(297 days)
No
The description focuses on the physical components and function of a breathing circuit for delivering heated, humidified gases. There is no mention of AI/ML in the intended use, device description, or performance studies.
No.
This device delivers heated, humidified breathing gases for spontaneously breathing patients but does not treat a disease or condition itself; it is an accessory to respiratory support equipment.
No
The device is a breathing circuit designed to deliver heated, humidified gases for respiratory support, not to diagnose a condition.
No
The device description clearly outlines physical components like an extruded bubble tube, temperature sensor clips, a gown clip, and an optional disposable exhalation port, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of heated, humidified breathing gases to spontaneously breathing adult patients." This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as a "gas conduit between respiratory support equipment and a patient interface." This further reinforces its role in delivering gases, not analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on functional performance related to gas delivery and pressure, as well as human factors, not diagnostic accuracy metrics like sensitivity, specificity, or AUC in the context of diagnosing a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to facilitate respiratory support, which is a treatment or supportive therapy.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Intended User: Respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician (for predicate exhalation port); Under the supervision of trained medical personnel (for subject exhalation port).
Care Setting: Hospital and long-term care environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | ||
|---|---|---|
| Reproductive Use (Part 21 CFR 321 Subpart D) Source Tissue Use (21 CFR 1271 Subpart C) | Reproductive Use (Part 21 CFR 321 Subpart D) | Source Tissue Use (21 CFR 1271 Subpart C) |
| Reproductive Use (Part 21 CFR 321 Subpart D) | 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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3
510(k) Summary
As Required by 21 CFR 807.92
I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Nicholas Yap
Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| 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 | |
| Breathing Circuit | K122432 | |
| • Used to support claims of | ||
| substantial equivalence with respect | ||
| to performance and system |
compatibility
4
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.
5
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
F&P 850A61 | Predicate Device
F&P AirSpiral Heated Breathing Tube
(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
humidified respiratory gases | Heated breathing tube for delivery of
humidified respiratory gases | Identical |
| Indications for 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. | Heated breathing tube for delivery of
humidified respiratory gases. For use with
AIRVO and AIRVO2 Series humidifiers in
hospitals and long-term care facilities. For
use at flows from 2 to 60 L/min depending on
the patient interface. | Equivalent |
| Availability | Prescription use
(Part 21 CFR 801 Subpart D) | Prescription use
(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Spontaneously breathing adult patients
requiring flows between 10 – 120 L/min
depending on the required therapy and
patient interface. | Spontaneously breathing patient requiring
flows between 2 - 60 L/min. | Equivalent |
| Parameter | Subject Device
F&P 850A61 | Predicate Device
F&P AirSpiral Heated Breathing Tube
(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
Sustaining | No | No | Identical |
| Operation and Safety Features | | | |
| Principle of Operation | Connects to a humidifier. Powered by the
humidifier to maintain heat as a conduit for
humidified heated respiratory gases.
Connects the humidifier to the patient
interface. | Connects to a humidifier. Powered by the
humidifier to maintain heat as a conduit for
humidified heated respiratory gases.
Connects the humidifier to the patient
interface. | Identical |
| Tube Dimensions | Length: 1.6 m
Internal Diameter: 17 mm | Length: 1.8 m
Internal Diameter: 13.1 mm | Equivalent |
| Design of the Tube
Construction | Heated tube to transport humidified gas
between the humidification chamber and the
Patient End
Two-spiral wall tubing design:
Insulating spiral made of Spiral-wound
bubble tubingHeating spiral encapsulating heater wire | Heated tube to transport humidified gas
between the Unit End and the Patient End
Two-spiral wall tubing design:
Insulating spiral made of Spiral-wound
bubble tubingHeating spiral encapsulating heater wire | Identical |
| Temperature Sensor | A removable temperature and flow sensor
are used at the humidification chamber outlet
port which is an accessory to the F&P
MR850 humidifier. | An integrated temperature sensor at the
patient end of the tube eliminates the need
for external probes, cables or adaptors. | Similar |
| Parameter | Subject Device
F&P 850A61 | Predicate Device
F&P AirSpiral Heated Breathing Tube
(K162553) | Comments |
| | A removable temperature sensor is used at
the patient end port which is an accessory to
the F&P MR850 humidifier. | | |
| Heater Wire Lumen Design | Consists of filament conductor.
