(114 days)
Not Found
No
The device description relies on established physical principles (ultrasonic pulse transit time, pressure sensing) and calibration data, with no mention of AI or ML algorithms for data processing or decision-making.
No
The device is an oxygen analyzer used to measure oxygen purity, flow, and pressure of oxygen concentrators, not to directly treat patients.
No
The UltraMaxO2 Oxygen Analyzer measures the performance of oxygen concentrators, not a patient's physiological state. It is used for servicing and repairing equipment, not for diagnosing medical conditions in individuals.
No
The device description explicitly lists hardware components such as ABS plastic enclosures, ultrasonic oxygen sensor tube body, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors, and an LCD screen.
Based on the provided information, the UltraMaxO2 Oxygen Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure oxygen purity, flow, and pressure at the outlet of an oxygen concentrator. This is a measurement of the performance of a medical device (the oxygen concentrator), not a measurement of a biological sample from a patient.
- Device Description: The device analyzes the gas produced by the oxygen concentrator using ultrasonic pulses and pressure sensors. It does not interact with or analyze any biological fluids or tissues from a patient.
- Lack of Biological Sample Analysis: IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health. The UltraMaxO2 does not do this.
The UltraMaxO2 is a device used for quality control and performance testing of another medical device (an oxygen concentrator). It's a tool for servicing and maintaining equipment used in patient care, but it doesn't directly diagnose or monitor a patient's condition by analyzing their biological samples.
N/A
Intended Use / Indications for Use
The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
Product codes (comma separated list FDA assigned to the subject device)
CCL
Device Description
The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. Both the subject and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. In addition, the subject and predicate devices are capable of measuring flow from 0 to 10 LPM with an accuracy of +/- 0.2 LPM. The subject and predicate devices are battery powered and use ultrasonic based oxygen sensing. These devices are not intended to be used by patients who are prescribed oxygen, nor are they intended to continuously monitor or confirm oxygen delivery to a patient.
The UltraMaxO2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment.
The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen.
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
Not Found
Intended User / Care Setting
Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
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 functional and performance tests for substantial equivalence testing and the results are noted in the attached table.
- No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication as evidenced in Section 5.0 by comparison to the predicate devices currently cleared for sale in the US market.
- The conclusion drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices identified in 3) above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy of Oxygen Concentration: +/- 1.5% Full Scale (at constant temp. & optimal flow)
- Accuracy of Flow Measurement: +/- 0.2 LPM
- Accuracy of Pressure: +/- 0.5%
- Response Time: Less than or equal to 17 sec.
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.
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
DEC 1 4 2011 510(k) Summary of Safety and Effectiveness This summary of safety and effectiveness is provided as part of this Pre-Market Notification in compliance with 21 CFR Part 807, Subpart E, section 807.92, as a means of providing sufficient detail to provide understanding of the basis for a determination of substantial equivalence. } } Submitter's name, address, telephone number, a contact person and the date the summary was prepared. Maxtec, LLC Submitter's name/address: 6526 South Cottonwood Street Salt Lake City, Utah 84107 (801) 266-5300 Phone: (801) 270-5590 Fax: Tammy Lavery, RAC Contact Name: Director of Regulatory and Quality Contact Title: Contact Address: Maxtec, LLC Salt Lake City, UT 84107 (801) 327-9870 Phone: (801) 270-5590 Fax: Date Summary prepared: 08/19/2011 2) Subject device information: Device Name: Ultrasonic Oxygen Gas Analyzer UltraMaxO2 Oxygen Analyzer Trade Name(s): Oxygen Gas Analyzer Common/Usual Name: Analyzer, Gas, Oxygen, Gaseous-phase Classification Names: Classification: II CCL Product Code: CFR Reference: 21 CFR 868.1720
- The following predicate devices were used to establish substantial equivalence for the UltraMaxO2 Oxygen Analyzer:
Anesthesiology
- 510(k) # K072469: "DigiFLO Concentrator Analyzer" .
- 510(k) # K984295: "Check O2 Plus Oxygen Analyzer" .
- 510(k) # K983500: "Pro2 Check Oxygen Indicator" .
- Description of the subject device:
Classification Panel:
ুন প্রায়
The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. Both the subject and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. In addition, the subject and predicate devices are capable of measuring flow from 0 to 10 LPM with an accuracy of +/-
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6526 South Cottonwood Street · Salt Lake City, Utah 84107 · www.maxtecinc.com · 866.4.maxtec
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0.2 LPM. The subject and predicate devices are battery powered and use ultrasonic based oxygen sensing. These devices are not intended to be used by patients who are prescribed oxygen, nor are they intended to continuously monitor or confirm oxygen delivery to a patient. As per predicates listed above, the indication noted has been cleared by the FDA.
The UltraMaxQ2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment.
The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen. Further detail concerning components is included as appropriate within the 510k submission.
