221734).

What is the FDA product code for Maxtec MaxO2 ME+p?

CCL. It is classified under 21 CFR 868.1720 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Maxtec MaxO2 ME+p?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Maxtec MaxO2 ME+p?

Maxtec - MaxO2 ME (K153659); Caradyne - Criterion 40 (K992101).

Who can help prepare an FDA 510(k) submission like Maxtec MaxO2 ME+p?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Maxtec MaxO2 ME+p

K221734 · Maxtec, LLC · CCL · Apr 1, 2023 · Anesthesiology

Device Facts

Record ID	K221734
Device Name	Maxtec MaxO2 ME+p
Applicant	Maxtec, LLC
Product Code	CCL · Anesthesiology
Decision Date	Apr 1, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1720
Device Class	Class 2
Attributes	Pediatric

Intended Use

The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

Device Story

Battery-powered oxygen and pressure monitor; single assembly. Inputs: oxygen concentration via galvanic fuel cell (MAX-550E) and airway pressure via solid-state pressure transducer. Device processes signals to display real-time oxygen concentration and pressure; provides user-selectable high/low alarms for both parameters. Used in hospital and sub-acute settings; operated by clinicians. Output: visual LCD display of oxygen/pressure levels and audible/visual alarms. Healthcare providers use output to monitor patient respiratory gas delivery; aids in clinical decision-making regarding ventilation parameters. Benefits: continuous monitoring of oxygen and pressure levels to ensure patient safety during respiratory therapy.

Clinical Evidence

No clinical data. Bench testing only. Compliance with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55, and biocompatibility standards (ISO 10993 series, ISO 18562 series).

Technological Characteristics

Microprocessor-controlled monitor. Oxygen sensing via galvanic fuel cell; pressure sensing via solid-state transducer. Powered by 4 AA alkaline batteries. Dimensions: 3.6" x 5.8" x 1.2". Connectivity: standalone. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55, AIM 7351731. Biocompatibility per ISO 10993 and ISO 18562.

Indications for Use

Indicated for continuous monitoring of oxygen concentration and airway pressure in patients ranging from newborns to adults in hospital and sub-acute settings. Not for life-support or life-sustaining use.

Regulatory Classification

Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

Predicate Devices

Maxtec - MaxO2 ME (K153659)
Caradyne - Criterion 40 (K992101)

