(290 days)
Not Found
No
The summary describes a standard oxygen and pressure monitor with alarms, and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training and test sets.
No.
The device is an oxygen and pressure monitor, not a device that directly treats a condition or provides therapy. Its intended use is for monitoring, and it explicitly states it is "not intended as a life-supporting device or life sustaining device."
No
The device is an oxygen and pressure monitor. It measures and displays oxygen concentration and pressure but does not perform any diagnostic analysis or provide a diagnosis of a medical condition.
No
The device description explicitly states it is a "battery powered oxygen and pressure monitor in a single assembly," indicating it is a physical hardware device with integrated sensors and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the concentration of oxygen and pressure being delivered to patients. This involves measuring parameters directly related to the patient's respiratory support, not analyzing samples taken from the patient (like blood, urine, or tissue).
- Device Description: The device measures oxygen concentration from a "gas source" and monitors pressure. This aligns with monitoring the gas being supplied to the patient, not analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device monitors the gas being delivered to the body, not the body itself or samples from it.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCL, CAP
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.
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
newborns to adults
Intended User / Care Setting
hospital and sub-acute settings.
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:
A number of tests were performed 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
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 Testing: No animal testing was performed.
Clinical Testing: 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 - MaxO2 ME - K153659, Caradyne - Criterion 40 - K992101
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.
Not Found
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
§ 868.1720 Oxygen gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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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.