(219 days)
OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.
However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (F&P Optiflow+ Duet Nasal Cannula) |
|---|---|---|
| Product Code | BTT (Same as predicate) | BTT |
| Device Classification | 21 CFR §868.5450 (Same as predicate) | 21 CFR §868.5450 |
| Classification Panel | Anesthesiology (Same as predicate) | Anesthesiology |
| Indications for Use (General Equivalence) | Equivalent to predicate | More specific than predicate, but within its scope |
| Availability | Prescription Use (Same as predicate) | Prescription Use |
| Patient Population | Pediatric (10+) to Adult (More specific than predicate) | Pediatric (10 years and up) to adult. |
| Patient Acuity | Spontaneously breathing (Same as predicate) | Spontaneously breathing patients. |
| Patient Monitoring | Appropriate monitoring required (Same as predicate) | Appropriate patient monitoring must be used at all times. |
| Use Environment | Home, Hospital, sub-acute, long-term care facilities | Home and Hospital environment, sub-acute facilities, long-term (managed) care facilities (OPT96X Series); Home and long-term (managed) care facilities (MYDUET Series) |
| Reusability | Single patient-use only, < 14 days in hospital, < 30 days in home/long-term | Single patient-use, < 14 days in hospital/sub-acute, < 30 days in home/long-term |
| Number of Cannula Sizes | Small, Medium, Large (Same as predicate) | Small, Medium, Large |
| Headgear Adjustment Method | Identical to predicate | Headstrap through slots on Headstrap Buckle |
| Size Identification Color Coding | Identical to predicate | Small: Orange; Medium: Blue; Large: Green |
| F&P Airvo 2 System Flow Range | Small: 10–50 L/min; Medium/Large: 10–60 L/min | OPT962 (Small): 10–50 L/min; OPT964 (Medium): 10–60 L/min; OPT966 (Large): 10–60 L/min |
| F&P Airvo 3 System Flow Range | Small: 10–60 L/min; Medium/Large: 10–70 L/min | OPT962 (Small): 10–60 L/min; OPT964 (Medium): 10–70 L/min; OPT966 (Large): 10–70 L/min |
| MR850 System Flow Range | All sizes: 5-60 L/min | OPT962 (Small): 5-60 L/min; OPT964 (Medium): 5-60 L/min; OPT966 (Large): 5-60 L/min |
| F&P 950 System Flow Range | (Predicate not cleared for this system) | OPT962 (Small): 5-70 L/min; OPT964 (Medium): 5-70 L/min; OPT966 (Large): 5-70 L/min |
| F&P myAirvo System Flow Range | Small: 10-50 L/min; Medium/Large: 10-60 L/min | MYDUETSMALL: 10-50 L/min; MYDUETMEDIUM: 10-60 L/min; MYDUETLARGE: 10-60 L/min |
| Shelf life | Not claimed on predicate labeling | 3 years |
| Transport and Storage Temperature Range | -10 °C to +50 °C | -10 °C to +50 °C |
| Sterility | Device not provided sterile | Device not provided sterile |
| Biocompatibility (ISO 10993-1:2018; ISO 18562-1:2017) | Compliance with standards | Tested to standards |
| Conical Connectors (ISO 5356-1:2015) | Compliance with standard | Tested to standard |
| Usability Engineering (IEC 62366-1:2015+A1:2020) | Compliance with standard | Tested to standard |
| Packaging Integrity (ISTA 2A:2011) | Compliance with standard | Tested to standard |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" or "sample size" in the context of an AI/ML study.
- The "testing" mentioned refers to non-clinical bench testing and compliance with recognized standards. For these types of tests, sample sizes would be determined by the specific standard's requirements for the particular test (e.g., number of devices for flow rate testing, number of samples for biocompatibility).
- Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a clinical data study for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The device is a physical medical device (nasal cannula), not an AI/ML algorithm requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable, as there is no "test set" adjudicated by experts for an AI/ML algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable in the context of an AI/ML device. For this physical device, "ground truth" would equate to established physical, chemical, and biological properties, and performance characteristics measured against industry standards.
8. The sample size for the training set:
- This information is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- This information is not applicable. This is not an AI/ML device.
In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (nasal cannula) demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with standards. It does not contain information related to AI/ML device acceptance criteria or studies.
{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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 7, 2024
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K231956
Trade/Device Name: F&P Optiflow+ Duet Nasal Cannula Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: February 6, 2024 Received: January 8, 2024
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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.
