The Hudson RCI Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas.

Device Description

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Dri-Tech Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".

The adult dual limb configuration consists of 19mm ID inspiratory limbs with 22mm connectors that are compliant to ISO 5356-1.2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. The adult circuits have a length of 1.7m on the inspiratory limb, and are kitted with the accessories described below:

Tubing Adaptor: 22mm male to male adaptor for various connections as required.
. Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement.
. Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections.
. Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit:

. Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow.
The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:
Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line.
Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.
Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor.
15mm Adaptor: Optional accessory required for connecting to certain patient interfaces.
Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line.
Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections.
Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience.
The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the Hudson RCI Dri-Tech Breathing Circuits. This document outlines the device's characteristics, intended use, and a comparison with a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria in the form of numerical performance targets, nor does it detail a study that proves the device meets such criteria using a test set, expert adjudication, or MRMC/standalone performance metrics. The information provided heavily focuses on bench testing to established industry standards (e.g., ISO 5367:2014, ISO 80601-2-74:2017) and biocompatibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific numerical acceptance criteria (e.g., a specific percentage for sensitivity or specificity) are not stated for AI/algorithm performance. The document describes a comparison to a predicate device and adherence to recognized standards, which are the basis for the FDA's substantial equivalence determination for this breathing circuit, not an AI-powered diagnostic device.

Similarly, other requested information such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, and ground truth establishment are not applicable to the type of device and testing described in this FDA submission. The device is a medical accessory, not an AI/ML-driven diagnostic or assistive tool.

Key takeaways from the document regarding "acceptance criteria" and "study":

Acceptance Criteria (as implied by the regulatory submission): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to a predicate device and meeting the requirements of recognized international standards for breathing circuits. These standards define performance characteristics such as resistance to flow, compliance, and leakage.
- Resistance to Flow: Less than 1.8 cmH2O @ 30 LPM (per ISO 5367:2014)
- Compliance: Less than 5 mL/cmH2O @ 60 cmH2O (per ISO 5367:2014)
- Leakage: Less than 30 ml/min @ 60 cmH2O (per ISO 5367:2014)
- Biocompatibility: Meeting the requirements of ISO 10993-1:2018 and ISO 18562-1:2017 for gas pathway evaluation (particulate matter, VOCs, leachables in condensate).
- Safety: Meeting ISO 80601-2-74:2017 (Safety Testing), IEC 60601-1:2005 (Electrical Safety), and IEC 60601-1-2:2014 (EMC).
- Useful Life: Meeting requirements for an intended 12-day useful life.
Study That Proves the Device Meets the Criteria: The "study" described is a compilation of non-clinical bench testing.
- Performance Testing (Bench): This included verification of features like length, leakage rate, compliance, resistance to flow (with and without bend), adaptor retention, circuit weight, ventilator accessory flow rate, expiratory star lumen tubing kink and crush resistance, moisture removal, and pressures.
- Biocompatibility Testing: Evaluated cytotoxicity, irritation/intracutaneous reactivity, sensitization, genotoxicity, material mediated pyrogenicity, and extractables/leachables. Gas pathway evaluation included particulate matter and VOCs.
- Electrical Safety and EMC Testing: Per IEC 60601-1 and IEC 60601-1-2.
- Human Factors and Usability Testing: Summative testing was performed.

Therefore, I cannot populate the table or provide detailed responses to the AI/ML-specific questions as they are not relevant to the provided text.

In summary, based on the provided document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (derived from standards):
  - Resistance to Flow: < 1.8 cmH2O @ 30 LPM (ISO 5367:2014)
  - Compliance: < 5 mL/cmH2O @ 60 cmH2O (ISO 5367:2014)
  - Leakage: < 30 ml/min @ 60 cmH2O (ISO 5367:2014)
  - Useful Life: 12 days
  - Biocompatibility: Pass ISO 10993-1:2018 & ISO 18562-1:2017 (Particulate matter, VOCs, etc.)
  - Electrical Safety/EMC: Pass IEC 60601-1, IEC 60601-1-2, ISO 80601-2-74:2017
- Reported Device Performance: The document states the device met the requirements of the standards for these parameters. For instance, for resistance to flow, it states "At each flow rate the resistance to flow is below 1.8 cmH2O (1.8 hPa) as required by the standard." For compliance, "At 60 cmH2O the compliance is below... 5 mL/cmH2O (adult) as required by the standard." For leakage, "At 60 cmH2O the leakage is 40 ml/min or less as required by the standard." Specific numerical results are not provided beyond meeting the thresholds.
Sample sizes used for the test set and the data provenance: Not applicable to this type of device testing. Testing was non-clinical bench testing of the physical breathing circuits.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a breathing circuit's physical performance is established by direct measurement against engineering specifications and industry standards.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML-driven device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For physical performance testing, the ground truth is defined by the numerical limits and methodologies specified in the relevant international standards (e.g., ISO 5367, ISO 80601). For biocompatibility, it's defined by the toxicological and chemical profiling methods in ISO 10993 and ISO 18562.
The sample size for the training set: Not applicable. The device is not based on AI/ML.
How the ground truth for the training set was established: Not applicable.

