(116 days)
The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
The Precision Flow® - Heliox consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.
The Vapotherm Precision Flow® - Heliox is a medical device intended to warm and humidify breathing gases, specifically a heliox/oxygen mixture, for neonate/infant, pediatric, and adult patients in hospital and sub-acute settings.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists various standards that the Precision Flow® - Heliox met, with some exceptions. It also includes functional and design verification tests. The "Reported Device Performance" for these tests is generally stated as: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." Specific quantitative performance data is limited within this summary but is generally implied by compliance with the referenced standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| I. Compliance with Standards: | "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." (Implied compliance with the intent of the standard, with specific exceptions noted) |
| ISO 62304: Medical Device Software - Software Life Cycle Process | Met |
| ISO 8185:2007: Respiratory tract humidifiers for medical use | Met |
| ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met |
| ISO 10993-10:2010: Tests for Irritation and Sensitization | Met |
| ISO 11195:1995: Gas mixers for medical use - Stand-alone gas mixers | Met |
| ISO 14971:2007: Medical devices - Application of risk management to medical devices | Met |
| ANSI/AAMI/ISO 15223-1:2007/A1:2008: Medical Devices - Symbols to be used with Medical Device Labels, Labeling and information to be supplied - Part 1: General Requirements | Met |
| ANSI/AAMI ES60601-1:2005: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Met |
| ANSI/AAMI/IEC 60601-1-2:2007 3rd edition: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests | Met (with exceptions: Section 5: Device cannot produce hazardous radiation; Section 6: Anesthetic mixtures not applicable) |
| EN60601-1-4:1999: Medical Electrical Equipment: Part 1: General Requirements for Safety 4. Collateral Standard: Programmable Electrical Medical Systems | Met |
| IEC 60601-1-8 2006-10: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Met |
| IEC 60529 IPX1: Drip Proof | Met |
| AAMI TIR 32:2004: Software Risk Management | Met |
| AAMI TIR 36:2007: Validation of Software | Met |
| ISTA -1A:2001: Procedure 1A: Packaged-Products weighing 150 LB (68 KG) or Less | Met |
| EPA/625/R-96/010b (VOC) Method TO-15 (1999): Compendium Method TO-15 Determination of Volatile Organic Compounds (VOCs) in Air collected in specially-Prepared canisters and analyzed by chromatography/mass spectrometry (GC/MS) | Met |
| NIOSH Method 0500 (1994): NIOSH manual of Analytical methods (NMNM) fourth edition August 1994 (Particulate Matter Testing) | Met |
| II. Design Verification Plan (Required Tests): | "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." |
| Functional Performance Test | Met |
| Alarms & Fault Conditions Test | Met |
| Patient Connector Attachment Test | Met |
| Water Connector Attachment Test | Met |
| Extended Life Test | Met |
| Membrane Switch and Adjustment Dial Test | Met |
| Software Verification Test | Met |
| Fluid & Gas Pathways Leak Test | Met |
| Cartridge Insertion Test | Met |
| Door Test | Met |
| IPX Test | Met |
| Environmental Temperature/Humidity Extremes Test | Met |
| III. Performance Characteristics (Implied by Comparison for Substantial Equivalence): | |
| Oxygen % Range | 21 to 100% (Equivalent to predicates) |
| FiO2 Accuracy | 2 to 40 lpm: +/-2%; 1 to 2 lpm: +/-5% (Equivalent to predicates) |
| Max Flow Range | 40 lpm (Equivalent to predicates) |
| Alarm Sound Level (Medium Priority) | 47 dB @ 1m (Equivalent to predicate) |
| Alarm Sound Level (Low Priority) | 45 dB @ 1m (Equivalent to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide specific sample sizes for particular performance tests or explicitly mention a "test set" in the context of clinical or image-based studies. The performance data section broadly states: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." This implies that the design verification tests listed were conducted on the device.
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with cited standards and internal design verification plans.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The tests are likely laboratory or bench testing, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of device and study. The testing for the Precision Flow® - Heliox involves engineering and performance validation against objective technical standards (e.g., flow rates, temperature, alarm function, electrical safety), not subjective interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation relies on objective measurements against engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a medical gas humidifier/blender, not an AI-powered diagnostic or decision-support tool. It does not involve human readers interpreting cases with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. The device is hardware with integrated software for control, not a standalone algorithm. Its performance is inherent to its physical operation and control systems.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective engineering specifications, technical standards (e.g., ISO, ANSI/AAMI, IEC), and manufacturer-defined design requirements. This includes accuracy of gas blending, flow rates, temperature control, alarm thresholds, electrical safety, and biocompatibility.
8. The Sample Size for the Training Set
- This is not applicable in the context of a traditional "training set" for machine learning or AI models. The device's software is likely developed using standard software engineering practices and verified accordingly, rather than trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the reasons stated above. The "ground truth" for the device's operational parameters is derived from engineering design, relevant medical standards, and intended physiological effects of humidified gas delivery.
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510(k) SUMMARY
Vapotherm, Inc.'s Precision Flow® - Heliox
OCT - 7 2011
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, Maryland 21666
410-604-0808 Ext. 209 Phone: Facsimile: 410-604-3978
Contact Person: Gregory A. Whitney
Date Prepared: September 26, 2011
Name of Device and Name/Address of Sponsor
Precision Flow® - Heliox
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, Maryland 21666
Common or Usual Name
Humidifier, Respiratory Gas (Direct Patient Interface) ... .
Classification Name
Humidifier, Respiratory Gas (Direct Patient Interface)
Predicate Device
Primary Device: Precision Medical, Inc. Heliox/Oxygen Blender, K090781 Secondary Device: Precision Flow® - Air, K072845
The Precision Medical device is a mechanical device and the Precision Flow® device is electronic/mechanical device. The Precision Medical predicate device is compared to the Precision Flow® device for mechanical aspects and the Precision Flow® - Heliox is compared to the Precision Flow® - Air for electronic functions. The Precision Medical
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device depends on adding external stand alone devices (i.e. flowmeter, oxygen analyzer) to it for some functions. The Precision Flow® - Heliox has the same functions residing in the unit.
Intended Use / Indications for Use
The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Technological Characteristics
The Precision Flow® - Heliox consists of two parts:
and the more of the comments of the first and with a
The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection.
The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.
1. Main unit:
- · The flow of heliox and oxygen is measured by mass flow sensors. The mass flow sensors are configured for the specific gravity of the type of breathing gas. The blending function is independent from the type of gas. The operating software calculates the required flow of each needed to reach the target flow and oxygen percentage set by the operator. The system controls gas flows accordingly by adjusting proportional solenoid valves on the gas lines. An oxygen sensor monitors the gas mixture and signals any discrepancy between target and measured percentage. The oxygen sensor is automatically calibrated with oxygen at power-up and every 24 hours.
- · Firmware running in the main unit uses sensors to monitor gas pressure, water level and water temperature, and to detect air leaks into the water circuit (bubble detector). Alarms are displayed if any parameters are
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outside the normal range. Other indicators show low charge in the backup battery, and the type of cartridge installed. An internal battery backup will maintain the set flow and oxygen blend for at least 15 minutes without AC power.
2. Disposable components:
- · Vapor Transfer Cartridge. In the cartridge blended gas passes through membrane made of a specially developed polymer. Warm water circulates and diffuses as vapor through the membrane material into the gas stream. Unlike most humidifiers, there is no direct contact between the water and gas streams. The gas stream leaves the cartridge essentially saturated with vapor at the set temperature.
- · Triple-lumen heated delivery tube. The warmed humidified gas passes through the center lumen. The center lumen is surrounded by two outer lumens carrying warmed water to maintain the temperature of the inner lumen and to minimize rain-out. A proprietary short nasal cannula is connected to the end of the delivery tube and passes the humidified breathing gas to the patient's nose.
- · Disposable module. The module houses a water reservoir, pump, connections for the cartridge and delivery tube, and sensor interfaces to the main unit. Water is pumped past a heater plate through the outer lumens of the delivery tube. Returning water passes through the outer jacket of the Vapor Transfer Cartridge where some water is lost as vapor to the gas stream. There is no direct contact between water and gas flows. The water then returns to the pump reservoir. Heater power is adjusted continuously to maintain the set temperature. Water flows into the circuit from the water bag to replace evaporative losses in the Vapor Transfer Cartridge. Air is purged to atmosphere from the circulation via a hydrophobic filter membrane.
The device front panel has a LCD display which performs the following functions:
- Displays .
- o Gas flow
- o Delivered oxygen concentration
- Temperature of gas delivered 0
- Alarms for ◆
- o Water level for humidifier
- General fault o
- o Blocked tube (water for humidifier)
- Battery charging status o
- Cartridge fault (humidifier cartridge) o
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- o Cartridge type (2 are available for lower flows and higher flow)
- o Supply gas fault
- Encoder knob .
- o For selecting settings
- Run / Standby button .
- Status LED .
- Alarm mute .
Performance Data:
In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected.
The Precision Flow® - Heliox met the following standards with exceptions:
| # | Document Number | Title |
|---|---|---|
| 1 | ISO 62304 | Medical Device Software - Software Life Cycle Process |
| 2 | ISO 8185:2007 | Respiratory tract humidifiers for medical use |
| 3 | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Testsfor in vitro cytotoxicity |
| 4 | ISO 10993-10:2010 | Tests for Irritation and Sensitization |
| 5 | ISO 11195:1995 | Gas mixers for medical use - Stand-alone gas mixers |
| 6 | ISO 14971:2007 | Medical devices - Application of risk management tomedical devices |
| 7 | ANSI/AAMI/ISO 15223-1:2007/A1:2008 | Medical Devices - Symbols to be used with MedicalDevice Labels, Labeling and information to be supplied- Part 1: General Requirements |
| 8 | ANSI/AAMI ES60601-1:2005 | Medical electrical equipment – Part 1: Generalrequirements for basic safety and essentialperformance |
| 9 | ANSI/AAMI/IEC 60601-1-2:2007 3rd edition | Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: ElectromagneticCompatibility - Requirements and testsGeneral Requirements for Safety with exceptions:Section 5:Device can not produce hazardousradiationSection 6:Anesthetic mixtures not applicable |
| 9 | ANSI/AAMI/IEC 60601-1-2:2007 3rd edition | Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: ElectromagneticCompatibility - Requirements and testsGeneral Requirements for Safety with exceptions:Section 5:Device can not produce hazardousradiationSection 6:Anesthetic mixtures not applicable |
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| # | Document Number | Title |
|---|---|---|
| 10 | EN60601-1-4:1999 | Medical Electrical Equipment: Part 1: GeneralRequirements for Safety 4. Collateral Standard:Programmable Electrical Medical Systems |
| 11 | IEC 60601-1-8 2006-10 | General requirements, tests and guidance for alarmsystems in medical electrical equipment and medicalelectrical systems |
| 12 | IEC 60529 IPX1 | Drip Proof |
| 13 | AAMI TIR 32:2004 | Software Risk Management |
| 14 | AAMI TIR 36:2007 | Validation of Software |
| 15 | ISTA -1A:2001 | Procedure 1A: Packaged-Products weighing 150 LB(68 KG) or Less |
| 16 | EPA/625/R-96/010b (VOC)Method TO-15(1999) | Compendium Method TO-15 Determination of VolatileOrganic Compounds (VOCs) in Air collected inspecially-Prepared canisters and analyzed bychromatography/mass spectrometry (GC/MS) |
| 17 | NIOSH Method 0500(1994) | NIOSH manual of Analytical methods (NMNM) fourthedition August 1994 (Particulate Matter Testing) |
Design Verification Plan:
Listing of all Required Tests
- Functional Performance Test .
- Alarms & Fault Conditions Test ●
- Patient Connector Attachment Test .
- Water Connector Attachment Test .
- Extended Life Test .
- Membrane Switch and Adjustment Dial Test .
- Software Verification Test ●
- Fluid & Gas Pathways Leak Test .
- ... .. .. . . . . . . . Cartridge Insertion Test . . . . . . . Comments of the country of the status
- . Door Test
- IPX Test .
- Environmental Temperature/Humidity Extremes Test .
Substantial Equivalence
The Precision Flow® - Heliox is as safe and effective as the predicate and the Precision Medical Heliox/Oxygen Blender (K090781).
