(114 days)
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.
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. 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.
The UltraMaxO2 Oxygen Analyzer is a device designed to measure oxygen purity, flow, and pressure from oxygen concentrators.
Here's a breakdown of its acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the UltraMaxO2 Oxygen Analyzer are implicitly derived from the performance claims and comparison to predicate devices. The study demonstrates that the UltraMaxO2 meets or exceeds the performance of its predicates.
| Parameter | Acceptance Criteria (Predicate Performance - typically the most stringent or comparable) | Reported UltraMaxO2 Performance |
|---|---|---|
| Oxygen Concentration | ||
| Measurement Range | 20.8 – 95.7% (DigiFlo), 73 – 95.6% (Check O2 Plus), 20.9 – 100% (Pro2 Check) | 20.9 – 96% |
| Accuracy | ± 1.8% (DigiFlo), ± 2% Full Scale (Check O2 Plus), ± 2% Full Scale (Pro2 Check) | ± 1.5% Full Scale (at constant temp. & optimal flow) |
| Flow Measurement | ||
| Measurement Range | 0 – 20 LPM (O2, DigiFlo), 0 – 10 LPM (Air, DigiFlo), 0 – 6 LPM (Check O2 Plus), 0 – 10 LPM (Pro2 Check) | 0 – 10 LPM |
| Accuracy | ± 0.2 LPM (DigiFlo), ± 0.3 LPM (Check O2 Plus), ± 0.3 LPM (Pro2 Check) | ± 0.2 LPM |
| Pressure Measurement | ||
| Measurement Range | 0 – 35 PSI (DigiFlo), 0 – 10 PSI (Check O2 Plus), 0 – 10 PSI (Pro2 Check) | 0.5 – 50 PSI (3.4 – 344 kPa) |
| Accuracy | ± 0.5% (DigiFlo), ± 2% Full Scale (Check O2 Plus), ± 1% Full Scale (Pro2 Check) | ± 0.5% |
| Response Time | 0.1 sec (DigiFlo), 1 min and 45 sec ± 5 sec (Check O2 Plus), 10 sec (Pro2 Check) | Less than or equal to 17 sec. |
| Operating Temperature | 10 – 40 C° (DigiFlo), 15 – 35 C° (Check O2 Plus), 0 – 41 C° (Pro2 Check) | 15 – 40 C° (59 – 104 F°) |
| Other Features | ||
| Sensor | Ultrasonic (All Predicates) | Ultrasonic |
| Low Battery Alarm or Indicator | Low Battery Indicator (All Predicates) | Low Battery Indicator |
| Power Source | 1 Battery: Alkaline 9V (All Predicates) | 2 Batteries: AA (Alkaline) – 2 x 1.5 V |
| Display | LCD (All Predicates) | LCD |
| Dimensions | 9" x 1.5" x 1" (DigiFlo), 3.3" x 7.5" x 1.25" (Check O2 Plus), 3.60" x 5.75" x 1.29" (Pro2 Check) | 3.16" x 5.10" x 1.04" (80.3mm x 129.5mm x 26.4mm) |
| Weight | 179 g (DigiFlo), 10 oz. (295 g) (Check O2 Plus), 9 oz. (255.15 g) (Pro2 Check) | 0.4 lbs (181 g) |
Study Proving Device Meets Acceptance Criteria:
The provided document refers to non-clinical functional and performance tests that were conducted to establish substantial equivalence. These tests aimed to demonstrate that the UltraMaxO2 performs as well as, or better than, the legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinical functional and performance tests" but does not detail the number of units tested or the number of measurements taken.
- Data Provenance: The tests were non-clinical, likely conducted in a laboratory or manufacturing environment. The country of origin of the data is not specified, but the submitter (Maxtec, LLC) is based in Salt Lake City, Utah, USA, implying the testing likely occurred in the USA. The data is prospective as it was generated specifically for the submission to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This was a non-clinical device performance test, not an evaluation requiring expert interpretation of results for ground truth. The 'ground truth' would have been established by reference standards or calibrated measurement equipment.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was a non-clinical performance test comparing measurements against known standards or predicate device specifications, an adjudication method for interpretations is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication as evidenced...by comparison to the predicate devices currently cleared for sale in the US market."
- Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no MRMC or clinical study involving human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the fundamental performance evaluation was a standalone assessment of the device's accuracy in measuring oxygen purity, flow, and pressure. While not an 'algorithm-only' test in the AI sense, it represents the device's inherent capability independent of human interpretation. The "non-clinical functional and performance tests" assess the device's outputs directly against established standards or predicate device performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical functional and performance tests, the ground truth would have been established using calibrated reference standards or known gas mixtures/flow rates/pressures. For example, a known concentration of oxygen gas would be fed into the device, and the device's reading would be compared to that known concentration. Similarly, known flow rates and pressures would be applied. When comparing to predicate devices, the predicate device's established performance served as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The UltraMaxO2 Oxygen Analyzer is a measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device uses an ultrasonic pulse measurement method with "calibration data stored in the device." This calibration data would be established during manufacturing and testing, and is not a "training set" like those used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the AI/ML context. The device's internal calibration data is established by feeding known, precise inputs (e.g., specific oxygen concentrations, flow rates, pressures) into the device during its manufacturing and calibration process. The device's internal algorithms are then set to accurately report these known inputs. This would involve highly accurate laboratory equipment as the ground truth.
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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.
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| UltraMax O2 Oxygen Analyzer- Subject Device | DigiFlowConcentratorAnalyzer-K072469 | Check O2Plus OxygenAnalyzer -K984295 | Pro2 CheckOxygenIndicator-K983500 | |
|---|---|---|---|---|
| Indications for Use | The UltraMaxO₂ Oxygen Analyzer is a toolused to measure oxygen purity, flow andpressure of an oxygen concentrator. TheUltraMaxO₂ Oxygen Analyzer is intendedto be used in an environment where oxygenconcentrators are being serviced or repaired.This includes hospitals, nursing homes,extended care facilities, patient homes, andrespiratory device service and repaircenters. | Same | Same | Same |
| Sensor | Ultrasonic | Same | Same | Same |
| Low Battery Alarmor Indictor | Low Battery Indicator | Same | Same | Same |
| MeasurementCapability - O₂MeasurementRange | 20.9 – 96% | 20.8 – 95.7% | 73 – 95.6% | 20.9 – 100% |
| Accuracy ofOxygenConcentration | $\pm$ 1.5% Full Scale(at constant temp. & optimal flow) | $\pm$ 1.8% | $\pm$ 2%Full Scale | $\pm$ 2%Full Scale (atconstant temp.and pressure) |
| MeasurementCapability - FlowRange | 0 – 10 LPM | O₂ 0 – 20 LPMAir 0 – 10 LPM | 0 – 6 LPM | 0 – 10 LPM |
| Accuracy of FlowMeasurement | $\pm$ 0.2 LPM | $\pm$ 0.2 LPMBoth O₂ and Air | $\pm$ 0.3 LPM(5% of fullscale) | $\pm$ 0.3 LPM(3% of fullscale) |
| MeasurementCapability -Pressure Range | 0.5 – 50 PSI3.4 – 344 kPa | 0 – 35 PSI(as noted in 510(k)and 0-30 noted inattached labeling)0 – 207 kPa | 0 – 10 PSI0 – 68.95 kPa | 0 – 10 PSI |
| Accuracy ofPressure | $\pm$ 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 LowBattery Indicator | LCD | Same | Same | Same |
| Dimensions | 3.16" x 5.10" x 1.04"(80.3mmx 129.5mm x 26.4mm) | 9" x 1.5" x 1" | 3.3" x 7.5" x1.25" | 3.60" x 5.75" x1.29" |
| Response Time | Less than or equal to 17 sec. | 0.1 sec | 1 min and 45sec $\pm$ 5 sec | 10 sec. |
| Weight | 0.4 lbs (181 g) | 179 g | 10 oz. (295 g) | 9 oz. (255.15 g) |
| OperatingTemperature | 15 – 40 C°(59 – 104 F°) | 10 – 40 C°(From OriginalSubmission and10 – 45 C° inattached 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.
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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
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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:
§ 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).