Summary

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June 4, 2024

Medline Industries, LP Phyllis Kondor Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093

Re: K234032

Trade/Device Name: Hudson RCI Dri-Tech Breathing Circuits: HUD99035/Dri-Tech Adult Circuit: HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit: HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit: HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II

Product Code: BZE Dated: December 20, 2023 Received: December 20, 2023

Dear Phyllis Kondor:

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.

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concerning your device in the Federal Register.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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 Sleep Disordered Breathing, Respiratory and Anesthesia 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K234032

Device Name

Hudson RCI Dri-Tech Breathing Circuits:

HUD99035/Dri-Tech Adult Circuit

HUD99035KIT/Dri-Tech Adult Circuit Kit

HUD99098KIT/Single Limb Adult Dri-Tech Kit

HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit

HUD900/Dri-Tech Ventilator Accessory

HUD901/Dri-Tech Ventilator Accessory Extension Line

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

Section 17 510(k) Summary

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Submission Correspondent

Phyllis Kondor Regulatory Affairs Specialist pkondor@medline.com 1-800-633-5463

Summary Preparation Date May 8, 2024

Type of 510(k) Submission

Traditional

Device Name / Classification

Trade Name: Hudson RCI® Dri-Tech™ Breathing Circuits Model Numbers:

HUD99035 / Dri-Tech Adult Circuit
HUD99035KIT / Dri-Tech Adult Circuit Kit
HUD99098KIT / Single Limb Adult Dri-Tech Kit
HUD99098KITF / Single Limb Adult Dri-Tech Filter Kit
. HUD900 / Dri-Tech Ventilator Accessory
HUD901 / Dri-Tech Ventilator Accessory Extension Line

Classification Name: Breathing system heater Product Code: BZE Classification Panel: Anesthesiology (Respiratory) Regulatory Class: Class II Regulation Number: 21 CFR 868.5270

Predicate Device

Hybernite RT Single Limb and Dual Heated Breathing Circuits (K151461)

Device Description

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare

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Image /page/5/Picture/0 description: The image features the Medline logo, which consists of the company's name in bold, white letters against a dark blue square background. A stylized white starburst or cross shape is positioned behind the text, with its points extending beyond the edges of the square. The overall design is clean and professional, conveying a sense of medical expertise and reliability.

Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

Tubing Adaptor: 22mm male to male adaptor for various connections as required.
. Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement.
. Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections.
. Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.

Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit:

. Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow.
The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:
Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line.
Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.
Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor.
15mm Adaptor: Optional accessory required for connecting to certain patient interfaces.
Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line.
Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections.

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Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience.
The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.

Indications for Use

The Hudson RCl® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator, and to maintain the temperature of humidified inspired gas.

Principle of Operation

The basic principle of operation of the Hudson RCI Dri-Tech Breathing circuit is the inspiratory limb attaches to the Hudson RCI Neptune Heated Humidifier (which is attached to the ventilator inhalation port) and the expiratory limb attaches to the ventilator. The circuit acts as a conduit to ventilate the patient, and maintains the heat and humidity through the use of heated wire within the circuit.

