(247 days)
Not Found
No
The device description focuses on material properties and physical features of a tracheal tube, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device, a tracheal tube, is used for airway management, which is a therapeutic intervention to maintain or improve a patient's breathing.
No
The device is a tracheal tube used for airway management, acting as a physical conduit. While it has features that aid in confirming placement (radio-opaque line for X-ray, depth marks), its primary function is not to diagnose a condition or disease, but rather to facilitate breathing. The X-ray is used to confirm the tube's position, not to diagnose a patient's medical state.
No
The device description clearly outlines a physical medical device made of PVC with features like a radio-opaque line, cuff, pilot balloon, and depth marks. It is intended for oral and/or nasal intubation, which is a physical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral and/or nasal intubation for airway management." This is a direct intervention on the patient's body to manage their airway, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (tracheal tube) used for intubation. It mentions features like thermosensitive material, a radio-opaque line for X-ray confirmation, a connector, a cuff, a Murphy eye, and depth marks. These are all characteristics of a medical device used for a physical procedure.
- No mention of testing biological samples: There is no indication that this device is used to test or analyze any biological samples (blood, urine, tissue, etc.) from the patient.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This tracheal tube does not fit that description.
N/A
Intended Use / Indications for Use
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.
Product codes
BTR
Device Description
A range of sterile, single use tracheal tubes for oral and/or nasal intubation intended for airway management. Manufactured from clear polyvinyl chloride (PVC) incorporating the following features:
- Thermosensitive materials with sufficient initial rigidity for intubation which then conforms to the individuals respiratory tract at body temperature ensuring minimum trauma.
- Radio-opaque Blue Line ® to confirm correct tube placement by X-ray
- All Portex® tracheal tubes are packed with a 15mm connector conforming to ISO5356
- Sterile unless the unit pack is opened or damaged
- Cuffed tracheal tubes are designed with a high volume tapered low pressure cuff and all . have an attached pilot balloon with a one way luer valve
- Smooth Murphy eve
- As a reference during intubation, the tracheal tubes have depth marks in centimetres which indicates the distance to distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult, Paediatric, excluding neonatal and infant use.
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SECTION 5: SUMMARY
JUN 26 2009
1
| Trade Name: | Portex® Tracheal Tube |
|---|---|
| Common Name: | Tracheal Tube |
| Classification Name: | Tube, Tracheal (21 CFR 888.5730, Product Code BTR) |
| Contact Person: | Brian Farias, RAC |
| Regulatory Affairs Manager | |
| Smiths Medical North America | |
| 10 Bowman Drive | |
| Keene, NH 03431 | |
| Tel: +1 603-352-3812, ext 2493 | |
| Fax: +1 603-355-8157 | |
| www.smiths-medical.com | |
| E-Mail: brian.farias@smiths-medical.com | |
| Date: | 07, October 2008 |
| Equivalent to: | Well Lead Aircare™ Endotracheal tube (K.042683) |
| Device Description: | A range of sterile, single use tracheal tubes for oral and/or nasal intubation |
| intended for airway management. Manufactured from clear polyvinyl | |
| chloride (PVC) incorporating the following features: | |
| • Thermosensitive materials with sufficient initial rigidity for intubation | |
| which then conforms to the individuals respiratory tract at body | |
| temperature ensuring minimum trauma. | |
| • Radio-opaque Blue Line ® to confirm correct tube placement by X-ray | |
| • All Portex® tracheal tubes are packed with a 15mm connector | |
| conforming to ISO5356 | |
| • Sterile unless the unit pack is opened or damaged | |
| • Cuffed tracheal tubes are designed with a high volume tapered low | |
| pressure cuff and all have an attached pilot balloon with a one way luer | |
| valve | |
| • Smooth Murphy eye | |
| • As a reference during intubation, the tracheal tubes have depth marks in | |
| centimetres which indicates the distance to distal tip. | |
| Intended Use: | Portex® tracheal tubes are intended for oral and/or nasal intubation for |
| airway management. Expert clinical judgement should be exercised | |
| in the selection of the appropriate tracheal tube size and style for an | |
| individual patient. For adult, Paediatric excluding neonatal and infant | |
| use. |
.
14
1
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Portex® Tracheal Tube
Indications for Use:
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
13
2
SECTION 11: EXECUTIVE SUMMARY
Description of the Device A.
A range of sterile, single use tracheal tubes for oral and/or nasal intubation intended for airway management. Manufactured from clear polyvinyl chloride (PVC) incorporating the following features:
- · Thermosensitive materials with sufficient initial rigidity for intubation which then conforms to the individuals respiratory tract at body temperature ensuring minimum trauma.
- · Radio-opaque Blue Line® to confirm correct tube placement by X-ray
- · All Portex® tracheal tubes are packed with a 15mm connector conforming to ISO5356
- · Sterile unless the unit pack is opened or damaged
- Cuffed tracheal tubes are designed with a high volume tapered low pressure cuff and all . have an attached pilot balloon with a one way luer valve
- · Smooth Murphy eve
- · As a reference during intubation, the tracheal tubes have depth marks in centimetres which indicates the distance to distal tip.
B. Indications for Use
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.
C. Compliance with relevant standards
The products conform to the relevant requirements of the ISO 5361:1999 Anaesthetic and respiratory equipment - Tracheal tubes and connectors. Evidence of this compliance is supplied in Exhibit F
D. Comparison with Predicate Devices
A comparison of Portex® Tracheal Tube with the predicate device is presented in Table 2. This comparison supports a claim of substantial equivalence by virtue of the similarity between the Portex® Tracheal Tube and the identified predicate in terms of indications for use, design characteristics, presentation, method of sterilization, materials of composition, packaging and performance characteristics.
3
SECTION 13: SUBSTANTIAL EQUIVALENCE
A. Predicate Devices
The Portex® Tracheal Tube is substantially equivalent to the existing marketed Class II device identified in Table 3. The predicate device has been cleared by FDA for commercial distribution in USA via pre-amendment route.
| C
able 3 | | 3 - Predicate device for Portex® Tracheal Tube
CALIFORNIA A LA MILLIAM ME R E E LE LI R E B E E E E E E E E E E E E E E E LE E LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LEA E |
|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Device Trade Name | Product Codes | 510(k) Submitter | 510(k) Number(s) |
|---|---|---|---|
| Well Lead Aircare™ | |||
| Endotracheal tube | 100/100/050-095 | Well Lead Medical | K042683 |
B. Substantial Equivalence Rationale
1. Indications for Use
The indications for use of the Portex® Tracheal Tube are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.
Tracheal tube maximum period of use 29 days.
The above indications for use are substantially equivalent to that of the predicate device, Well Lead AircareTM Endotracheal tube (K042683),
2. Substantial Equivalence
i) Device Design and Material Composition
The device design and material composition equivalence data between the Portex Tracheal Tube and the predicate device is provided in table 4.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and a circular seal around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the seal.
Public Health Service
JUN 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smiths Medical ASD, Incorporated C/O Mr. Ian Stace Principal Project Engineer Smiths Medical International Limited Boundary Road Hythe, Kent UNITED KINGDOM CT216JN
Re: K083119
Trade/Device Name: Portex® Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: June 11, 2009 Received: June 16, 2009
Dear Mr. Stace:
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 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.
5
Page 2 - Mr. Stace
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Punones
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number: K083119
Device Name:
Portex® Tracheal Tube
Indications for Use:
Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.
Prescription Use_ X (Per 21 CFR 801 Subpart D)
···
AND/ OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Schutten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083119
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