Related Devices

K251245 — OxyMinder Pro (10310) · Bio-Med Device, Inc. · Aug 11, 2025
K992101 — CRITERION 40 OR PM 40 · Caradyne, Ltd. · Jan 6, 2000
K231895 — Maxtec MaxBlend2+p · Maxtec, LLC · Dec 4, 2023
K063096 — PRECISION OXYGEN MONITOR · Precision Medical, Inc. · Feb 27, 2007
K153659 — MaxO2ME · Maxtec, LLC · Jun 10, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. April 1, 2023 Maxtec, LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704 Re: K221734 Trade/Device Name: Maxtec - MaxO2 ME+p Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL, CAP Dated: February 28, 2023 Received: February 28, 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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. 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, # James J. Lee -S James J. Lee. Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221734 Device Name MaxO2 ME+p Indications for Use (Describe) The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p 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) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Date Prepared: | 31-Mar-23 | |----------------------------------------------------------------------------------------|------------------------------------------------------------------| | Maxtec, Inc. 2305 South 1070 West Salt Lake City, UT 84119 Tel - 732-244-0010 | | | Official Contact: | Sidra Hankins - VP of QARA | | Submission Correspondent: | Paul Dryden ProMedic, LLC | | Proprietary or Trade Name: | Maxtec - MaxO2 ME+p | | Classification CFR: Classification Code: Classification Name: | 21 CFR 868.1720 CCL Analyzer, Gas, Oxygen, Gaseous-Phase | | Classification CFR: Classification Code: Classification Name: | 21 CFR 868.2600 CAP Monitor, Airway Pressure | | Primary Predicate Device: Secondary Predicate Device: | Maxtec - MaxO2 ME - K153659 Caradyne - Criterion 40 - K992101 | ## Device Description: The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms. The MaxO2ME+p comply with the following standards: - 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: 2014 Collateral standard: Electromagnetic Disturbances Requirements and Tests ● - AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System ● Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - IEC 60601-1-8 2006+A1 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 ## Indications for Use: The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device. {4}------------------------------------------------ # Patient Population: Newborns to Adult patients for MaxO2 ME+p. # Environments of use: MaxO2 ME+p: Hospital and sub-acute settings. We present the proposed device vs. the predicate and reference in the Tables below. {5}------------------------------------------------ # Table 1 - Comparison of the proposed device vs. the Primary Predicate MaxO2 ME | Attributes | Proposed MaxO2ME+p | Primary Predicate Maxtec - MaxO2 ME K153659 | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. | The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device. | | New indication | Adding pressure monitoring | N/A | | Environments of Use | Hospital and sub-acute settings | Pre-hospital, hospital and sub-acute settings | | Patient Population | Newborns to adults | Newborns to adults | | Oxygen % Range | 0.0 to 100% | 0.0 to 100% | | Oxygen Resolution | 0.1% | 0.1% | | Accuracy and Linearity | ±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale | ±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale | | 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 | | 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 | 800-1012 mBars | | Humidity | 0-95% (non-condensing) | 0-95% (non-condensing) | | Power requirements | 4 – AA Alkaline batteries | 4 – AA Alkaline batteries | | Battery Life | Approx. 5000 hours, typical use | Approx. 5000 hours, typical use | | Low Battery Indications | Battery indicator on LCD display | "LOWBAT" icon on LCD display | | Sensor Type | Maxtec MAX-550E galvanic fuel cell | Maxtec MAX-550E galvanic fuel cell | | Expected Sensor Life | > 1,500,000 %O2 Hours, over 2 years typical application | > 1,500,000 %O2 Hours, over 2 years typical application | | Alarm Systems | High/Low alarms, flashing yellow LEDs Nominal 975 Hz audio buzzer (IEC 60601-1-8) | High/Low alarms, flashing yellow LEDs 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%-99% (>1% higher than low alarm) | | Attributes | Proposed MaxO2ME+p | Primary Predicate Maxtec - MaxO2 ME K153659 | | Accuracy | Exact to display alarm value | Exact to display alarm value | | Dimensions | 3.6"(W) x 5.8"(H)x1.2"(D) | 3.6"(W) x 5.8"(H)x1.2"(D) | | Weight | Approx. 1.01 lbs. | Approx. 