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director, Respiratory Devices Team DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,
{2}------------------------------------------------
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K231956
Device Name
F&P Optiflow+ Duet Nasal Cannula
Indications for Use (Describe)
OPT96X Model:
The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.
This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model:
The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.
This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
{4}------------------------------------------------
510(k) Summary
As Required by 21 CFR 807.92
| I.SUBMITTER | |
|---|---|
| Company Name and Address | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
| Prepared and Submitted by | Jung Yun LeeRegulatory Affairs Associate |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz |
| Date prepared | 30 June 2023 |
| II.DEVICE | |
| Name of Device | F&P Optiflow+ Duet Nasal Cannula |
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
III. PREDICATE DEVICE
- Predicate device: . o F&P Optiflow+ Nasal Cannula OPT94X, K162553
IV. DEVICE DESCRIPTION
The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients.
The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
{5}------------------------------------------------
A list of the subject device product codes can be found below:
| Model | Product Code | Product Description |
|---|---|---|
| OPT96XThis device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. | OPT962 | Nasal Cannula - Small |
| OPT964 | Nasal Cannula - Medium | |
| OPT966 | Nasal Cannula - Large | |
| MYDUETXXXThis device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. | MYDUETSMALL | myAirvo Small Duet Nasal Cannula 2-pack |
| MYDUETMEDIUM | myAirvo Medium Duet Nasal Cannula 2-pack | |
| MYDUETLARGE | myAirvo Large Duet Nasal Cannula 2-pack |
V. INDICATIONS FOR USE
The indications for use for the OPT96X Model and the MYDUETXXX Model are below:
OPT96X Model:
The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.
This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model:
The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.
This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
{6}------------------------------------------------
| Design/TechnologicalCharacteristic | Subject Device(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)(F&P Optiflow+ Nasal Cannula,OPT94X) | Comments |
|---|---|---|---|
| Classification | |||
| Product Code | BTT | BTT | |
| Device Classification | 21 CFR §868.5450 | 21 CFR §868.5450 | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | |
| Indications for use | |||
| Indications for use | OPT96X ModelThe F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed | Nasal cannula patient interface for delivery of humidified respiratory gases. | The Indications for Use statement for the subject device is more specific than the predicate device.Target population and operating environment have been defined for the subject devices, for clarity. |
| Design/TechnologicalCharacteristic | Subject Device(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)(F&P Optiflow+ Nasal Cannula,OPT94X) | Comments |
| MYDUETXXX ModelThe F&P Optiflow+ Duet is a nasal cannulapatient interface for use with specifiedrespiratory gas humidifiers to treatspontaneously breathing pediatric (10 yearsand up) and adult patients who wouldbenefit from receiving high flow warmedand humidified respiratory gases to theupper airway. | |||
| This device is designed to be used in a long-term care facility by appropriately qualifiedhealthcare professionals, or in the home bylay users operating the device as prescribedby a healthcare professional. | |||
| Availability | Prescription use.(Part 21 CFR 801 Subpart D) | Prescription use.(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Pediatric (10 years and up) to adult. | Mainly Adult Patients. | Patient population for the subject deviceis more specific than the predicate device. |
| Patient Acuity | Spontaneously breathing patients. | Spontaneously breathing patients. | Identical |
| Patient Monitoring | Appropriate patient monitoring must beused at all times. | Appropriate patient monitoring must beused at all times. | Identical |
| Use Environment | OPT96X Series:Home and Hospital environment, sub-acute | Home and Hospital environment, long-term(managed) care facilities | The addition of sub-acute facilities doesnot affect / change the user group andIdentical |
| Design/TechnologicalCharacteristic | Subject Device(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)(F&P Optiflow+ Nasal Cannula,OPT94X) | Comments |
| facilities, long-term (managed) carefacilities | patient population compared to thepredicate. | ||
| MYDUET Series:Home and long-term (managed) carefacilities | |||
| Reusability | Single patient-use only, < 14 days inhospital, including sub-acute facilities | Single patient-use only, < 14 days inhospital | Identical |
| Single patient-use only, < 30 days in home,and long-term care facilities | Single patient-use only, < 30 days in homeand long-term care facilities | ||
| Number of CannulaSizes | Both Hospital and Home models areavailable in:SmallMediumLarge | Both Hospital and Home models areavailable in:SmallMediumLarge | Identical |
| Compatibility with other devices | |||
| HumidifierCompatibility | Airvo 2 and myAirvo 2 (K131895)Airvo 3 (K221338)MR850 humidifier (K110019)F&P 950 Respiratory Humidifier(K220703) | Airvo 2 and myAirvo 2 (K131895)MR850 humidifier (K110019) | The predicate was not cleared for usewith the Airvo 3 or the F&P 950 System. |
| Design/TechnologicalCharacteristic | Subject Device(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)(F&P Optiflow+ Nasal Cannula,OPT94X) | Comments |
| Nasal Cannula Design | |||
| Overall CannulaConstruction | The F&P Optiflow+ Duet Nasal Cannula ismade up of two sub-assemblies that connectto the Nasal Prong component. | The F&P Optiflow+ Nasal Cannula is madeup of two sub-assemblies that connect to theNasal Prong component. | Identical |
| The two sub-assemblies are: | The two sub-assemblies are: | ||
| Tubing sub-assembly Headgear sub-assembly | Tubing sub-assembly Headgear sub-assembly | ||
| Headgear Adjustment | The headgear size adjustment (i.e. headstraplength and tightness adjustment) methodcomprises of the Headstrap componentlooping through (and being retained by) twoslots on the Headstrap Buckle component. | The headgear size adjustment (i.e. headstraplength and tightness adjustment) methodcomprises of the Headstrap componentlooping through (and being retained by) twoslots on the Headstrap Buckle component. | Identical |
| Size Identification ColorCoding | Size Small: OrangeSize Medium: BlueSize Large: Green | Size Small: OrangeSize Medium: BlueSize Large: Green | Identical |
| Performance Specifications | |||
| F&P Airvo 2 SystemFlow Range | OPT962 (Small) 10 – 50 L/minOPT964 (Medium) 10 – 60 L/minOPT966 (Large) 10 – 60 L/min | OPT942 (Small) 10 – 50 L/minOPT944 (Medium) 10 – 60 L/minOPT946 (Large) 10 – 60 L/min | Identical |
| F&P Airvo 3 SystemFlow Range | OPT962 (Small) 10 – 60 L/minOPT964 (Medium) 10 – 70 L/minOPT966 (Large) 10 – 70 L/min | OPT942 (Small) 10 – 60 L/minOPT944 (Medium) 10 – 70 L/minOPT946 (Large) 10 – 70 L/min | Identical |
| Design/TechnologicalCharacteristic | Subject Device(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)(F&P Optiflow+ Nasal Cannula,OPT94X) | Comments |
| MR850 System FlowRange | OPT962 (Small) 5 - 60 L/minOPT964 (Medium) 5-60 L/minOPT966 (Large) 5 - 60 L/min | OPT942 (Small) 5 - 60 L/minOPT944 (Medium) 5-60 L/minOPT946 (Large) 5 - 60 L/min | Identical |
| F&P 950 System FlowRange | OPT962 (Small) 5 - 70 L/minOPT964 (Medium) 5 - 70 L/minOPT966 (Large) 5 - 70 L/min | N/A | The predicate was not cleared for usewith the F&P 950 System. |
| F&P myAirvo SystemFlow Range | MYDUETSMALL 10-50 L/minMYDUETMEDIUM 10-60 L/minMYDUETLARGE 10-60 L/min | OPT942E (Small) 10-50 L/minOPT944E (Medium) 10-60 L/minOPT946E (Large) 10-60 L/min | Identical |
| Shelf life | 3 years | Shelf life not claimed on labeling | The subject device claims a 3-year shelflife. |
| Transport and StorageTemperature range | -10 °C to +50 °C | -10 °C to +50 °C | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVIC VI.
ison of features, performance data, and intended use demonstrate that the F&P Solo Mask Range is substantially equivals The com
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
The F&P Optiflow+ Duet Nasal Cannula has been tested to applicable requirements to the following standards:
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing 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
- ISO 5356-1:2015 Anesthetic and respiratory equipment Conical connectors: Part 1: ● Cones and sockets
- IEC 62366-1:2015+A1:2020 Medical devices Application of usability engineering to . medical devices
- ISTA 2A:2011 International Safety Transit Association Guidelines Procedure 2A: . Packaged-Products weighing 150 lb (68 kg) or less
VIII. CONCLUSIONS
The F&P Optiflow+ Duet Nasal Cannula is substantially equivalent to the predicate based on patient population, intended uses, comparison of the technological characteristics, and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.
§ 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).