(234 days)
No
The 510(k) summary describes a physical medical device (endotracheal tube) and its performance testing, with no mention of software, algorithms, AI, or ML.
No
This device is an endotracheal tube intended for intubation and airway management, which is a supportive and facilitative function, not a therapeutic one that directly treats a medical condition or disease.
No
Explanation: The device is an endotracheal tube intended for airway management (intubation), not for diagnosing conditions.
No
The device description clearly outlines physical components like a tube, cuff, inflation system, and valve, indicating it is a hardware medical device.
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 or nasal intubation of the trachea for anesthesia and airway management. This is a direct intervention on the patient's airway.
- Device Description: The device is a physical tube with a cuff designed to be inserted into the trachea.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such tests on biological samples.
The device is a therapeutic and airway management device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea
Indicated Patient Age Range
Pediatric and Adults
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 bench testing has been conducted to verify the performance of the subject device the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP will perform as intended and is substantially equivalent to the predicate device. Bench top testing has been conducted on the subject device per ISO 5361:2016 (FDA 1-118) and all testing requirements were met. The following tests were performed on terminally sterilized samples which met all defined acceptance criteria:
- Connector Pull Test
- Cuff Performance
- Inflation Line Pull Test
- Fluid Seal Test
- Kink Resistance
- Print Adherence
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff. Non DEHP met the standard supporting a 5-year shelf life.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, bevel angle, radius of curvature, cuff diameter, connectors and met the standard. The subject device was compared to the predicate device and considered substantially equivalent as the device met the same acceptance criteria as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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May 20, 2024
Covidien LLC Stephanie Reneau Principal Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K233341
Trade/Device Name: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490. 87495. 87410) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: April 12, 2024 Received: April 12, 2024
Dear Stephanie Reneau:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and
2
Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
Indications for Use (Describe)
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP
This summary of 510(k) safety and effectiveness information for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR $807.92.
SUBMITTER INFORMATION
Submitted Bv: Covidien, llc 6135 Gunbarrel Avenue Boulder, CO 80301
Establishment Registration Number: 2936999
Date Prepared: 05/14/2024
Contact Person:
Stephanie Reneau
Principal Regulatory Affairs Specialist
Phone: 303-305-2713
Email : stephanie.reneau@medtronic.com
DEVICE
Trade Name: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP
Common Name: Endotracheal Tube with Cuff
Classification Regulation: 21 CFR § 868.5730
Classification Name: Tube, Tracheal (w/wo connector)
Regulatory Class: Class II
Product Code: BTR
Review Panel: Anesthesiology
PREDICATE DEVICE
Predicate Manufacturer: Covidien llc
Predicate Trade Name: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non-DEHP
Predicate 510(k): K223130
5
DEVICE DESCRIPTION
The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.
INTENDED USE
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.
TECHNOLOGICAL CHARACTERISTICS
The subject device is substantially equivalent to the predicate device in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: standard 15mm connector, Magill curve, similar material composition, and similar size range. The following technological characteristics were compared between the subject device, predicate devices, and reference device to demonstrate substantial equivalence in Table 1 below:
6
| Characteristics | Subject Device:
Shiley™
Oral/Nasal
Endotracheal
Tube
Intermediate
Cuff, Non-
DEHP | Predicate
Device:
Shiley™
Pediatric
Oral/Nasal
Endotracheal
Tube with
TaperGuard™
Cuff, non-DEHP
(K223130) | Reference
Device
Shiley™ Hi-Lo
Oral/Nasal
Tracheal Tube
Cuffed,
Intermediate,
Murphy Eye
(K965132) | Reference
Device
Cuffed
Tracheal Tube
(Multiple)
(K871204) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for
Use | Oral or nasal
intubation of the
trachea for
airway
management. | Oral or nasal
intubation of the
trachea for airway
management. | Intubation of
trachea for
airway
management | Intubation of
trachea for
airway
management |
| Patient Population | Pediatric and
Adults | Pediatric | Pediatric and
Adults | Pediatric and
Adults |
| Use | Single Patient
Use | Single Patient
Use | Single Patient
Use | Single Patient
Use |
| Product Size
Range (nominal
inside diameter) | 3.0-10.0 mm | 2.5-6.0 mm | 3.0 to 10.0 mm | 5.0 to 10.0 mm |
| Shelf Life | 5 years | 5 years | 5 years | 5 years |
| Sterilization | Ethylene Oxide
(SAL) of 10-6 | Ethylene Oxide
(SAL) of 10-6 | Ethylene Oxide
(SAL) of 10-6 | Ethylene Oxide
(SAL) of 10-6 |
| MRI
Compatibility | MRI Conditional | MRI Conditional | MRI
Conditional | MRI
Conditional |
Table 1. Comparison of Technological Characteristics
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SUBSTANTIAL EQUIVALENCE DISCUSSION
Indications for Use
The subject device and predicate device share the same intended use, both devices provide tracheal access for airway management. The subject and predicate devices are indicated for facilitating oral or nasal intubation of the trachea.
