(195 days)
Not Found
No
The device description and intended use focus on the physical components and function of a breathing set accessory for a humidifier, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an accessory to a respiratory humidifier and is intended for the delivery of heated humidified high-flow respiratory gases to adult patients in a hospital setting for therapeutic purposes.
No
Explanation: The device is described as an accessory for a respiratory humidifier intended for the delivery of heated humidified high flow respiratory gases. Its purpose is to deliver treatment, not to diagnose a condition.
No
The device description explicitly lists physical components like a dry line, water bag, humidification chamber, inspiratory limb, tubing clips, and datechange stickers. It also describes the flow of gas through these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of heated humidified high flow respiratory gases to adult patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a breathing set accessory for a respiratory humidifier. It facilitates the delivery of gases to the patient's airway. This is a medical device used for treatment, not for examining specimens from the body to diagnose conditions.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for diagnosis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on delivering respiratory support directly to the patient.
N/A
Intended Use / Indications for Use
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.
The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.
The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.
The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.
The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airway via the nose
Indicated Patient Age Range
adult patients
Intended User / Care Setting
appropriately qualified healthcare professionals who perform anesthesia care and airway management / hospital
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™ Oxygen Kit was completed and confirms the subject device does not raise new questions of safety and effectiveness. The testing provided demonstrates that the reusability characteristic and environment of use of the subject device is substantially equivalent to the predicates.
The F&P Optiflow™ Oxygen Kit has been tested to the 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 80601-2-74:2017 Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- ISO 5367:2014
- AAMI TIR12:2010
- AAMI ST98:2022
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2024
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K233821
Trade/Device Name: F&P Optiflow Oxygen Kit (AA451J) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: May 29, 2024 Received: May 29, 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.
1
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" (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 QS 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 DHT1C: Division of Sleep Disordered Breathing, Respiratory and
2
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
3
Indications for Use
510(k) Number (if known) K233821
Device Name F&P Optiflow Oxygen Kit (AA451J)
Indications for Use (Describe)
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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 | Danica Tung |
| | Regulatory Affairs Market Manager |
| Contact Person | Reena Daken |
| | Regulatory Affairs Manager |
| | Telephone: +64 9 574 0100 |
| | Email: reena.daken@fphcare.co.nz |
| Date Prepared | 13 June 2024 |
| II. DEVICE | |
| Name of Device | F&P Optiflow™ Oxygen Kit (AA451J) |
| Common/Usual Name | Inspiratory tube |
| Classification Name | Respiratory gas humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
PREDICATE DEVICE lll.
- Primary Predicate Device: Optiflow™ Oxygen Kit, K211096 .
- Secondary Predicate: F&P 950 Respiratory Humidifier, K220703
5
DEVICE DESCRIPTION IV.
The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.
The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.
The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.
The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.
The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.
INDICATIONS FOR USE V.
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
6
COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.
| Design/Technological
Characteristic | Subject Device
(AA451J - K233821) | Primary Predicate Device
(AA403 - K211096) | Secondary Predicate Device
(AA451SU - K220703) | Similarity of subject
device to
primary/secondary
predicate device |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This breathing set is an accessory to the
F&P 950 Respiratory Humidifier to be used
within the limits of its stated technical
specifications.
It is intended for delivery of heated humidified
high flow respiratory gases to adult patients in
a hospital.
This product can be used on multiple patients
when used with a hydrophobic filter between
the product and the patient interface for a
maximum of 24 hours after setup.
This product is for use by appropriately
qualified healthcare professionals who perform
anesthesia care and airway management. | This product delivers respiratory gases to
adult patients. It is intended for use with an
MR810 humidifier at flows from 5 to 70
L/min.
This product can be used on multiple
patients when used with a hydrophobic filter
between the product and the patient interface
for a maximum of 24 hours after set-up.
This product is indicated for the delivery of
Nasal High Flow (NHF) by appropriately
qualified healthcare professionals under the
direction of a physician anesthesiologist in a
medical procedure or surgical room.
Qualitative carbon dioxide sampling can be
used at nasal cannula flow rates from 5 to 50
L/min.
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. | The breathing set is an accessory to the
F&P 950 Respiratory Humidifier. It is
intended for delivery of heated humidified
respiratory gases to adult, adolescent and
child patients, within the limits of its stated
technical specifications. | Equivalent.
The subject device and
the predicate devices are
intended for use with
humidifiers.
The primary predicate is
intended for use with the
MR810 humidifier,
whereas the subject
device is intended for use
with the F&P 950
humidifier.
The subject device and
secondary predicate are
both intended for use
with the F&P 950
humidifier. |
| Design/Technological
Characteristic | Subject Device
(AA451J - K233821) | Primary Predicate Device
(AA403 - K211096) | Secondary Predicate Device
(AA451SU - K220703) | Similarity of subject
device to
primary/secondary
predicate device |
| Operation and safety features | | | | |
| Patient Population | Adult patients | Adult patients | Adult, adolescent and child patients | Identical to primary
predicate |
| Intended Use
Environment | Hospitals | Hospitals | Hospital or long-term care facility | Identical to primary
predicate |
| Availability | Prescription use | Prescription Use | Prescription use | Identical |
| Operating Principle | Breathing circuit kit contains a dryline,
humidification chamber, and inspiratory limb
to create a single limb for the delivery of high
flow therapy. | Breathing circuit kit contains a dryline,
humidification chamber, and inspiratory
limb to create a single limb for the delivery
of high flow therapy. | Breathing circuit kit contains a dryline,
humidification chamber, and inspiratory
limb to create a single limb for the delivery
of high flow therapy. | Identical |
| Reusability | Multi-patient use | Multi-patient use | Single Use | Identical to primary
predicate |
| Duration of Use |