The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

Device Description

The Blue Line Ultra Suctionaid (BLUS) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLUS is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLUS is cuffed. The cuff provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. BLUS has a clear suction line terminating with a suction orifice above the cuff which allows any pooled secretions to be aspirated. The suction line terminates with a connector for suction devices and a Luer port to connect to either a syringe or a vacuum control valve which is included in the pack. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLUS is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the stoma site for tube change insertion. The BLUS tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula, Tracheostomy tube disconnection wedge, cleaning brush and a patient notes label. The change kit includes a tube change J tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.

AI/ML Overview

The provided text is a 510(k) summary for the Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Tube. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria with specific metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not present in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (Reported)
Substantial Equivalence (Overall)	The device is substantially equivalent in safety and effectiveness in its intended use to existing legally marketed devices.
Integrated Suction Line	Adds a lateral protrusion to the main tube without sharp corners or edges.
Inner Cannula (Reusable Feature)	Can be removed, cleaned, and replaced. Substantially equivalent to predicate 2 (Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, K811033) in its reusable nature.
Tube Change Guide Wire	Additional component compared to predicate 1. Substantially equivalent to predicate 3 (Portex Inc. Percutaneous Dilatory Tracheostomy Kit with Speciality Tracheostomy Tube, K980466) in its tube change guide wire feature.
Disconnection Wedge	Additional component compared to predicate 1. Substantially equivalent to predicate 5 (Portex Inc Steri-Cath Closed Ventilation Suction System, K923559) in its disconnection wedge feature.
Suction Control Valve	Additional component compared to predicate 1. Substantially equivalent to predicate 6 (Bivona Aire-Cuf Tracheostomy Tube with talk attachment, K912967) in its suction control valve feature.
Aspiration of Subglottic Secretions	Allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis. (Compared to Predicate 4: Mallinckrodt Hi-Lo Evac Tracheal Tube, K965132, regarding the procedure of removing subglottic secretions).
Airway Maintenance	Indicated for airway maintenance of tracheostomised patients.

2. Sample Size for Test Set and Data Provenance

Sample Size (Test Set): Not specified. The document refers to "Performance data for the proposed device is shown in section 8.0 Performance," but Section 8.0 is not included in the provided text. The submission relies on comparison to predicate devices, not specific clinical trial data with a defined test set.
Data Provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence, the "study" is primarily a comparative analysis against existing devices in terms of design, materials, and intended use, rather than a prospective clinical study generating new data.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable/Not specified. Ground truth as typically understood for AI models (e.g., expert consensus on images) is not relevant here. The evaluation is based on engineering design, material properties, and comparison to legally marketed predicate devices.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable/Not specified. This type of adjudication is typically for diagnostic interpretation studies, which is not the nature of this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document is for a physical medical device (tracheostomy tube), not an AI diagnostic/interpretive tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: No, a standalone algorithm performance study was not performed. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the proposed device is substantially equivalent in its design, materials, and intended use. This is primarily an engineering and regulatory comparison rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for Training Set

Sample Size (Training Set): Not applicable/Not specified. This concept is for AI/ML models, not for the regulatory approval of a physical medical device through a 510(k) pathway.

9. How Ground Truth for Training Set was Established

How Ground Truth was Established: Not applicable. (See #8).

Summary

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Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Kits. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

DATE SUBMITTED: 12th June 2003

SUBMITTER: Portex Ltd Hythe Kent England, CT21 6JL

CONTACT PERSON: Mr Steve Ogilvie, Regulatory and Scientific Affairs Director, Portex Ltd. Military Road, Hythe, Kent, England. CT21 6DB Phone 00 44 (0) 1303 208011 Fax 00 44 (0)1303 262798

DEVICE NAME: Blue Line Ultra Suctionaid Tracheostomy Tube

COMMON NAME AND CLASSIFICATION: Tracheostomy tube. Class II BTO, 21 CFR 868.5800

PREDICATE DEVICES:

Portex Inc Flexible D.I.C Tracheostomy tube, already marketed in the USA under K912124 ●
. Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula, already marketed in the USA under K811033.
Portex Inc. Percutaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube, already marketed . in the USA under K980466
Mallinckrodt Hi-Lo Evac Tracheal Tube , already marketed in the USA under K965132.
Portex Inc Steri-Cath Closed Ventilation Suction System already marketed in the USA under K923559
Bivona Aire-Cuf Tracheostomy tube with talk attachment already marketed in the USA under K912967 .

