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

{0}------------------------------------------------ Image /page/0/Picture/0 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". 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. {1}------------------------------------------------ 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) 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. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The logo consists of the word "MEDLINE" in bold, white letters, positioned to the left of a stylized white cross-like symbol. The cross has a unique design, with its arms tapering to points, giving it a modern and distinctive appearance. 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 {5}------------------------------------------------ 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. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, bold letters. A white symbol that resembles a stylized cross or starburst is behind the text. The background is a solid dark blue color. 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®<br>Dri-Tech™ Breathing<br>Circuits (Adult) | Predicate Device<br>Hybernite RT Single Limb<br>and Dual Heated Breathing<br>Circuits (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-Tech<br>Breathing Circuit is intended<br>for pediatric to adult<br>patients in a professional<br>healthcare environment as a<br>conduit for warmed and<br>humidified respiratory gases<br>between a patient and a<br>ventilator and includes<br>heated wires for use with<br>the Hudson RCI Neptune<br>Heated Humidifier.<br>These devices are indicated<br>for single patient use only. | The Hybernite RT heated<br>breathing circuits are<br>intended to carry warmed /<br>moistened gas from the<br>humidifier to the patient's<br>airways. The Hybernite RT<br>breathing tubes are<br>indicated for patient<br>populations from neonates<br>to adults. They may be<br>used in the home or<br>hospital environments.<br>They are for single patient<br>use only. | Similar. Both the<br>subject device and the<br>predicate device are<br>intended to serve as a<br>conduit for warm,<br>humidified respiratory<br>gas from a ventilator to<br>the patient's airways.<br>The predicate device<br>(K151461) is cleared for<br>use in both home and<br>professional healthcare<br>environments while the<br>subject device is<br>seeking clearance for<br>use in professional<br>healthcare<br>environments only. The<br>predicate device is | #### TABLE 17-1: COMPARISON OF PROPOSED AND PREDICATE DEVICES {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the Medline logo against a solid 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 white and appears to be composed of four elongated, pointed shapes converging 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. > 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, {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The word "MEDLINE" is in bold, sans-serif font. Above the text is a white symbol that resembles a stylized star or compass rose. The symbol has four points, each pointing in a different direction. | | | | therefore the | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | indications for use are | | | | | substantially | | | | | equivalent. | | Reusability | Single patient use,<br>disposable | Single patient use,<br>disposable | Identical. | | Regulation Number | 868.5270 | 868.5270 | Identical. | | Prescription vs. OTC | Prescription | Prescription | Identical. | | Contraindications | No known contraindications | No known<br>contraindications | Identical. | | Sterile vs. Non-Sterile | Not sterile | Not sterile | Identical. | | Patient Population | Pediatric and adults | Neonates to adults | Similar. The subject<br>device is not intended<br>for neonates and<br>infants. The exclusion<br>of the neonate and<br>infant patient<br>population from the<br>subject device does not<br>raise any additional<br>questions of safety and<br>effectiveness | | Environment of Use | Professional healthcare<br>environment | Home and Healthcare<br>Environment | Similar.<br>The Hudson RCI Dri-<br>Tech Breathing Circuit<br>is not being used in the<br>home environment,<br>while the predicate<br>device includes the<br>home as an<br>environment of use.<br>The Professional<br>Healthcare<br>environment remains<br>unchanged for the<br>proposed device. The<br>exclusion of the home<br>environment from the<br>subject device does not<br>raise any additional<br>questions of safety and<br>effectiveness. | | Useful Life | Dispose of the product once<br>patient therapy has been<br>completed or after a<br>maximum of 12 days | Dispose of the product<br>once patient therapy has<br>been completed or after a<br>maximum of 30 days | Similar. While the<br>predicate device is<br>cleared for a longer<br>useful life (30 days)<br>than the proposed<br>device, the Dri-Tech<br>breathing circuits have<br>met all applicable<br>useful life and<br>biocompatibility<br>requirements for the<br>intended 12-day useful<br>life and will be labeled<br>as intended. A longer<br>useful life is more<br>challenging to meet as<br>longer use leads to<br>more opportunities for<br>an issue to arise.<br>Therefore, a shorter<br>useful claim does not | | Compatible<br>Connectors | Standard connector (22mm) | Standard Connector<br>(22mm) | Identical. | | Compatible<br>Accessories | Tubing adaptors Humidifier limb Tubing hanger Accessory tee(s) Ventilator accessory and<br>extension line Pressure monitoring<br>line(s) and adaptors | Tubing adaptors Humidifier limb | Similar. The proposed<br>Dri-Tech breathing<br>circuits may be<br>packaged or assembled<br>with additional Class I<br>devices as compared to<br>the predicate. As<br>additional accessories<br>can potentially affect<br>safety and<br>effectiveness, testing<br>was completed using<br>all accessories to<br>ensure their use did<br>not introduce any new<br>risks or negatively | | | | | affect performance.