(201 days)
Not Found
No
The device description focuses on the physical characteristics and function of a reinforced tracheal tube, with no mention of AI or ML.
No.
This device is designed for "airway management during anaesthesia" and is used to maintain the patency of the lumen, ensure inspiratory and expiratory gases are directed through the tube, and prevent aspiration. These functions are supportive and facilitative for medical procedures, rather than directly treating a disease or condition.
No
Explanation: The device is a tracheal tube used for airway management during anesthesia, not for diagnosing a condition or disease. Its function is to facilitate ventilation and prevent aspiration, which are therapeutic and management functions.
No
The device description clearly describes a physical tracheal tube with metal wire reinforcement, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Portex Reinforced Tracheal Tube is a device inserted into the trachea to manage the airway during medical procedures. It is a physical device used in vivo (within the body) to facilitate breathing and deliver gases.
- Lack of Diagnostic Testing: The description focuses on the physical properties and function of the tube for airway management. There is no mention of testing samples, analyzing biological markers, or providing diagnostic information.
Therefore, the Portex Reinforced Tracheal Tube falls under the category of a medical device used for therapeutic or supportive purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
BTR
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 occlude against the trachea, ensuring that inspiratory and expiratory gases are prevented from escaping 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 patients 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Performance data for the proposed device is shown in Section 8.0 Performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K841872, K990619, K962389, K962175, K030570
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
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 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:
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. .
1
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.
2
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.
3
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.
4
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
5
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