- Statement of indication for use:
The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
- Technological characteristics:
The technological characteristics of the design, materials, chemical composition, and energy source, etc. of the UltraMaxO2 Oxygen Analyzer are, for the most part, the same as the predicate devices identified in 3) above. Maxtec has not introduced any new technological characteristics for the UltraMaxO2 device.
- Non-clinical functional and performance tests for substantial equivalence testing and the results a. are noted in the attached table.
- No clinical studies were performed No clinical studies were performed for the UltraMaxO2 as the b. device represents a well known technology for a recognized indication as evidenced in Section 5.0 by comparison to the predicate devices currently cleared for sale in the US market.
-
- The conclusion drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices identified in 3) above.
2
| | UltraMax O2 Oxygen Analyzer
- Subject Device | DigiFlow
Concentrator
Analyzer-
K072469 | Check O2
Plus Oxygen
Analyzer -
K984295 | Pro2 Check
Oxygen
Indicator-
K983500 |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------|
| Indications for Use | The UltraMaxO₂ Oxygen Analyzer is a tool
used to measure oxygen purity, flow and
pressure of an oxygen concentrator. The
UltraMaxO₂ Oxygen Analyzer is intended
to be used in an environment where oxygen
concentrators are being serviced or repaired.
This includes hospitals, nursing homes,
extended care facilities, patient homes, and
respiratory device service and repair
centers. | Same | Same | Same |
| Sensor | Ultrasonic | Same | Same | Same |
| Low Battery Alarm
or Indictor | Low Battery Indicator | Same | Same | Same |
| Measurement
Capability - O₂
Measurement
Range | 20.9 – 96% | 20.8 – 95.7% | 73 – 95.6% | 20.9 – 100% |
| Accuracy of
Oxygen
Concentration | $\pm$ 1.5% Full Scale
(at constant temp. & optimal flow) | $\pm$ 1.8% | $\pm$ 2%
Full Scale | $\pm$ 2%
Full Scale (at
constant temp.
and pressure) |
| Measurement
Capability - Flow
Range | 0 – 10 LPM | O₂ 0 – 20 LPM
Air 0 – 10 LPM | 0 – 6 LPM | 0 – 10 LPM |
| Accuracy of Flow
Measurement | $\pm$ 0.2 LPM | $\pm$ 0.2 LPM
Both O₂ and Air | $\pm$ 0.3 LPM
(5% of full
scale) | $\pm$ 0.3 LPM
(3% of full
scale) |
| Measurement
Capability -
Pressure Range | 0.5 – 50 PSI
3.4 – 344 kPa | 0 – 35 PSI
(as noted in 510(k)
and 0-30 noted in
attached labeling)
0 – 207 kPa | 0 – 10 PSI
0 – 68.95 kPa | 0 – 10 PSI |
| Accuracy of
Pressure | $\pm$ 0.5% | $\pm$ 0.5% | $\pm$ 2%
Full Scale | $\pm$ 1%
Full Scale |
| Power Source &
Requirements | 2 Batteries:
AA (Alkaline) – 2 x 1.5 V | 1 Battery:
Alkaline 9 V | 1 Battery:
Alkaline 9 V | 1 Battery:
Alkaline 9 V |
| Display and Low
Battery Indicator | LCD | Same | Same | Same |
| Dimensions | 3.16" x 5.10" x 1.04"
(80.3mm
x 129.5mm x 26.4mm) | 9" x 1.5" x 1" | 3.3" x 7.5" x
1.25" | 3.60" x 5.75" x
1.29" |
| Response Time | Less than or equal to 17 sec. | 0.1 sec | 1 min and 45
sec $\pm$ 5 sec | 10 sec. |
| Weight | 0.4 lbs (181 g) | 179 g | 10 oz. (295 g) | 9 oz. (255.15 g) |
| Operating
Temperature | 15 – 40 C°
(59 – 104 F°) | 10 – 40 C°
(From Original
Submission and
10 – 45 C° in
attached labeling.) | 15 – 35 C°
(59 – 95 F°) | 0 – 41 C°
(32 – 105 F°) |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tammy Lavery Director of Regulatory and Quality Maxtec. LLC 6526 South Cottonwood Street Salt Lake City, Utah 84107
DEC 1 4 2011
Re: K112402
Trade/Device Name: UltraMaxO2 Oxygen Analyzer Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: December 9, 2011 Received: December 12, 2011
Dear Ms. Lavery:
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.
4
Page 2 - Ms. Lavery
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Antron D.m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1.3 Indications for Use Statement
510(k) Number (if known): K112402
Device Name: UltraMaxO2 Oxygen Analyzer
Indications for Use:
The Indications for use for the Maxtec Handheld Oxygen Analyzer and Accessories are as follows:
The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
L. Schultheis
Division Sign-Offi Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: