F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

K212031 · Fisher & Paykel Healthcare, Ltd. · BTT · Apr 22, 2022 · Anesthesiology

Device Facts

• Record ID: K212031
• Device Name: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Apr 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

Device Story

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit provides gas conduit between respiratory support equipment (MR850 Humidifier) and patient interface (mask, nasal prongs, tracheostomy). Inspiratory limb (1.6m extruded bubble tube) connects humidification chamber to patient; includes temperature sensor clips and gown clip. Optional disposable exhalation port (DEP) for NIV applications features perforated ventilation hole and pressure line port. Device is single-use, prescription-only, non-sterile. Clinicians (respiratory therapists, nurses) set up circuit; humidifier maintains gas heat/humidity. Output is heated, humidified gas delivered to patient. Benefits include consistent humidity/temperature delivery for respiratory support, aiding patient comfort and therapy efficacy.

Clinical Evidence

Bench testing only. Performance verified via ISO 80601-2-74, IEC 60601-1, ISO 5356-1, ISO 5367, and ISO 18562. Comparative bench testing of exhalation port flow, pressure port volume, and tidal volume delivery confirmed equivalence to predicate. Human factors validation study with 15 US-licensed respiratory therapists confirmed critical tasks can be performed safely.

Technological Characteristics

Heated breathing circuit with two-spiral wall tubing (insulating bubble tube + heating spiral with encapsulated heater wire). Materials: Polycarbonate (exhalation port). Dimensions: 1.6m length, 17mm ID. Connectivity: Connects to F&P MR850 Humidifier. Sterilization: Non-sterile. Standards: ISO 80601-2-74, IEC 60601-1, ISO 5356-1, ISO 5367, ISO 10993, ISO 18562.

Indications for Use

Indicated for spontaneously breathing adult patients requiring heated, humidified breathing gases in hospital and long-term care environments.

Regulatory Classification

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.

Predicate Devices

• F&P AirSpiral Heated Breathing Tube (K162553)
• Bipap Vision Ventilatory Support (K982454)

Reference Devices

• F&P RT380 Adult Evaqua 2 Dual Heated Breathing Circuit (K122432)

Submission Summary (Full Text)

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April 22, 2022

Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K212031

Trade/Device Name: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: March 22, 2022 Received: March 22, 2022

Dear Reena Daken:

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. 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. 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.

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brandon Blakely, Ph.D. Respiratory Devices Team 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

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# Indications for Use

510(k) Number (if known) K212031

Device Name F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

Indications for Use (Describe)

For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border: none;"><tr><td><div style="display: inline-block; vertical-align: middle;"> <img alt="Checked" src="checkbox_checked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Reproductive Use (Part 21 CFR 321 Subpart D) </td><td><div style="display: inline-block; vertical-align: middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Source Tissue Use (21 CFR 1271 Subpart C) </td></tr></table> | <div style="display: inline-block; vertical-align: middle;"> <img alt="Checked" src="checkbox_checked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Reproductive Use (Part 21 CFR 321 Subpart D) | <div style="display: inline-block; vertical-align: middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Source Tissue Use (21 CFR 1271 Subpart C) |
| <div style="display: inline-block; vertical-align: middle;"> <img alt="Checked" src="checkbox_checked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Reproductive Use (Part 21 CFR 321 Subpart D) | <div style="display: inline-block; vertical-align: middle;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width: 15px; height: 15px; vertical-align: middle;"/> </div> Source Tissue Use (21 CFR 1271 Subpart C) | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# As Required by 21 CFR 807.92

# I. SUBMITTER

| Company Name and Address | Fisher & Paykel Healthcare Limited<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Nicholas Yap<br>Regulatory Affairs Specialist |
| Contact Person | Reena Daken<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Prepared | 22 April 2022 |

#### DEVICE =

| Device Name | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit |
|---------------------|-------------------------------------------------|
| Common/Usual Name | Heated Breathing Tube |
| Classification Name | Respiratory gas humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |

#### PREDICATE DEVICE III.

| Predicate Device | F&P AirSpiral Heated Breathing Tube | K162553 |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------|
| Secondary Predicate Device | Bipap Vision Ventilatory Support | K982454 |
| Reference Device(s) | F&P RT380 Adult Evaqua 2 Dual Heated<br>Breathing Circuit | K122432 |
| • Used to support claims of<br>substantial equivalence with respect<br>to performance and system | | |

compatibility

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# DEVICE DESCRIPTION

The F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (850A61) is designed to provide a gas conduit between respiratory support equipment and a patient interface such as a mask, nasal prongs or tracheostomy interface for a spontaneously breathing Adult patient.

The Inspiratory Limb is an extruded bubble tube design 1.6 metres in length, and is intended to connect the gas path from humidification chamber to the patient interface. Additionally, temperature sensor clips and a gown clip are included to aid in cable management and to affix the circuit to a gown or sheet. The subject device is single use, prescription only and is provided in a non-sterile state.

The Disposable Exhalation Port is an optional accessory for NIV applications. It features a perforated ventilation hole and a 22mm/15mm coaxial taper connectir for connecting to patient interfaces and a 22mm tapered male connector for connecting to the patient end of the Inspiratory Limb. It also features a capped port for connecting to the Pressure Line.

#### INDICATIONS FOR USE IV.

For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

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#### COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE V.

A comparison of intended use, features, and performance specifications demonstrate that the subject device is substantially equivalent to the predicate device.

| Parameter | Subject Device<br>F&P 850A61 | Predicate Device<br>F&P AirSpiral Heated Breathing Tube<br>(K162553) | Comments |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | |
| Manufacturer | Fisher & Paykel Healthcare Ltd. | Fisher & Paykel Healthcare Ltd. | |
| Device Regulation | Class II, Regulation: 21 CFR 868.5270 | Class II, Regulation: 21 CFR 868.5270 | Identical |
| Product Code | BTT | BTT | |
| Classification Panel | Anesthesiology | Anesthesiology | |
| Intended Use and Indications for Use | | | |
| Intended Use | Heated breathing tube for delivery of<br>humidified respiratory gases | Heated breathing tube for delivery of<br>humidified respiratory gases | Identical |
| Indications for Use | For the delivery of heated, humidified<br>breathing gases to spontaneously breathing<br>adult patients. This breathing set is suitable<br>for use with Fisher & Paykel Healthcare<br>MR850 Humidifiers in hospital and long-term<br>care environments. | Heated breathing tube for delivery of<br>humidified respiratory gases. For use with<br>AIRVO and AIRVO2 Series humidifiers in<br>hospitals and long-term care facilities. For<br>use at flows from 2 to 60 L/min depending on<br>the patient interface. | Equivalent |
| Availability | Prescription use<br>(Part 21 CFR 801 Subpart D) | Prescription use<br>(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Spontaneously breathing adult patients<br>requiring flows between 10 – 120 L/min<br>depending on the required therapy and<br>patient interface. | Spontaneously breathing patient requiring<br>flows between 2 - 60 L/min. | Equivalent |
| Parameter | Subject Device<br>F&P 850A61 | Predicate Device<br>F&P AirSpiral Heated Breathing Tube<br>(K162553) | Comments |
| Operating Environment | Hospital and long-term care environments | Hospital and long-term care facilities | Identical |
| Reusability | Single use | Single use | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Life Supporting or Life<br>Sustaining | No | No | Identical |
| Operation and Safety Features | | | |
| Principle of Operation | Connects to a humidifier. Powered by the<br>humidifier to maintain heat as a conduit for<br>humidified heated respiratory gases.<br>Connects the humidifier to the patient<br>interface. | Connects to a humidifier. Powered by the<br>humidifier to maintain heat as a conduit for<br>humidified heated respiratory gases.<br>Connects the humidifier to the patient<br>interface. | Identical |
| Tube Dimensions | Length: 1.6 m<br>Internal Diameter: 17 mm | Length: 1.8 m<br>Internal Diameter: 13.1 mm | Equivalent |
| Design of the Tube<br>Construction | Heated tube to transport humidified gas<br>between the humidification chamber and the<br>Patient End<br>Two-spiral wall tubing design:<br>Insulating spiral made of Spiral-wound<br>bubble tubingHeating spiral encapsulating heater wire | Heated tube to transport humidified gas<br>between the Unit End and the Patient End<br>Two-spiral wall tubing design:<br>Insulating spiral made of Spiral-wound<br>bubble tubingHeating spiral encapsulating heater wire | Identical |
| Temperature Sensor | A removable temperature and flow sensor<br>are used at the humidification chamber outlet<br>port which is an accessory to the F&P<br>MR850 humidifier. | An integrated temperature sensor at the<br>patient end of the tube eliminates the need<br>for external probes, cables or adaptors. | Similar |
| Parameter | Subject Device<br>F&P 850A61 | Predicate Device<br>F&P AirSpiral Heated Breathing Tube<br>(K162553) | Comments |
| | A removable temperature sensor is used at<br>the patient end port which is an accessory to<br>the F&P MR850 humidifier. | | |
| Heater Wire Lumen Design | Consists of filament conductor.<br>Position in tube: Double helix wound<br>moulded into bead of tube wall.<br>Filament insulation: Filament is moulded into<br>the bead. The bead provides thermal<br>insulation. | Consists of filament conductor.<br>Position in tube: Double helix wound<br>moulded into bead of tube wall.<br>Filament insulation: Filament is moulded into<br>the bead. The bead provides thermal<br>insulation. | Identical |
| Clips | Allows the breathing tube to be attached to<br>clothing or bedding and to position the tube<br>to suit the clinician and patient | Allows the breathing tube to be attached to<br>clothing or bedding and to position the tube<br>to suit the clinician and patient | Identical |
| Humidifier Compatibility | F&P MR850 Respiratory Humidifier | F&P AIRVO / AIRVO2 Series Humidifier<br>F&P myAIRVO / myAIRVO2 Series<br>Humidifier | Similar |
| Water Chamber<br>Compatibility | MR290V autofill chamber<br>• Single patient use only | 900PT290E auto fill chamber,<br>• Single patient use only<br>HC360 manual fill chamber,<br>• Single patient reuse | Identical |
| Patient Interface<br>Compatibility | HF Indication:<br>• Interface with 22 mm male connector<br>(ISO 5356) e.g. OPT944 Nasal<br>Cannula (K162553)<br>NIV Indication: | HF Indication:<br>• OPT942, OPT944, OPT946 Nasal<br>Cannula<br>• OPT970 Tracheostomy Direct<br>Connection<br>• OPT980 Mask Interface Adapter | Equivalent |
| Parameter | Subject Device<br>F&P 850A61 | Predicate Device<br>F&P AirSpiral Heated Breathing Tube<br>(K162553) | Comments |
| | Non-vented mask with 22 mm male connector (ISO 5356) and exhalation port e.g. RT045 Mask (K170367) Vented mask with 22 mm female connector (ISO 5366) e.g. RT047 Mask (K191624) All are single patient use only | OPT316, OPT318 Junior Nasal Cannula All are single patient use only | |
| <b>Performance</b> | | | |
| Flow Range | 10 – 120 L/min<br>HF (MR850 Invasive Mode):<br>10 – 60 L/min NIV (MR850 Mask Mode): 10 – 120 L/min | 2 – 60 L/min<br>Default Mode: 10 – 60 L/min Junior Mode: 2 – 5 L/min | The expanded flow rate<br>range of the subject device is<br>supported by the reference<br>device (K122432), which is<br>also indicated for use up to<br>120 L/min when used with<br>MR850. |
| Shelf Life | 2 Years | 5 Years | Both devices were<br>preconditioned using<br>equivalent methods to<br>simulate shelf life and<br>performance was verified<br>thereafter. |
| Useful Life | Single patient use – 14 days in Hospital /<br>Long-term care facilities | Single patient use – 14 days in Hospital /<br>Long-term care facilities | Identical |
| Humidity Delivery | Noninvasive Mode: > 12 mg/L<br>Invasive Mode: > 33 mg/L | Noninvasive indications: >12 mg/L Default and Junior modes Invasive indications: > 33 mg/L Default and Junior modes | Identical |

