(273 days)
Not Found
No
The summary describes a physical medical device (tracheostomy tube) and its materials and performance testing, with no mention of software, algorithms, AI, or ML.
Yes.
The device is used to maintain an airway for patients with compromised breathing, which directly addresses a medical condition to improve health.
No
Explanation: The device is a tracheostomy tube designed for airway maintenance, not for diagnosing a condition. Its function is to provide an artificial airway, mechanical ventilation support, or manage secretions, all of which are treatment or management functions, not diagnostic ones.
No
The device description clearly states it is a physical tracheostomy tube and associated components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Portex® Blue Line Ultra® Paediatric Tracheostomy Tube is a medical device used to maintain an airway in a patient's trachea. It is a physical device inserted into the body, not used to analyze samples taken from the body.
- Intended Use: The intended use clearly states "airway maintenance of tracheostomised patients," which is a therapeutic and supportive function, not a diagnostic one.
The information provided describes a medical device used for patient care, not for laboratory testing or analysis of biological samples.
N/A
Intended Use / Indications for Use
Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.
Product codes
JOH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
Paediatric
Intended User / Care Setting
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. Prescribe by physician only.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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3
| 510(k) SUMMARY
Portex®
Blue Line Ultra®
Paediatric Tracheostomy Tube | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 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