(258 days)
Not Found
No
The summary describes a physical medical device (nasal cannula) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients, which is a therapeutic intervention.
No
The device is a nasal cannula used for delivering Nasal High Flow (NHF) therapy. It is clearly described as a therapy delivery device, not for diagnosis.
No
The device description clearly states it is a physical nasal cannula interface made of hardware components, not software.
Based on the provided information, the F&P Optiflow™ 3S nasal cannula is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients using specified respiratory gas humidifiers. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a nasal cannula interface for delivering gases. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely related to delivering respiratory support.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The F&P Optiflow™ 3S nasal cannula does not fit this description.
N/A
Intended Use / Indications for Use
The F&P Optiflow™ 3S nasal cannula is a 14 day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients. This product is designed to be used by appropriately qualified healthcare professionals in a hospital / institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The F&P Optiflow™ 3S Nasal Cannula is intended to be used in a hospital / institutional environment. A dual 22 mm male ISO taper and AIRVO™ specific connector allows connection to breathing circuits to receive humidified breathing gases from F&P 850™ and AIRVO™ systems. The F&P Optiflow™ 3S Nasal Cannula is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ 3S Nasal Cannula is a prescription only device, provided in a nonsterile state.
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 patients
Intended User / Care Setting
appropriately qualified healthcare professionals in a hospital / institutional environment.
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)
Performance testing of the F&P Optiflow™ 3S Nasal Cannula was completed to demonstrate substantial equivalence of the F&P Optiflow™ 3S Nasal Cannula to the predicate device.
- Shelf life simulation was based on ASTM F1980-07, ISO 11607-1:2006/A1 2014 and ISO . 291:2008(E).
- . Transportation simulation was based on ISTA 2A Packaged-Products weighing 150lb (68kg) or less.
- Relevant Humidification Output and Thermal Overshoot testing. .
- Gas path and headgear joint and connection strength testing following selected pre-conditioning . intended to simulate worst case life scenarios.
- . Gas path leak testing following selected pre-conditioning intended to simulate worst case life scenarios.
- . 24-hour maximum accumulated and emitted condensation testing intended to simulate worst case.
The F&P Optiflow™ 3S Nasal Cannula has been tested to applicable requirements of the following standards: - ISO 5356-1:2015 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones . and sockets
Biocompatibility testing:
- ISO 10993-1:2009, 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 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- . ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- ISO 10993-12:2012, Biological evaluation of medical devices Part 12: Sample preparation and ● reference material
- ISO 10993-17:2002, Biological evaluation of medical devices Part 17: Establishment of . allowable limits for leachable substances
- . ISO 10993-18:2005, Biological evaluation of medical devices - Part 18: chemical characterization of materials
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications, Part 1: Evaluation and testing within a risk management process
- . ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 2: Tests for emissions of particulate matter
- ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare ● applications, Part 3: Tests for emissions of volatile organic compounds (VOCs)
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.
F&P Optiflow+ Nasal Cannula – K162553
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.
Not Found
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). On the left is the Department of Health & Human Services USA seal. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 19, 2020
Fisher & Paykel Healthcare Ltd Reena Daken Senior Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K191818
Trade/Device Name: F&P Optiflow 3S Nasal Cannula Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: February 14, 2020 Received: February18 , 2020
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, 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) K191818
Device Name F&P Optiflow 3S Nasal Cannula
Indications for Use (Describe)
The F&P Optiflow™™ 3S nasal cannula is a 14 day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients. This product is designed to be used by appropriately qualified healthcare professionals in a hospital / institutional environment.
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) |
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510(k) Summary
| Date prepared | 18 March 2020 |
|---|---|
| Company Name and Address | Fisher and Paykel Healthcare |
| 15 Maurice Paykel Place, East Tamaki, | |
| Auckland 2013, | |
| New Zealand | |
| Submitter | Masar Mohammad |
| Contact Person | Reena Daken |
| Senior Regulatory Affairs Specialist | |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0158 | |
| Reena.Daken@fphcare.co.nz | |
| Trade name | F&P OptiflowTM 3S Nasal Cannula |
| Common name | Nasal Cannula |
| Classification name | Respiratory Gas Humidifier (accessory to) |
| Class II (21 CFR §868.5450 | |
| Product Code BTT (Anaesthesiology) | |
| Predicate Device | F&P Optiflow+ Nasal Cannula – K162553 |
Device Description
The F&P Optiflow™ 3S Nasal Cannula is intended to be used in a hospital / institutional environment. A dual 22 mm male ISO taper and AIRVO™ specific connector allows connection to breathing circuits to receive humidified breathing gases from F&P 850™ and AIRVO™ systems. The F&P Optiflow™ 3S Nasal Cannula is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ 3S Nasal Cannula is a prescription only device, provided in a nonsterile state.
4
Indications for Use Statement
The F&P Optiflow™ 3S nasal cannula is a 14 day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) therapy to spontaneously breathing adult patients. This product is designed to be used by appropriately qualified healthcare professionals in a hospital / institutional environment.
Non-Clinical Performance Data
Performance Testing
Performance testing of the F&P Optiflow™ 3S Nasal Cannula was completed to demonstrate substantial equivalence of the F&P Optiflow™ 3S Nasal Cannula to the predicate device.
- Shelf life simulation was based on ASTM F1980-07, ISO 11607-1:2006/A1 2014 and ISO . 291:2008(E).
- . Transportation simulation was based on ISTA 2A Packaged-Products weighing 150lb (68kg) or less.
- Relevant Humidification Output and Thermal Overshoot testing. .
- Gas path and headgear joint and connection strength testing following selected pre-conditioning . intended to simulate worst case life scenarios.
- . Gas path leak testing following selected pre-conditioning intended to simulate worst case life scenarios.
- . 24-hour maximum accumulated and emitted condensation testing intended to simulate worst case.
The F&P Optiflow™ 3S Nasal Cannula has been tested to applicable requirements of the following standards:
- ISO 5356-1:2015 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones . and sockets
Biocompatibilitv
- ISO 10993-1:2009, 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 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- . ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- ISO 10993-12:2012, Biological evaluation of medical devices Part 12: Sample preparation and ● reference material
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- ISO 10993-17:2002, Biological evaluation of medical devices Part 17: Establishment of . allowable limits for leachable substances
- . ISO 10993-18:2005, Biological evaluation of medical devices - Part 18: chemical characterization of materials
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications, Part 1: Evaluation and testing within a risk management process
- . ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 2: Tests for emissions of particulate matter
- ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare ● applications, Part 3: Tests for emissions of volatile organic compounds (VOCs)
Technological Characteristics Comparison
A comparison of the F&P Optiflow™ 3S Nasal Cannula and the predicate device is provided in table below.
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| Subject Device | Predicate Device | Comments | ||
|---|---|---|---|---|
| F&P Optiflow 3S Nasal Cannula | F&P Optiflow+ Nasal Cannula | |||
| Intended use / Indications for use | Intended Use / | |||
| Indications for Use | The F&P Optiflow™ 3S nasal cannula is a | |||
| 14 day single use nasal cannula interface | ||||
| for use with specified respiratory gas | ||||
| humidifiers to deliver Nasal High Flow | ||||
| (NHF) therapy to spontaneously breathing | ||||
| adult patients. This product is designed to | ||||
| be used by appropriately qualified | ||||
| healthcare professionals in a hospital / | ||||
| institutional environment. | Nasal cannula patient interface for delivery | |||
| of humidified respiratory gases. | The Intended Use / Indications for Use | |||
| statement for the subject device is more | ||||
| specific than the predicate device. | ||||
| Availability | Prescription use. | |||
| (Part 21 CFR 801 Subpart D) | Prescription use. | |||
| (Part 21 CFR 801 Subpart D) | Identical. | |||
| Patient Population | Adult patients. | Adult patients. | Identical. | |
| Operating | ||||
| Environment | Hospital environment. | Home or hospital environment. | Similar. | |
| The Operating Environment for the subject | ||||
| device is a subset of the predicate device | ||||
| Reusability | Single patient use only, |