0.89 lbs. | | Accessories | Diverter Tee adapter (15 mmm x 22 mm fittings) Pressure monitoring line Mounting brackets DC power adapter | Diverter Tee adapter (15 mmm x 22 mm fittings) Mounting brackets DC power adapter | | Standards | ES 60601-1 IEC 60601-1-2 IEC 60601-1-8 ISO 80601-2-55 | ES 60601-1 IEC 60601-1-2 IEC 60601-1-8 ISO 80601-2-55 | | | Features related to pressure monitoring discussed in Table 2 | | {6}------------------------------------------------ Table 2 - Comparison of the proposed device vs. the predicate. | Attributes | Proposed MaxO2ME+p | Secondary Predicate Caradyne Criterion 40 K992101 | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | New indication | Pressure monitoring | Pressure monitoring | | Indications for Use | The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. | Intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g., resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capabilities. The device has been designed for stationary and intra-institution transport only. | | Environments of Use | Hospital and sub-acute settings | Hospital, sub-acute institutions, home care | | Patient Population | Newborns to adults | Not specified | | Technology | Microprocessor controlled device | Microprocessor controlled device | | Pressure sensor type | Solid-state pressure transducer | Solid-state pressure transducer | | Displayed information | | | | | Low pressure a larm setting High pressure a larm setting Alarm silence indicator Power supply indicator Average (mean) pressure Audible and visual alarm | Low pressure a larm setting High pressure a larm setting Status of alarm silence and time remaining Peak pressure Real-time pressure Power source and status Audible and visual alarm | | Attributes | Proposed MaxO2ME+p | Secondary Predicate Caradyne Criterion 40 K992101 | | Pressure Measurement Range | -15 to +60 cmH2O | Up to +99 cmH2O | | Pressure Resolution | 1 cmH2O | 1 cmH2O | | Display resolution | 0.5 cmH2O | 0.5 cmH2O | | Total Accuracy | $\pm$ 1 cmH2O | $\pm$ 1 cmH2O | | Low alarm range | 1 - 30 cmH2O | 1-20 cmH2O | | High alarm range | 1 – 60 cmH2O | 5 - 99 cmH2O | | Alarm delay | 3 seconds (pressure only) | 1-20 sec | | Zero calibration | Yes | Yes | | System interface | Disposable tubing with filter and with or without Nafion connects to in-line tee or face mask | Disposable tubing with filter connects to in-line tee or face mask | | Operating Temperature | 15°C-40°C, 0-95% RH | 15°C-45°C, 15-95%RH | | Storage Temperature | -15°C-50°C @ 95% RH | -40°C-60°C@95%RH | | Atmospheric Pressure | 800-1013 m Bars | No specified | | Power requirements | 4x - AA alkaline batteries | AC / DC | | Battery Life | 5000 hours | Up to 24 hours | | Biocompatibility | Externally communicating, tissue, permanent | Externally communicating, tissue, permanent | | Standards | ES 60601-1 IEC 60601-1-2 AIM Standard 7351731:2017 IEC 60601-1-8 ISO 80601-2-55 | IEC 601-1 IEC 601-1-2 | {7}------------------------------------------------ # 510(k) Summary Page 5 of 7 {8}------------------------------------------------ # Substantial Equivalence Discussion and Conclusion As discussed the only new feature is the addition of the pressure monitoring feature. As all other features and performance are identical to the reference, we will only discuss the new pressure monitoring feature. # Indications for Use The subject device, MaxO2 ME+p, have added the feature of measuring and monitoring pressure. The indications are similar to the primary predicate K152659 Maxtec – MaxO2 ME for measuring oxygen concentration and the secondary predicate K992101, Caradyne - Criterion 40 for measuring and monitoring pressure. # Environment of Use The subject device, MaxO2 ME+p, has similar environments of use when compared to the primary predicate K152659 Maxtec - MaxO2 ME and the secondary predicate K992101. Caradyne - Criterion 40. However, the subject device is not intended for the home care setting like the secondary predicate. This difference does not raise different concerns of safety or effectiveness. # Population The subject device, MaxO2 ME+p, has similar patient population as the primary predicate K152659 Maxtec - MaxO2 ME and the secondary predicate K992101, Caradyne - Criterion 40. The K992101, Caradyne - Criterion 40 did not specify a patient population, but measurement of pressure would have included the same population as the subject device. While it is not specified in the predicates, the population does not raise different concerns of safety or effectiveness. # Performance Specifications The subject device, MaxO2 ME+p, has similar performance specifications when compared to the secondary predicate K992101, Caradyne - Criterion 40. There are differences in the pressure measurement range between the devices with the subject device limited to a maximum of 60 cmH2O and the predicate measures up to 99 cmH2O. The alarm setting ranges are also adjusted for this lower maximum pressure. The alarm delay for the subject device is 3 seconds as compared to the predicate which can be up to 20 seconds. This difference does not raise different concerns of safety or effectiveness. ## 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: 2014 Collateral standard: Electromagnetic Disturbances Requirements and Tests . - AIM Standard 7351731: 2017 Electromagnetic Immunity Test for Exposure to Radio Frequency ● Identification Readers - 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 {9}------------------------------------------------ # Biocompatibility Patient contacting materials were evaluated per: - 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 . ## Animal No animal testing was performed. # Clinical No human clinical testing was performed. ## Conclusion We have performed a comparison of specifications in the above table and found the proposed model to be substantially equivalent.