The Shiley™ Oral/Nasal Endotracheal Intermediate Cuff, Non DEHP is designed with a high volume, low pressure cuff which comes in two cuff shapes based on tube size to provide air and fluid seal. Additionally, the subject device uses the same materials used in the predicate device.
Technical Characteristics Comparison
The subject and predicate devices have the same technological characteristics (Magill curve, 15 mm connector, inflation system, similar size range and material composition). The subject device was tested to comply with FDA recognized standards related to airway devices, ISO 5361, ISO 5356 and ISO 18190 (see Declaration of Conformity section).
The subject device can be considered substantially equivalent to the predicate device as they both have the same intended use, designed in accordance with ISO 5361 and ISO 5356 requirements.
PERFORMANCE DATA
Performance bench testing has been conducted to verify the performance of the subject device the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP will perform as intended and is substantially equivalent to the predicate device. Bench top testing has been conducted on the subject device per ISO 5361:2016 (FDA 1-118) and all testing requirements were met. The following tests were performed on terminally sterilized samples which met all defined acceptance criteria:
- Connector Pull Test ●
- Cuff Performance ●
- Inflation Line Pull Test ●
- Fluid Seal Test
- Kink Resistance ●
- Print Adherence ●
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff. Non DEHP met the standard supporting a 5-year shelf life.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, bevel angle, radius of curvature, cuff diameter, connectors and met the standard. The subject device was compared to the predicate device and considered substantially equivalent as the device met the same acceptance criteria as the predicate device.
8
BIOCOMPATIBILITY TESTING
- The following biocompatibility testing was performed in accordance with ISO 10993-1:2018 (FDA 2-258). The subject device has two different resins, one for sizes 3.0 to 8.0 mm and second for sizes 8.5 to 10.0 mm. Testing from predicate device was leveraged for sizes 3.0-8.0 mm and for sizes 8.5 mm to 10.0 mm, testing was performed on final finished subject device.
- Cytotoxicity ●
- Implantation ●
- Sensitization
- Irritation/Intracutaneous reactivity ●
- Material Mediated Pyrogenicity .
HUMAN FACTORS
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP was evaluated for human factors/usability study and found to be in conformance with EN 62366-1:2015 + A1:2020 Medical devices- Application of usability engineering medical devices standard.
STERILIZATION
Sterilization by ethylene oxide has been validated for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP.
ANIMAL PERFORMANCE TESTING
Not applicable. Non animal performance testing was required to demonstrate the device's safety and effectiveness.
CLINICAL PERFORMANCE TESTING
Not applicable. Non animal performance testing was required to demonstrate the device's safety and effectiveness.
CONCLUSION
Based on the information included in this premarket notification submission, the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP met all predetermined acceptance criteria as specified in the applicable standards, test protocols and FDA guidance documents. Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is considered substantially equivalent to ShileyTM Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, non-DEHP, predicate device and reference devices Shiley™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed, Intermediate, Murphy Eye (K965132) and Cuffed Tracheal Tube, Multiple (K871204) currently marketed for the same intended use.