Smart Check O2 (MA0236)

K250002 · Life Spark Medical, LLC · CCL · Apr 24, 2025 · Anesthesiology

Device Facts

• Record ID: K250002
• Device Name: Smart Check O2 (MA0236)
• Applicant: Life Spark Medical, LLC
• Product Code: CCL · Anesthesiology
• Decision Date: Apr 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check 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.

Device Story

Smart Check O2 is a handheld ultrasonic oxygen analyzer for verifying oxygen concentrator performance. Used by technicians in workshops or patient homes; not patient-contacting. Device uses ultrasonic time-of-flight measurements (upstream/downstream) to determine gas flow rate and oxygen concentration. Internal sensors measure temperature and pressure for accuracy. Output displayed on LCD. Features include: continuous flow measurement; pulse volume measurement for conserving concentrators (integrating flow over pulse duration); and manual pressure check mode (blocking exhaust port). Device is battery-operated and firmware-controlled. Provides objective performance data to technicians to facilitate maintenance and repair decisions, ensuring concentrators deliver correct oxygen levels to patients.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against consensus standards including ANSI AAMI ES60601-1, ANSI AAMI HA60601-1-11, ANSI AAMI IEC 60601-1-2, and ISO 80601-2-55.

Technological Characteristics

Handheld ultrasonic gas analyzer. Materials: Piezo-electric ultrasonic transducers, injection-molded structural components, PCBA. Energy: 2x AA alkaline batteries. Sensing: Ultrasonic time-of-flight, internal temperature/pressure sensors. Connectivity: Standalone. Firmware-controlled microprocessor. Standards: ANSI AAMI ES60601-1, ANSI AAMI HA60601-1-11, ANSI AAMI IEC 60601-1-2, ISO 80601-2-55.

Indications for Use

Indicated for use by technicians to measure oxygen purity, flow, and pressure at the outlet of oxygen concentrators in clinical, residential, and service environments. Not for use on patients.

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 Ultramax Oxygen Analyzer (K112402)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 24, 2025

Life Spark Medical, LLC
Darryl Zitting
Biomedical Engineer
2430 W 350 N
Washington, Utah 84737

Re: K250002
Trade/Device Name: Smart Check O2 (MA0236)
Regulation Number: 21 CFR 868.1720
Regulation Name: Oxygen Gas Analyzer
Regulatory Class: Class II
Product Code: CCL
Dated: December 30, 2024
Received: January 2, 2025

Dear Darryl Zitting:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250002 - Darryl Zitting
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

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K250002 - Darryl Zitting
Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250002 | |
| Device Name Smart Check O2 (MA0236) | |
| Indications for Use (Describe) | |
| The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check 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. | |
| 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 [e-mail] | |
| "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." | |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

# 510(k) Summary – K250002

## Life Spark Medical
2430 W 350 N, Hurricane, UT 84737
Tel [phone]
E-mail – [e-mail]

## Contact Person
Darryl Zitting

## Date Summary Prepared
Mar-27-2025

## Subject Device Trade Name
Smart Check O2

## Common Name
Oxygen Gas Analyzer

## Classification
Analyzer, Gas, Oxygen, Gaseous-Phase (21 CFR 868.1720, Product Code CCL, Class 2)

## Predicate Device
Maxtec Ultramax Oxygen Analyzer, 510(k) # K112402

## Subject Device Description
The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting.

The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions.

Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing.

The Smart Check O2 is for prescription use only.

## Key Components:
- Handheld analyzer unit
- Removable battery door
- Replaceable sample tube
- Two Alkaline AA cells

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LIFESPARK
MEDICAL
510(k) Summary – K250002

# Key Performance Characteristics

All key performance characteristics are listed in the subsequent Substantial Equivalence Comparison Table.

# Indication for Use Statement

The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check 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 Smart Check O2 are substantially equivalent to the predicate device including:

- Physical Form: Handheld
- Energy Source: Battery operated
- Method of operation: Ultrasonic, upstream/downstream time-of-flight measurement
- Control Mechanism: Firmware controlled microprocessor
- Material composition: Piezo-electric ultrasonic transducers, injection molded structural components, and common PCBA materials / integrated circuit components.

# Non-Clinical Performance Data

The Smart Check O2 complies with the following consensus standards:

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021]

Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]

ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]

ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023]

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)]

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Model: | Smart Check O2 | UltraMaxO2 | | |
| Manufacturer: | Life Spark Medical | Maxtec | | |
| Product Code: | CCL (Class 2) - Analyzer, Gas,
Oxygen, Gaseous-Phase | CCL (Class 2) - Analyzer, Gas,
Oxygen, Gaseous-Phase | Same | No |
| Patient Population: | Not for use on patients, only
oxygen concentrators. | Not for use on patients, only
oxygen concentrators. | Same | No |
| Indications for Use: | The Smart Check O2 is a tool used
to measure oxygen purity, flow,
and pressure at the outlet of an
oxygen concentrator. The Smart
Check 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 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 | No |
| User Interface: | Input: Tactile dome switches
(buttons)
Output: Segmented LCD with
backlight | Input: Tactile dome switches
(buttons)
Output: Segmented LCD without
backlight | Similar | No:
Improved visibility
in low light without
adding risks. |
| Use Environment: | Hospitals, nursing homes,
extended care facilities, patient
homes, and respiratory device
service and repair centers. | Hospitals, nursing homes,
extended care facilities, patient
homes, and respiratory device
service and repair centers. | Same | No |

