(182 days)
Not Found
No
The summary describes a physical nasal cannula and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to administer respiratory gas to patients, which is a therapeutic intervention for respiratory support.
No
The device is a nasal cannula used to administer respiratory gas. It delivers heated and humidified gas and is intended for use as a patient interface, not for diagnostic purposes.
No
The device description clearly outlines physical components like prongs, lariat, bolo, and hydrocolloid pads, indicating it is a hardware device.
Based on the provided text, the Hudson RCI Comfort Flo® CubCannula™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for administering respiratory gas to a spontaneously breathing patient through both nostrils. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description details a nasal cannula with prongs, lariat, and bolo, designed to deliver heated and humidified gas. This aligns with a respiratory support device, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device is a medical device used for respiratory support, specifically delivering gas to the patient.
N/A
Intended Use / 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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nostrils
Indicated Patient Age Range
- Neonates, birth to 1 month of age
- Infants, 1 month to 2 years of age
- Children, 2 to 12 years of age
Intended User / Care Setting
professional healthcare environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility Testing: 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.
Performance Testing (Bench): Tests performed include 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, Peel Testing, Transportation simulation, and 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.
Key results: Conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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"
1
Page
2
(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).
2
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
3
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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4
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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 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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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
Page 2 of 7
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Traditional 510(k) Premarket Notification Hudson RCI® Comfort Flo®
| Device Characteristic | Proposed Device
Comfort Flo® CubCannula™ | Primary Predicate Device F&P
Optiflow Junior 2/2+ Nasal
Cannula Interface Range
K222197 | Comparison
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®
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. | The Fisher & Paykel Healthcare
Optiflow Junior 2 nasal cannula is a
single use nasal cannula intended
for use with a nasal high flow
therapy (NHF) system to deliver
heated and humidified nasal high
flow therapy to spontaneously
breathing patients.
This product is designed for use in
hospital environments and must be
prescribed by a physician. The
intended pediatric subpopulations
targeted for use of the F&P
Optiflow Junior 2 Nasal Cannula
range includes:
• 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 | Similar. The
indications for use
for the subject and
predicate device are
similar with the
exception the
environment of use.
The predicate is
cleared for use in
hospital
environments only,
while the subject
device is seeking
clearance in
professional
healthcare
environments. |
| Shelf Life | 2 years | 3 years | Similar. The subject
device has a shelf
life of 2 years while
the predicate has a
shelf life of 3 years. |
| Useful Life | 10 days | 7 days | Similar. The subject
device has a
maximum useful life
of 10 days while the
predicate device has
a maximum useful
life of 7 days.
Testing has been
performed to
validate the 10-day
useful life (safety |
| | | | factor included). |
| Prescription vs. OTC | Prescription | Prescription | Identical |
| 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. | 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. | 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 |
| Operating
Environment | Professional Healthcare | Hospital environment | Identical |
| Ambient Operating
Temperature | 20-26°C | 18 - 26 °C | Similar. The ambient temperatures of
both the
CubCannula and the
predicate device are
nearly identical.
The maximum
temperature range
is identical to the
predicate. The
minimum value
does not extend
beyond the
approved limits of
the predicate
device. As the
ambient
temperature 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 Cannula
Sizes | | | | | | | subject device is
within that of the
predicate, this does
not raise and
additional concerns
for safety and
effectiveness of the
subject device.
Similar. The subject
device includes the |
|---------------------------|--------------------------------------------------------------------|------|--------------------------|------------------------------------------------------------------|------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Available in five different sizes
which are indicated by color. | | | Available in six different sizes which
are indicated by color | | | same sizes as the
predicate (Extra
Small, Small,
Medium, Large,
Extra Large) with the
exception of the
Extra Extra Large
size. The exclusion
of this additional
size offered with the
predicate device
does not raise any
additional concerns
of safety and
effectiveness for the
subject device. |
| | | | | | | | |
| Flow Rates | Product
Code | Size | Flow
Rates
(L/min) | Product
Code | Size | Flow
Rates
(L/min) | Similar. The
flowrates of both
the CubCannula and
the 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 fall
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.
No values extend |
| | HUD2701L | L | 1-25 | | L | | beyond the cleared |
| | HUD2701XL | XL | 1-25 | OJR418 | XL | 0.5-25 | limits of the
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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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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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.