Hudson RCI Comfort Flo® CubCannula™

K241778 · Medline Industries, LP · BTT · Dec 19, 2024 · Anesthesiology

Device Facts

• Record ID: K241778
• Device Name: Hudson RCI Comfort Flo® CubCannula™
• Applicant: Medline Industries, LP
• Product Code: BTT · Anesthesiology
• Decision Date: Dec 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM. CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations: - Neonates, birth to 1 month of age - Infants, 1 month to 2 years of age - Children, 2 to 12 years of age CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician. CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

Device Story

Single-use nasal cannula; delivers heated/humidified respiratory gas to spontaneously breathing pediatric patients (neonates to 12 years). Input: heated/humidified air/oxygen mixture from external humidification system. Output: gas delivery via two-prong interface. Used in professional healthcare environments; prescribed by physicians. Features soft silicone prongs, kink/crush-resistant lariat, color-coded sizing, and hydrocolloid pads (CubPads) for facial securement. Device facilitates respiratory support; clinical decision-making relies on physician assessment of patient respiratory needs. Benefits include patient comfort and effective gas delivery.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993, ISO 18562), mechanical performance (connection strength, flow leak, thermal overshoot), and shelf/useful life validation.

Technological Characteristics

Single-use nasal cannula; silicone construction. Includes hydrocolloid pads. Conical connectors per ISO 5356-1:2015. Flow rates 1-25 LPM. Non-sterile. Bench testing per ISO 80601-2-74:2017, ASTM F1980-21, and ASTM D4169-22.

Indications for Use

Indicated for spontaneously breathing neonates (birth to 1 month), infants (1 month to 2 years), and children (2 to 12 years) requiring heated and humidified respiratory gas delivery at flow rates of 1-25 LPM. Contraindicated for patients where CPAP is contraindicated, including non-spontaneous breathing; pneumothorax; pneumocephalus; cerebrospinal fluid leak; hypotension; or injury/trauma/deformity exacerbated by nasal prongs.

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)

Submission Summary (Full Text)

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December 19, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

Medline Industries, LP. Nicole Schaffer Regulatory Affairs Manager Three Lakes Drive Northfield, Illinois 60093

Re: K241778

Trade/Device Name: Hudson RCI Comfort Flo® CubCannula™ Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: June 20, 2024 Received: November 20, 2024

Dear Nicole Schaffer:

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.

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"

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Page

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(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 OS 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 Rue"). 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-devices/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 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Ethan L. Nyberg -S

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) K241778

Device Name Hudson RCI Comfort Flo® CubCannula™

Indications for Use (Describe)

The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM.

CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations:

- · Neonates, birth to 1 month of age
- · Infants, 1 month to 2 years of age
- · Children, 2 to 12 years of age

CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician.

CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

|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 is white and is set against a blue background. The word "MEDLINE" is in bold, sans-serif letters. To the right of the word is a white starburst symbol.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo® CubCannula™ K241778

# 510(k) Summary K241778

# Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

# Submission Correspondent

Nicole Schaffer Regulatory Affairs Manager [e-mail]

# Summary Preparation Date

December 19, 2024

# Type of 510(k) Submission

Traditional

# Device Name / Classification

Trade Name: Hudson RCI Comfort Flo® CubCannula™ Classification Name: Respiratory Gas Humidifier Product Code: BTT Classification Panel: Anesthesiology (Respiratory) Regulatory Class: Class II Regulation Number: 21 CFR 868.5450 Common/Usual Name: Nasal Cannula

# Predicate Device

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

# Device Description

The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use.

The following table lists the Hudson RCI Comfort Flo® CubCannula™ and CubPad™ model numbers and configurations.

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is white and is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol to the right of the word.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo CubCannula™ K241778

The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.

| IGME J 2: VIIIIsulativils | | | | |
|---------------------------|------------------------------------------------------|--|--|--|
| Model Number | Description | | | |
| HUD2701XS | Cub Cannula – Extra Small | | | |
| HUD2701S | Cub Cannula — Small | | | |
| HUD2701M | Cub Cannula — Medium | | | |
| HUD2701L | Cub Cannula — Large | | | |
| HUD2701XL | Cub Cannula – Extra Large | | | |
| HUD2702 | Cub Cannula Replacement Pads – Small (CubPads Small) | | | |
| HUD2703 | Cub Cannula Replacement Pads – Large (CubPads Large) | | | |

#### Indications for Use

The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM.

CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations:

- · Neonates, birth to 1 month of age
- Infants, 1 month to 2 years of age
- Children, 2 to 12 years of age

CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician. CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

#### Patient Population

- Neonates, birth to 1 month of age
- Infants, 1 month to 2 years of age
- Children, 2 to 12 years of age

#### Contraindications

This therapy must not be used where continuous positive airway pressure (CPAP) is contraindicated. This includes:

- · Non-spontaneous breathing.
- Injury, congenital abnormalities and anatomical malformations where bi-nasal prongs or physical conditions where positive airway pressure is contraindicated, including but not limited to: pneumothorax, pneumocephalus, cerebrospinal fluid leak, and hypotension.
- Injury/trauma/severe deformity that might be exacerbated by use of nasal prongs or mask.

#### Environments of Use

- . Professional healthcare environment
Table 3-2: Comparison of Subject vs. Predicate

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Image /page/6/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points, creating a dynamic and recognizable emblem for the company.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo®

| Device Characteristic | Proposed Device<br>Comfort Flo® CubCannula™ | Primary Predicate Device F&P<br>Optiflow Junior 2/2+ Nasal<br>Cannula Interface Range<br>K222197 | Comparison<br>Analysis |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medline Industries | Fisher & Paykel Healthcare Ltd | |
| Product Code | BTT | BTT | Identical |
| Regulation Number | 868.5450 | 868.5450 | Identical |
| Indications for Use | The Hudson RCI Comfort Flo®<br>CubCannula™ is a single use nasal<br>cannula intended to administer<br>respiratory gas to a spontaneously<br>breathing patient through both<br>nostrils delivering flow rates<br>ranging from 1 to 25 LPM.<br><br>CubCannula™ is a patient interface<br>used to deliver heated and<br>humidified gas to the following<br>populations:<br>• Neonates, birth to 1 month of age<br>• Infants, 1 month to 2 years of age<br>• Children, 2 to 12 years of age<br><br>CubCannula™ is designed for use in<br>professional healthcare<br>environments and must be<br>prescribed by a physician.<br>CubCannula is used in conjunction<br>with the Humidification System<br>intended to provide a continuous<br>flow of heated and humidified<br>air/oxygen mixtures to<br>spontaneously breathing patients. | The Fisher & Paykel Healthcare<br>Optiflow Junior 2 nasal cannula is a<br>single use nasal cannula intended<br>for use with a nasal high flow<br>therapy (NHF) system to deliver<br>heated and humidified nasal high<br>flow therapy to spontaneously<br>breathing patients.<br><br>This product is designed for use in<br>hospital environments and must be<br>prescribed by a physician. The<br>intended pediatric subpopulations<br>targeted for use of the F&P<br>Optiflow Junior 2 Nasal Cannula<br>range includes:<br>• Neonates, birth up to 1 month of<br>age<br>• Infants, 1 month up to 2 years of<br>age<br>• Children, 2 years up to 12 years of<br>age | Similar. The<br>indications for use<br>for the subject and<br>predicate device are<br>similar with the<br>exception the<br>environment of use.<br>The predicate is<br>cleared for use in<br>hospital<br>environments only,<br>while the subject<br>device is seeking<br>clearance in<br>professional<br>healthcare<br>environments. |
| Shelf Life | 2 years | 3 years | Similar. The subject<br>device has a shelf<br>life of 2 years while<br>the predicate has a<br>shelf life of 3 years. |
| Useful Life | 10 days | 7 days | Similar. The subject<br>device has a<br>maximum useful life<br>of 10 days while the<br>predicate device has<br>a maximum useful<br>life of 7 days.<br>Testing has been<br>performed to<br>validate the 10-day<br>useful life (safety |
| | | | factor included). |
| Prescription vs. OTC | Prescription | Prescription | Identical |
| Contraindications | This therapy must not be used<br>where continuous positive airway<br>pressure (CPAP) is contraindicated.<br>This includes:<br>• Non-spontaneous breathing.<br>• Injury, congenital abnormalities<br>and anatomical malformations<br>where bi-nasal prongs or physical<br>conditions where positive airway<br>pressure is contraindicated,<br>including but not limited to:<br>pneumothorax, pneumocephalus,<br>cerebrospinal fluid leak, and<br>hypotension.<br>• Injury/trauma/severe deformity<br>that might be exacerbated by use<br>of nasal prongs or mask. | This therapy must not be used<br>where continuous positive airway<br>pressure (CPAP) is contraindicated.<br>This includes:<br>• Non-spontaneous breathing.<br>• Injury, congenital abnormalities<br>and anatomical malformations<br>where bi-nasal prongs or physical<br>conditions where positive airway<br>pressure is contraindicated,<br>including but not limited to:<br>pneumothorax, pneumocephalus,<br>cerebrospinal fluid leak, and<br>hypotension.<br>• Injury/trauma/severe deformity<br>that might be exacerbated by use<br>of nasal prongs or mask. | Identical |
| Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Identical |
| Single Use vs.<br>Reusable | Single Use | Single Use | Identical |
| Patient Population | • Neonates, birth to 1 month of age<br>• Infants, 1 month to 2 years of age<br>• Children, 2 to 12 years of age | • Neonates, birth to 1 month of age<br>• Infants, 1 month to 2 years of age<br>• Children, 2 to 12 years of age | Identical |
| Patient Acuity | Spontaneously breathing patients | Spontaneously breathing patients | Identical |
| Operating<br>Environment | Professional Healthcare | Hospital environment | Identical |
| Ambient Operating<br>Temperature | 20-26°C | 18 - 26 °C | Similar. The ambient temperatures of<br>both the<br>CubCannula and the<br>predicate device are<br>nearly identical.<br>The maximum<br>temperature range<br>is identical to the<br>predicate. The<br>minimum value<br>does not extend<br>beyond the<br>approved limits of<br>the predicate<br>device. As the<br>ambient<br>temperature of the |

