Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula

K240163 · Medline Industries, LP · BTT · Sep 27, 2024 · Anesthesiology

Device Facts

• Record ID: K240163
• Device Name: Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
• Applicant: Medline Industries, LP
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Device consists of nasal cannulas (Comfort Flo and Comfort Flo Plus) and tracheostomy adapters; used with external humidification systems to deliver heated, humidified air/oxygen mixtures to spontaneously breathing patients. Cannulas interface with patient nares; tracheostomy adapter connects to tracheostomy tubes via 15mm/22mm connectors. Used in professional healthcare settings (hospitals, long-term care) by clinicians. Provides alternative to oxygen face masks, allowing patient to talk, eat, and drink during therapy. Benefits include safe, effective delivery of respiratory gas therapy. No internal electronics or software; passive interface device.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series, ISO 18562 series), mechanical performance (connection strength, leak testing), and simulated use testing (useful life, shelf life).

Technological Characteristics

Passive nasal cannula and tracheostomy adapter interfaces. Materials evaluated per ISO 10993-1:2018 and ISO 18562 series for gas pathway biocompatibility. Connectors: 15mm/22mm standard. Non-sterile, single-use, disposable. No energy source, software, or algorithms.

Indications for Use

Indicated for spontaneously breathing adult and pediatric patients (Comfort Flo: 2+ years; Comfort Flo Plus: 12+ years) in professional healthcare environments for delivery of heated, humidified air/oxygen mixtures.

Regulatory Classification

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.

Predicate Devices

• F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197)

Reference Devices

• F&P Optiflow 3S Nasal Cannula (K191818)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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# 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: [e-mail]

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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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.

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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<br>Characteristic | Proposed Device | Predicate Device<br>K222197 | Reference Device<br>K191818 | Comparison<br>Analysis |
|--------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------|------------------------|
| Product Name | Hudson RCI® Comfort<br>Flo Nasal Cannula and<br>Hudson RCI® Comfort<br>Flo Plus Cannula | F&P Optiflow Junior<br>2/2+ Nasal Cannula<br>Interface Range | F&P Optiflow 3S<br>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<br>Number | 868.5450 | 868.5450 | 868.5450 | Same |

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| Classification<br>Name | Respiratory gas<br>humidifier<br>(accessory to) | Respiratory gas<br>humidifier | Respiratory gas<br>humidifier<br>(accessory to) | Same |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Panel | Anesthesiology | Anesthesiology | Anesthesiology | Same |
| Intended<br>Use/Indications<br>for use | Hudson RCI®<br>Comfort Flo nasal<br>cannulas are intended<br>to be used in<br>conjunction with the<br>Comfort Flo<br>Humidification<br>System to provide a<br>continuous flow of<br>heated and humidified<br>air/oxygen mixtures to<br>spontaneously<br>breathing patients.<br><br>It is indicated for<br>single use by adult and<br>pediatric (2 years and<br>above) patients in<br>professional healthcare<br>environments.<br><br>Hudson RCI® Comfort<br>Flo® Plus cannulas are<br>intended to be used in<br>conjunction with the<br>Humidification<br>System to provide a<br>continuous flow of<br>heated and humidified<br>air/oxygen mixtures to<br>spontaneously<br>breathing patients.<br><br>It is indicated for<br>single use by adult and<br>pediatric (12 years and | F&P Optiflow<br>Junior 2<br><br>The Fisher & Paykel<br>Healthcare Optiflow<br>Junior 2 nasal<br>cannula is a single<br>use nasal cannula<br>intended for use with<br>a nasal high flow<br>therapy (NHF)<br>system to deliver<br>heated and<br>humidified nasal high<br>flow therapy to<br>spontaneously<br>breathing patients.<br>This product is<br>designed for use in<br>hospital<br>environments and<br>must be prescribed by<br>a physician.<br><br>The intended<br>pediatric<br>subpopulations<br>targeted for use of the<br>F&P Optiflow Junior<br>2 Nasal Cannula<br>range includes: | The F&P<br>Optiflow™ 3S<br>nasal cannula is a<br>14-day single use<br>nasal cannula<br>interface for use<br>with specified<br>respiratory gas<br>humidifiers to<br>deliver Nasal High<br>Flow (NHF)<br>therapy to<br>spontaneously<br>breathing adult<br>patients. This<br>product is designed<br>to be used by<br>appropriately<br>qualified healthcare<br>professionals in a<br>hospital /<br>institutional<br>environment. | Same<br><br>Although the<br>wording is not<br>identical to<br>predicate's<br>indications for<br>use as seen on<br>510k summary<br>the proposed<br>device and the<br>predicate device<br>have the same<br>overall<br>indicated use, of<br>providing a<br>continuous flow<br>of heated and<br>humidified air<br>to<br>spontaneously<br>breathing<br>patients.<br><br>Both the<br>predicate and<br>proposed<br>Hudson RCI®<br>Comfort Flo<br>nasal cannulas<br>are indicated for<br>single use by<br>pediatric<br>population<br>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+<br>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.<br>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.<br>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<br>the F&P Optiflow<br>Junior 2+ Nasal<br>Cannula includes:<br>Infants, 1 month<br>up to 2 years of<br>age Children, 2 years<br>up to 12 years of<br>age | F&P Optiflow<br>Junior 2 HM<br>Cannula:<br>The Fisher & Paykel<br>Healthcare<br>Optiflow™ Junior 2<br>nasal cannula is a<br>single use nasal<br>cannula intended for<br>use with a nasal high<br>flow (NHF) therapy<br>system to deliver<br>heated and<br>humidified nasal high<br>flow therapy to<br>spontaneously<br>breathing patients.<br>This product is<br>designed for use in<br>long term care<br>environments and<br>must be prescribed by<br>a physician.<br>The intended<br>pediatric | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|

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| subpopulation | |
|-------------------------------------------------|--|
| targeted for use on | |
| the F&P Optiflow | |
| Junior 2 Nasal | |
| Cannula includes: | |
| • Infants, 1<br>month up to 2<br>years of age | |
| • Children, 2<br>years up to 12<br>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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| | | The intended<br>pediatric<br>subpopulation<br>targeted for use on<br>the F&P Optiflow<br>Junior 2+ Nasal<br>Cannula includes:<br>• Infants, 1<br>month up to 2<br>years of age<br>• Children, 2<br>years up to 12<br>years of age | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Population | Comfort Flo Nasal<br>Cannulas: Adult and<br>pediatric patients (2<br>years and above)<br><br>Comfort Flo Plus<br>Cannulas: Adult and<br>pediatric patients (12<br>years and above) | Neonates: Birth up to<br>1 month of age<br><br>Infants: 1 month up<br>to 2 years of age<br><br>Children: 2 years up<br>to 12 years of age | Adults | Similar<br>The proposed<br>device, Comfort<br>Flo Nasal<br>Cannula and the<br>predicate device<br>is intended for<br>pediatric<br>populations 2<br>years and<br>above.<br><br>The proposed<br>device, Comfort<br>Flo Plus<br>Cannula is<br>indicated for<br>additional<br>patient<br>population to<br>accommodate<br>for pediatric<br>population (12<br>years and<br>above). |

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| | | | | The proposed<br>devices,<br>Comfort Flo<br>Cannula and<br>Comfort Flo<br>Plus Cannula<br>are indicated for<br>adult patient<br>population<br>which is<br>equivalent to<br>the reference<br>device<br>(K191818). |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Acuity | Spontaneously<br>breathing patients | Spontaneously<br>breathing patients | Spontaneously<br>breathing patients | Same |
| Prescription vs.<br>OTC | Prescription Use (Rx)<br>only | Prescription Use (Rx)<br>only | Prescription Use<br>(Rx) only | Same |
| Operating<br>Environment | Professional<br>Healthcare<br>environment | Hospital environment<br>and long-term care<br>environments | Hospital<br>environment | Same<br>Professional<br>healthcare<br>environment<br>includes<br>hospital and<br>long-term care<br>environments |
| System<br>Specifications | When set to Comfort<br>Flo Humidification<br>System<br>Recommended Flow<br>Rates:<br>Comfort Flo Cannula:<br>Pediatric 1-20<br>LPM<br>Adult 1-60 LPM | When the Airvo 2<br>system is set to Junior<br>mode<br>OJR416, OJR416HM<br>(Large) 2 – 20 L/min<br>OJR418, OJR418HM<br>(Extra Large) 2 – 25<br>L/min | AIRVO / AIRVO 2<br>Humidifier with<br>900PT56x-series<br>tube; or tube and<br>chamber kit (e.g.<br>900PT561)<br>Flow Range:<br>OPT1042 (Small)<br>10 - 50L/min<br>OPT1044<br>(Medium) 10 - 60 | Similar<br>The upper range<br>of flow rate of<br>pediatric<br>population of<br>20LPM is same<br>as the predicate<br>device.<br>The lower range<br>of flow rate of<br>pediatric |
| | Large 1-60 LPM<br>Medium 1-60 LPM<br>Small 1-60 LPM | OJR520, OJR520HM<br>(XXL) 10 – 50 L/min<br>When the MR850 is<br>set to invasive mode<br>OJR410<br>(Extra small) 0.5-8<br>L/min | OPT1046 (Large)<br>10 - 60 L/min | proposed device<br>is validated to<br>1LPM<br>The upper range<br>of flow rate of<br>adult population<br>is covered in the |
| | | OJR412<br>(Small) 0.5-9 L/min<br>OJR414<br>(Medium) 0.5-10<br>L/min<br>OJR416<br>(Large) 0.5 - 23<br>L/min<br>OJR418<br>(Large) 0.5 - 25<br>L/min<br>OJR418, OJR520<br>(Double Extra Large)<br>1 - 35 L/min | | reference device<br>(K191818). |
| Single Use vs.<br>Reusable | Single Use only | Single Use only | Single Use only | Same |
| Useful Life | 30 days | 7 days | < 14 days | The proposed<br>device claims a<br>30 day useful<br>life |
| Shelf-Life | 5 Years | 3 Years | 3 Years | The proposed<br>device claims a<br>5 year shelf life |
| Sterile vs. Non-<br>Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs.<br>Non-Disposable | Disposable | Disposable | Dispose of<br>according to<br>hospital protocol | Same |

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K240163- 510(k) Premarket Notification Hudson RCI® Comfort Flo Cannula and Hudson RCI® Comfort Flo Plus Cannula

#### 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 . 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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Image /page/15/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid blue color. The logo is simple and clean, with a focus on the company name and a memorable graphic.

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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Image /page/16/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol behind it. The starburst is positioned so that it appears to be behind and slightly above the text.

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).