Position in tube: Double helix wound
moulded into bead of tube wall.
Filament insulation: Filament is moulded into
the bead. The bead provides thermal
insulation. | Consists of filament conductor.
Position in tube: Double helix wound
moulded into bead of tube wall.
Filament insulation: Filament is moulded into
the bead. The bead provides thermal
insulation. | Identical |
| Clips | Allows the breathing tube to be attached to
clothing or bedding and to position the tube
to suit the clinician and patient | Allows the breathing tube to be attached to
clothing or bedding and to position the tube
to suit the clinician and patient | Identical |
| Humidifier Compatibility | F&P MR850 Respiratory Humidifier | F&P AIRVO / AIRVO2 Series Humidifier
F&P myAIRVO / myAIRVO2 Series
Humidifier | Similar |
| Water Chamber
Compatibility | MR290V autofill chamber
• Single patient use only | 900PT290E auto fill chamber,
• Single patient use only
HC360 manual fill chamber,
• Single patient reuse | Identical |
| Patient Interface
Compatibility | HF Indication:
• Interface with 22 mm male connector
(ISO 5356) e.g. OPT944 Nasal
Cannula (K162553)
NIV Indication: | HF Indication:
• OPT942, OPT944, OPT946 Nasal
Cannula
• OPT970 Tracheostomy Direct
Connection
• OPT980 Mask Interface Adapter | Equivalent |
| Parameter | Subject Device
F&P 850A61 | Predicate Device
F&P AirSpiral Heated Breathing Tube
(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 | |
| Performance | | | |
| Flow Range | 10 – 120 L/min
HF (MR850 Invasive Mode):
10 – 60 L/min NIV (MR850 Mask Mode): 10 – 120 L/min | 2 – 60 L/min
Default Mode: 10 – 60 L/min Junior Mode: 2 – 5 L/min | The expanded flow rate
range of the subject device is
supported by the reference
device (K122432), which is
also indicated for use up to
120 L/min when used with
MR850. |
| Shelf Life | 2 Years | 5 Years | Both devices were
preconditioned using
equivalent methods to
simulate shelf life and
performance was verified
thereafter. |
| Useful Life | Single patient use – 14 days in Hospital /
Long-term care facilities | Single patient use – 14 days in Hospital /
Long-term care facilities | Identical |
| Humidity Delivery | Noninvasive Mode: > 12 mg/L
Invasive Mode: > 33 mg/L | Noninvasive indications: >12 mg/L Default and Junior modes Invasive indications: > 33 mg/L Default and Junior modes | Identical |
6
7
8
9
| Technical Characteristic | Secondary Predicate Device
Philips Disposable Exhalation Port (K982454) | Subject Device
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 |
10
PERFORMANCE DATA VI.
Summary of non-clinical tests
The F&P 850A61 has been tested to applicable requirements of the following standards:
| Standards and
| Designation Number | Standards Title |
|---|---|
| ISO 80601-2-74:2017 | Medical electrical equipment - Part 2-74: Particular requirements for |
| basic safety and essential performance of respiratory humidifying | |
| equipment | |
| IEC 60601- | |
| 1:2005+AMD1:2012 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| AIM 7351731 Rev | |
| 2.0:2017 | Medical Electrical Equipment and System Electromagnetic Immunity |
| Test for Exposure to Radio Frequency Identification Readers | |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment - Conical connectors: Part 1: |
| Cones and sockets | |
| ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and |
| connectors | |
| IEC 60601-1-6 ed | |
| 3.1:2013 | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Usability | |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to |
| medical devices | |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for |
| genotoxicity, carcinogenicity and reproductive toxicity | |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical |
| characterization of medical device materials within a risk | |
| management process | |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - Part 1: Evaluation and testing within a risk | |
| management process | |
| ISTA 3A | Packaged Products for Parcel Delivery System Shipment 70 kg (150 |
| lb) or Less |
11
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.