OxyMinder

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March 17, 2022 Bio-Med Devices, Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704 Re: K213948 Trade/Device Name: OxyMinder Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: February 25, 2022 Received: February 28, 2022 Dear Paul Dryden: We have reviewed vour 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. 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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 mediation-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, Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213948 Device Name OxyMinder Indications for Use (Describe) The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Date Prepared: Bio-Med Devices, Inc. 61 Soundview Rd Guilford, CT 06437 USA Tel - 203-458-0202 | Official Contact: | Ken K Close - Regulatory Affairs Manager | |----------------------------|------------------------------------------| | Submission Correspondent: | Paul Dryden | | | ProMedic, LLC | | | 131 Bay Point Dr NE | | | St. Petersburg, FL 33704 | | Proprietary or Trade Name: | OxyMinder | | Common/Usual Name: | Oxygen gas analyzer | | Classification CFR: | 21 CFR 868.1720 | | Classification Code: | CCL | | Classification Name: | Analyzer, Gas, Oxygen, Gaseous-Phase | | Class: | Class II | | Predicate Device: | Maxtec MaxO2ME (K153659) | | Common/Usual Name: | Oxygen gas analyzer | | Classification CFR: | 21 CFR 868.1720 | | Classification Code: | CCL | | Classification Name: | Analyzer, Gas, Oxygen, Gaseous-Phase | | Class: | Class II | ## Device Description: The OxyMinder is an air / oxygen blender mounted oxygen monitor capable of measuring the oxygen concentration from 18 to 100%. A Bio-Med specified oxygen sensor mounted to the blender outputs a voltage which is used by the OxyMinder to determine the concentration of oxygen. The OxyMinder calibrates at ambient air (21%) and 100% oxygen. The OxyMinder is software controlled. To measure the gas mixture of the blender the OxyMinder takes a sample of the gases to the sensor through a separate port and manifold which is separate from the gas pathway to the patient. This sample is then exhausted to the room. The OxyMinder sampling stream is not part of the gas pathway to the patient. The OxyMinder is used for continuous monitoring of the concentration of oxygen delivered to patients via air oxygen blenders. The monitor provides the following features: - Continuously displays the concentrated Oxygen level delivered to a patient. O - Accepts user inputs via touch screen or button (power button). O - Provides visual alarm messages, and audible alarms. O - Displays the current alarm setting levels (High and Low O2 alarms). O - Provides on-screen configuration tools such as O2 sensor calibration, touchscreen calibration, O audio test, etc. - Monitors and displays the battery level and power source. O - Ensures clean hospital airlines by automatically purging system periodically. o {4}------------------------------------------------ ### 510(k) Summary Page 2 of 7 The OxyMinder is designed to be mounted to a Bio-Med Devices air / oxygen blender via a manifold that houses the oxygen sensor and a solenoid. In addition to the primary function of monitoring oxygen concentration, the OxyMinder provides an automatic gas supply line purge function. ### Indications for Use: The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics. ### Patient Population: The monitor is not population dependent. As it fits on a cleared Bio-Med blender has established the population. ### Environments of use: Hospital and subacute settings. We present the proposed device vs. the predicate in the Table below. {5}------------------------------------------------ # 510(k) Summary Page 104 of 7 | Attributes | Predicate | Subject | Differences | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Maxtec MaxO2ME (K153659) | Bio-Med Devices OxyMinder | | | Indications for Use | The MaxO2ME oxygen monitor is<br>intended for continuous monitoring of<br>the concentration of oxygen being<br>delivered to patients ranging from<br>newborns to adults. It can be used in<br>the pre-hospital, hospital and sub-<br>acute settings. The MaxO2ME is not<br>intended as a life supporting device. | The OxyMinder is intended for<br>continuous monitoring of the<br>concentration of oxygen being<br>delivered to patients ranging from<br>newborns to adults. This device can<br>be used in the hospital and subacute<br>settings. The monitor is not<br>intended as a life supporting device<br>or for diagnostics. | Similar | | Environments of<br>Use | Pre-hospital, hospital and sub-acute<br>settings | Hospital and subacute settings | Similar Subject device does not include pre-<br>hospital which is not in its intended use<br>Both devices are MRI Unsafe | | Patient Population | newborns to adults | newborns to adults | Similar (based on indications) | | Measurement<br>Range | 0.0 to 100% | 18% – 100% O2 | The subject device is only intended for use with<br>an air/oxygen blender which will not deliver<br>oxygen below 18%, thus this is the minimum<br>range for the OxyMinder. | | Resolution | 0.1% | Displayed to nearest whole integer | The OxyMinder verifies the proper oxygen<br>concentration from the a ir/oxygen blender. The<br>resolution of the a ir/oxygen blender knob is in<br>10% increments. The predicate can be used as a<br>standalone oxygen monitor where the resolution<br>of 0.1% is beyond the accuracy of the sampling<br>cell. | | Accuracy and<br>Linearity | ±1% of full scale at constant<br>temperature, RH and pressure when<br>calibrated at full scale | ±1.0% of full scale at constant<br>temperature and pressure | Similar | | Total Accuracy | ±3% Actual oxygen level over full<br>operating temperature range | ±2.5% Actual oxygen level over the<br>full operating temperature range | Similar | | Response Time | 90% of final value in approx. 15<br>seconds at 23°C | 90% of final value in approximately<br>6 seconds | Similar | | Warm-up Time | None required | None required | Similar | | Operating<br>Temperature | 15°C – 40°C (59°F – 104°F) | 0° – 50°C [32° - 122° F] | Similar | | Attributes | Predicate<br>Maxtec MaxO2ME (K153659) | Subject<br>Bio-Med Devices OxyMinder | Differences | | Storage<br>Temperature | -15°C – 50°C (5°F – 122°F) | 0° - 40° C [32° - 104° F] | Similar | | Atmospheric<br>Pressure | 800 - 1012 m Bars | 345 - 2068 mBars | Similar | | Humidity | 0-95% (non-condensing) | 5 - 95% | Similar | | Power requirements | 4 - AA Alkaline batteries | External DC and internal<br>rechargeable lithium-ion battery | Subject device includes external power and<br>rechargeable, appropriate for its intended use. | | Battery Life | Approx. 5000 hours, typical use | 16 hours at 100% brightness. | Subject device is primarily used stationary<br>(connected to air / oxygen blender) where<br>external power is available. | | Low Battery<br>Indications | "LOWBAT" icon on LCD display | On-screen icon & audible alarm | Similar | | Sensor Type | Maxtec MAX-550E galvanic fuel cell | Analytical Industries<br>PSR-11-917-J10 (510(k K952736) | Similar | | Expected Sensor<br>Life | > 1,500,000%O2 Hours, over 2 years<br>typical application | > 900,000%O2 Hours | The sensor manufacturer provides the following<br>specifications.<br>902,880 %O2 Hours = 60 months in the<br>following conditions: In air (20.9% O2) at 25°C<br>and 1 atm.<br>Changes in Oxygen levels, temperature and<br>pressure produce a proportional change in output<br>and an inversely proportional change in<br>expected life. | | Alarm Systems | High/Low alarms, flashing yellow<br>LEDs<br>Nominal975 Hz audio buzzer (IEC<br>60601-1-8) | Connect AC power (external power<br>disconnected when battery is low) | Similar<br>More alarm functionality for the subject device | | | | Low O2 alarm | | | | | High O2 alarm | | | | | Recalibrate O2 sensor<br>Replace O2 sensor<br>Low battery | | | Attributes | Predicate<br>Maxtec MaxO2ME (K153659) | Subject<br>Bio-Med Devices OxyMinder | Differences | | Low Oxygen Alarm Range | 15%-99% (>1% lower than high alarm) | 18%-100% (>1% lower than high alarm) | Similar | | High Oxygen Alarm Range | 16%-99% (>1% higher than low alarm) | 19%-105% (>1% lower than low alarm) | Similar | | Alarm Accuracy | Exact to display alarm value | Exact to display alarm value | Similar | | Dimensions | 3.6"(W) x 5.8"(H)x1.2”(D) | 7.86" W x 8.12" H x 4.39" D | Similar | | Weight | Approx. 0.89 lbs. | 1.5 lbs. | Similar | | Materials in Gas Pathway | The oxygen sensor | No materials in the patient gas pathway | The OxyMinder sampling stream is sidestream off the patient gas pathway through a separate port and manifold than that which is used to deliver the gas to the patient.