(162 days)
No
The device description and performance studies focus on the physical characteristics and standard testing of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
A tracheostomy tube used for airway management directly contributes to the treatment and management of a patient's respiratory condition, making it a therapeutic device.
No
The device is described as a tracheostomy tube intended to provide an artificial airway for airway management, not to diagnose a condition.
No
The device description clearly states it is a physical tracheostomy tube, a hardware device, and there is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing tracheal access for airway management." This is a direct intervention on the patient's body to facilitate breathing, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical tube inserted into the trachea. This is a medical device used for treatment and support, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This tracheostomy tube does not fit that definition.
N/A
Intended Use / Indications for Use
The device is intended for use in providing tracheal access for airway management.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal
Indicated Patient Age Range
Neonatal & pediatric
Intended User / Care Setting
Hospitals, long-term care facilities, home care
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)
Biocompatibility testing
The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests included are cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity, material mediated rabbit pyrogen, implantation, chemical characterization, and risk assessment.
Sterilization and Packaging Validation
Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135-1 and ISO 10993-7 is acceptable. Packaging validation was in accordance with ISO 11607-1.
MRI Compatibility
MRI safety and compatibility and MR compatibility labeling for the subject devices in accordance with FDA guidance "Establishing Safety and Compatibility of Passive Implants in the MR Environment", and ASTM F2503-13.
Bench Testing
Bench testing on the subject device was conducted in accordance with ISO 5366-3, ISO 5356-1. In addition, internal bench testing to assess the cuff performance, connector mechanical performance and cannula bend were performed.
Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence.
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
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
510(k) SUMMARY K182861
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the Shiley™ Neonatal/Pediatric Tracheostomy Tube.
| Submitted By: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 19, 2019 |
| Contact Person: | Yaara Basevitch
Regulatory Affairs Manager
(720) 891-0214 |
| Proprietary Name: | Shiley™ Neonatal/Pediatric Tracheostomy Tube |
| Common Name: | Tracheostomy Tube & Tube Cuff |
| Device Classification Regulation: | 21 CFR 868.5800 – Class II |
| Device Product Code & Panel: | JOH |
| Predicate Devices: | Shiley™ Neonatal/Pediatric Tracheostomy Tube Cuffless
(K122531)
Shiley™ Neonatal/Pediatric Tracheostomy Tube with
TaperGuard™ Cuff (K142298) |
| Reference Device: | Shiley™ Neonatal/Pediatric long Tracheostomy Tube
(K945513)
Shiley™ cuffed Pediatric long Tracheostomy Tube
(K955680) |
Device Description
The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.
Indications for Use/Intended Use
The device is intended for use in providing tracheal access for airway management.
Technological Characteristics Comparison
The subject device is identical in intended use, basic design, functionality, and size range to the predicate devices. The subject device features a few design and material changes compared to the predicates. The
1
cannula angle of the subject device features a more narrowed angle range in comparison to the predicate device. The subject device features a one-piece flange with integrated 15mm connector; whereas, the predicate featured a two-piece design. The materials of the subject device cannula, 15mm connector and flange, and cuff were changed to a different grade of non-DEHP PVC in comparison to the predicate device. A comparison table is provided below.
