The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

Device Description

Single use. A Tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Portex Ltd PVC, Single-use Reinforced tracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gases are directed 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. Uncuffed tubes are used mainly for paediatric applications who require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The reinforced tracheal tube (Cuffed Murphy eye) is available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm only. The reinforced tracheal tube (Uncuffed) is available in sizes 3.0, 3.5, 4.0, 4.5 and 5.0mm only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial publication. Therefore, much of the requested information regarding a device meeting specific acceptance criteria through a dedicated study is not present in this submission.

However, I can extract the available information and explain why other details are missing based on the nature of a 510(k) submission.

Analysis of the Provided Text and Missing Information:

The document describes the Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. It details the device, its intended use, and compares its technological characteristics to several predicate devices to establish substantial equivalence.

1. A table of acceptance criteria and the reported device performance

This information is not explicitly present in the provided 510(k) summary. A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (materials, design, performance standards) rather than reporting against specific, pre-defined acceptance criteria from a new, comprehensive performance study that would generate detailed performance metrics like sensitivity, specificity, accuracy, etc.

The document states:

"TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:" section, which lists comparisons of materials, design (reinforced tube, cuff, print markings, inflation line, pilot balloon, connector) between the proposed device and various predicate devices. This implicitly suggests that the acceptance criteria are met if these characteristics are deemed equivalent to existing, safely marketed devices.
"PERFORMANCE / CLINICAL DATA: Performance data for the proposed device is shown in Section 8.0 Performance." However, Section 8.0 is not included in the provided text. This section would likely contain the specifics of any performance testing conducted. Without it, we cannot create a table of acceptance criteria and reported device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. Since the document is a 510(k) summary focused on substantial equivalence, it does not typically detail the specifics of clinical trial design, sample sizes for test sets, or data provenance in the way a research paper would. If performance data were included in the unprovided Section 8.0, it might contain some of this information, but it's not guaranteed to be as detailed as requested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/available from the provided text for the following reasons:

The device is an endotracheal tube, a mechanical device. Its performance is typically evaluated through engineering tests (e.g., tensile strength, kink resistance, material biocompatibility) and sometimes limited clinical observations, not through image interpretation or diagnostic tasks that would require "ground truth" established by experts in the context of diagnostic accuracy.
The 510(k) process for such devices relies on demonstrating equivalence to predicate devices, often through non-clinical bench testing and material characterization, rather than extensive clinical studies requiring expert consensus on "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/available for the same reasons as point 3. Adjudication methods are relevant in studies where human interpretation of data is involved and a consensus or tie-breaking mechanism is needed to establish ground truth or evaluate diagnostic performance, which is not the primary mechanism for evaluating an endotracheal tube in a 510(k) submission.

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

This information is not applicable/available.

The device is a physical medical device (endotracheal tube), not an AI-powered diagnostic tool or imaging software.
Therefore, an MRMC study and the concept of "human readers" improving with AI assistance are irrelevant to this device.

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

This information is not applicable/available for the same reasons as point 5. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/available for the same reasons as point 3. The evaluation of this device would involve engineering specifications, biocompatibility testing, and potentially some clinical observation of device function (e.g., ease of insertion, kink resistance in use), rather than ground truth in the diagnostic sense.

8. The sample size for the training set

This information is not applicable/available. The device is not a 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/available for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K032412" in a handwritten style. The text is oriented diagonally, with the characters appearing slightly distorted due to the handwriting. The background is plain white, which makes the dark text stand out.

JAN 2 6 2004

Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

DATE SUBMITTED:	16 June 2003
SUBMITTER:	Portex LtdHytheKentEngland, CT21 6JL
CONTACT PERSON:	Mr Steve Ogilvie,Regulatory and Scientific Affairs Director,Portex Ltd,Military Road,Hythe, Kent, England. CT21 6DBPhone 00 44 (0)1303 208011

Fax 00 44 (0)1303 262798

DEVICE NAME:

Reinforced Tracheal tubes Cuffed Reinforced Tracheal tubes Uncuffed

COMMON NAME AND CLASSIFICATION:

Reinforced Tracheal Tube. Class II BTR, 21 CFR 868.5730

PREDICATE DEVICES:

Device comparison

Predicate 1: Mallinckrodt Tracheal tube Uncuffed already marketed in the USA under K841872 ●
Predicate 2: Rüsch Tracheal tube Cuffed already marketed in the USA under K990619 .
Predicate 3: Portex Blue Line Tracheal tube PVC Cuffed (100/199) already marketed in the . USA from 1976 under pre-amendment arrangement.
Predicate 4: Euromedical Reinforced Endotracheal Tube already marketed in the USA under . K962389
Predicate 5: Blue Line Adjustable flange tracheostomy tube (AFT) already marketed in the . USA under K962175
Predicate 6. Blue Line Ultra Tracheostomy tube already marketed in the USA under K030570. .

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Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

DEVICE DESCRIPTION:

Single use.

A Tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, oral surgery.

The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.

The Portex Ltd PVC, Single-use Reinforced tracheal tube is available in cuffed and uncuffed variants. The rortex Life I + + + + = = = against the trachea, ensuring that inspiratory and expiratory The carr is mendou to prohe 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 preventing toos of venthant from entering the lungs. Uncuffed tubes are used mainly for paediatric aspirated stomations require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.

The reinforced tracheal tube (Cuffed Murphy eye) is available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm only.

o.s, 7.0 and 7.0mm only.
The reinforced tracheal tube (Uncuffed) is available in sizes 3.0, 3.5, 4.0, 4.5 and 5.0mm only.

INTENDED USE:

(Include significant Clinical Performance requirements)

(Include significant Chined I retrormance realisms in the may of or oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:

The proposed device is substantially equivalent to Predicate device 1 - Mallinckrodt Tracheal tube Cuffed/Uncuffed (clear PVC), in all aspects except the following:

Reinforced tube with (Murphy eye). The reinforced tracheal tube with additional ◆ metal wire spiral reinforcement for the proposed device is identical in material mour wire sphal remong used in Predicate 4- Euromedical reinforced endotracheal tube. The proposed device tube has a straight profile which is identical to the profile in Predicate 2.

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Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

Cuff. The cuff for the proposed device is identical in material composition and to that of . Predicate 6.
The print markings. The print ink for the proposed device is identical in composite to . the ink used for Predicate 6. The print layout for the proposed device displays similar information as the layout on Predicate 3.
Inflation line and pilot balloon. Both the proposed device and Predicate 6's material . composite for the inflation line and pilot balloon is identical. The pilot balloon is identically marked.
Connector. The proposed device and Predicate 5 share the same material composition, . moulded in natural Cyrolite. The proposed device connector spigot is solvent bonded to the tube, (substantially equivalent to Predicate 1), which allows the distal end to sit flush against the butt of the metal spiral preventing the tube from kinking.

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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2004

Mr. Steve Ogilvie Regulatory and Scientific Affairs Director Portex Ltd. Military Road Hythe, Kent England CT21 6DB

Re: K032112

Trade Device Name: Portex Reinforced Tracheal Tube (Cuffed and Uncuffed) Regulation Number: 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: not dated Received: October 28, 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrive 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 approvincians of the Act. The general controls provisions of the Act include controls provisions of the restration, 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 (1 MA), it may be subject to the of Federal Regulations, Title 21, Parts 800 to 898. In your device ear to foundsh further announcements concerning your device in the Ecderal Register.

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Page 2 - Mr. Steve Ogilvie

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act rised that I Da determination that your device complies with other requirements mount that I Drime and regulations administered by other Federal agencies. or the Act of ally I ouchar taken is requirements, including, but not limited to: registration 1 od intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libang (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as out form in als of 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) I mis letter will anow your copa 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), rr you desire specific at 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free Dribion (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. 510(K) Notification

SECTION 4.0: STATEMENT OF INDICATION FOR USE

K032112 510(K) Number (if known):

Page 1 of 1

DEVICE NAME:

Reinforced Tracheal Tubes Cuffed Reinforced Tracheal Tubes Uncuffed

INDICATIONS FOR USE:

The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal 1. The Pollex Kelliforeed Trached. The anaesthesia. The product may be used where the intubation for all way management darms andestined is in the prone position so that a non-reinforced tracheal tube might become kinked.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

foulk

ivision Sign-Off) Division of Anesthesiolo Infection Control, De

510(k) Number: K032112

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).