(249 days)
No
The device description and performance testing focus on the physical components and their ability to deliver heated and humidified air/oxygen. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
Yes
The devices are intended to provide continuous flow of heated and humidified air/oxygen mixtures, allowing for the safe and effective delivery of oxygen therapy to patients, which classifies them as therapeutic devices.
No
The device is described as providing a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components such as cannulas, tubes, chin straps, and tracheostomy adapters, and the performance studies focus on bench testing of these physical attributes. There is no mention of software as a component or function of the device.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use of these devices is to deliver heated and humidified air/oxygen mixtures to spontaneously breathing patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The descriptions detail components for delivering gas to the patient's respiratory system (nasal cannulas, tracheostomy adapter, tubing). They do not describe components for analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or calibrators.
These devices are clearly intended for respiratory support and therapy, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments.
Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
Hudson RCI® Comfort Flo Nasal Cannulas
Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric.
Hudson RCI® Comfort Flo Plus Cannulas
Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients.
The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually.
Hudson RCI® Comfort Flo Plus Cannulas
Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort.
It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy.
Hudson RCI® Tracheostomy Adaptor
The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea.
The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system.
It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.
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
Hudson RCI® Comfort Flo Nasal Cannulas: Adult and pediatric (2 years and above)
Hudson RCI® Comfort Flo Plus Cannulas: Adult and pediatric (12 years and above)
Intended User / Care Setting
Professional healthcare 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)
Summary of Non-Clinical Testing
Testing was conducted to demonstrate substantial equivalence of Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula to the predicate, F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197). A summary of testing is presented below with more information provided in the applicable sections.
Biocompatibility Testing
The biocompatibility evaluation for Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The patient contacting materials of Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula that contact the patient and the humidified gas have been characterized as external communicating (indirect gas pathway), tissue/bone/dentin communicating with a potential for permanent contact (>30 days) due to cumulative use and surface device intact skin contacting, with a potential for permanent (>30 days) contact due to cumulative use. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2009 Annex A.
The following tests were performed to evaluate the biocompatibility of Comfort Flo Cannula
- ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- 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 10993-6:2016– Tests for local effects after implantation
- ISO 10993-3:2014- Tests for genotoxicity, carcinogenicity and reproductive 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)
Performance Testing (Bench)
The following tests were performed on Comfort Flo Cannula and Comfort Flo Plus Cannula.
- Post aging Visual Inspection
- Relevant Humidity Output testing
- Thermal Overshoot testing
- Gas path and headgear joint and connection strength testing following selected pre-conditioning intended to simulate worst case life scenarios.
- Flow Leak Test/ Gas path leak testing
- Head Gear Testing
- Shelf Life Testing
- Useful Life Testing
- Transportation simulation
- ISO gauging
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Other Testing NA
Summary of Clinical Testing Not applicable.
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). 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
Medline Industries, LP. Sirisha Kommana Sr. Regulatory Affairs Specialist Three Lakes Drive Nortfield, Illinois 60093
Re: K240163
Trade/Device Name: Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: August 28, 2024 Received: August 28, 2024
Dear Sirisha Kommana:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
John S.
Bender -S
Digitally signed by
John S. Bender -S
Date: 2024.09.27
15:35:43 -04'00'
for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K240163
Device Name
Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
Indications for Use (Describe)
Hudson RCI® Comfort Flo Nasal Cannulas:
Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments.
Hudson RCI® Comfort Flo® Plus Cannulas:
Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.
| 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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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white abstract star shape. The background is a dark blue square. The logo is simple and modern, and the colors are clean and professional.
dline Industries.
K240163- 510(k) Premarket Notification Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Contact Person: Sirisha Kommana, Senior Regulatory Affairs Specialist Email: SKommana@medline.com
Summary Preparation Date January 18, 2024
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Hudson RCI® Comfort Flo Nasal Cannula and Hudson RCI® Comfort Flo Plus Cannula Common Name: Nasal Cannula Classification Name: Humidifier, Respiratory Gas, (accessory to) Product Code: BTT Classification Panel: Anesthesiology Regulatory Class: Class II Regulation Number: 21 CFR 868.5450
Predicate Device
Primary Predicate: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197) Reference Device: F&P Optiflow 3S Nasal Cannula (K191818)
Device Description
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white abstract symbol that resembles a stylized cross or star. The background is a solid dark blue color. A gray bar is visible on the right side of the image.
edline Industries. hree Lakes Drive
240163-510/k) Premarket Notificatio ludson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula
Hudson RCI® Comfort Flo Nasal Cannulas
Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric.
Hudson RCI® Comfort Flo Plus Cannulas
Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients.
The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually.
Hudson RCI® Comfort Flo Plus Cannulas
Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort.
It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy.
Hudson RCI® Tracheostomy Adaptor
The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea.
The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system.
It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.
6
Image /page/6/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is written in white, bold, sans-serif font, stacked on top of a white, stylized lightning bolt. A small portion of a gray rectangle is visible on the right side of the image.
edline Industries. hree Lakes Drive
K240163- 510(k) Premarket Notificatio Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula
Indications for Use
Hudson RCI® Comfort Flo Nasal cannulas:
Hudson RC1® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediatric (2 years and above) patients in professional healthcare environments.
Hudson RCI® Comfort Flo® Plus cannulas:
Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.
Contraindications
None
Summary of Technological Characteristics
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device
Characteristic | Proposed Device | Predicate Device
K222197 | Reference Device
K191818 | Comparison
Analysis |
|--------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------|------------------------|
| Product Name | Hudson RCI® Comfort
Flo Nasal Cannula and
Hudson RCI® Comfort
Flo Plus Cannula | F&P Optiflow Junior
2/2+ Nasal Cannula
Interface Range | F&P Optiflow 3S
Nasal Cannula | N/A |
| 510(k) Reference | K240163 | K222197 | K191818 | N/A |
| Product Owner | Medline Industries, LP | Fisher and Paykal | Fisher and Paykal | N/A |
| Product Code | BTT | BTT | BTT | Same |
| Regulation
Number | 868.5450 | 868.5450 | 868.5450 | Same |
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Image /page/7/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, bold letters, stacked on top of a white symbol that resembles a stylized star or cross. The background of the logo is a solid blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
| Classification
Name | Respiratory gas
humidifier
(accessory to) | Respiratory gas
humidifier | Respiratory gas
humidifier
(accessory to) | Same |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Panel | Anesthesiology | Anesthesiology | Anesthesiology | Same |
| Intended
Use/Indications
for use | Hudson RCI®
Comfort Flo nasal
cannulas are intended
to be used in
conjunction with the
Comfort Flo
Humidification
System to provide a
continuous flow of
heated and humidified
air/oxygen mixtures to
spontaneously
breathing patients.
It is indicated for
single use by adult and
pediatric (2 years and
above) patients in
professional healthcare
environments.
Hudson RCI® Comfort
Flo® Plus cannulas are
intended to be used in
conjunction with the
Humidification
System to provide a
continuous flow of
heated and humidified
air/oxygen mixtures to
spontaneously
breathing patients.
It is indicated for
single use by adult and
pediatric (12 years and | F&P Optiflow
Junior 2
The Fisher & Paykel
Healthcare Optiflow
Junior 2 nasal
cannula is a single
use nasal cannula
intended for use with
a nasal high flow
therapy (NHF)
system to deliver
heated and
humidified nasal high
flow therapy to
spontaneously
breathing patients.
This product is
designed for use in
hospital
environments and
must be prescribed by
a physician.
The intended
pediatric
subpopulations
targeted for use of the
F&P Optiflow Junior
2 Nasal Cannula
range includes: | 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. | Same
Although the
wording is not
identical to
predicate's
indications for
use as seen on
510k summary
the proposed
device and the
predicate device
have the same
overall
indicated use, of
providing a
continuous flow
of heated and
humidified air
to
spontaneously
breathing
patients.
Both the
predicate and
proposed
Hudson RCI®
Comfort Flo
nasal cannulas
are indicated for
single use by
pediatric
population
above 2years. |
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| above) patients in professional healthcare environments. | Neonates, birth up to 1 month of age Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of age F&P Optiflow Junior 2+
The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulation | The proposed device (Hudson RCI® Comfort Flo® Plus cannulas) has additional pediatric patient population to accommodate patient population above 12 years of age.
The proposed devices (Hudson RCI® Comfort Flo® nasal cannulas and Hudson RCI® Comfort Flo® Plus cannulas) are also indicated for use in adult patient population, which is equivalent to the reference device (K191818). |
| ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| targeted for use on
the F&P Optiflow
Junior 2+ Nasal
Cannula includes:
Infants, 1 month
up to 2 years of
age Children, 2 years
up to 12 years of
age | F&P Optiflow
Junior 2 HM
Cannula:
The Fisher & Paykel
Healthcare
Optiflow™ Junior 2
nasal cannula is a
single use nasal
cannula intended for
use with a nasal high
flow (NHF) therapy
system to deliver
heated and
humidified nasal high
flow therapy to
spontaneously
breathing patients.
This product is
designed for use in
long term care
environments and
must be prescribed by
a physician.
The intended
pediatric | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
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Image /page/10/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is composed of four pointed shapes converging at a central point, creating a dynamic and modern design. The logo is set against a solid blue background, providing a clean and professional look.
| subpopulation | |
|---|---|
| targeted for use on | |
| the F&P Optiflow | |
| Junior 2 Nasal | |
| Cannula includes: | |
| • Infants, 1 | |
| month up to 2 | |
| years of age | |
| • Children, 2 | |
| years up to 12 | |
| years of age | |
| F&P Optiflow | |
| Junior 2+ HM | |
| Cannula: | |
| The Fisher & Paykel | |
| Healthcare | |
| Optiflow™ Junior 2+ | |
| nasal cannula is a | |
| single use nasal | |
| cannula intended for | |
| use with a nasal high | |
| flow (NHF) therapy | |
| system to deliver | |
| heated and | |
| humidified nasal high | |
| flow therapy to | |
| spontaneously | |
| breathing patients. | |
| This product is | |
| designed for use in | |
| long term care | |
| environments and | |
| must be prescribed by | |
| a physician. |
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Image /page/11/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white letters on a blue square. There is a white star-like shape to the right of the word.
| | | The intended
pediatric
subpopulation
targeted for use on
the F&P Optiflow
Junior 2+ Nasal
Cannula includes:
• Infants, 1
month up to 2
years of age
• Children, 2
years up to 12
years of age | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Population | Comfort Flo Nasal
Cannulas: Adult and
pediatric patients (2
years and above)
Comfort Flo Plus
Cannulas: Adult and
pediatric patients (12
years and above) | Neonates: Birth up to
1 month of age
Infants: 1 month up
to 2 years of age
Children: 2 years up
to 12 years of age | Adults | Similar
The proposed
device, Comfort
Flo Nasal
Cannula and the
predicate device
is intended for
pediatric
populations 2
years and
above.
The proposed
device, Comfort
Flo Plus
Cannula is
indicated for
additional
patient
population to
accommodate
for pediatric
population (12
years and
above). |
12
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| | | | | The proposed
devices,
Comfort Flo
Cannula and
Comfort Flo
Plus Cannula
are indicated for
adult patient
population
which is
equivalent to
the reference
device
(K191818). |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Acuity | Spontaneously
breathing patients | Spontaneously
breathing patients | Spontaneously
breathing patients | Same |
| Prescription vs.
OTC | Prescription Use (Rx)
only | Prescription Use (Rx)
only | Prescription Use
(Rx) only | Same |
| Operating
Environment | Professional
Healthcare
environment | Hospital environment
and long-term care
environments | Hospital
environment | Same
Professional
healthcare
environment
includes
hospital and
long-term care
environments |
| System
Specifications | When set to Comfort
Flo Humidification
System
Recommended Flow
Rates:
Comfort Flo Cannula:
Pediatric 1-20
LPM
Adult 1-60 LPM | When the Airvo 2
system is set to Junior
mode
OJR416, OJR416HM
(Large) 2 – 20 L/min
OJR418, OJR418HM
(Extra Large) 2 – 25
L/min | AIRVO / AIRVO 2
Humidifier with
900PT56x-series
tube; or tube and
chamber kit (e.g.
900PT561)
Flow Range:
OPT1042 (Small)
10 - 50L/min
OPT1044
(Medium) 10 - 60 | Similar
The upper range
of flow rate of
pediatric
population of
20LPM is same
as the predicate
device.
The lower range
of flow rate of
pediatric |
| | Large 1-60 LPM
Medium 1-60 LPM
Small 1-60 LPM | OJR520, OJR520HM
(XXL) 10 – 50 L/min
When the MR850 is
set to invasive mode
OJR410
(Extra small) 0.5-8
L/min | OPT1046 (Large)
10 - 60 L/min | proposed device
is validated to
1LPM
The upper range
of flow rate of
adult population
is covered in the |
| | | OJR412
(Small) 0.5-9 L/min
OJR414
(Medium) 0.5-10
L/min
OJR416
(Large) 0.5 - 23
L/min
OJR418
(Large) 0.5 - 25
L/min
OJR418, OJR520
(Double Extra Large)
1 - 35 L/min | | reference device
(K191818). |
| Single Use vs.
Reusable | Single Use only | Single Use only | Single Use only | Same |
| Useful Life | 30 days | 7 days | 30 days) due to cumulative use and surface device intact skin contacting, with a potential for permanent (>30 days) contact due to cumulative use. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2009 Annex A.
The following tests were performed to evaluate the biocompatibility of Comfort Flo Cannula
- . ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- 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 . Toxicitv
- ISO 10993-6:2016– Tests for local effects after implantation ●
- ISO 10993-3:2014- Tests for genotoxicity, carcinogenicity and reproductive 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
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K240163- 510(k) Premarket Notificatio Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula
- 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)
Performance Testing (Bench)
The following tests were performed on Comfort Flo Cannula and Comfort Flo Plus Cannula.
- Post aging Visual Inspection ●
- Relevant Humidity Output testing ●
- Thermal Overshoot testing
- Gas path and headgear joint and connection strength testing following selected pre-conditioning intended to simulate worst case life scenarios.
- Flow Leak Test/ Gas path leak testing ●
- Head Gear Testing
- Shelf Life Testing ●
- Useful Life Testing ●
- Transportation simulation
- . ISO gauging
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Other Testing NA
Summary of Clinical Testing Not applicable.
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K240163- 510(k) Premarket Notification Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula
Conclusion
In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Medline Industries, LP. concludes that the Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula are as safe and as effective for their intended use as the predicate device F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197).