Who is the manufacturer of Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Smiths Medical Asd, Inc. filed the 510(k) submission for Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720).

What is the FDA product code for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

JOH. It is classified under 21 CFR 868.5800 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Bivona Uncuffed Pediatric Tracheostomy Tube (K912469); Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless (K122531).

Who can help prepare an FDA 510(k) submission like Portex Blue Line Ultra Paediatric Tracheosomy Tube?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Portex Blue Line Ultra Paediatric Tracheosomy Tube

K170720 · Smiths Medical Asd, Inc. · JOH · Dec 7, 2017 · Anesthesiology

Device Facts

Record ID	K170720
Device Name	Portex Blue Line Ultra Paediatric Tracheosomy Tube
Applicant	Smiths Medical Asd, Inc.
Product Code	JOH · Anesthesiology
Decision Date	Dec 7, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5800
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.

Device Story

The Portex Blue Line Ultra Paediatric Tracheostomy Tube is a medical-grade PVC device designed to provide an artificial airway for pediatric patients. It features a 90-degree curve, a 15mm connector for integration with standard respiratory/anesthesia equipment, and a radio-opaque blue line for X-ray visualization. The device is intended for single-patient use for up to 29 days. It is used in clinical settings (critical care, non-critical care, long-term care) and home care environments, typically managed by healthcare professionals. The tube is secured via a neck strap. By maintaining a patent airway, the device facilitates mechanical ventilation and secretion management, directly supporting respiratory function in patients with airway obstructions or trauma. The device is MRI-safe due to its non-conductive, non-metallic, and non-magnetic construction.

Clinical Evidence

Bench testing only. No clinical data. Testing included ISO 5366-3 and ISO 5366:2016 (paediatric tracheostomy tube requirements), ISO 5356-1 (15mm connector compatibility), ISO 18190 (airway device evaluation), ISO 10993-1 (biocompatibility), ISO 11135/11747 (sterilization/microbiology), and ASTM F2503-13 (MRI safety). Human factors validation per ISO 62366 confirmed performance is acceptable for intended use.

Technological Characteristics

Materials: Medical grade PVC with non-phthalate (DEHT) plasticizer. Features: 90-degree curve, 15mm connector, radio-opaque barium-sulfate blue line. Dimensions: 3.0mm to 5.0mm ID. Connectivity: Standard 15mm interface for breathing circuits. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 5366-3:2001, ISO 5366:2016, ISO 5356-1, ISO 18190, ISO 10993-1, ISO 62366, ASTM F2503-13.

Indications for Use

Indicated for airway maintenance in pediatric patients requiring an artificial airway due to trauma or medical conditions, including those requiring prolonged mechanical ventilation, unable to manage airway secretions, or with upper airway obstruction.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