DEVICE DESCRIPTION:

The BLUS is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only.

BLUS is cuffed. The cuff provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs.

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Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Kits. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

BLUS has a clear suction line terminating with a suction orifice above the cuff which allows any pooled secretions to be aspirated. The suction line terminates with a connector for suction devices and a Luer port to connect to either a syringe or a vacuum control valve which is included in the pack.

The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.

The BLUS is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the stoma site for tube change insertion.

The BLUS tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula, Tracheostomy tube disconnection wedge, cleaning brush and a patient notes label. The change kit includes a tube change j tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO.

Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.

INTENDED USE:

Portex Blue Line Ultra Suctionaid Trachestomy Tube is indicated for airway maintenance of trachesstomised patients. Suctionaid allows aspiration of contaminated mucous and subglottic secretions that of lect and build up between the tracheostomy tube cuff and the glottis.

TECHNOLOGICAL CHARICTUREISTICS OF PROPOSED VERSUS PREDICATE DEVICES:

The proposed device is substantially equivalent to Predicate device 1 Portex Inc Flexible D.I.C . Tracheostomy tube (K912124), in all aspects except the following:
Suction line. The proposed device has an integrated suction line. The integrated suction line adds a lateral . protrusion of the main tube in comparison to Predicatel in such a way that no sharp corners or edges are present. The procedure for removing subglottic secretions from above the cuff with an integrated suction line is compared to Predicate 4.
Inner cannula. The basic design and materials of the inner cannula of Predicate 1 and the proposed device are substantially equivalent. However, the inner cannula of Predicate 1 is disposable, where as the inner cannula of the proposed device can be removed from the tracheostomy tube, cleaned and replaced. The reuseable feature of the proposed device's inner cannulae is compared to Predicate 2.
Tube change guide wire. The tube change guide wire is an additional component to Predicate 1. This component is compared to predicate device 3.
. Disconnection Wedge. The disconnection wedge is an additional component to Predicate 1. This component is compared to predicate device 5.

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Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Kits, 510(K) Notification

SECTION 5.0 : 510K SUMMARY

Suction Control Valve. The Suction control valve is an additional component to Predicac I This . component is compared to predicate device 6.
The re-useable feature of the proposed device's inner cannulae is substantially courvalent to Predicate 2 -. Shiley Low Pressure Cuffed Tracheostomy Tube with Reusable Inner Cannula (K811033). Note, only the reusable nature of the inner cannula is compared.
The tube change guide wire of the proposed device is substantially equivalent to Predicate 3 Portex Inc. . Percutaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube (K980466) Note, only the tube change guide wire is compared.
The integrated suction line is substantially equivalent to Predicate 4 Mallinckrodt Hi-Lo Evav Tracheal . Tube (K965132). Note that only the procedure of removing subglottic secretions from above the cuff is compared.
. The disconnection wedge is substantially equivalent to Predicate 5 Portex Inc Steri-Cath closed ventilation suction system (K923559) Note that only the disconnection wedge is compared.
The Suction control valve is substantially equivalent to the suction control valve of Predicate 6 Bivona Aire-. Cuf Tracheostomy Tube with talk attachment (K912967) Note that only the control valve is compared.

PERFORMANCE / CLINICAL DATA:

Performance data for the proposed device is shown in section 8.0 Performance.

CONCLUSION:

Comparison of the proposed device to the predicate devices supports the conclusion that the proposed device is substantially equivalent in safety and effectiveness in its intended use to existing legally marketed devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "U.S. Department of Health & Human Services - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes above it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2003

Mr. Steve Ogilvie Regulatory and Scientific Affairs Director Portex Limited Hythe, Kent CT21 6JL ENGLAND

Re: K030570

Trade/Device Name: Portex Blue Line Ultra Suctionaid Tracheostomy Tube (Cuffed) with reusable inner cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube Regulatory Class: II Product Code: BTO Dated: June 12, 2003 Received: June 20, 2003

Dear Mr. Ogilvie:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Steve Ogilvie

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Susan Runze

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4.0. STATEMENT OF INDICATION FOR USE

KO30570 Page 1 of 1 510(K) Number (If known):

Device Name: Portex Blue Line Ultra Suctionaid Tracheostomy Tube

Indications for use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. A. W.

ivision Sian Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_

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.