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| Technical Characteristic | Secondary Predicate Device<br>Philips Disposable Exhalation Port (K982454) | Subject Device<br>F&P Disposable Exhalation Port | Comments |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | This item is supplied as a component in a complete breathing system and supports the respective indications for use. | This item is supplied as a component in the circuit kit and supports the respective indications for use. | |
| Availability | Prescription only | Prescription only | |
| Patient Population | Adult | Adult | |
| Patient State | Spontaneously breathing | Spontaneously breathing | |
| Patient Monitoring | Appropriate patient monitoring | Appropriate patient monitoring | Identical |
| Operating Environment | Hospital and long-term care | Hospital and long-term care | |
| User Group | Respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician | Under the supervision of trained medical personnel | |
| Reusability | Single Patient Use | Single Patient Use | |
| Useful Life | - | 14 days | |
| Technical Specifications and Features | | | |
| Connection to interface | ISO 5356-1 Conical connectors (22mm male and 15mm female) | ISO 5356-1 Conical connectors (22mm male and 15mm female) | |
| Connection to circuit | ISO 5356-1 Conical connectors (22mm male) | ISO 5356-1 Conical connectors (22mm male) | Identical |
| Connection to pressure port | Compatible with 1/8" pressure line and port cap | Compatible with 1/8" pressure line and port cap | |
| Inhalation Path Diameter (min) | 15.2 mm | 15.2 mm | |
| Exhalation Port functional performance | >15 L/min @ 4 cmH2O | >15 L/min @ 4 cmH2O | Equivalent |
| Pressure port functional performance | 3 mL air volume | 3.5 mL air volume | Equivalent |
| Inhalation Path functional performance | 17% Tidal volume discrepancy | 13% Tidal volume discrepancy | Equivalent |
| Materials | | | |
| Materials | Polycarbonate | Polycarbonate | Identical |

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#### PERFORMANCE DATA VI.

# Summary of non-clinical tests

The F&P 850A61 has been tested to applicable requirements of the following standards:

| Standards and<br>Designation Number | Standards Title |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 80601-2-74:2017 | Medical electrical equipment - Part 2-74: Particular requirements for<br>basic safety and essential performance of respiratory humidifying<br>equipment |
| IEC 60601-<br>1:2005+AMD1:2012 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests |
| AIM 7351731 Rev<br>2.0:2017 | Medical Electrical Equipment and System Electromagnetic Immunity<br>Test for Exposure to Radio Frequency Identification Readers |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment - Conical connectors: Part 1:<br>Cones and sockets |
| ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and<br>connectors |
| IEC 60601-1-6 ed<br>3.1:2013 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Usability |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to<br>medical devices |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for<br>genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical<br>characterization of medical device materials within a risk<br>management process |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications - Part 1: Evaluation and testing within a risk<br>management process |
| ISTA 3A | Packaged Products for Parcel Delivery System Shipment 70 kg (150<br>lb) or Less |

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In addition to the standards listed above, the following testing has been completed to demonstrate substantial equivalence:

### Exhalation Port Equivalence:

A comparison of the flow rates through the exhalation port for the subject and predicate DEP was tested. Testing showed there is minimal difference in flow rate between the predicate and subject DEP at any of the pressures tested.

## Pressure Port Equivalence:

A comparison of the inspired volume required for the inspiration of a breath was performed using the subject and predicate DEP.

The comparative testing showed the tidal volumes of the subject DEP within 1 mL of the predicate DEP and can be considered to have an equivalent sensitivity to a breath being taken by the patient.

### Inhalation Path Equivalence:

A comparison of the tidal volumes delivered to the patient in relation to the volumes set on the ventilator showed the configurations using the subject DEP have a smaller tidal volume difference than those using the predicate DEP, and hence allow equivalent accuracy of delivery of therapy to the patient.

### Human Factors Evaluation

A Human Factors and Usability Engineering validation study was conducted, and documentation was provided as per FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". Validation study participants included 15 experienced, US Licensed Respiratory Therapists, and the report demonstrates that the critical tasks of the 850A61 breathing set can be completed by experienced respiratory therapists.

#### VII. CONCLUSIONS

The F&P 850A61 is substantially equivalent to the predicate device based on intended use, patient population, comparison of the technological characteristics and performance specifications. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.