(167 days)
No
The summary describes a passive breathing circuit with heated wires for temperature maintenance and condensation reduction. There is no mention of any computational analysis, learning, or adaptive behavior that would indicate the presence of AI/ML. The testing focuses on physical properties, biocompatibility, and basic performance metrics like flow rate and resistance.
No
The device is described as a "conduit of breathing gas between a patient and a ventilator" and functions to "maintain the temperature of humidified inspired gas" and minimize condensation. It is an accessory to a ventilator system rather than a device that directly treats a medical condition.
No
The device is a breathing circuit designed to deliver breathing gas between a patient and a ventilator and maintain the temperature of humidified inspired gas. It is a conduit and does not perform any diagnostic function.
No
The device description clearly details physical components such as tubing, heated wires, adaptors, and other accessories, indicating it is a hardware device, not software-only.
Based on the provided text, the Hudson RCI Dri-Tech Breathing Circuits are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is a "conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas." This describes a device used in vivo (on a living patient) for respiratory support, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details components like tubing, adaptors, heated wires, and connections to patient interfaces (like tubes and masks). These are all consistent with a respiratory support device used directly with a patient.
- Performance Studies: The performance studies focus on biocompatibility, mechanical performance (leakage, compliance, resistance), electrical safety, and human factors. These are typical tests for medical devices used in direct patient care, not for IVD devices which would focus on analytical performance and clinical validity of diagnostic results.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Hudson RCI Dri-Tech Breathing Circuits are a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients
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)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Flow (Inspiratory Limb): Dri-Tech Adult: Less than 1.8 cmH2O @ 30 LPM (per ISO 5367:2014). This meets the requirement of being below 1.8 cmH2O (1.8 hPa) as required by the standard.
Compliance: Dri-Tech Adult: Less than 5 mL/cmH2O @ 60 cmH2O (per ISO 5367:2014). At 60 cmH2O the compliance is below 1.5 mL/cmH2O (infant) and 5 mL/cmH2O (adult) as required by the standard.
Leakage: Less than 30 ml/min @ 60 cmH2O (per ISO 5367:2014). At 60 cmH2O the leakage is 40 ml/min or less as required by the standard.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hybernite RT Single Limb and Dual Heated Breathing Circuits (K151461)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Hudson RCI Neptune Heated Humidifier (K131912)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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®
Dri-Tech™ Breathing
Circuits (Adult) | Predicate Device
Hybernite RT Single Limb
and Dual Heated Breathing
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
Breathing Circuit is intended
for pediatric to adult
patients in a professional
healthcare environment as a
conduit for warmed and
humidified respiratory gases
between a patient and a
ventilator and includes
heated wires for use with
the Hudson RCI Neptune
Heated Humidifier.
These devices are indicated
for single patient use only. | The Hybernite RT heated
breathing circuits are
intended to carry warmed /
moistened gas from the
humidifier to the patient's
airways. The Hybernite RT
breathing tubes are
indicated for patient
populations from neonates
to adults. They may be
used in the home or
hospital environments.
They are for single patient
use only. | Similar. Both the
subject device and the
predicate device are
intended to serve as a
conduit for warm,
humidified respiratory
gas from a ventilator to
the patient's airways.
The predicate device
(K151461) is cleared for
use in both home and
professional healthcare
environments while the
subject device is
seeking clearance for
use in professional
healthcare
environments only. The
predicate device is |
TABLE 17-1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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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,
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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 known | |
| contraindications | Identical. | ||
| Sterile vs. Non-Sterile | Not sterile | Not sterile | Identical. |
| Patient Population | Pediatric and adults | Neonates to adults | Similar. The subject |
| device is not intended | |||
| for neonates and | |||
| infants. The exclusion | |||
| of the neonate and | |||
| infant patient | |||
| population from the | |||
| subject device does not | |||
| raise any additional | |||
| questions of safety and | |||
| effectiveness | |||
| Environment of Use | Professional healthcare | ||
| environment | Home and Healthcare | ||
| Environment | Similar. | ||
| The Hudson RCI Dri- | |||
| Tech Breathing Circuit | |||
| is not being used in the | |||
| home environment, | |||
| while the predicate | |||
| device includes the | |||
| home as an | |||
| environment of use. | |||
| The Professional | |||
| Healthcare | |||
| environment remains | |||
| unchanged for the | |||
| proposed device. The | |||
| exclusion of the home | |||
| environment from the | |||
| subject device does not | |||
| raise any additional | |||
| questions of safety and | |||
| effectiveness. | |||
| Useful Life | Dispose of the product once | ||
| patient therapy has been | |||
| completed or after a | |||
| maximum of 12 days | Dispose of the product | ||
| once patient therapy has | |||
| been completed or after a | |||
| maximum of 30 days | Similar. 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. A longer | |||
| useful life is more | |||
| challenging to meet as | |||
| longer use leads to | |||
| more opportunities for | |||
| an issue to arise. | |||
| Therefore, a shorter | |||
| useful claim does not | |||
| Compatible | |||
| Connectors | Standard connector (22mm) | Standard Connector | |
| (22mm) | Identical. | ||
| Compatible | |||
| Accessories | Tubing adaptors Humidifier limb Tubing hanger Accessory tee(s) Ventilator accessory and | ||
| extension line Pressure monitoring | |||
| line(s) and adaptors | Tubing adaptors Humidifier limb | Similar. The proposed | |
| Dri-Tech breathing | |||
| circuits may be | |||
| packaged or assembled | |||
| with additional Class I | |||
| devices as compared to | |||
| the predicate. As | |||
| additional accessories | |||
| can potentially affect | |||
| safety and | |||
| effectiveness, testing | |||
| was completed using | |||
| all accessories to | |||
| ensure their use did | |||
| not introduce any new | |||
| risks or negatively | |||
| affect performance. | |||
| Verification testing was | |||
| completed specific to | |||
| usage of the ventilator | |||
| accessory, and useful | |||
| life testing was | |||
| completed with the | |||
| ventilator accessories, | |||
| all adaptors, tubing | |||
| hangers, and pressure | |||
| monitoring accessories | |||
| to ensure safety and | |||
| efficacy. | |||
| Circuit Configurations | Single Limb and Dual Limb | ||
| Heated Wire Circuit | Single Limb and Dual Limb | ||
| Heated Wire Circuit | Identical. | ||
| Power Source | Humidifier controlled | Humidifier controlled | Identical. |
| Mode of Action | When a voltage is applied, a | ||
| current flows through the | |||
| heating wires. Due to the | |||
| wire resistance, heat is | |||
| dissipated through the wall | |||
| of the tube construction | |||
| into the air flow in the | |||
| lumen of the tubing. As a | |||
| result, the air passing | |||
| through the tubing is | |||
| warmed and humidified | |||
| reducing or eliminating | |||
| water condensation and/or | |||
| pooling of water in the | |||
| breathing circuit. | When a voltage is applied, | ||
| a current flows through the | |||
| heating wires. Due to the | |||
| wire resistance, heat is | |||
| dissipated through the wall | |||
| of the tube construction | |||
| into the air flow in the | |||
| lumen of the tubing. As a | |||
| result, the air passing | |||
| through the tubing is | |||
| warmed reducing or | |||
| eliminating water | |||
| condensation and/or | |||
| pooling of water in the | |||
| breathing circuit. | Identical. | ||
| Energy Used/Delivered | Due to the wire resistance, | ||
| heat is dissipated through | |||
| the wall of the tube | |||
| construction into the air | |||
| flow in the lumen of the | |||
| tubing. |
The raising of the gas
temperature does not | Due to the wire resistance,
heat is dissipated through
the wall of the tube
construction into the air
flow in the lumen of the
tubing.
The raising of the gas
temperature does not | Similar. The proposed
device is tested to the
most current revision
(ISO 80601-2-74:2017)
of the applicable
standard that the
predicate was originally
tested to. By meeting |
| | exceed a specific enthalpy of
197 kJ/m³ (equivalent to
43°C at 100% relative
humidity) | exceed 40°C. | the requirement of the
latest standard
revision, the circuit is
shown to be safe and
effective without
raising any additional
questions of safety and
effectiveness. |
| Length and Diameter | Length:
Inspiratory: 1.7m
Expiratory: 2.0m
Circuit Inner Diameter: 19
mm Ø | The Hybernite RT tubing
has a range of tubing
dimensions, depending on
the clinical application
connected to the
humidifier:
Internal diameter from
10 mm to 22 mm
Length from 0.3 meters to
2.4 meters | Similar. The proposed
device ID varies slightly
from the predicate
device but is within the
range that our
predicate device claims
and has testing to
support. The length
and diameter of the
circuit can potentially
affect compressible gas
volume within the
circuit and resistance
to flow; however, the
proposed device was
tested for compliance
and resistance to flow
to ISO 5367:2014 and
met the requirements
of the standard for
breathing circuits. As
the length and
diameters are within
the predicate range
and tested to the latest
standards, no
additional questions of
safety and |
| | | | effectiveness are raised
by the differences. |
| Heating Wire | Encased | Encased | Identical. |
| Resistance to Flow
(Inspiratory Limb) | Dri-Tech Adult:
Less than 1.8 cmH2O @ 30
LPM (per ISO 5367:2014) | Hybernite Adult:
Less than .06 hPa/LPM @
30 LPM (per ISO
5367:2014) | Identical. Following ISO
5367:2014, the
proposed breathing
circuit is tested at
15LPM and 30 LPM. At
each flow rate the
resistance to flow is
below 1.8 cmH2O (1.8
hPa) as required by the
standard |
| Compliance | Dri-Tech Adult:
Less than 5 mL/cmH2O @ 60
cmH2O (per ISO 5367:2014) | Hybernite Adult:
Less than 5 mL/hPa @ 60
hPa (per ISO 5367:2014) | Identical. Following ISO
5367:2014, the
proposed breathing
circuits were tested at
60 cmH2O. At 60
cmH2O the compliance
is below 1.5 mL/cmH2O
(infant) and 5
mL/cmH2O (adult) as
required by the
standard |
| Leakage | Less than 30 ml/min @ 60
cmH2O (per ISO 5367:2014) | Unknown | Following ISO
5367:2014, the
proposed breathing
circuits was tested at
60 cmH2O. At 60
cmH2O the leakage is
40 ml/min or less as
required by the
standard |
| Standards | BS EN ISO 5367:2014
BS EN ISO 5356-1:2015 | ISO 5367
ISO 5356 | Identical. Latest
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 | | | |
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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.
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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.
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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.
14
Image /page/14/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, block letters, stacked on top of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. The background of the logo is a solid, dark blue color.
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.