| SUBJECT | PREDICATE | |||
|---|---|---|---|---|
| Shiley™ Neonatal/Pediatric | ||||
| Tracheostomy Tube | ||||
| (cuffed & cuffless) | Shiley™ | |||
| Neonatal/Pediatric | ||||
| Tracheostomy Tube – | ||||
| cuffed [K142298] | Shiley™ | |||
| Neonatal/Pediatric | ||||
| Tracheostomy Tube – | ||||
| cuffless [K122531] | ||||
| Intended Use | Providing tracheal access for | |||
| airway management | Identical | Identical | ||
| Patient Population | Neonatal & pediatric | Identical | Identical | |
| Environment of Use | Hospitals, long-term care | |||
| facilities, home care | Identical | Identical | ||
| Use | Single patient | Identical | Identical | |
| Sterilization | Ethylene oxide | Identical | Identical | |
| Shelf Life | 5 years | Identical | Identical | |
| MR Compatibility | MR Conditional (cuffed); | |||
| MR Safe (cuffless) | Not specified | Not specified | ||
| DESIGN | ||||
| Device Design | Per ISO 5366-1, ISO 5366-3, | |||
| ISO 5356-1 | Per ISO 5366-1, ISO 5366- | |||
| 3, ISO 5356-1 | Per ISO 5366-1, ISO 5366- | |||
| 3, ISO 5356-1 | ||||
| Neonatal | 2.5 - 4.5 | Identical | Identical | |
| Size Range | Pediatric | 2.5 - 6.5 | Identical | Identical |
| Transparent flexible material | ||||
| with integrated connector | Transparent flexible | |||
| material; 2-piece design | Transparent flexible | |||
| material; 2-piece design | ||||
| Flange | ||||
| Connector | Flexible, integrated with | |||
| flange (1-piece design) | Rigid 15mm cap molded to | |||
| flange (2-piece design) | Rigid 15mm cap molded | |||
| to flange (2-piece design) | ||||
| Cannula Angle | 120° (105-120°) | 120° | 120° | |
| Cuffed | Lumen present | Identical | N/A | |
| Cannula Wall | Cuffless | No lumen | N/A | Lumen present |
| Radiopaque Cannula | Yes | Yes | Yes | |
| Cuff | Taper-shaped, low-pressure | Identical | N/A | |
| Inflation System | Inflation line, pilot balloon, | |||
| inflation valve, luer guard | Identical | N/A | ||
| Obturator & Neck Strap | Identical to predicate | Identical | Identical | |
| MATERIALS | ||||
| Cannula | Non-DEHP PVC | Non-DEHP PVC | Non-DEHP PVC | |
| Flange | Non-DEHP PVC | Non-DEHP PVC | Non-DEHP PVC | |
| 15mm Connector | Non-DEHP PVC | ABS | ABS | |
| Cuff | Non-DEHP PVC | Non-DEHP PVC | N/A | |
| Inflation | ||||
| System | Inflation | |||
| line | Non-DEHP PVC | Identical | N/A | |
| Pilot | ||||
| balloon | Non-DEHP PVC | Identical | ||
| Inflation valve | PVC housing with metal spring and nitrile gasket | Identical | ||
| Luer guard | Non-DEHP PVC | Identical | ||
| Obturator | Polypropylene | Identical | Identical | |
| Neck Strap | Cotton | Identical | Identical |
2
Substantial Equivalence - Summary of Performance Testing
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility testing
The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests included are cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity, material mediated rabbit pyrogen, implantation, chemical characterization, and risk assessment.
Sterilization and Packaging Validation
Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135-1 and ISO 10993-7 is acceptable. Packaging validation was in accordance with ISO 11607-1.
MRI Compatibility
MRI safety and compatibility and MR compatibility labeling for the subject devices in accordance with FDA guidance "Establishing Safety and Compatibility of Passive Implants in the MR Environment", and ASTM F2503-13.
Bench Testing
Bench testing on the subject device was conducted in accordance with ISO 5366-3, ISO 5356-1. In addition, internal bench testing to assess the cuff performance, connector mechanical performance and cannula bend were performed.
Substantial Equivalence - Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence.
Substantial Equivalence - Conclusions
No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject devices can be considered substantially equivalent.
3
Indications for Use
510(k) Number (if known) K182861
Device Name
Shiley Neonatal/Pediatric Tracheostomy Tube
Indications for Use (Describe)
The device is intended for use in providing tracheal access for airway management.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/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.
Covidien Yaara Basevitch Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K182861
Trade/Device Name: Shiley Neonatal/Pediatric Tracheostomy Tube Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: February 19, 2019 Received: February 21, 2019
Dear Yaara Basevitch:
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 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
5
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure