(190 days)
Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.
The Shiley ™ Adult Flexible Tracheostomy Tube Cuffless is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial ainway in order to provide access to the patient's airway for airway management. It contains an integrated 15 mm connector for use with standard ventilation and anesthesia equipment. The tracheostomy tube has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. This tracheostomy tube can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial airway in order to provide access to the patient's airway management. It contains an intecrated 15 mm connector for use with standard ventilation and anesthesia equipment. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. The tracheostomy tube has a taper-shaped, low-pressure cuff to provide an effective air and fluid seal and minimize tracheal wall damage. The cuff inflation line has a luer valve with an integral pilot balloon. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
When inserted in a tracheotomy stoma, the device may be secured in place with a neck strap around the patient's neck which is attached to an integral neck plate. It also may be secured in place by using the suture holes in the flange of the tracheostomy tube, thereby providing for a secure artificial ainway for spontaneous breathing or direct connection to ventilation or anesthesia equipment.
The provided text describes a 510(k) premarket notification for new Shiley™ Adult Flexible Tracheostomy Tubes. It is an application for a medical device seeking a determination of substantial equivalence to a legally marketed predicate device, and thus often does not involve extensive clinical studies. The document primarily focuses on demonstrating that the new device is as safe and effective as existing ones through non-clinical data.
Because this is a 510(k) submission, the "acceptance criteria" discussed are typically related to meeting established standards and performance benchmarks analogous to the predicate devices, rather than achieving specific accuracy metrics in a clinical study. The study presented is non-clinical performance testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" as would be found in a clinical trial for diagnostic accuracy (e.g., target sensitivity/specificity). Instead, the performance requirements are implicit in meeting the ISO standards and demonstrating equivalent performance to predicate devices in various non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 5356-1:2004 (Conical connectors) | Achieved (Non-clinical testing performed) |
| Compliance with ISO 5366-1:2009 (Adult Tracheostomy Tubes) | Achieved (Non-clinical testing performed) |
| Compliance with ISO 5361:2012 (Tracheal tubes and connectors) | Achieved (Non-clinical testing performed) |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Genotoxicity, Subchronic toxicity implantation, Chemical characterization, Risk assessment) | Achieved (Non-clinical testing performed) |
| Adequate Cuff Pressure Mapping (for cuffed tubes) | Achieved (Performance testing performed) |
| Adequate Flange Tape Tie strength | Achieved (Performance testing performed) |
| No Air Leakage | Achieved (Performance testing performed) |
| Adequate Inflation Line Pull Strength | Achieved (Performance testing performed) |
| No Cuff Puncture & Adequate Air Seal | Achieved (Performance testing performed) |
| Smooth Insertion/Removal | Achieved (Performance testing performed) |
| Compatibility with Percutaneous Dilatational Tracheotomy (PDT) | Achieved (Performance testing performed, for relevant models) |
| Sterility Assurance Level (SAL) of 10^-6 | Achieved, "utilizing the existing equivalent validated cycle 2." |
| 2-year shelf life | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Non-Clinical Data" and lists various types of non-clinical testing. It also states "Clinical Data - Not required to show substantial equivalence."
Therefore:
- Sample Dize for Test Set: Not applicable in the context of human patients or medical images. The "test set" consisted of physical devices subjected to various engineering and biological safety tests. The specific number of devices tested for each non-clinical assessment is not detailed in this summary.
- Data Provenance: The data is from laboratory (non-clinical) testing conducted by Covidien. The country of origin for the data is not specified, but would typically be the location of the manufacturing and testing facilities. It is retrospective in the sense that the device was developed and then tested, but not "retrospective" as typically used for clinical data from past patient records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For non-clinical tests, the "ground truth" is typically defined by standardized methods, specifications, and regulatory requirements (e.g., ISO standards), rather than expert consensus on patient data.
4. Adjudication Method
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data. For non-clinical, objective tests, results are typically determined by adherence to established protocols and measurement techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Data - Not required to show substantial equivalence." This type of study would involve human readers (like radiologists) evaluating cases, which is clinical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (tracheostomy tube), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with recognized international standards: e.g., ISO 5356-1:2004, ISO 5366-1:2009, ISO 5361:2012.
- Performance specifications derived from predicate devices: The new device must perform comparably or better than the legally marketed predicate devices (Shiley™ Tracheostomy Tubes K962173 and Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes K963732).
- Established biological safety parameters: As defined by biocompatibility testing (cytotoxicity, sensitization, irritation, etc.).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, and a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
Covidien Brianna Reynolds Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, CO 80301
Re: K142296
Trade/Device Name: Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube with TaperGuardTM Cuff, Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: January 22, 2015 Received: January 23, 2015
Dear Ms. Reynolds,
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. 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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K142296 510(k) Number (if known):
Device Name:
Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula
Indications for Use:
- Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is ● intended for use in providing tracheal access for airway management.
- . Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
- Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner . Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
- o The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.
Prescription Use X (Part 21 CFR 801 Subpart D) (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)
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Image /page/3/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. The word is in blue and is positioned to the right of a blue and white square logo. The logo consists of a dark blue square with a light blue vertical line and a white rectangle in the center.
510(k) Summary
Date summary prepared 23 February 2015
510(k) Submitter/Holder
Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301
Contact
Danielle Mueller Regulatory Affairs Manager Phone: 303-305-2603 Fax: 303-305-2212
Name of Device
| Trade Name: | Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner CannulaShiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, DisposableInner Cannula |
|---|---|
| Catalog Numbers: | xUNxx and xCNxx |
| Common Name: | Tube Tracheostomy and Tube Cuff |
| Classification Name: | JOH, Tube Tracheostomy and Tube Cuff (21 CFR 868.5800) Class II, 73-Anesthesiology |
Purpose of Submission
The purpose of this submission is to introduce the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula. The subject and predicate device have the submission is to notify the FDA of the following changes:
- Updated the materials used in the Tracheostomy tubes to a Medical Grade PVC ● with a citrate and DEHT based plasticizer
- . Addition of the Covidien taper-shaped cuff referred to as TaperGuard
- Tapered tracheostomy tube tip compatible with percutaneous insertion ●
- Line extension to include 3 intermediate sizes for cuffed and cuffless .
- Integrated ISO compliant 15 mm connector
- Flexible molded flange ●
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Predicate Device
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula were compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:
| Trade Name: | Shiley ™ Tracheostomy Tubes |
|---|---|
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K962173 |
| Manufacturer: | Covidien, formerly Tyco Healthcare |
| Trade Name: | Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes |
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K963732 |
| Manufacturer: | Covidien, formerly Tyco Healthcare |
Intended Use
The device is intended to be used to provide an artificial airway in order to provide access to the patient's airway for airway management. When inserted in a tracheotomy stoma, the device is secured in place with a neck strap around the patient's neck which is attached to an integral neck plate, thereby providing for a secure artificial ainway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
Indications for Use
- . Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
- Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner . Cannula is intended for use in providing tracheal access for airway management.
- . Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff. Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
- The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ . Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.
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De vice De scription
The Shiley ™ Adult Flexible Tracheostomy Tube Cuffless is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial ainway in order to provide access to the patient's airway for airway management. It contains an integrated 15 mm connector for use with standard ventilation and anesthesia equipment. The tracheostomy tube has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. This tracheostomy tube can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial airway in order to provide access to the patient's airway management. It contains an intecrated 15 mm connector for use with standard ventilation and anesthesia equipment. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. The tracheostomy tube has a taper-shaped, low-pressure cuff to provide an effective air and fluid seal and minimize tracheal wall damage. The cuff inflation line has a luer valve with an integral pilot balloon. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
When inserted in a tracheotomy stoma, the device may be secured in place with a neck strap around the patient's neck which is attached to an integral neck plate. It also may be secured in place by using the suture holes in the flange of the tracheostomy tube, thereby providing for a secure artificial ainway for spontaneous breathing or direct connection to ventilation or anesthesia equipment.
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| Subject Device: | Predicate Device | Predicate Device | |
|---|---|---|---|
| Shiley ™ Adult Flexible Tracheostomy TubeCuffless, Disposable Inner Cannula and Shiley ™Adult Flexible Tracheostomy Tube withTaperGuard™ Cuff, Disposable Inner Cannula | Shiley ™ Tracheostomy Tubes(K962173)(Cuffless and Cuffed) | Shiley ™ DCT Adult Cuffed PercutaneousTracheostomy Tubes (K963732) | |
| Indications forUse | Shiley ™ Adult Flexible Tracheostomy TubeCuffless, Disposable Inner Cannula is intended foruse in providing tracheal access for airwaymanagement. | This device is intended for use in providingtracheal access for airway management. | This device is intended for use in providingtracheal access for airway management.The device is primarily intended for use in |
| Shiley ™ Adult Flexible Tracheostomy Tube withTaperGuard™ Cuff, Disposable Inner Cannula isintended for use in providing tracheal access forairway management. | conjunction with Percutaneous DilatationalTracheostomy and is inserted into the patientusing the introducer provided with thePercutaneous kit. | ||
| The Shiley ™ Disposable Inner Cannula isintended to be used with the appropriate Shiley ™Adult Flexible Tracheostomy Tube withTaperGuard™ Cuff or Cuffless to providetracheal access for airway management. | |||
| Shiley ™ Adult Flexible Tracheostomy Tube withTaperGuard™ Cuff, Disposable Inner Cannula isalso intended for use with Cook® PercutaneousDilatational Tracheotomy (PDT) procedures. | |||
| Intended Use | The device is intended to be used to provide andartificial airway in order to provide access to thepatient's airway for airway management. Wheninserted in a tracheotomy stoma, the device issecured in place with a neck strap around thepatient's neck which is attached to an integral neckplate, thereby providing for a secure artificialairway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment. | The device is intended to be used to provide andartificial airway in order to provide access to thepatient's airway for airway management. Wheninserted in a tracheotomy stoma, the device issecured in place with a neck strap around thepatient's neck which is attached to an integralneck plate, thereby providing for a secure artificialairway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment | The device is intended to be used to provideand artificial airway in order to provide access tothe patient's airway for airway management.When inserted in a tracheotomy stoma, thedevice is secured in place with a neck straparound the patient's neck which is attached toan integral neck plate, thereby providing for asecure artificial airway for spontaneousbreathing or direct hook-up to ventilation oranesthesia equipment |
| Device class | Class 2 | Class 2 | Class 2 |
| Product code | JOH | JOH | JOH |
| PatientPopulation | Adult patients requiring an artificial airway | Adult patients requiring an artificial airway | Adult patients requiring an artificial airway |
| Environment ofUse | The product shall be used in a clinical environmentsuch as critical care units of a hospital, non-criticalcare units of a hospital, long term care facilitiesand home care. | The product shall be used in a clinicalenvironment such as critical care units of ahospital, non-critical care units of a hospital, longterm care facilities and home care. | The product shall be used in a clinicalenvironment such as critical care units of ahospital, non-critical care units of a hospital,long term care facilities and home care. |
| Invasive / Non-Invasive | Invasive | Invasive | Invasive |
| Sterilization | Sterile: The SAL is 10E-6 utilizing the existingequivalent validated cycle 2. | Sterile: The SAL is 10E-6 utilizing the existingvalidated cycle 66. | Sterile: The SAL is 10E-6 utilizing the existingvalidated cycle 66. |
| Shelf Life | 2-year shelf life | 5-year shelf life | 5-year shelf life |
| Materials | |||
| Cannula | Medical Grade PVC with a citrate Based plasticizer | Medical Grade PVC | Medical Grade PVC |
| Neck Plate | Medical Grade PVC with a citrate based plasticizer | Medical Grade PVC | Medical Grade PVC |
| 15 MM connector | Polymethylpentene - TPX | Medical Grade PVC | Medical Grade PVC |
| Cuff if applicableby product type | Medical Grade PVC with a DEHT based plasticizer | Medical Grade PVC | Medical Grade PVC |
| Inflation System | Medical Grade PVC with a citrate based plasticizer | Medical Grade PVC andAcrylonitrile butadiene styrene (ABS) | Medical Grade PVC andAcrylonitrile butadiene styrene (ABS) |
| Obturator | Medical Grade Polypropylene | Medical Grade Polypropylene | Medical Grade Polypropylene |
| Tie Strap | Cotton | Cotton | Cotton |
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| Subject Device | Predicate Device | Predicate Device | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shiley ™ Adult Flexible Tracheostomy TubeCuffless, Disposable Inner Cannula and Shiley ™Adult Flexible Tracheostomy Tube withTaperGuard ™ Cuff, Disposable Inner Cannula | Shiley ™ Tracheostomy Tubes(K962173)(Cuffless and Cuffed) | Shiley ™ DCT Adult Cuffed PercutaneousTracheostomy Tubes (K963732) | ||||||||||||