A comparison of the devices is as follows:
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| # | Manufacturer | Precision Medical, Inc.Heliox/Oxygen Blender;K090781 | Vapotherm, Inc. PrecisionFlow® - Oxygen/Heliox,K111640 | Comments |
|---|---|---|---|---|
| 1 | Indications forUse | The Precision Medical, Inc. HelioxBlender Oxygen System isintended to deliver blendedHelium and oxygen in a hospitalsetting. Oxygen concentrationscan be dialed from 20% to 100%for heliox tank mixtures of 20%oxygen/ 80% helium, and 30% to100% for heliox tank mixtures of30% oxygen/ 70% helium. TheBlender is not intended as a lifesupporting device. | The Precision Flow® - Helioxis intended to warm and addmoisture to breathing gasesfrom an external source foradministration toneonate/infant, pediatric andadult patients in the hospitaland sub-acute institutions. Itadds heat and moisture to ablended medical heliox (79%helium, 21% oxygen)/oxygenmixture and assures theintegrity of the precise heliox(79% helium, 21%oxygen)/oxygen mixture viaan integral oxygen analyzer.The flow rates may be from 1to 40 liters per minute vianasal cannula. | Equivalent |
| 2 | Patientpopulation | Infant, pediatric, and adultpatients. | Neonate/infant, pediatric andadult patients | Equivalent |
| 3 | Technology | Mechanical | Electronic/Mechanical | Equivalent |
| 4 | Gases Mixed | Heliox & Oxygen | Heliox & Oxygen | Equivalent |
| 5 | Heliox/OxygenMixtures | 79% Heliox, 21% Oxygen | 79% Heliox, 21% Oxygen | Equivalent |
| 6 | Oxygen %Range | 21 to 100% | 21 to 100% | Equivalent |
| 7 | OxygenConcentrationMonitor | Requires an external oxygenanalyzer with alarm. Accuracyrequires a gas bleed operation atflow settings below 15 lpm forHigh Flow and 3 lpm for Low Flow | Internal oxygen analyzerindependent of blenderfunction | EquivalentPF-Heliminatesuser error atset up |
| 8 | OxygenConcentrationRange | 21 to 100% | 21 to 100% | Equivalent |
| 9 | Correct HelioxFlow Rates | Manual Oxygen FlowmeterConversion Chart Needed | Automatically | EquivalentPF-H haslessopportunityfor error |
| 10 | SupplyPressureRange | 30 to 75 psi Heliox + Oxygenmust be within 10 psi of eachother | 4 to 70 psi, Device unaffectedby input gas pressuredifferences, Heliox medicalgrade & certified gas cylinder | Equivalent |
| # | Manufacturer | Precision Medical, Inc.Heliox/Oxygen Blender,K090781 | Vapotherm, Inc. PrecisionFlow® - Oxygen/Heliox,K111640 | Comments |
| 11 | OperatingTemperature | 15° to 40°C | 33° to 43° C | Equivalent |
| 12 | Environment ofuse | Institutional environments | Hospital and sub-acuteinstitutions | Equivalent |
| 13 | Condition Gas:Warm &Humidify | Need to add auxiliary equipment | Integrated into device | EquivalentPF-Heliminatesuser error inassembly |
| 14 | FiO2 Accuracy | +/- 3% of full scale @ 50 psi | 2 to 40 lpm: +/-2%1 to 2 lpm: +/-5% | Equivalent |
| 15 | Alarms | Alarms for Gas Bypass &Oxygen/Heliox Supply GasConnected | Alarms for General Fault(internal component failure),Blocked Delivery Tube, WaterOut, Disposable Water Pathfunction, Battery Charging(AC disconnected), VaporTransfer Cartridge type &fault, Gas Supply, GasTemperature | EquivalentPF-Hprovidesalarms formultiplealarmconditions |
| 16 | Alarm SoundLevel | >/= to 80 db at 1 ft. | Medium Priority 47 db @ 1 mLow Priority 45 db @ 1 m | Equivalent |
| 17 | Primary OutletFlow Range | High Flow 15 to 120 lpmLow Flow 3 to 30 lpm(With both supply pressures at 50psi with Bleed Closed*) | 1 to 40 lpm | Equivalent |
| 18 | Auxiliary OutletFlow Range | High Flow 2 to 100 IpmLow Flow 3 to 30 Ipm(With both supply pressures at 50psi with Bleed Open) | Auxiliary outlet not needed | Equivalent |
| 19 | Inlet Fitting | DISS or NIST | DISS or NIST | Equivalent |
| 20 | Bleed Flow@50 psi | 3 Ipm or less | Not required for PF-Hfunctionality | EquivalentPH-H easierto use, nobleed offrequired tooperate |
| 21 | No. of PrimaryOutlet Ports | 1 | 1 | Equivalent |
| 22 | No. of AuxiliaryOutlet Ports | 1 | 0 | PF-H forsingle patientuse |
| # | Item | Vapotherm, Inc. PrecisionFlow® - Oxygen/Air, K072845 | Vapotherm, Inc. PrecisionFlow® - Oxygen/Heliox,K111640 | Comments |
| 1 | Indications forUse | Precision Flow® is intended foruse to add warm moisture tobreathing gases from an externalsource for administration to aneonate/infant, pediatric andadult patients in the hospital,sub-acute institutions, and homesettings. It adds heat andmoisture to a blended medicalair/oxygen mixture and assuresthe integrity of the preciseair/oxygen mixture via an integraloxygen analyzer. | The Precision Flow® - Heliox isintended to warm and addmoisture to breathing gasesfrom an external source foradministration toneonate/infant, pediatric andadult patients in the hospitaland sub-acute institutions. Itadds heat and moisture to ablended medical heliox (79%helium, 21% oxygen)/oxygenmixture and assures theintegrity of the precise heliox(79% helium, 21%oxygen)/oxygen mixture via anintegral oxygen analyzer. Theflow rates may be from 1 to 40liters per minute via nasalcannula. | Equivalent |
| 2 | Patientpopulation | Neonate/infant, pediatric, andadult patients. | Neonate/infant, pediatric andadult patients | Equivalent |
| 3 | Technology | Electronic/Mechanical | Electronic/Mechanical | Equivalent |
| 4 | Oxygen %Range | 21 to 100% | 21 to 100% | Equivalent |
| 5 | OxygenConcentrationMonitor | Internal oxygen analyzer | Internal oxygen analyzer | Equivalent |
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- The Precision Medical, Inc. Heliox/Oxygen Blender needs a minimum input flow rate of 30 psi to operate. In order to delivery a lower flow rate to the patient, the excess gas is vented to atmosphere (bleed).
