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.

AI/ML Overview

This document describes the Portex Blue Line Ultra Paediatric Tracheostomy Tube (BLU PAEDS) and asserts its substantial equivalence to predicate devices, thus demonstrating that it meets acceptance criteria for its intended use. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BLU PAEDS are established by demonstrating compliance with relevant ISO standards and comparable performance to the predicate devices. The document frames this as "substantial equivalence" rather than explicit numeric acceptance criteria for each characteristic.

Acceptance Criteria Category (implied by testing)	Reference/Standard	Reported Device Performance (Summary)
Mechanical Performance	ISO 5366-3, ISO 5366:2016 (with one exception)	Bench testing confirmed the BLU PAEDS device meets essential requirements for paediatric tracheostomy tubes, addressing the 90-degree curve design difference from predicates.
Breathing System Connection Compatibility	ISO 5356-1	Bench testing confirmed compatibility with breathing system connections via the 15mm connector, ensuring it works with standard anesthetic and respiratory equipment.
Airway Device Evaluation	ISO 18190	Bench testing evaluated the device for its intended use as an airway device.
Material Properties	Radiopacity, cleaning agents compatibility, MRI compatibility	Material bench testing confirmed radiopacity (blue line of radio-opaque material), compatibility with cleaning agents (consistent with IFU), and MRI safety (verified per ASTM F2503-13, as materials are nonconductive, nonmetallic, and nonmagnetic).
Human Factors/Usability	ISO 62366	Design Validation / Human Factors study conducted to ensure the device's performance is acceptable for its intended use. (Details of metrics not provided).
Sterility	ISO 11135, ISO 11747	Sterilization/Microbiology Validation conducted to ensure product sterility to the end user, achieving a Sterility Assurance Level (SAL) of 10-6.
Biocompatibility	ISO 10993-1:2009	Biocompatibility assessment confirmed that the subject device materials (Medical Grade Polyvinyl Chloride (PVC) with non-phthalate plasticizer (DEHT)) are biocompatible and equivalent to the base materials of the Shiley predicate device, addressing the difference from the silicone Bivona predicate.
Shelf Life	Not explicitly referenced, but tested	5-year shelf life, similar to the primary predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each bench test conducted. Instead, it states: "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." This implies sufficient samples were used to meet the requirements of the standards cited.

The data provenance is prospective, non-clinical bench testing performed by the manufacturer, Smiths Medical. The "country of origin of the data" is not explicitly stated but would typically be the location of Smith Medical's testing facilities, likely within the USA given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by the specifications and criteria outlined in the relevant ISO standards and internal design requirements, rather than expert consensus on a test set in the way one might see for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not provided. As "ground truth" for non-clinical bench testing is based on device specifications and standard compliance, a formal adjudication method by external experts (like 2+1 or 3+1) is not typically applicable or described in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (tracheostomy tube), not a diagnostic AI system or an assistive technology that improves human "reading" performance. Therefore, this type of study is not relevant to its clearance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable to the Portex Blue Line Ultra Paediatric Tracheostomy Tube. It is a physical medical device, not an algorithm, and does not have "standalone" performance in the context of AI. Its performance is inherent to its design and material properties.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of this device is primarily based on:

Compliance with established international standards (e.g., ISO 5366-3, ISO 5366, ISO 5356-1, ISO 18190, ISO 10993-1, ISO 11135, ISO 11747, ASTM F2503-13).
Engineering specifications and design controls to ensure the device performs as intended for airway maintenance in paediatric patients.
Comparison to legally marketed predicate devices to establish substantial equivalence in safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

{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}------------------------------------------------

510(k) SUMMARY Portex® Blue Line Ultra® Paediatric Tracheostomy Tube
Date of Summary Preparation:	December 5, 2017 - revised
Submitter:	Smiths Medical6000 Nathan LaneMinneapolis, MN 55442USA
Establishment Registration Number:	3012307300 (Minneapolis)
Company Contact (Primary):	James TaufenDirector Regulatory AffairsEmail: james.taufen@smiths-medical.comOffice: 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/ JOHTracheostomy 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 NumberClearance Date
Bivona Uncuffed PediatricTracheostomy Tube (wire reinforced)Original Applicant: Bivona Medical	JOH21 CFR$ 868.5800	K912469Cleared Jun 14, 1991

Additional Predicate Devices:

Additional Predicate Device Name	Product Code	FDA 510k NumberClearance Date
Shiley Neonatal, Pediatric, PediatricLong Tracheostomy Tube CufflessOriginal Applicant: Covidien	JOH21 CFR$\S$ 868.5800	K122531Cleared Oct 9, 2012

General Device Description:

Indications for Use:

Product Name	FDA 501(k) orPMA NumbersandProduct Codes	Indications For Use
Portex® Blue LineUltra® PaediatricTracheostomy Tube	JOH	Portex® Blue Line Ultra® Paediatric TracheostomyTubes are indicated for airway maintenance oftracheostomised 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}------------------------------------------------

ProductCharacteristics	Subject DeviceSmiths MedicalBlue Line UltraPaediatric TrachTubes	PRIMARYPredicate DeviceBivona PediatricTracheostomyK912469	ADDITIONALPredicate DeviceShiley Neonatal,PediatricK122531	Compare
Product Code	JOH	JOH	JOH	Same
Patient Population	Paediatric	Paediatric	Paediatric	Same
Intended Use	Paediatric patients thatrequire an artificialairway due to trauma ormedical condition.Maximumrecommended period ofuse 29 days.	Paediatric patientsthat require anartificial airwaydue to trauma ormedical condition.Maximumrecommendedperiod of use 29days.	This device isintended for use inproviding trachealaccess for airwaymanagement.	Same
IndicationsFor Use	The Blue Line PediatricTracheostomy Tube isindicated for airwaymaintenance oftracheostomy patients	The Bivonatracheostomy tubeis intended fordirect airwayaccess for atracheostomisedpatient for up to 29days.It may bereprocessed forsingle-patient useup to 5 times.	This device isintended for use inproviding trachealaccess for airwaymanagement	Similar
Single Patient Use	Single Use forMaximum 29 Days	Single Use forMaximum 29 Days	Single Use forMaximum 29 Days	Same
Environment of Use	The product shall beused in a clinicalenvironment such asthe pediatric criticalcare units of a hospital,non-critical care units ofa hospital, long carefacilities and homecare.	The product shallbe used in aclinicalenvironment suchas the neonatal,pediatric or criticalcare units of ahospital, non-critical care unitsof a hospital, longcare facilities andhome care.	The product shall beused in a clinicalenvironment such asthe neonatal,pediatric or criticalcare units of ahospital, non-criticalcare units of ahospital, long carefacilities and homecare.	Same
Design ProductAngle	90 degrees	120 degrees	120 degrees	Different
Cuff on Tube	UncuffedPediatric TracheostomyTube	UncuffedPediatricTracheostomyTube	UncuffedPediatricTracheostomy Tube	Same
CleaningInstructions	Available in IFU	Available in IFU	Available in IFU	Same
Design by Standard	ISO 5366-3:2001 andISO 5366: 2016	ISO 5366-3:2001	ISO 5366-3:2001	Same
ProductCharacteristics	Subject DeviceSmiths MedicalBlue Line UltraPaediatric TrachTubes	PRIMARYPredicate DeviceBivona PediatricTracheostomyK912469	ADDITIONALPredicate DeviceShiley Neonatal,PediatricK122531	Compare
Materials	Medical GradePolyvinyl Chloride(PVC)Non-phthalate (DEHT)Plasticizer	Medical GradeSiliconeNot Applicable	Medical GradePolyvinyl Chloride(PVC)Non-phthalatePlasticizer	Same forPVC
View by X-Ray	Blue Line of radio-opaque materialBarium-Sulphate	Reinforced radio-opaque materialWire	Constructed withradio-opaquematerial (IFU)	Same
Package contents	TubeNeck strap (CottonTape)	TubeNeck StrapObturatorDisconnectWedge	TubeNeck StrapObturator	Similar
MechanicalConnection	15mm connector forattachment to breathingsystems / mechanicalventilation	15mm connectorfor attachment tobreathing systems/ mechanicalventilation	15mm connector tostandard ventilationand anesthesiaequipment	Same
Surgical Procedure	Anterior surgicalapproach of TracheaAnatomy	Anterior surgicalapproach ofTrachea Anatomy	Anterior surgicalapproach of TracheaAnatomy	Same
Functionally	Provide patient anartificial airway due totrauma or medicalcondition; Insertion in atracheotomy stoma;Neck strap used forsecure deviceplacement	Provide patient anartificial airwaydue to trauma ormedical condition;Insertion in atracheotomystoma; Neck strapused for securedevice placement	Provide patient anartificial airway inorder to provideaccess to thepatient's airway;Insertion in atracheotomy stoma;Neck strap used forsecure deviceplacement	Same
Sterilization	Ethylene Oxide (EO)Sterile SAL 10-6 to EndUser	Ethylene Oxide(EO) Sterile SAL10-6 to End User	Ethylene Oxide (EO)Sterile SAL 10-6 toEnd User	Same
Biocompatibility	Compatible materialsISO 10993-1:2009	CompatiblematerialsISO 10993-1:2009	Compatible materialsISO 10993-1:2009	Same
Shelf Life	5-year shelf life	5 years	Unknown	Same
MagneticResonance Image(MRI)	MRI Safe	MRI ConditionalK082641	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

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
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.(b)
Classification. Class II.