Page 3 | 10

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Concentrator
Compatibility: | Continuous flow concentrators and
pulsing (conserving)
concentrators. | Continuous flow concentrators
only. | New feature
using same
technology. | No:
See following
Substantial
Equivalence
Discussion. |
| Oxygen Measurement
Range:
(concentrator) | 20.9 - 96% | 20.9 - 96% | Same | No |
| Oxygen Measurement
Accuracy: | +/- 1.5% | +/-1.5% | Same | No |
| Oxygen Measurement
Resolution: | 0.1% | 0.1% | Same | No |
| Flow Measurement
Range: | 0-10LPM | 0-10LPM | Same | No |
| Flow Measurement
Accuracy: | +/-0.2 LPM | +/-0.2 LPM | Same | No |
| Flow Measurement
Resolution: | 0.1 LPM | 0.1 LPM | Same | No |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Pressure
Measurement Range: | 0 - 40 PSI | 0.5 - 50 PSI | Similar | No: The highest
pressure generated
by concentrators,
currently on the
market, is 35 psi.
Future
concentrators
offering higher
supply pressures
are not anticipated
due to patient
safety
considerations. |
| Pressure
Measurement
Accuracy: | +/-0.5% of reading | +/-0.5% of reading | Same | No |
| Pressure
Measurement
Resolution: | 0.1 PSI | 0.1 PSI | Same | No |
| Pulse Volume
Measurement Range: | 3 - 200 ml | Does not measure pulse volume | New feature
using same
technology. | No:
See Substantial
Equivalence
Discussion. |
| Pulse Volume
Measurement
Accuracy: | +/- 3 ml | Does not measure pulse volume | New feature
using same
technology. | No:
See Substantial
Equivalence
Discussion. |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Pulse Volume
Measurement
Resolution: | 0.1 ml up to 100 ml, 1 ml above
100 ml | Does not measure pulse volume | New feature
using same
technology. | No:
See Substantial
Equivalence
Discussion. |
| Response Time: | 10 seconds | ≤17 seconds | Similar | No: Subject device
response time is
improved compared
to predicate. |
| Start-up (Warm-up)
Time: | 2.5 seconds | < 1 second | Similar | No: No new risks
associated with
adding 1.5 seconds
to the analyzer
boot-up time. |
| Operating
Temperature: | 5°C - 40°C | 15°C - 40°C | Incremental
Improvement | No: Subject device
operating temp.
range is wider, and
compliant with the
requirements of
ANSI/AAMI
HA60601-1-11
subclause 4.2.3.1. |

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{10}

LIFESPARK
MEDICAL
510(k) Summary -
K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Storage Temperature: | -25°C - 70°C | -15°C - 60°C | Incremental
Improvement | No: Subject device
storage temp. range
is wider, and
compliant with the
requirements of
ANSI/AAMI
HA60601-1-11
subclause 4.2.2 |
| Atmospheric
Pressure: | 700 – 1060 hPa (mbar) | 800 - 1000 mbar (hPa) | Similar | No: Subject device
operating pressure
range is wider, and
compliant with the
requirements of
ANSI/AAMI
HA60601-1-11
subclause 4.2.3.1. |
| Humidity: | 0 - 90% (non-condensing) | 0 - 95% (non-condensing) | Similar | No: Subject device
operating humidity
range is compliant
with the
requirements of
ANSI/AAMI
HA60601-1-11
subclause 4.2.3.1. |
| Power Source: | 2x AA Alkaline Batteries | 2x AA Alkaline Batteries | Same | No |
| Battery Life: | > 16,000 read cycles | 16,500 read cycles | Same | No |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Dimensions: | 75 mm x 147 mm x 27 mm | 80.3 mm x 129.5 mm x 26.4 mm | Similar | No: Sizes of
predicate and
subject devices are
very similar and
both suitable for the
use environment.
No new risks
associated with the
minor differences
in size. |
| Weight: | 230 g | 181 g | Similar | No: Weight of
predicate and
subject devices are
similar and both
suitable for the user
population. No new
risks associated
with the minor
differences in
weight. |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

| Substantial
Equivalence
Comparison Table | Subject Device
(K250002) | Predicate device
(K112402) | Comparison | Does the difference
raise new questions of
safety and
effectiveness? |
| --- | --- | --- | --- | --- |
| Electromagnetic
Emissions
compliance: | Group 1, Class B | Group 1, Class A | Similar | No: Subject device was tested to the more challenging CISPR 11 Class B requirements for residential environments per ANSI/AAMI HA60601-1-11 clause 12. |
| Ingress rating: | IP22 | IPX1 | Incremental Improvement | No: Subject device complies with the more stringent ingress rating requirements for residential environments per ANSI/AAMI HA60601-1-11 subclause 8.3.1. |

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LIFESPARK
MEDICAL
510(k) Summary – K250002

# Substantial Equivalence Discussion and Conclusion

The Smart Check O2 is substantially equivalent in environment, user population, application and performance when compared to the predicate device. Minor differences, as noted by "similar" or "incremental improvement" in the comparison column of the table, exist primarily as a result of direct compliance with the recommendations of the homecare standard ANSI/AAMI HA60601-1-11. All noted differences are minor and do not result in new or increased risks.

## Pulse Mode:

In addition to displaying % oxygen and continuous flow rate, the subject device can calculate and display pulse volume, for pulsing ("conserving") concentrators, using multiple flow reading measurements. This feature is not significantly different than measuring continuous flow rate because it uses the exact same measurement methods and technology to make repeated flow measurements, then calculates the additional data (pulse volume) by integrating flow rate over the time period of the pulse. This difference does not introduce new or different risks compared to the predicate.

The conclusions drawn from the non-clinical tests (discussed above) demonstrate that the device is substantially equivalent to the predicate device.

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