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

AI/ML Overview

Based on the provided text, the device in question is the Hudson RCI Comfort Flo® CubCannula™, a nasal cannula. The document is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study as might be done for a novel device or pre-market approval (PMA) pathway.

Therefore, the information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined primary and secondary endpoints is not explicitly present for this 510(k) submission. Instead, the focus is on demonstrating equivalence through non-clinical testing (biocompatibility and bench testing).

Here's an analysis of the provided information relative to your questions, with specific callouts where information is not available due to the nature of a 510(k) substantial equivalence submission:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the way a clinical study report would. Instead, it lists the non-clinical tests performed and states that they revealed "passing results" or that "emissions are well below the health-based thresholds." The "acceptance criteria" are implied by the standards cited and the statement of compliance.

Implied Acceptance (Compliance) and Reported Performance (Statement of Passing):

Test Category	Implied Acceptance (Standard/Requirement)	Reported Device Performance
Biocompatibility	ISO 10993-1:2018 (General Evaluation), ISO 10993-5: 2009 (Cytotoxicity), ISO 10993:10: 2010 (Irritation & Sensitization), ISO 10993-11:2017 (Systemic Toxicity), ISO 10993-6:2016 (Local Effects after Implantation), ISO 10993-3:2014 (Genotoxicity, Carcinogenicity, Reproductive Toxicity), ISO 10993-12:2012 (Sample Prep), ISO 10993-17:2002 (Allowable Limits for Leachables), ISO 10993-18:2005 (Chemical Char.); ISO 18562-1:2017 (Breathing Gas), ISO 18562-2:2017 (Particulate Matter), ISO 18562-3:2017 (VOCs).	"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.""the CubCannula referenced in this document is biocompatible and does not present a foreseen biological and/or toxicological risk."
Performance (Bench)	ISO 5356-1:2015 (Conical connectors), ISO 80601-2-74:2017 (Respiratory devices), ASTM F1980-21 (Accelerated Aging), ASTM D4169-22 (Shipping Containers).	Performed tests include: Post aging Visual Inspection, Relevant Humidity Output testing, Thermal Overshoot testing, Connection strength testing, Flow Leak Test/Gas path leak testing, Shelf Life Testing, Useful Life Testing, Peel Testing, Transportation simulation, ISO gauging. All are implicitly stated as having demonstrated substantial equivalence. Specific quantitative results are not provided in this summary. For "Useful Life," it states: "Testing has been performed to validate the 10-day useful life (safety factor included)."
Product Characteristics	Maintain functional equivalence (e.g., flow rates, patient population, counter-indications) to predicate device.	Flow rates (1-25 LPM) are similar to the predicate (0.5-25 LPM, max 36LPM for XXL size not included). Useful life (10 days) has been validated vs predicate (7 days). Shelf life (2 years) vs predicate (3 years). These differences were assessed not to raise new safety/effectiveness concerns.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to a 510(k) submission based on non-clinical (bench) testing, not a clinical study. The "test set" would refer to the physical units of the device tested in the lab, but the number of units is not specified. There is no patient data or country of origin for the data as no clinical testing was performed ("No clinical testing was performed").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there was no clinical study, no patient data, and therefore no "ground truth" established by experts in the context of clinical interpretation or outcomes. The ground truth for the non-clinical tests would be the established performance standards set by the cited ISO and ASTM documents.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no clinical study or expert review for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical medical device (nasal cannula), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as it is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no clinical study comparing the new device's performance against a "ground truth" in patients was conducted per the document ("No clinical testing was performed"), the concept of "ground truth" in a clinical sense is not applicable. For the non-clinical testing, the "ground truth" is adherence to the specified performance characteristics and safety profiles as measured against the requirements of the cited ISO and ASTM standards. These standards define the acceptable range for each test parameter (e.g., cytotoxicity, leachable substances thresholds, connection strength, leak rates).

8. The sample size for the training set

This is not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

Summary

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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

(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 nschaffer@medline.com

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 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

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

Page 2 of 7

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

Device Characteristic	Proposed DeviceComfort Flo® CubCannula™	Primary Predicate Device F&POptiflow Junior 2/2+ NasalCannula Interface RangeK222197	ComparisonAnalysis
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®CubCannula™ is a single use nasalcannula intended to administerrespiratory gas to a spontaneouslybreathing patient through bothnostrils delivering flow ratesranging from 1 to 25 LPM.CubCannula™ is a patient interfaceused to deliver heated andhumidified gas to the followingpopulations:• Neonates, birth to 1 month of age• Infants, 1 month to 2 years of age• Children, 2 to 12 years of ageCubCannula™ is designed for use inprofessional healthcareenvironments and must beprescribed by a physician.CubCannula is used in conjunctionwith the Humidification Systemintended to provide a continuousflow of heated and humidifiedair/oxygen mixtures tospontaneously breathing patients.	The Fisher & Paykel HealthcareOptiflow Junior 2 nasal cannula is asingle use nasal cannula intendedfor use with a nasal high flowtherapy (NHF) system to deliverheated and humidified nasal highflow therapy to spontaneouslybreathing patients.This product is designed for use inhospital environments and must beprescribed by a physician. Theintended pediatric subpopulationstargeted for use of the F&POptiflow Junior 2 Nasal Cannularange includes:• Neonates, birth up to 1 month ofage• Infants, 1 month up to 2 years ofage• Children, 2 years up to 12 years ofage	Similar. Theindications for usefor the subject andpredicate device aresimilar with theexception theenvironment of use.The predicate iscleared for use inhospitalenvironments only,while the subjectdevice is seekingclearance inprofessionalhealthcareenvironments.
Shelf Life	2 years	3 years	Similar. The subjectdevice has a shelflife of 2 years whilethe predicate has ashelf life of 3 years.
Useful Life	10 days	7 days	Similar. The subjectdevice has amaximum useful lifeof 10 days while thepredicate device hasa maximum usefullife of 7 days.Testing has beenperformed tovalidate the 10-dayuseful life (safety
			factor included).
Prescription vs. OTC	Prescription	Prescription	Identical
Contraindications	This therapy must not be usedwhere continuous positive airwaypressure (CPAP) is contraindicated.This includes:• Non-spontaneous breathing.• Injury, congenital abnormalitiesand anatomical malformationswhere bi-nasal prongs or physicalconditions where positive airwaypressure is contraindicated,including but not limited to:pneumothorax, pneumocephalus,cerebrospinal fluid leak, andhypotension.• Injury/trauma/severe deformitythat might be exacerbated by useof nasal prongs or mask.	This therapy must not be usedwhere continuous positive airwaypressure (CPAP) is contraindicated.This includes:• Non-spontaneous breathing.• Injury, congenital abnormalitiesand anatomical malformationswhere bi-nasal prongs or physicalconditions where positive airwaypressure is contraindicated,including but not limited to:pneumothorax, pneumocephalus,cerebrospinal fluid leak, andhypotension.• Injury/trauma/severe deformitythat might be exacerbated by useof nasal prongs or mask.	Identical
Sterile vs. Non-Sterile	Non-sterile	Non-sterile	Identical
Single Use vs.Reusable	Single Use	Single Use	Identical
Patient Population	• Neonates, birth to 1 month of age• Infants, 1 month to 2 years of age• Children, 2 to 12 years of age	• Neonates, birth to 1 month of age• Infants, 1 month to 2 years of age• Children, 2 to 12 years of age	Identical
Patient Acuity	Spontaneously breathing patients	Spontaneously breathing patients	Identical
OperatingEnvironment	Professional Healthcare	Hospital environment	Identical
Ambient OperatingTemperature	20-26°C	18 - 26 °C	Similar. The ambient temperatures ofboth theCubCannula and thepredicate device arenearly identical.The maximumtemperature rangeis identical to thepredicate. Theminimum valuedoes not extendbeyond theapproved limits ofthe predicatedevice. As theambienttemperature of the

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

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

Range of CannulaSizes							subject device iswithin that of thepredicate, this doesnot raise andadditional concernsfor safety andeffectiveness of thesubject device.Similar. The subjectdevice includes the
	Available in five different sizeswhich are indicated by color.			Available in six different sizes whichare indicated by color			same sizes as thepredicate (ExtraSmall, Small,Medium, Large,Extra Large) with theexception of theExtra Extra Largesize. The exclusionof this additionalsize offered with thepredicate devicedoes not raise anyadditional concernsof safety andeffectiveness for thesubject device.

Flow Rates	ProductCode	Size	FlowRates(L/min)	ProductCode	Size	FlowRates(L/min)	Similar. Theflowrates of boththe CubCannula andthe predicate device
	HUD2701XS	XS	1-8	OJR410	XS	0.5-8	are nearly identical.All five allowable
	HUD2701S	S	1-8	OJR412	S	0.5-9	flowrate ranges fallwithin 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.No values extend
	HUD2701L	L	1-25		L		beyond the cleared
	HUD2701XL	XL	1-25	OJR418	XL	0.5-25	limits of thepredicate 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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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.

Regulation Number and Section

§ 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).