Summary of Technological Characteristics

Device Characteristic	Subject Device Hudson RCI®Dri-Tech™ BreathingCircuits (Adult)	Predicate DeviceHybernite RT Single Limband Dual Heated BreathingCircuits (K151461)	Comparison Analysis
Manufacturer	Medline Industries, LP	Plastiflex Healthcare
Product Code	BZE	BZE	Identical.
Classification	Class II	Class II	Identical.
Indications for Use	The Hudson RCI Dri-TechBreathing Circuit is intendedfor pediatric to adultpatients in a professionalhealthcare environment as aconduit for warmed andhumidified respiratory gasesbetween a patient and aventilator and includesheated wires for use withthe Hudson RCI NeptuneHeated Humidifier.These devices are indicatedfor single patient use only.	The Hybernite RT heatedbreathing circuits areintended to carry warmed /moistened gas from thehumidifier to the patient'sairways. The Hybernite RTbreathing tubes areindicated for patientpopulations from neonatesto adults. They may beused in the home orhospital environments.They are for single patientuse only.	Similar. Both thesubject device and thepredicate device areintended to serve as aconduit for warm,humidified respiratorygas from a ventilator tothe patient's airways.The predicate device(K151461) is cleared foruse in both home andprofessional healthcareenvironments while thesubject device isseeking clearance foruse in professionalhealthcareenvironments only. Thepredicate device is

TABLE 17-1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

cleared for use in neonates to adults while the subject device is seeking clearance for use in pediatric through adult patients. The subject device does not include neonates or infants in its indications for use. Both the subject and predicate device are indicated for single patient use.

Our device is not adding additional patient populations or environments of use versus the device cleared in K151461, as the predicate device is cleared for broader patient populations and environments of use. The differences in the indications for use for the subject device and predicate device are solely the expanded environment of use and patient population cleared under K151461.The exclusion of the home environment and the neonate and infant population from the subject device does not raise any additional questions of safety and effectiveness in the subject device as these are characteristics cleared in K151461,

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			therefore the
			indications for use are
			substantially
			equivalent.
Reusability	Single patient use,disposable	Single patient use,disposable	Identical.
Regulation Number	868.5270	868.5270	Identical.
Prescription vs. OTC	Prescription	Prescription	Identical.
Contraindications	No known contraindications	No knowncontraindications	Identical.
Sterile vs. Non-Sterile	Not sterile	Not sterile	Identical.
Patient Population	Pediatric and adults	Neonates to adults	Similar. The subjectdevice is not intendedfor neonates andinfants. The exclusionof the neonate andinfant patientpopulation from thesubject device does notraise any additionalquestions of safety andeffectiveness
Environment of Use	Professional healthcareenvironment	Home and HealthcareEnvironment	Similar.The Hudson RCI Dri-Tech Breathing Circuitis not being used in thehome environment,while the predicatedevice includes thehome as anenvironment of use.The ProfessionalHealthcareenvironment remainsunchanged for theproposed device. Theexclusion of the homeenvironment from thesubject device does notraise any additionalquestions of safety andeffectiveness.
Useful Life	Dispose of the product oncepatient therapy has beencompleted or after amaximum of 12 days	Dispose of the productonce patient therapy hasbeen completed or after amaximum of 30 days	Similar. While thepredicate device iscleared for a longeruseful life (30 days)than the proposeddevice, the Dri-Techbreathing circuits havemet all applicableuseful life andbiocompatibilityrequirements for theintended 12-day usefullife and will be labeledas intended. A longeruseful life is morechallenging to meet aslonger use leads tomore opportunities foran issue to arise.Therefore, a shorteruseful claim does not
CompatibleConnectors	Standard connector (22mm)	Standard Connector(22mm)	Identical.
CompatibleAccessories	Tubing adaptors Humidifier limb Tubing hanger Accessory tee(s) Ventilator accessory andextension line Pressure monitoringline(s) and adaptors	Tubing adaptors Humidifier limb	Similar. The proposedDri-Tech breathingcircuits may bepackaged or assembledwith additional Class Idevices as compared tothe predicate. Asadditional accessoriescan potentially affectsafety andeffectiveness, testingwas completed usingall accessories toensure their use didnot introduce any newrisks or negatively
			affect performance.Verification testing wascompleted specific tousage of the ventilatoraccessory, and usefullife testing wascompleted with theventilator accessories,all adaptors, tubinghangers, and pressuremonitoring accessoriesto ensure safety andefficacy.
Circuit Configurations	Single Limb and Dual LimbHeated Wire Circuit	Single Limb and Dual LimbHeated Wire Circuit	Identical.
Power Source	Humidifier controlled	Humidifier controlled	Identical.
Mode of Action	When a voltage is applied, acurrent flows through theheating wires. Due to thewire resistance, heat isdissipated through the wallof the tube constructioninto the air flow in thelumen of the tubing. As aresult, the air passingthrough the tubing iswarmed and humidifiedreducing or eliminatingwater condensation and/orpooling of water in thebreathing circuit.	When a voltage is applied,a current flows through theheating wires. Due to thewire resistance, heat isdissipated through the wallof the tube constructioninto the air flow in thelumen of the tubing. As aresult, the air passingthrough the tubing iswarmed reducing oreliminating watercondensation and/orpooling of water in thebreathing circuit.	Identical.
Energy Used/Delivered	Due to the wire resistance,heat is dissipated throughthe wall of the tubeconstruction into the airflow in the lumen of thetubing.The raising of the gastemperature does not	Due to the wire resistance,heat is dissipated throughthe wall of the tubeconstruction into the airflow in the lumen of thetubing.The raising of the gastemperature does not	Similar. The proposeddevice is tested to themost current revision(ISO 80601-2-74:2017)of the applicablestandard that thepredicate was originallytested to. By meeting
	exceed a specific enthalpy of197 kJ/m³ (equivalent to43°C at 100% relativehumidity)	exceed 40°C.	the requirement of thelatest standardrevision, the circuit isshown to be safe andeffective withoutraising any additionalquestions of safety andeffectiveness.
Length and Diameter	Length:Inspiratory: 1.7mExpiratory: 2.0mCircuit Inner Diameter: 19mm Ø	The Hybernite RT tubinghas a range of tubingdimensions, depending onthe clinical applicationconnected to thehumidifier:Internal diameter from10 mm to 22 mmLength from 0.3 meters to2.4 meters	Similar. The proposeddevice ID varies slightlyfrom the predicatedevice but is within therange that ourpredicate device claimsand has testing tosupport. The lengthand diameter of thecircuit can potentiallyaffect compressible gasvolume within thecircuit and resistanceto flow; however, theproposed device wastested for complianceand resistance to flowto ISO 5367:2014 andmet the requirementsof the standard forbreathing circuits. Asthe length anddiameters are withinthe predicate rangeand tested to the lateststandards, noadditional questions ofsafety and
			effectiveness are raisedby the differences.
Heating Wire	Encased	Encased	Identical.
Resistance to Flow(Inspiratory Limb)	Dri-Tech Adult:Less than 1.8 cmH2O @ 30LPM (per ISO 5367:2014)	Hybernite Adult:Less than .06 hPa/LPM @30 LPM (per ISO5367:2014)	Identical. Following ISO5367:2014, theproposed breathingcircuit is tested at15LPM and 30 LPM. Ateach flow rate theresistance to flow isbelow 1.8 cmH2O (1.8hPa) as required by thestandard
Compliance	Dri-Tech Adult:Less than 5 mL/cmH2O @ 60cmH2O (per ISO 5367:2014)	Hybernite Adult:Less than 5 mL/hPa @ 60hPa (per ISO 5367:2014)	Identical. Following ISO5367:2014, theproposed breathingcircuits were tested at60 cmH2O. At 60cmH2O the complianceis below 1.5 mL/cmH2O(infant) and 5mL/cmH2O (adult) asrequired by thestandard
Leakage	Less than 30 ml/min @ 60cmH2O (per ISO 5367:2014)	Unknown	Following ISO5367:2014, theproposed breathingcircuits was tested at60 cmH2O. At 60cmH2O the leakage is40 ml/min or less asrequired by thestandard
Standards	BS EN ISO 5367:2014BS EN ISO 5356-1:2015	ISO 5367ISO 5356	Identical. Latestrevisions are used for
BS EN ISO 80601-2-74:2017	ISO 8185	all applicable
BS EN ISO 10993-1:2018	ISO 10993	standards, and
BS EN ISO 18562-1:2017	IEC 60601-1	superseded standards
BS EN 60601-1:2006	IEC 60601-1-2	have been replaced
BS EN 60601-1-2:2015	IEC 62366	(ISO 80601 replacing
BS EN 62366-1:2015		ISO 8185)
IEC 60601-4-2:2016

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Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

As evidenced by the predicate device comparison table above, the Hudson RC1® Dri-Tech™ Breathing Circuits have the same characteristics as the predicate device, including intended use, operating principles, and fundamental scientific technology. The Hudson RC® Dri-Tech™ Breathing Circuits have undergone non-clinical testing that covers electrical and thermal safety, environmental conditions, functional verification, and performance testing.

