(331 days)
No
The description focuses on the physical characteristics and performance of a standard endotracheal tube, with no mention of AI or ML capabilities. The performance studies are bench tests verifying physical properties and equivalence to predicate devices.
No
The device is described as an endotracheal tube intended for facilitating intubation, which is a supportive function for medical procedures (like ventilation or surgery), rather than directly treating a disease or condition itself.
No
Explanation: The device is an endotracheal tube used for facilitating intubation, which is a therapeutic and supportive procedure, not a diagnostic one. Its stated intended use is to facilitate intubation, and the device description and performance studies focus on its physical and mechanical properties for that purpose.
No
The device description clearly outlines a physical medical device (endotracheal tube) with hardware components (tube, cuff, inflation system). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facilitating oral or nasal intubation of the trachea." This is a procedure performed directly on a patient's body to establish an airway.
- Device Description: The description details a physical tube designed to be inserted into the trachea.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits used in a laboratory or point-of-care setting.
This device is a medical device used for a therapeutic procedure (establishing an airway), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.
Product codes
BTR
Device Description
The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. 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
Pediatrics
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 that the performance of the subject device the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is substantially equivalent to the predicate devices and that the subject device will perform as intended. Bench-top testing have been conducted on subject device in accordance with ISO 5361:2016 and all testing requirements were met. The following tests were performed on terminally sterilized unaged and aged samples which met all defined acceptance criteria:
- Print Adherence Test
- Cuff herniation
- Cuff performance
- Inflation line pull test
- Connector pull force
- Kink test
- Tube collapse
- Fluid Seal test
- Radius Curvature test
- MRI Safety and compatibility tests
The Shiley™ Pediatric oral/nasal endotracheal tube with Cuff, non-DEHP unaged and aged met the standard, supporting the 5-year shelf life.
The Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, including bevel angle, curvature, cuff diameter, connectors. The subject device met the standard. The Shiley™ Pediatric oral/Nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was compared to the predicate device for the functional and mechanical tests and met the same acceptance criteria as the predicate device, demonstrating substantial equivalence.
Biocompatibility Testing:
The following Biocompatibility testing was performed in accordance with ISO 10993-1:2009 and FDA guidance on Use of International Standard ISO 10993-1
- Cytotoxicity
- Implantation
- Sensitization
- Irritation / Intracutaneous reactivity
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Subacute/sub chronic toxicity
- Genotoxicity
- Particulate matter and VOC (ISO 18562-2:2017 & ISO 18562-3:2017)
Human Factors:
A Human Factors / Usability Study was conducted and the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was found to be in conformance with the IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices standard.
Sterilization:
Sterilization by ethylene oxide has been validated for Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP.
Animal Performance Testing:
Not applicable. No animal performance testing was required to demonstrate device safety and effectiveness.
Clinical Performance Testing:
No clinical performance testing was required to demonstrate device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Covidien Anila Tarte Principal Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K223130
Trade/Device Name: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: June 27, 2023 Received: June 27, 2023
Dear Anila Tarte:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 -5
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and 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
2
Indications for Use
Submission Number (if known)
Device Name
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
ndications for Use (Describe)
The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating 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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3
510(k) Summary
Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP
This summary of 510(k) safety and effectiveness information for the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ 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 By:
Covidien, llc 6135 Gunbarrel Avenue Boulder, CO 80301
Establishment Registration Number: 2936999
Date Prepared: June 25, 2023
Contact Person:
Anila Tarte Principal Regulatory Affairs Specialist Phone: 978-496-6694 Email: anila.k.tarte(@medtronic.com
DEVICE
| Trade Name: | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with
TaperGuard™ Cuff, Non-DEHP (86125, 86130, 86135, 86140,
86145, 86150, 86155, 86160) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Endotracheal Tube with cuff |
| Classification Regulation: | 21 CFR 868.5730 |
| Classification Name: | Tracheal tube – Class II |
Class II Regulatory Class:
BTR Product Code:
Anesthesiology Review Panel:
4
PREDICATE DEVICE
| Predicate Manufacturer: | Covidien llc |
|---|---|
| Predicate Trade Name: | Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, |
| Murphy Eye | |
| Predicate 510(k): | K151381 |
| PREDICATE DEVICE | |
| Predicate Manufacturer: | Covidien llc |
| Predicate Trade Name: | Hi-Lo Evac and Evac II Endotracheal Tubes |
| Predicate 510(k): | K965132 |
| REFERENCE DEVICE | |
| Predicate Manufacturer: | Covidien llc |
| Predicate Manufacturer: | Covidien llc |
|---|---|
| Predicate Trade Name: | Shiley™ Neonatal/Pediatric Tracheostomy Tube |
| Predicate 510(k): | K182861 |
DEVICE DESCRIPTION
The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. 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™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.
TECHNOLOGICAL CHARACTERISTICS
The subject device is substantially equivalent to the predicate devices in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: Cuff, standard 15mm connector, Magill curve, similar material composition, and similar size range. The following technological characteristics were compared between the subject device and predicate devices to demonstrate substantial equivalence in Table 5.1 below:
5
| Characteristic | Subject Device ShileyTM
Pediatric oral/nasal
endotracheal tube with
TaperGuardTM Cuff, non-
DEHP | Primary Predicate Device
MallinckrodtTM Oral/Nasal
Tracheal Tube Cuffless,
Non- DEHP-, Murphy Eye
[K151381] | Secondary
Predicate
device
Hi-Lo Evac and Evac
II Endotracheal
Tubes
(K965132) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Oral or nasal intubation
of the trachea for airway
management. | Oral or nasal intubation
of the trachea for airway
management. | The Hi-Lo- EvacTM
endotracheal tube is
indicated for airway
management by
oral/nasal intubation
of the trachea
particularly in cases
where duration of
intubation is expected
to be more than 24
hours or may
not be
predictable. |
| Patient
Population | Pediatrics | Pediatrics | Pediatrics,
Adults |
| Use | Single patient | Single patient | Single patient |
| Device Design | Per ISO 5361:2016,
ISO 5356-1 | Per ISO 5361:2012,
ISO 5356-1 | Per ISO 5361:1999,
ISO
5356-1 |
| Product Size
range (nominal inside
diameter) | 2.5-6.0mm | 2.0 - 7.0mm | 3.0 - 10.0mm |
| Shelf life | 5 years | 5 years | 5 years |
| Sterilization | SAL: 1X10-6 ETO
Sterilization | SAL: 1X10-6 ETO
Sterilization | SAL: 1X10-6 ETO
Sterilization |
Table 5.1: Comparison of Technological Characteristics
Substantial Equivalence Discussion
Indications for Use
The subject device and predicate devices share intended use. The subject device as well as predicate devices provide tracheal access for airway management. Subject device and predicate devices are indicated for facilitating oral or nasal intubation of the trachea.
The Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP is designed with a low-pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal.
6
Additionally, the subject device tube and cuff uses identical materials used in the primary device and reference device respectively.
Technological Characteristics Comparison
The subject and predicate devices have the same technological characteristics (Magill curve, similar size range, similar material composition, cuff, inflation line, 15 mm connector). The subject device was tested to comply with FDA recognized standards related to Airway devices, ISO 18190, ISO 5361 and ISO 5356 (see Section Declaration of Conformity). As the subject and predicate devices have the same intended use, designed in accordance with ISO 5361, and performance in compliance with ISO 5361 requirements, the subject device can be considered substantially equivalent to the predicate device.
PERFORMANCE DATA
Performance Bench Testing has been conducted to verify that the performance of the subject device the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is substantially equivalent to the predicate devices and that the subject device will perform as intended. Bench-top testing have been conducted on subject device in accordance with ISO 5361:2016 and all testing requirements were met. The following tests were performed on terminally sterilized unaged and aged samples which met all defined acceptance criteria:
- . Print Adherence Test
- Cuff herniation ●
- . Cuff performance
- Inflation line pull test ●
- Connector pull force
- Kink test
- Tube collapse
- Fluid Seal test .
- Radius Curvature test ●
- . MRI Safety and compatibility tests
The Shiley™ Pediatric oral/nasal endotracheal tube with Cuff, non-DEHP unaged and aged met the standard, supporting the 5-year shelf life.
The Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, including bevel angle, curvature, cuff diameter, connectors. The subject device met the standard. The Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was
7
compared to the predicate device for the functional and mechanical tests and met the same acceptance criteria as the predicate device, demonstrating substantial equivalence.
Biocompatibility Testing
The following Biocompatibility testing was performed in accordance with ISO 10993-
1:2009 and FDA guidance on Use of International Standard ISO 10993-1
- . Cytotoxicity
- Implantation .
- Sensitization ●
- Irritation / Intracutaneous reactivity ●
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity ●
- Subacute/sub chronic toxicity ●
- Genotoxicity ●
- . Particulate matter and VOC (ISO 18562-2:2017 & ISO 18562-3:2017)
Human Factors
A Human Factors / Usability Study was conducted and the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was found to be in conformance with the IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices standard.
Sterilization
Sterilization by ethylene oxide has been validated for Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP.
Animal Performance Testing
Not applicable. No animal performance testing was required to demonstrate device safety and effectiveness.
Clinical Performance Testing
No clinical performance testing was required to demonstrate device safety and effectiveness.
CONCLUSION
Based on the information included in this premarket notification submission, the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP met all predetermined
8
acceptance criteria as specified by the applicable standards, FDA guidance documents and test protocols. Therefore, the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is considered substantially equivalent to the predicate devices currently marketed for the same intended use.