(266 days)
No
The summary describes a physical device for delivering respiratory gases and sampling CO2. There is no mention of AI, ML, or any software-based analysis or decision-making capabilities.
Yes.
The device delivers respiratory gases to adult patients, including Nasal High Flow (NHF) and Low Flow Oxygen, and can be used for pre-oxygenation and short-term supplemental oxygenation, all of which are therapeutic interventions.
No
Explanation: While the device can perform "qualitative carbon dioxide sampling," its primary purpose, as stated in "Intended Use / Indications for Use" and "Device Description," is to deliver respiratory gases. The CO2 sampling is a secondary function used for monitoring, not for primary diagnosis of a condition. The sampling is used "at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms" and "for pre-oxygenation and short-term supplemental oxygenation...during intubation," which are procedural tasks rather than diagnostic ones.
No
The device description clearly states it is a "medical device intended to deliver respiratory gases" and describes physical components like a "Nasal Oxygen Cannula with CO2 Sampling" and "CO2 sampling accessory." This indicates a hardware component is central to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the delivery of respiratory gases (Nasal High Flow and Low Flow Oxygen) to patients. While it includes a CO2 sampling feature, this is for monitoring exhaled gases from the patient's body, not for testing a sample in vitro (outside the body).
- Device Description: The description focuses on delivering gases and sampling exhaled gases. It doesn't mention analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any of the typical components or processes associated with in vitro diagnostic testing.
- Clinical Performance Data: The submission explicitly states that clinical performance data was not relied upon to demonstrate substantial equivalence. IVD submissions typically rely heavily on clinical performance data to validate the accuracy and reliability of the diagnostic test.
- Predicate Devices: The predicate and reference devices are also respiratory support devices, not IVDs.
The CO2 sampling feature is for monitoring a physiological parameter (exhaled CO2) directly from the patient, which falls under the category of patient monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and long-term care facilities.
This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals.
Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a medical device intended to deliver respiratory gases to the patient and provide a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer. The device is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a prescription only device, provided in a non-sterile 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.
Hospitals and long-term care facilities.
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™ Nasal Oxygen Cannula with CO2 Sampling was completed to determine that the differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling to the predicate device.
- Shelf life testing was performed following accelerated aging conditioning as per ASTM F1980-16 to demonstrate product requirements continue to be met after 18 months of storage.
- Transportation testing was performed following transportation to ISTA 2A:2011 Packaged-Products 150 lbs (68 kgs) or Less.
- The following additional performance testing has also been completed to confirm the safety and effectiveness of the Optiflow™ Nasal Oxygen Cannula with CO2 Sampling:
- Nasal Cannula Leak Test
- CO2 Sampling Tube Leak Test
- Resistance to flow of the CO2 Sampling Tube
- Resistance to flow during compression of the CO2 Sampling Tube
- Testing was performed to ensure functional requirements were met after transport, storage, and simulated use conditioning.
- Strength testing of CO2 Sampling Tube's permanent connections after transport, storage, and simulated use conditioning.
- Testing to validate the device's CO2 Sampling functionality
- Usability testing conducted on the use of the CO2 Sampling feature and the warnings and directions for use related to the CO2 Sampling feature only.
The Optiflow™ Nasal Oxygen Cannula with CO2 Sampling has been tested to applicable requirements of the following standards:
- ISO 594-2. "Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings".
- ISO 5356-1:2004 "Anesthetic and Respiratory Equipment- Conical Connectors- Part 1: Cones and Sockets".
- ISO 5361:2012 "Anesthetic and Respiratory Equipment-Tracheal tubes and connectors"
- ISO 10993-1 Fifth Edition 2018-08 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process".
- ISO 18562-1 First Edition 2017-03, "Biocompatibility evaluation of breathing gas pathways in healthcare applications- Part 1: Evaluation and testing within a risk management process".
Clinical performance data has not been relied upon in this marketing submission to demonstrate substantial equivalence between the subject and predicate devices.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 16, 2021
Fisher & Paykel Healthcare Ltd. Reena Daken Senior Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K201723
Trade/Device Name: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: February 12, 2021 Received: February 16, 2021
Dear Reena Daken:
We have reviewed vour 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 (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,
Todd Courtney 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) K201723
Device Name
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
Indications for Use (Describe)
This product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and long-term care facilities.