<br>Similar except the oxygen sampling gas stream is not in the patient gas pathway. | | Accessories | Diverter<br>Tee adapter (15 mmm x 22 mm fittings)<br>Galvanic cell<br>Mounting brackets<br>DC power adapter | Galvanic cell<br>Power Adaptor<br>Mounting Bracket | | | AutoPurge | Not available but has a manual purge when the blender is on. | The OxyMinder has a scheduled purge feature to allow an automated purge of the gas sources connected to the blender when the device is not in use. This allows purging of equal amounts of flow of oxygen and air from the gas sources, ensuring that any contamination to the air and oxygen sources caused by backflow through the blender will be purged | This feature is not part of the patient performance or risk analysis.<br>It is used when the blender is left connected to the gas sources and not in use. | {6}------------------------------------------------ # 510(k) Summary Page 105 of 7 {7}------------------------------------------------ # 510(k) Summary Page 106 of 7 {8}------------------------------------------------ ## Substantial Equivalence Discussion and Rationale The table above compares the key features of the proposed device with the identified predicate -Maxtec MaxO2ME (K153659). The comparison demonstrates that the proposed devices can be found to be substantially equivalent. ### Indications for Use - The indications for use are similar for the proposed device when compared to the predicate device. Discussion - Both devices are indicated for use for monitoring oxygen levels. Both devices have equivalent range and accuracy specification. Both devices have similar alarm functionality. Minor difference does not raise different concerns of risk than the predicate. ### Technology and construction - The technology is identical to the predicate device using a galvanic fuel cell for measurement technology. Discussion - The differences in how the gas is measured and additional features do not raise different concerns of safety or effectiveness compared to the predicate. ### Environment of Use - The environments of use are similar to predicate which are clinical settings. Discussion - The subject device does not include pre-hospital which is in keeping with its use with the compatible Bio-Med Devices air / oxygen blender. ### Patient Population - The patient population of the predicate device is newborns to adults as is the subject device. Discussion - The subject and predicate have identical patient populations ### Non-Clinical Testing Summary - A series of non-clinical performance / bench testing was performed that includes: - Shelf-life / Aging ● - Software Verification and Validation ● - IEC 60601-1 ● - IEC 60601-1-2 - IEC 60601-1-8 ● - IEC 80601-2-55 - Auto-purge functionality ● - Oxygen Accuracy with Blender ● - Battery Performance Testing ● Discussion - The test results met the applicable standards and are similar to the reported performance of the predicate device. ### Biocompatibility - The predicate device has materials in the gas pathway, the subject device does not. Discussion - As the subject device has not patient contacting materials (indirect or gas pathway) biocompatibility testing is not applicable {9}------------------------------------------------ # Discussion of Differences – There are no significant differences in critical function between the proposed device and the predicate device. The subject device is intended to specifically be used with only a Bio-Med Devices cleared air / oxygen blender. A secondary feature of the OxyMinder is the auto-purge feature, which mitigates gas line contamination in the hospital medical gas pipelines due to minimal backflow when air/oxygen blender is left connected and unused for extended periods of time. The predicate device is not limited to use with only an air / oxygen blender, has a manual purge feature when it is in use, and can be used in the pre-hospital environment. The performance testing has demonstrated that the subject device met the applicable standard performance requirements. The above table plus the risk analysis do not identify any new or different risks compared to the predicate. ## Substantial Equivalence Conclusion The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.