(106 days)
Not Found
No
The document describes a physical medical device (tracheostomy tube) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device provides tracheal access for airway management, serving as an artificial airway, but does not actively treat a disease or condition.
No.
The device is a tracheostomy tube intended for providing tracheal access and airway management, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical tracheostomy tube, which is a hardware medical device, not software.
No, 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. These tests are performed outside the body (in vitro).
- Device Function: The Shiley™ Adult Flexible Tracheostomy Tube is a device that is inserted into the body (specifically, the trachea) to provide an artificial airway. It is used for airway management and in surgical procedures (PDT).
- Intended Use: The intended use clearly states "to provide tracheal access for airway management" and "for use with Percutaneous Dilatational Tracheotomy (PDT) procedures." These are direct interventions on the body, not tests performed on samples.
The description and intended use of this device clearly place it in the category of a surgical or airway management device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Shiley™ Adult Flexible Tracheostomy Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Reusable Intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The subject device represents a line extension introducing the option of a reusable inner cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
Adults
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)
Product performance testing, including insertion/removal force, lock & pinch force, and tests per ISO 5366-1:2009 and ISO 5361:2012 were performed with the conclusion that the subject devices can be expected to perform as well as the predicate and can be considered substantially equivalent. The cleaning methods for the reusable inner cannula were validated in accordance with AAMI TIR 30. The results from ethylene oxide residual tests on the EtO-sterilized device demonstrated compliance to ISO 10993-7:2008 for the device's intended use. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other, with a flowing element extending from the bottom profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2015
Covidien Danielle Mueller Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, CO 80301
Re: K150844
Trade/Device Name: Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: June 10, 2015 Received: June 11, 2015
Dear Ms. Mueller:
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.
1
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,
Tejashri 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
2
Indications for Use
510(k) Number (if known)
Device Name
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula
Indications for Use (Describe)
The Shiley™ Adult Flexible Tracheostomy Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Reusable Intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
| 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) |
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."
3
510(k) SUMMARY
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 use of the Shiley™ Adult Flexible Tracheostomy Tube, Reusable Inner Cannula.
| Submitted By: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 10, 2015 |
| Contact Person: | Danielle Mueller
Regulatory Affairs Manager
(303) 305-2603 |
| Proprietary Name: | Shiley™ Adult Flexible Tracheostomy Tube with
TaperGuard™ Cuff, Reusable Inner Cannula
Shiley™ Adult Flexible Tracheostomy Tube Cuffless,
Reusable Inner Cannula |
| Common Name: | Tracheostomy Tube & Tube Cuff |
| Device Classification Regulation: | 21 CFR 868.5800 – Class II |
| Device Product Code & Panel: | JOH |
| Predicate Devices: | Shiley™ Adult Flexible Tracheostomy Tube, Disposable
Inner Cannula (K142296)
Shiley™ Tracheostomy Tubes (K962173) |
Device Description
The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The subject device represents a line extension introducing the option of a reusable inner cannula.
Indications for Use/Intended Use
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.
4
Technological Characteristics Comparison
The subject device is identical to the predicate Shiley™ Adult Flexible Tracheostomy Tube, Disposable Inner Cannula (K142296) with the exception of the inner cannula material and reuse status.
| SUBJECT | PREDICATE | ||
|---|---|---|---|
| Shiley™ Adult Flexible Tube, | |||
| Reusable Inner Cannula | Shiley™ Adult Flexible Tube, | ||
| Disposable Inner Cannula | |||
| [K142296] | Shiley™ Tracheostomy Tubes | ||
| [K962173] | |||
| Intended Use | Intended for use in providing | ||
| tracheal access for airway | |||
| management. Also intended for | |||
| use with Percutaneous | |||
| Dilatational Tracheotomy (PDT) | |||
| procedures. | Identical | Intended for use in providing | |
| tracheal access for airway | |||
| management in adults. | |||
| Patient | |||
| Population | Adults | Identical | Identical |
| Environment of | |||
| Use | Hospitals, long-term care | ||
| facilities, home care | Identical | Identical | |
| Use | Single patient | Identical | Identical |
| Inner Cannula | |||
| Use | Reusable within single patient | Disposable | Reusable & disposable options |
| available | |||
| Cuff | Cuffless or taper-shaped cuff | Identical | Cuffless or barrel-shaped cuff |
| Size Range | ID: 6.5mm-10.0mm | ||
| OD: 9.4mm-13.8mm | |||
| Length: 62mm-79mm | Identical | ID: 5.0 - 8.9mm | |
| OD: 9.4 - 13.8mm | |||
| Length: 65 - 81mm | |||
| Sterilization | Ethylene Oxide | Identical | Identical |
| Shelf Life | 2 years | Identical | 5 years |
| MATERIALS | |||
| Outer cannula | Medical grade PVC with citrate- | ||
| based plasticizer | Identical | Medical grade PVC | |
| Inner cannula | High density polyethylene | Low density polyethylene | Reusable: polycarbonate & |
| polypropylene | |||
| Disposable: polypropylene & PVC | |||
| Flange | Medical grade PVC with citrate- | ||
| based plasticizer | Identical | Medical grade PVC | |
| 15mm | |||
| Connector | Polymethylpentene | Identical | Medical grade PVC |
| Cuff | Medical grade PVC with DEHT- | ||
| based plasticizer | Identical | Medical grade PVC | |
| Inflation System | Medical grade PVC with citrate- | ||
| based plasticizer | Identical | Medical grade PVC | |
| Obturator | Medical grade polypropylene | Identical | Identical |
| Tie Strap | Cotton | Identical | Identical |
5
Substantial Equivalence - Non-Clinical Evidence
Product performance testing, including insertion/removal force, lock & pinch force, and tests per ISO 5366-1:2009 and ISO 5361:2012 were performed with the conclusion that the subject devices can be expected to perform as well as the predicate and can be considered substantially equivalent. The cleaning methods for the reusable inner cannula were validated in accordance with AAMI TIR 30. The results from ethylene oxide residual tests on the EtO-sterilized device demonstrated compliance to ISO 10993-7:2008 for the device's intended use. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use.
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.