This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals.
Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
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
As Required by 21 CFR 807.92(c)
l. 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 | Amelia Ortiz Rios
Senior Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Market Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 16 March 2021 |
II. DEVICE
| Name of Device | F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling |
|---|---|
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory gas humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
PREDICATE DEVICE lll.
- Predicate device: ●
- K162553 F&P Optiflow™+ Nasal Cannula o
- . Reference device:
- K162343 Westmed Gas Sampling Cannula with O2 Delivery o
IV. DEVICE DESCRIPTION
The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a medical device intended to deliver respiratory gases to the patient and provide a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer. The device is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a prescription only device, provided in a non-sterile state.
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Principle of Operation
The subject device is an interface which delivers respiratory gases to the patient from a humidification system or a flow meter. The internal diameter of the tube and the geometry of the manifold, gas path connector and nasal prongs have been designed to reduce turbulent flow, allowing it to deliver respiratory gas at both low and high flows.
The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling may be connected to breathing circuits and a humidifier or it may also be used with a flow meter, such as, the Compensated Thorpe Tube Flowmeter. the Nasal Oxygen Cannula may be connected to breathing circuits through a male medical taper connector as per ISO 5356-1:2015 'Anaesthetic and respiratory equipment – Conical connectors - Part 1: Cones and sockets'.
The nasal cannula delivers respiratory gases from the inspiratory tube to the patient. The nasal cannula is fitted onto the patient and attached to the inspiratory tube using the above connector. The CO2 sampling component connects to a commercially available carbon dioxide sampling line (not included with this product) and is fitted on the patient to sample exhaled gas from either the nares, or mouth.
INDICATIONS FOR USE V.
This product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and long-term care facilities.
This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals.
Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Design/technological | Subject device | Predicate device | Rationale for Substantial Equivalence |
|---|---|---|---|
| characteristic for | F& P Optiflow™ Nasal Oxygen | F&P Optiflow™+ Nasal Cannula | |
| comparison | Cannula with CO2 Sampling | ||
| Indications for Use | This product is a single-patient-use | ||
| device that delivers respiratory gases to | |||
| adult patients in hospitals and long-term | |||
| care facilities. | |||
| This product is indicated for the delivery | |||
| of Nasal High Flow (NHF) and Low Flow | |||
| Oxygen to spontaneously breathing | |||
| patients by appropriately qualified | |||
| healthcare professionals. | |||
| Qualitative carbon dioxide sampling can | |||
| be used at nasal cannula flow rates from | |||
| 5 to 50 L/min in operating and procedure | |||
| rooms. | |||
| This product can be used for pre- | |||
| oxygenation and short-term | |||
| supplemental oxygenation (up to 10 | |||
| minutes) during intubation in operating | |||
| rooms under the direction of a physician | |||
| anesthesiologist. | |||
| This product is not intended for apneic | |||
| ventilation. | Nasal cannula patient interface for | ||
| delivery of humidified respiratory gases. | Equivalent | ||
| The intended uses are equivalent. | |||
| The subject and predicate devices are both | |||
| intended to deliver high flow humidified | |||
| respiratory gases. | |||
| The subject device has a carbon dioxide | |||
| sampling functionality which is supported | |||
| through performance testing as per the | |||
| reference device, K162343. | |||
| Availability | Prescription use. | ||
| (Part 21 CFR 801 Subpart D) | Prescription use. | ||
| (Part 21 CFR 801 Subpart D) | Identical. | ||
| Patient Population | Adult patients. | Mainly adult patients. | Equivalent. |
| Patient population for the subject device is a | |||
| subset of the patient population of the predicate | |||
| device. | |||
| Operating | |||
| Environment | Hospitals and long term care facilities. | Hospitals and long term care facilities. | Identical. |
| Reusability and | |||
| Duration of Use | Single patient use only for a maximum | ||
| period of 24 hours. | Single patient use only, |