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font and is positioned to the left of a white starburst symbol. The starburst symbol has four points, with the top and bottom points being longer than the left and right points.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo®

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Image /page/8/Picture/0 description: The image features the logo of 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 white, and the background is a solid, dark blue color, creating a clean and professional look.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo® CubCannula™ K241778

| Range of Cannula<br>Sizes | | | | | | | subject device is<br>within that of the<br>predicate, this does<br>not raise and<br>additional concerns<br>for safety and<br>effectiveness of the<br>subject device.<br>Similar. The subject<br>device includes the |
|---------------------------|--------------------------------------------------------------------|------|--------------------------|------------------------------------------------------------------|------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Available in five different sizes<br>which are indicated by color. | | | Available in six different sizes which<br>are indicated by color | | | same sizes as the<br>predicate (Extra<br>Small, Small,<br>Medium, Large,<br>Extra Large) with the<br>exception of the<br>Extra Extra Large<br>size. The exclusion<br>of this additional<br>size offered with the<br>predicate device<br>does not raise any<br>additional concerns<br>of safety and<br>effectiveness for the<br>subject device. |
| | | | | | | | |
| Flow Rates | Product<br>Code | Size | Flow<br>Rates<br>(L/min) | Product<br>Code | Size | Flow<br>Rates<br>(L/min) | Similar. The<br>flowrates of both<br>the CubCannula and<br>the predicate device |
| | HUD2701XS | XS | 1-8 | OJR410 | XS | 0.5-8 | are nearly identical.<br>All five allowable |
| | HUD2701S | S | 1-8 | OJR412 | S | 0.5-9 | flowrate ranges fall<br>within the allowable |
| | HUD2701M | M | 1-8 | OJR414 | M | 0.5-10 | flow ranges of the |
| | HUD2701M | M | 1-8 | OJR416 | L | 0.5-23 | predicate device.<br>No values extend |
| | HUD2701L | L | 1-25 | | L | | beyond the cleared |
| | HUD2701XL | XL | 1-25 | OJR418 | XL | 0.5-25 | limits of the<br>predicate device. |
| | | | | OJR520 | XXL | 1-36 | |

# Summary of Non-Clinical Testing

Testing was conducted to demonstrate substantial equivalence of Hudson RCI Comfort Flo® CubCannula™ 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

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Image /page/9/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is oriented diagonally, with its points extending beyond the text, creating a dynamic and recognizable brand mark.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo® CubCannula™ K241778

The Comfort Flo® CubCannula was tested for biocompatibility using a combination of ISO 10993-1:2018 and ISO 18562-1:2017 methodologies. All biological endpoint testing including cytotoxicity, sensitization, irritation, acute systemic toxicity, and genotoxicity revealed passing results. The extractables/leachables testing on the humidified gas pathway components revealed MOS values greater than 1.0 after clinically relevant considerations and condensate attenuation. VOC and Particulates that the CubCannula emissions are well below the health-based thresholds for both volatile organic compounds and particulates. Based upon these results in conjunction with the ISO 10993-1:2018 testing, the CubCannula referenced in this document is biocompatible and does not present a foreseen biological and/or toxicological risk to those patient populations the device is intended for.

The following tests were performed to evaluate the biocompatibility of CubCannula:

- 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 CubCannula and CubPads:

- Post aging Visual Inspection
- Relevant Humidity Output testing
- Thermal Overshoot testing
- Connection strength testing following selected pre-conditioning
- Flow Leak Test/ Gas path leak testing ●
- Shelf Life Testing
- Useful Life Testing

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Image /page/10/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol to the right. The starburst has four points, with the top and bottom points being longer than the side points. The logo is set against a blue background.

Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo® CubCannula™ K241778

- Peel Testing
- . Transportation simulation
- ISO gauging

# Performance Testing (Bench) Standards:

- ISO 5356-1:2015, Anesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets. ●
- ISO 80601-2-74:2017 Medical electrical equipment- Part 2-74: Particular requirements for basic safety and essential performance of respiratory devices
- . ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems

# 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.

# Summary of Clinical Testing

Not applicable.

# 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® CubCannula™ are substantially equivalent to the predicate based on patient population, intended use, comparison of their technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.