| Sizes | Cuffless: | |||||||||||||
| REF | ID (mm) | OD (mm) | Length (mm) | REF | ID (mm) | OD (mm) | Length (mm) | REF | ID (mm) | OD (mm) | Length (mm) | Flange (mm) | ||
| 4UN65A | 6.5 | 9.4 | 62 | 4DCT | 5.0 | 9.4 | 62 | 6PERC | 6.4 | 10.8 | 74 | 24.1 | ||
| 5UN70A | 7.0 | 10.1 | 68 | 6DCT | 6.4 | 10.38 | 74 | 8PERC | 7.6 | 12.2 | 79 | 27.2 | ||
| 6UN75A | 7.5 | 10.8 | 74 | 8DCT | 7.6 | 12.2 | 79 | |||||||
| 7UN80A | 8.0 | 11.4 | 77 | 10DCT | 8.9 | 13.8 | 79 | |||||||
| 8UN85A | 8.5 | 12.2 | 79 | |||||||||||
| 9UN90A | 9.0 | 12.7 | 79 | Cuffed: | REF | ID (mm) | OD (mm) | Length (mm) | Flange | |||||
| 10UN10A | 10.0 | 13.8 | 79 | |||||||||||
| Cuffed: | ||||||||||||||
| REF | ID (mm) | OD (mm) | Length (mm) | Flange | ||||||||||
| 4CN65A | 6.5 | 9.4 | 62 | 20.6 | ||||||||||
| 5CN70A | 7.0 | 10.1 | 68 | 25.4 | ||||||||||
| 6CN75A | 7.5 | 10.8 | 74 | 25.4 | 4DCFS | 5.0 | 9.4 | 62 | 20 | |||||
| 7CN80A | 8.0 | 11.4 | 77 | 25.4 | 6DCFS | 6.4 | 10.38 | 74 | 24 | |||||
| 8CN85A | 8.5 | 12.2 | 79 | 28.6 | 8DCFS | 7.6 | 12.2 | 79 | 27 | |||||
| 9CN90A | 9.0 | 12.7 | 79 | 28.6 | 10DCFS | 8.9 | 13.8 | 79 | 29 | |||||
| 10CN10A | 10.0 | 13.8 | 79 | 28.6 | PercutaneousCompatible Size | Cuffed:-4CN65-5CN70-6CN75-7CN80-8CN85 | NA | 6 PERC8 PERC | ||||||
| PercutaneousCompatible Size | ||||||||||||||
| Cuffless:-4UN65-5UN70-6UN75-7UN80-8UN85 | ||||||||||||||
| Use | Single Patient Use | Single Patient Use | Single Patient Use | |||||||||||
| Design | Tracheostomy Tube Design | Tracheostomy Tube Design | Tracheostomy Tube Design | |||||||||||
| Standards met | ISO 5366-1:2009 Anesthetic and RespiratoryEquipment -- Tracheostomy Tubes -- Part 1: AdultTracheostomy Tubes | 5356 (1987)5366 (1985) | 5356 (1987)5366 (1985) | |||||||||||
| ISO 5356-1:2004 Anesthetic and respiratoryequipment - Conical connectors: Part 1: Conesand sockets | ||||||||||||||
| ISO 5361: 2012Anesthetic and respiratory equipment-Trachealtubes and connectors |
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Technological Characteristics
The Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have technological characteristics that differ from its predicates.
The materials used in the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have been updated to a Medical Grade PVC with a Citrate and DEHT plasticizer. The subject device includes the addition of the Covidien taper-shaped cuff referred to as TaperGuard. A flexible molded flange with an integrated 15mm connector was designed into the tracheostomy tube. A one piece disposable inner cannula was designed to facilitate use of the tracheostomy tube both with and without the inner cannula in place. Finally, a product line extension has been added to include 3 intermediate sizes of cuffed and cuffless product. All other fundamental technological characteristics are identical to the predicate devices.
Non-Clinical Data
The following types of non-clinical testing were performed to establish substantial equivalence to the predicates:
- -ISO 5356-1:2004
- ISO 5366-1:2009 -
- -ISO 5361:2012
- Biocompatibility: -
- Cytotoxicity o
- Sensitization O
- Irritation o
- Acute systemic toxicity O
- Genotoxicity O
- Subchronic toxicity implantation O
- Chemical characterization O
- Risk assessment O
- Performance testing:
- O Cuff pressure mapping
- Flange tape tie O
- Air leak O
- Inflation line pull tests O
- Cuff puncture & air seal tests O
- Insertion/removal tests O
- Percutaneous compatibility O
The results of these non-clinical tests show that the subject device can be considered substantially equivalent to the legally marketed predicate and no new questions of safety and efficacy have been raised.
Clinical Data
Not required to show substantial equivalence.
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Substantial Equivalence
The Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley ™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have the same fundamental technology and design of the predicate Shiley ™ Tracheostomy Tubes (K962173) and the Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes (K963732). The materials on the tracheostomy tube have been updated to include a medical grade PVC with citrate and DEHT based plasticizer. A tapered tracheostomy tube tip is compatible with percutaneous insertion has been included. The subject device also includes the addition of the Covidien taper-shaped cuff referred to as TaperGuard.
The changes in the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula do not impact the safety or effectiveness of the finished device.
Conclusion
Substantial equivalence of the subject device is shown through performance testing, as stated above. The subject and predicate devices have similar indications, size range, intended use, environment of use, and patient population. The subject and predicate devices differ in number of sizes available, taper shape, materials and enhanced basic design. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent.
§ 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.