The Hudson RC® Dri-Tech™ Breathing Circuits are identical to the predicate device in the following characteristics:

Intended use for carrying heated gas between a patient and a ventilator ●
Mode of Action ●
Circuit Configurations ●
Power source
Heating Wire
Standards
. Compliance
Resistance to Flow

The differences between the Dri-Tech™ Breathing Circuits and the predicate device are:

Patient population the predicate device is cleared for use in neonates to adult patients while the subject device ● is not intended for neonates and infants. The exclusion of the neonate and infant population from the subject device does not raise any additional questions of safety and effectiveness. The subject device and predicate are substantially equivalent as both are intended for use in children, adolescents, and adults.
. Environment of use – the predicate device is cleared for home use and use in professional healthcare environments while the subject device is only intended for use in professional healthcare environments. The exclusion of the home environment for the subject device does not raise any additional questions of safety and effectiveness as the subject and predicate are substantially equivalent as it relates to use in professional healthcare environments.
Useful life – while the predicate device is cleared for a longer useful life (30 days) than the proposed device, the Dri-Tech breathing circuits have met all applicable useful life and biocompatibility requirements for the intended 12 day useful life and will be labeled as intended. The proposed useful life for Dri-Tech does not exceed the cleared useful life for the predicate device and therefore does not raise any additional questions of safety and effectiveness.

These differences do not raise different risks or concerns of safety and effectiveness compared to the predicate. Based on the information provided, the Dri-Tech Breathing Circuits are substantially equivalent to the Hybernite Single Limb and Dual Heated Breathing Circuits.

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Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

Summary of Non-Clinical Testing

Biocompatibility Testing

Cytotoxicity
Irritation or Intracutaneous Reactivity
Sensitization
Genotoxicity
Implantation *
Material Mediated Pyrogenicity
Extractables/Leachables
Acute Systemic Toxicity *
Subacute Toxicity*
Subchronic Toxicity*
Chronic Toxicity*
Carcinogenicity*

Per ISO 10993-1:2018, these tests were evaluated

Additionally, due to the nature of contact, the Dri-Tech breathing circuits were also evaluated per Gas Pathway Evaluation per ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process.

The following gas pathway endpoints were tested or evaluated(*) based on the device categorization and intended use:

Particulate matter
VOCs
Leachables in Condensate*

The exterior circuit components are classified as intact with a Permanent contact duration (>30 days).

The following biological endpoints were evaluated based on the device categorization and intended use:

. Cytotoxicity
Irritation or Intracutaneous Reactivity
. Sensitization

Performance Testing (Bench)

Distribution Simulation Testing – Shipping and Packaging Integrity Time 0 Useful Life Validation Testing 1 Year Accelerated Aged Useful Life Validation Testing ISO 5356-1:2015 Gauge Testing

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Image /page/15/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is composed of four elongated, pointed shapes that converge at a central point, creating a dynamic and modern design.

Traditional 510(k) Premarket Notification Hudson RCI® Dri-Tech™ Breathing Circuits All information on this page is confidential.

ISO 5367:2014 Testing

-Length
Leakage Rate -
-Compliance
-Resistance to Flow
-Resistance to Flow with a Bend
-Adaptor Retention

Circuit Weight Testing

Dri-Tech Ventilator Accessory Flow Rate Testing

Expiratory Star Lumen Tubing Kink and Crush Resistance

Moisture Removal Performance Testing

Dri-Tech Ventilator Accessory and Circuit Related Pressures Testing

Expiratory Star Lumen Tubing Flow Rate (Information Only)

ISO 80601-2-74:2017 Safety Testing

IEC 60601-1:2005 Electrical Safety Testing

IEC 60601-1-2:2014 Electromagnetic Compatibility and Immunity Testing

Summative Human Factors and Usability Testing

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

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Hudson RCl® Dri-Tech™ Breathing Circuits are substantially equivalent to the Hybernite RT Single Limb and Dual Heated Breathing Circuits (K151461) with respect to the indications for use, patient population, environment of use, circuit configurations and technological characteristics.

Regulation Number and Section

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).