A comparison of the Precision Flow® - Oxygen/Heliox to the Precision Flow® - Oxygen/Air is as follows:
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| 6 | OxygenConcentrationRange | 21 to 100% | 21 to 100% | Equivalent | |
|---|---|---|---|---|---|
| 7 | SupplyPressureRange | 4 to 70 psi, Air/Oxygen | 4 to 70 psi, Heliox medicalgrade & certified gas cylinder | Equivalent | |
| 8 | OperatingTemperature | 33° to 43° C | 33° to 43° C | Equivalent | |
| 9 | Environment ofuse | Hospital and sub-acuteinstitutions | Hospital and sub-acuteinstitutions | Equivalent | |
| 10 | Condition Gas:Warm &Humidify | Integrated into device | Integrated into device | Equivalent | |
| 11 | FiO2 Accuracy | 1 to 40 lpm: +/- 2 % | 2 to 40 lpm: +/- 2%to 2 lpm: +/- 5% | 1 | Equivalent |
| 12 | Max FlowRange | 40 Ipm | 40 Ipm | Equivalent |
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| # | Item | Vapotherm, Inc. PrecisionFlow® - Oxygen/Air, K053232 | Vapotherm, Inc. PrecisionFlow® - Oxygen/Heliox;K111640 | Comments |
|---|---|---|---|---|
| 13 | Alarms | Alarms for General Fault (internalcomponent failure), BlockedDelivery Tube, Water Out,Disposable Water Path function,Battery Charging (ACdisconnected), Vapor TransferCartridge type & fault, GasSupply, Gas Temperature | Alarms for General Fault(internal component failure),Blocked Delivery Tube, WaterOut, Disposable Water Pathfunction, Battery Charging (ACdisconnected), Vapor TransferCartridge type & fault, GasSupply, Gas Temperature | Equivalent |
| 14 | Alarm SoundLevel | Medium Priority 47 db @ 1 mLow Priority 45 db @ 1 m. | Medium Priority 47 db @ 1 mLow Priority 45 db @ 1 m. | Equivalent |
| 15 | Inlet Fitting | DISS or NIST | DISS or NIST | Equivalent |
The Precision Flow® - Heliox has the same intended uses and similar indications, technological characteristics, and principles of operation as the Precision Medical, Inc. Heliox/Oxygen Blender (K090781). The conversion of the mass flow meter from air to Heliox and the minor change for the percentage oxygen range raises no new issues of safety or effectiveness. Performance data of the blending of Heliox and oxygen demonstrate that the Precision Flow® - Heliox is as safe and effective. Thus, the Precision Flow® - Heliox is substantially equivalent.
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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three wavy lines representing the head, body, and legs. The symbol is black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory A. Whitney Vice President Regulatory Affairs Vapotherm, Incorporated 198 Log Canoe Circle Stevensville, Maryland 21666
OCT - 7 2011
Re: K111640
Trade/Device Name: Vapotherm Precision Flow®, Heliox Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: September 26, 2011 Received: September 29, 2011
Dear Mr. Whitney:
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, Novever, 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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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 regencies. 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/ResourcesforYou/Industry/dsfault.htm.
Sincerely yours,
Th for
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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| Premarket Indication for Use Statement | |
|---|---|
| ---------------------------------------- | -- |
510(k) Number (if known): K ( 1 | 6 4 O
Vapotherm Precision Flow®, Heliox Device Name:
Indications for Use:
The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Prescription Use X _ AND/OR (Part 21 CFR 801 Subpart D)
Over-The counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. Schulin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 4-111640 Page __ of __
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).