Bivona Uncuffed Pediatric Tracheostomy Tube (K912469)
Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless (K122531)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym along with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The logo is commonly used to represent the FDA and its role in regulating food and drugs in the United States. December 7, 2017 Smiths Medical ASD, Inc. James Taufen Director Regulatory Affairs 6000 Nathan Lane North Minneapolis, Minnesota 55442 Re: K170720 Trade/Device Name: Portex Blue Line Ultra Paediatric Tracheosomy Tube Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: November 7, 2017 Received: November 8, 2017 Dear James Taufen: 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 (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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Tara A. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K170720 Device Name Smiths Medical Portex® Blue Line Ultra® Paediatric Tracheostomy Tube Indications for Use (Describe) Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ | <div> <img alt="smiths medical bringing technology to life" src="" width="200"/> </div> <div> 510(k) SUMMARY Portex® Blue Line Ultra® Paediatric Tracheostomy Tube </div> | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Date of Summary Preparation: | December 5, 2017 - revised | | Submitter: | Smiths Medical 6000 Nathan Lane Minneapolis, MN 55442 USA | | Establishment Registration Number: | 3012307300 (Minneapolis) | | Company Contact (Primary): | James Taufen Director Regulatory Affairs Email: james.taufen@smiths-medical.com Office: 763-383-3174 | | Trade Name(s): | Tracheostomy Tube, Paediatric | | Device Names(s): | Portex ® Blue Line Ultra ® Paediatric Tracheostomy Tube | | Device Classification: | Class II | | Regulation Number and Product Code(s): | 21 CFR § 868.5800/ JOH Tracheostomy tube and tube cuff | #### Purpose The purpose of this premarket notification Traditional 510(k) is to obtain FDA clearance of the Portex® Blue Line Ultra® Paediatric Tracheostomy Tube for pediatric patients requiring an artificial airway for airway maintenance. {4}------------------------------------------------ # Primary Predicate Device The primary predicate device for this submission is the currently marketed Smiths Medical Bivona Uncuffed Paediatric Tracheostomy Tube listed below. | Primary Predicate Device Name | Product Code | FDA 510k Number Clearance Date | |--------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------| | Bivona Uncuffed Pediatric Tracheostomy Tube (wire reinforced) Original Applicant: Bivona Medical | JOH 21 CFR \$ 868.5800 | K912469 Cleared Jun 14, 1991 | ### Additional Predicate Devices: | Additional Predicate Device Name | Product Code | FDA 510k Number Clearance Date | |----------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------| | Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless Original Applicant: Covidien | JOH 21 CFR $\S$ 868.5800 | K122531 Cleared Oct 9, 2012 | ### General Device Description: The Portex® Blue Line Ultra® Paediatric Tracheostomy Tube (Blue Paeds) is designed for the paediatric population who require an artificial airway due to trauma or medical condition. It is indicated for patients who require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. The subject device package consists of a paediatric tracheostomy tube and cotton tape (neck strap) and a maximum recommended period of use is 29 days. The tube is manufactured with a flange, blue line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for use when in-contact with patient tissue/bodily fluids/secretions. # Indications for Use: | Product Name | FDA 501(k) or PMA Numbers and Product Codes | Indications For Use | |-------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Portex® Blue Line Ultra® Paediatric Tracheostomy Tube | JOH | Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients | # Summary of Technological Characteristics: The subject device, Portex® Blue Line Ultra® Paediatric Tracheostomy Tube (Blue Paeds) shares the similar technological characteristics as their 510(k) cleared predicates, Bivona Paediatric Tracheostomy Tube and Shiley Cuffless Neonatal, Pediatric Long Tracheostomy Tube. {5}------------------------------------------------ | Product Characteristics | Subject Device Smiths Medical Blue Line Ultra Paediatric Trach Tubes | PRIMARY Predicate Device Bivona Pediatric Tracheostomy K912469 | ADDITIONAL Predicate Device Shiley Neonatal, Pediatric K122531 | Compare | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Product Code | JOH | JOH | JOH | Same | | Patient Population | Paediatric | Paediatric | Paediatric | Same | | Intended Use | Paediatric patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use 29 days. | Paediatric patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use 29 days. | This device is intended for use in providing tracheal access for airway management. | Same | | Indications For Use | The Blue Line Pediatric Tracheostomy Tube is indicated for airway maintenance of tracheostomy patients | The Bivona tracheostomy tube is intended for direct airway access for a tracheostomised patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times. | This device is intended for use in providing tracheal access for airway management | Similar | | Single Patient Use | Single Use for Maximum 29 Days | Single Use for Maximum 29 Days | Single Use for Maximum 29 Days | Same | | Environment of Use | The product shall be used in a clinical environment such as the pediatric critical care units of a hospital, non-critical care units of a hospital, long care facilities and home care. | The product shall be used in a clinical environment such as the neonatal, pediatric or critical care units of a hospital, non- critical care units of a hospital, long care facilities and home care. | The product shall be used in a clinical environment such as the neonatal, pediatric or critical care units of a hospital, non-critical care units of a hospital, long care facilities and home care. | Same | | Design Product Angle | 90 degrees | 120 degrees | 120 degrees | Different | | Cuff on Tube | Uncuffed Pediatric Tracheostomy Tube | Uncuffed Pediatric Tracheostomy Tube | Uncuffed Pediatric Tracheostomy Tube | Same | | Cleaning Instructions | Available in IFU | Available in IFU | Available in IFU | Same | | Design by Standard | ISO 5366-3:2001 and ISO 5366: 2016 | ISO 5366-3:2001 | ISO 5366-3:2001 | Same | | Product Characteristics | Subject Device Smiths Medical Blue Line Ultra Paediatric Trach Tubes | PRIMARY Predicate Device Bivona Pediatric Tracheostomy K912469 | ADDITIONAL Predicate Device Shiley Neonatal, Pediatric K122531 | Compare | | Materials | Medical Grade Polyvinyl Chloride (PVC) Non-phthalate (DEHT) Plasticizer | Medical Grade Silicone Not Applicable | Medical Grade Polyvinyl Chloride (PVC) Non-phthalate Plasticizer | Same for PVC | | View by X-Ray | Blue Line of radio- opaque material Barium-Sulphate | Reinforced radio- opaque material Wire | Constructed with radio-opaque material (IFU) | Same | | Package contents | Tube Neck strap (Cotton Tape) | Tube Neck Strap Obturator Disconnect Wedge | Tube Neck Strap Obturator | Similar | | Mechanical Connection | 15mm connector for attachment to breathing systems / mechanical ventilation | 15mm connector for attachment to breathing systems / mechanical ventilation | 15mm connector to standard ventilation and anesthesia equipment | Same | | Surgical Procedure | Anterior surgical approach of Trachea Anatomy | Anterior surgical approach of Trachea Anatomy | Anterior surgical approach of Trachea Anatomy | Same | | Functionally | Provide patient an artificial airway due to trauma or medical condition; Insertion in a tracheotomy stoma; Neck strap used for secure device placement | Provide patient an artificial airway due to trauma or medical condition; Insertion in a tracheotomy stoma; Neck strap used for secure device placement | Provide patient an artificial airway in order to provide access to the patient's airway; Insertion in a tracheotomy stoma; Neck strap used for secure device placement | Same | | Sterilization | Ethylene Oxide (EO) Sterile SAL 10-6 to End User | Ethylene Oxide (EO) Sterile SAL 10-6 to End User | Ethylene Oxide (EO) Sterile SAL 10-6 to End User | Same | | Biocompatibility | Compatible materials ISO 10993-1:2009 | Compatible materials ISO 10993-1:2009 | Compatible materials ISO 10993-1:2009 | Same | | Shelf Life | 5-year shelf life | 5 years | Unknown | Same | | Magnetic Resonance Image (MRI) | MRI Safe | MRI Conditional K082641 | Unknown | Similar | {6}------------------------------------------------ # Differences The subject and predicate devices include the same overall design, and same range of sizes, with the only difference being the tube 90 degree curve angle. The risks associated with 90 degree curve design were mitigated through 1) ISO 5366-3 standard compliance testing according to requirements for paediatric tracheostomy tube, 2) material selection of thermosensitive material, and 3) human factor studies. {7}------------------------------------------------ The BLU PAEDS device is manufactured with Polyvinyl Chloride (PVC) with non-phthalate plasticizer (DEHT) while the Bivona Paediatric Tube predicate device material is a medical grade silicone. These subject and primary predicate devices include the same intended use of 29 days for the pediatric patient population. The risk associated with prolonged exposure to new DEHT material was mitigated through successful ISO 10993 Standard testing demonstrating the material met all biocompatibility requirements for its intended use. The BLUE PAEDS MRI-safe compatibility was verified according to ASTM F2503-13 through material analysis determining that the materials are nonconductive, nonmetallic and nonmagnetic. Bivona device is labelled as MRI-conditional due to a wire-reinforced tube. MRI labeling for Shiley is unknown. #### Similarities Both the subject device and predicate devices indications for use are similar because they are all for single-patient use and indicated for airway maintenance of tracheostomy patients. The only difference is the predicate, Bivona Pediatric, is a silicone tracheostomy tube and may be reprocessed for single-patient use up to 5 times. Both the subject and predicate devices, have 15mm connectors for attachment to airway circuits, which are compatible with standard healthcare systems for use of humidification and/or ventilation equipment. Both, the subject and predicate devices provide a neck strap (cotton tape) for use to secure the tracheostomy tube placement to the patient. The subject device and predicate devices are prescribe by physician only, for single use and provided Ethylene Oxide (EO) sterile to the healthcare facility and/or end user. The size of the tube needed depends on the age and size of the child. The inner diameter is the actual diameter of breathing room and is also the uniform standard classification system in use today. The outer diameter is the actual size of the size and configuration offering is noted below: | Size: | ID | OD | Length | |--------|--------|--------|--------| | 3.0 mm | 3.0 mm | 4.2 mm | 36 mm | | 3.5 mm | 3.5 mm | 4.9 mm | 39 mm | | 4.0 mm | 4.0 mm | 5.5 mm | 43 mm | | 4.5 mm | 4.5 mm | 6.2 mm | 46 mm | | 5.0 mm | 5.0 mm | 6.9 mm | 50 mm | The predicate devices include a 2.5 and 5.5mm. Inner Diameter (ID) is defined in ISO 5366-3 and ISO 5366, and all three devices have same ID. Outer Diameter (OD) nominal is not defined in ISO standard, each device design can define proper OD (and wall thickness) depends on corresponding material properties. ### Summary of Performance Testing: Non-clinical testing of the components comprising each configuration of the subject BLUE PAEDS were assessed and tested appropriately to design controls; i.e. design verification, design validations. The test results conclude the BLUE PAEDS to be substantially equivalent to the predicate devices described herein (above). Testing listed below: {8}------------------------------------------------ - Bench Testing was conducted per ISO 5366-3 and ISO 5366:20161 to ensure the BLU ● PAEDS device meets the essential requirements for paediatric tracheostomy tubes. - Bench Testing was conducted per ISO 5356-12 to ensure the subject device is ● compatible with breathing system connection via 15mm connector; which are used for standard anesthetic and respiratory equipment. - Bench Testing was conducted per ISO 18190 to evaluate the device for use as an airway device and/or equipment. - . Material Bench Testing was conducted to ensure the subject device materials met radiopacity; cleaning agents (solutions) compatibility, MRI compatibility and qas/vapor compatibility. The cleaning instructions for the subject device complies to the common practice in a healthcare or home care setting; similar to cleaning instructions of the predicate devices. - Design Validation / Human Factors per ISO 62366 was conducted to ensure the subiect device performance is acceptable for its intended use. - . Sterilization/Microbiology Validation was conducted to ensure product sterility to the end user for ISO 11135 and ISO 11747. - . Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the subject device materials are biocompatible and equivalent with the same base materials of the Shiley predicate device. Smiths Medical considers the subject device, Portex® Blue Line Ultra® Paediatric Tracheostomy Tube performance to be substantially equivalent to the predicate device(s), because these devices are intended for paediatric patients that require an artificial airway due to trauma, a medical condition and/or airway maintenance. Smiths Medical demonstrated no different issues of safety and effectiveness were raised due to the similarities/differences between the subject device, Portex® Blue Line Ultra® Paediatric Tracheostomy Tube, and predicate/commercialized devices. Smiths Medical concludes the subject device is substantial equivalent for use in paediatric patients for the treatment of an artificial airway. 1 ISO 5366:2016 exception is the 15mm connector ID (clause 6.3.1.2) 2 ISO 5356 – Smiths complies with revision 2004 and 2015

Portex Blue Line Ultra Paediatric Tracheosomy Tube

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Portex Blue Line Ultra Paediatric Tracheosomy Tube

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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