<br>Verification testing was<br>completed specific to<br>usage of the ventilator<br>accessory, and useful<br>life testing was<br>completed with the<br>ventilator accessories,<br>all adaptors, tubing<br>hangers, and pressure<br>monitoring accessories<br>to ensure safety and<br>efficacy. | | Circuit Configurations | Single Limb and Dual Limb<br>Heated Wire Circuit | Single Limb and Dual Limb<br>Heated Wire Circuit | Identical. | | Power Source | Humidifier controlled | Humidifier controlled | Identical. | | Mode of Action | When a voltage is applied, a<br>current flows through the<br>heating wires. Due to the<br>wire resistance, heat is<br>dissipated through the wall<br>of the tube construction<br>into the air flow in the<br>lumen of the tubing. As a<br>result, the air passing<br>through the tubing is<br>warmed and humidified<br>reducing or eliminating<br>water condensation and/or<br>pooling of water in the<br>breathing circuit. | When a voltage is applied,<br>a current flows through the<br>heating wires. Due to the<br>wire resistance, heat is<br>dissipated through the wall<br>of the tube construction<br>into the air flow in the<br>lumen of the tubing. As a<br>result, the air passing<br>through the tubing is<br>warmed reducing or<br>eliminating water<br>condensation and/or<br>pooling of water in the<br>breathing circuit. | Identical. | | Energy Used/Delivered | Due to the wire resistance,<br>heat is dissipated through<br>the wall of the tube<br>construction into the air<br>flow in the lumen of the<br>tubing.<br><br>The raising of the gas<br>temperature does not | Due to the wire resistance,<br>heat is dissipated through<br>the wall of the tube<br>construction into the air<br>flow in the lumen of the<br>tubing.<br><br>The raising of the gas<br>temperature does not | Similar. The proposed<br>device is tested to the<br>most current revision<br>(ISO 80601-2-74:2017)<br>of the applicable<br>standard that the<br>predicate was originally<br>tested to. By meeting | | | exceed a specific enthalpy of<br>197 kJ/m³ (equivalent to<br>43°C at 100% relative<br>humidity) | exceed 40°C. | the requirement of the<br>latest standard<br>revision, the circuit is<br>shown to be safe and<br>effective without<br>raising any additional<br>questions of safety and<br>effectiveness. | | Length and Diameter | Length:<br>Inspiratory: 1.7m<br>Expiratory: 2.0m<br>Circuit Inner Diameter: 19<br>mm Ø | The Hybernite RT tubing<br>has a range of tubing<br>dimensions, depending on<br>the clinical application<br>connected to the<br>humidifier:<br>Internal diameter from<br>10 mm to 22 mm<br>Length from 0.3 meters to<br>2.4 meters | Similar. The proposed<br>device ID varies slightly<br>from the predicate<br>device but is within the<br>range that our<br>predicate device claims<br>and has testing to<br>support. The length<br>and diameter of the<br>circuit can potentially<br>affect compressible gas<br>volume within the<br>circuit and resistance<br>to flow; however, the<br>proposed device was<br>tested for compliance<br>and resistance to flow<br>to ISO 5367:2014 and<br>met the requirements<br>of the standard for<br>breathing circuits. As<br>the length and<br>diameters are within<br>the predicate range<br>and tested to the latest<br>standards, no<br>additional questions of<br>safety and | | | | | effectiveness are raised<br>by the differences. | | Heating Wire | Encased | Encased | Identical. | | Resistance to Flow<br>(Inspiratory Limb) | Dri-Tech Adult:<br>Less than 1.8 cmH2O @ 30<br>LPM (per ISO 5367:2014) | Hybernite Adult:<br>Less than .06 hPa/LPM @<br>30 LPM (per ISO<br>5367:2014) | Identical. Following ISO<br>5367:2014, the<br>proposed breathing<br>circuit is tested at<br>15LPM and 30 LPM. At<br>each flow rate the<br>resistance to flow is<br>below 1.8 cmH2O (1.8<br>hPa) as required by the<br>standard | | Compliance | Dri-Tech Adult:<br>Less than 5 mL/cmH2O @ 60<br>cmH2O (per ISO 5367:2014) | Hybernite Adult:<br>Less than 5 mL/hPa @ 60<br>hPa (per ISO 5367:2014) | Identical. Following ISO<br>5367:2014, the<br>proposed breathing<br>circuits were tested at<br>60 cmH2O. At 60<br>cmH2O the compliance<br>is below 1.5 mL/cmH2O<br>(infant) and 5<br>mL/cmH2O (adult) as<br>required by the<br>standard | | Leakage | Less than 30 ml/min @ 60<br>cmH2O (per ISO 5367:2014) | Unknown | Following ISO<br>5367:2014, the<br>proposed breathing<br>circuits was tested at<br>60 cmH2O. At 60<br>cmH2O the leakage is<br>40 ml/min or less as<br>required by the<br>standard | | Standards | BS EN ISO 5367:2014<br>BS EN ISO 5356-1:2015 | ISO 5367<br>ISO 5356 | Identical. Latest<br>revisions 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 | | | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized star-like symbol above it. The symbol is also white and appears to be composed of four intersecting lines. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star or compass symbol. The symbol is white and appears to be composed of four elongated triangles pointing outwards from a central point, creating a sense of direction or navigation. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image features the Medline logo set against a solid blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized, white starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points, creating a dynamic and recognizable emblem for the company. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image features the Medline logo set against a solid blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is white and appears to be composed of four elongated, pointed shapes converging at a central point, creating a dynamic and modern design. {13}------------------------------------------------ Image /page/13/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. Above the word is a white star-like symbol with four points. 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 int…